Swine Flu (cont.)

Where can I find more information about swine flu (H1N1)?

For additional information see the following:

http://www.cdc.gov/swineflu/ (Note: This site is updated frequently with ongoing information on swine flu [H1N1].)

http://www.cdc.gov/swineflu
/clinician_pregnant.htm

http://wwwn.cdc.gov/travel/

http://www.medicinenet.com/influenza
/article.htm

http://emedicine.medscape.com/article
/219557-overview

http://www.webmd.com/cold-and-flu
/swine-flu/default.htm

Updated timeline of H1N1 2009 swine flu news

This timeline is provided to keep readers updated on subjects, information, and data related to the flu outbreak first noted in Mexico in 2009 and to augment the information found in the article written above. Updates are written by Dr. Charles Davis.

11/20/09: In a CDC briefing, Dr. Schuchat indicated a decrease in flu activity, although for this time in the season, activity was still relatively high. Because of the unusual behavior so far of H1N1, she indicated that no one can predict if the decrease will continue or a new wave of infections will begin. She urged people to check the Flu.gov web site and view the CDC's recommendations for this holiday season's travel tips to lessen the chances of spreading the flu. She indicated how sorry she was that people are still frustrated in seeking H1N1 vaccine and not getting it. She noted that vaccine is being shipped to state health departments and is being shipped as soon as possible after production. In response to a question about mutant viruses found in Norway, she stated that the CDC will follow this information but said that currently there is no evidence the mutation has changed the H1N1 virus to make it more virulent or diminish vaccine response. She also noted that the CDC will follow developments reported in Wales where a small cluster of patients with of Tamiflu-resistant H1N1 have been reported. When asked about the approximate one-third of pediatric deaths that occur in previously healthy children, Dr. Schuchat indicated that a major common problem that developed in these H1N1-infected patients was a severe secondary bacterial lung infection with either Streptococci or Pneumococci. She indicated that a pneumococcal vaccine is available for children under 5 years old and encouraged its use.

As per two reports (from Mexico and the U.S. Armed Forces Health Surveillance Center (AFHSC) in Silver Spring, Maryland) that indicate that people vaccinated with the seasonal flu either show some protective response to H1N1 or less severe H1N1 disease, Dr. Schuchat indicated that current results from two other studies in Australia and the U.S. show no increase or decrease in protection from H1N1 with the conventional (seasonal) flu vaccine. There may be conflicting data from these four reports and perhaps with other reports. Regardless, Dr. Schuchat said, "What I can say is that we believe the seasonal flu vaccine is a good idea to protect against seasonal flu strains in general and the H1N1 vaccine is needed to protect against H1N1 disease." She also indicated it is likely that a strain of H1N1 virus will be included as one of the viruses included in the trivalent conventional vaccine for the next flu season.

11/19/09: A major contraindication for people not to get H1N1 flu vaccine (and other flu vaccines) is allergy to eggs; currently approved vaccines are produced using eggs. Dr. Catherine Monteleone, an allergist at the University of Medicine and Dentistry of New Jersey, has noted that there are ways for such people to get the H1N1 vaccine. She suggests that egg allergic or suspected egg allergic patients contact an allergist and get skin tested for egg allergy. If the test is negative, the person can get vaccinated; if the test is positive, some people can still get the vaccine using a special method. "It may still be possible to administer the vaccine in graded doses," she explained. "During the office visit, increasing doses are given every 15 minutes, for a total of five doses." Then the person is observed for 30 minutes, and if there are no reactions, the person is considered vaccinated. However, this vaccination needs to be done in a special setting where emergency interventions can be done if the person has an allergic reaction.

11/18/09: Two reports about H1N1 testing were available today. The first report from Loyola University warns that the current rapid flu tests may be dangerous because they are wrong so often (about 50%) and may cause caregivers to delay important treatment. The second report is that the FDA just gave Roche an emergency-use authorization for a new PCR test for H1N1 after multiple studies suggest it is reliable.

11/17/09: Novavax, Inc., announced it will begin studies in Mexico on a new vaccine against H1N1. Initially, about 1,000 people will participate. The new vaccine is made from virus-like particles (VLPs) that mimic a viral strain's outer coat but contain no viral genetic material. VLPs are produced by cell-culture technology and do not require culture in eggs like most currently approved flu vaccines.

The FDA has approved a fifth vaccine for use against H1N1; this vaccine is made by ID Biochemical Corporation of Quebec, Canada. Like the other four approved for use in the U.S., this vaccine is produced by growing the virus in eggs. This new approval will help get more vaccine to the U.S.

Researchers at La Jolla Institute for Allergy & Immunology have found that previous flu infections may provide at least some level of immunity to H1N1 by looking at molecular markers for seasonal influenza viruses dating back 20 years and comparing them with the molecular markers of the H1N1 virus. The study was published today in the proceedings of the National Academy of Sciences and suggests that T cells more readily recognize H1N1 than B cells and maybe these cells are responsible for less severe infections in individuals who have been exposed to flu viruses that have some similar molecular structures to the H1N1 virus. The investigators suggest that T cells, while not able by themselves to prevent H1N1 infection, do recognize these similar molecular structures and attack H1N1 in many individuals before the infection becomes severe. Since only about 17% of B cells that produce antibody recognized H1N1, the researchers said vaccination is still the best way to combat H1N1, especially for prevention.

11/16/09: People in other countries are experiencing the same concerns about H1N1 safety. The response from most medical departments is similar to that expressed in the U.S. For example, the Irish Department of Health says that the new vaccine is not related to the 1976 vaccine, that no evidence shows that thimerosal causes any problems, the vaccine is safe to use in pregnancy, and that its benefits far outweigh any risk. They reemphasized these points so that populations in other countries where H1N1 is prevalent (about 206 countries in the world) can gain confidence in the vaccine.

11/13/09: Yesterday afternoon, the CDC published revised estimates of numbers of U.S. people infected with H1N1. In the CDC report (http://www.cdc.gov/h1n1flu/
estimates_2009_h1n1.htm), the administrators describe the rationale for these new figures; they are based on best estimates of underreported cases and deaths from H1N1 flu due to the inability of each case being laboratory confirmed and the lag time of reporting from many hospitals and clinics. The CDC goes on to suggest the actual numbers may never be known and suggest the "true" numbers are most likely to be in the mid-level ranges (see above table). Their methodology and rationale is further detailed in several publications cited in this CDC web article.

The CDC also published estimated deaths from H1N1. The following is from the CDC:

CDC Estimates of 2009 H1N1 Cases and Related Hospitalizations and Deaths from April-October 17, 2009, by Age Group

2009 H1N1	Mid-Level Range*	Estimated Range *
Cases
0-17 years	~8 million	~5 million to ~13 million
18-64 years	~12 million	~7 million to ~18 million
65 years and older	~2 million	~1 million to ~3 million
Cases Total	~22 million	~14 million to ~34 million
Hospitalizations
0-17 years	~36,000	~23,000 to ~57,000
18-64 years	~53,000	~34,000 to ~83,000
65 years and older	~9,000	~6,000 to ~14,000
Hospitalizations Total	~98,000	~63,000 to ~153,000
Deaths
0-17 years	~540	~300 to ~800
18-64 years	~2,920	~1,900 to ~4,600
65 years and older	~440	~300 to ~700
Deaths Total	~3,900	~2,500 to ~6,100
* Deaths have been rounded to the nearest ten. Hospitalizations have been rounded to the nearest thousand, and cases have been rounded to the nearest million.

In an afternoon CDC news conference, Dr. Schuchat discussed the above estimates and indicated the data would be revised about every three weeks. She also addressed the lack of vaccine and indicated people should still seek out local sources that may have it. She addressed a question about some doctors and others who do not think the vaccine is "safe" and do not recommend it; she indicated that the CDC is as transparent on this issue as possible -- the CDC has repeatedly indicated it is safe. Dr. Schuchat also indicated that to date, that although this H1N1 flu is different from conventional (seasonal) flu, it is nowhere near the severity of the 1918 flu pandemic.

This week, the FDA approved GlaxoSmithKline's supplemental biologics license application for its unadjuvanted influenza A (H1N1) pandemic vaccine and also approved CSL Biotherapies' application for accelerated approval of its seasonal flu vaccine, Afluria (influenza virus vaccine) for use in the pediatric population aged 6 months and older. The FDA approval included labeling for CSL Biotherapies' influenza A (H1N1) 2009 monovalent vaccine, which is an inactivated influenza virus vaccine now indicated for active immunization of people 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. These approvals may allow additional vaccine supplies to become available.

11/12/09: Headlines (for example, CNN, New York Times) state CDC officials calculate over 4,000 deaths (as opposed to about 1,200 currently reported) are due to H1N1 flu. However, the new estimate of deaths will not be released until sometime next week because the CDC's consultants are still looking over the figures, said Glen Nowak, a CDC spokesman. The new data from the CDC will be based on both confirmed and likely H1N1 infections associated with deaths.

Amarillo Bioscience announced that studies with interferon (oral and nasal) have had good responses in controlling viral infections in animals, while another study group suggests that interferon can be used to control human flu infections. This is still in the developmental stages of research and has not been approved for use in the U.S. Another company, GalaxoSmithKline, announced that Pandemrix, an adjuvant used to enhance the flu vaccine, was very successful in a human trial to boost the immune response to vaccine. This is not approved for use in the U.S., but other countries may consider its use to reduce the vaccine amount needed to get an immune response and thereby have more vaccine doses available.

The Lancet just put online (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)61638-X/fulltext) an article about the results on H1N1 flu in Mexico, from April to July 31, 2009, on a large number of individuals (6,945 confirmed H1N1). The results are quite different from initial observations. The authors report that although the infection rate was highest in young people, the highest death rates were in the elderly (>70 years old was 10.3%). The authors indicated that people who had obtained regular yearly flu vaccinations were 35% less likely to get infected with H1N1. The data for the death rate under age 70 is as follows:

• 60-69 years 5.7%;



• 50-59 years 4.5%;



• 40-49 years 2.7%;



• 30-39 years 2%;



• under 1 year 1.6%;



• 20-29 years 0.9%;



• 1-9 years 0.3%;



• 10-19 years 0.2%.

11/11/09: NanoViricides, Inc., representatives have been invited to participate in a panel discussion at the Influenza Congress USA 2009, in Washington, D.C., on Nov. 19 due to the research success of "FluCide," an experimental antiviral drug reportedly highly effective against all forms of influenza A, including the recent "swine flu" 2009/CA/H1N1 strain, seasonal flu strains, as well as H5N1 bird flu strains. The antiviral has not been approved for use in humans, but it represents a new class of drugs that may useful in treating human viral infections in the near future.

11/9/09: A Harvard study conducted a poll of U.S. citizens (1, 073 people over age 18) from Oct. 30-Nov. 1 on the availability of the H1N1 vaccine. The results showed that 17% of American adults, 41% of parents, and 21% of high-priority adults have tried to get the H1N1 vaccine and 70% of adults who tried to get it for themselves were unable to get it. Only 34% of parents who tried to get the H1N1 vaccine for their children were successful in getting their children vaccinated. Among high-priority adults who tried to get the H1N1 vaccine, 66% were unable to get it. About 33% said they were frustrated in their efforts, but about 91% who failed to get the vaccine said they would try again.

Yesterday, the Society for Healthcare Epidemiology of America (SHEA), the Infectious Diseases Society of America (IDSA), and the Association for Professionals in Infection Control and Epidemiology (APIC) urged the Obama administration to issue an immediate moratorium on the Occupational Safety and Health Administration's (OSHA) enforcement of the current requirements to use N95 masks by health-care workers. This was done since two articles have indicated the N95 masks (which are in short supply and are expensive) do not offer better protection against H1N1 flu than the standard surgical masks.

11/6/09: The CDC's Dr. Schuchat commented on the availability of vaccine doses against novel H1N1 flu. She indicated that about 8-10 million doses per week would becoming available in the next few weeks. Although she noted some glitches in the distribution system, in general, it is still being distributed by population percentages. She indicated that about 38 million doses are currently available with about one-third being the nasal type; however, she empathizes with those seeking vaccine but cannot find it available. In terms of the H1N1 disease progression, she said, "More than half the hospitalizations are in people under 25. Ninety percent of the deaths are in people under 65 -- a flip-flop from what we see with seasonal flu. The pediatric deaths are high. Children have died from flu where the typing wasn't done, but that's an increase from last week's number. Two-thirds of the children who died from the H1N1 virus have underlying conditions that are increasing their risk of this problem. The leading underlying conditions in children who have died are severe neurologic problems like cerebral palsy and muscular dystrophy and asthma in terms of contributing to the severe outcomes." She further indicated that antiviral drugs are effective treatments and commented that the use of an intravenous antiviral medication has recently begun.

When asked about the risk of H1N1 mutating, Dr. Schuchat said, "Well, influenza viruses change. That's inevitable. Mutations occur. The key part is will we see something in the near future that makes it change markedly to something more severe than what we are seeing or is there a change that would occur to leave the virus to escape the vaccine? Both of those changes are possible. Fortunately, we haven't seen any of those yet. We have been testing many of the viruses. It hasn't changed genetically or in the immune characteristics." So far, that is good news because the H1N1 vaccine remains potentially effective in preventing most infections.

11/5/09: The American Veterinary Medical Association (AVMA) reported that health officials in Iowa confirmed that a domestic cat had tested positive for H1N1 swine flu. This is the first documented H1N1 domestic cat infection; the cat has recovered. Several family members had flu-like symptoms before the cat became ill. This is another likely case of human-to-animal flu transfer; such transfers have been reported in several countries (from humans to pigs), and there have been reports of transfer from humans to turkeys in Chile and Canada. The H1N1 virus has also been detected in other bird types and in ferrets, but the link to humans is not as clear as in the pig and cat transfers.

One of the few contraindications to getting the H1N1 flu vaccine is allergy to eggs or egg products. Phadia produces an ImmunoCAP allergy test that measures IgE antibodies, which indicates a clinical allergic reaction, to both egg white (f1) and ovomucoid (f233). The f1 test can help the physician to confirm or rule out an allergy to egg white. If an allergy to egg white is confirmed, the f233 follow-up test can be conducted to identify the severity of egg allergy and whether the child is at low or high risk for an allergic reaction. The FDA has approved this test for clinical IgE measurements.

11/4/09: At an afternoon CDC press conference yesterday, Dr. Frieden reiterated the need for both conventional (seasonal) and H1N1 vaccinations. He said that the supplies of both are being increased and was pleased that people were actively seeking vaccinations. He encouraged the use of antivirals according to the published CDC guidelines. He mentioned that people who are obese (body mass index = 40 or more) seem to have an increased risk for H1N1 complications but studies are ongoing. He indicated that donations of vaccine to other countries were still under study as to when that would occur. He was asked about a new journal article (JAMA 302.17 (2009): 1896-1902.) twice because the data found a higher death rate in older patients (>50) than younger once they were hospitalized, even though a higher number of younger people (<25 years old) were hospitalized. The paper states, "Overall fatality was 11% (118/1088) and was highest (18%-20%) in persons aged 50 years or older." This data was accumulated in California between Apr. 23 and Aug. 11, 2009. Dr Frieden indicated CDC data agreed with the findings of more hospitalizations in young people (<25 years old) and said caregivers "should think of H1N1 influenza in all age groups. It doesn't change what our recommendations would be for vaccination."

On the technical front, two new products are offered to improve diagnosis of H1N1. Repro-Med Systems, Inc., announced a new Specimen Collection Kit (SCK) for its RES-Q-VAC portable handheld suction pump. They claim the new kit makes it especially convenient for medical personnel to collect samples in accordance with guidance recommendations and local procedures, while other researchers suggest that data shows "flocked" (velvet-like surface) swabs collect better specimens for H1N1 detection.

11/3/09: WHO officials reported a rise in deaths (700) in the last week, with most occurring in the Americas; they further report an estimated 440,000 confirmed H1N1 flu cases. Flu experts state that the number of infected people is likely much higher since only confirmed infections and deaths are now being collected. The WHO also recommended only one-dose injection in children because of the world shortage of vaccine; however, the U.S. still recommends two doses in children ages 6 months through 9 years. The U.S. data suggests that a maximum of 55% of children showed protective antibodies 21 days after a single injection with younger children (6 months to 35 months) far less (25%). In other world-related news about H1N1, the Ukrainian prime minister closed schools, universities, public gatherings, and imposed travel restrictions for three weeks because of 53 deaths attributed to H1N1. The Afghan government has also closed schools for three weeks due to the rise in H1N1 flu cases.

The CDC announced that studies in pregnant women showed that a single dose of the injectable H1N1 vaccine showed protective antibodies in 92% of women after 21 days.

11/2/09: The CDC published (http://www.cdc.gov/eid/content/15/12/pdfs/
09-1413.pdf) the most recent estimates of novel H1N1 infections in the U.S. using methods that even local health districts can use to estimate their local number of H1N1 infections. The CDC estimates that between April and July 2009 about 1.8-5.7 million people in the U.S. became infected with H1N1. They also estimated about 9-21,000 hospitalizations during that time.

Research is ongoing for the development of antiviral vaccines, especially against novel H1N1 flu. A company, FluGen, announced that it has produced a CHO-cell line (Chinese Hamster Ovary cell line) in which the H1N1 virus can replicate (grow), thus producing H1N1 for vaccine production that is not based on viral growth in eggs. The company reports its viral growth is much faster than that for eggs yet produces good viral yields. This process is not yet in a production phase, and the vaccine is not yet approved by the FDA but eventually may result in a fast, less expensive egg-free way to produce flu (and other) vaccines.

A controversial research paper was presented that proposes that vaccination of children ages 6 months to 5 years of age theoretically could be detrimental if another pandemic of flu strikes. The authors said, "Preventing infection with seasonal influenza viruses by vaccination might prevent the induction of heterosubtypic immunity to pandemic strains, which might be a disadvantage to immunologically naïve people, such as infants." Because this is so controversial and may be construed by some people that as meaning that they should not vaccinate young children, the journal has published a commentary by other researchers that stated, "Public-health decisions should be based on the best clinical evidence available. There is ample evidence for the great burden of influenza in young children, and this burden appears during every influenza season. By contrast, there is no clinical evidence that vaccinating children against influenza would prevent the induction of heterosubtypic immunity and thereby be disadvantageous to children in the long run. While waiting for improved influenza vaccines, the simple question is Should we let young children suffer from a severe and potentially lethal but easily preventable illness just because there is a theoretical possibility that withholding vaccination might result in a slightly less severe illness sometime in the future? We believe that the answer to this question is a simple one (No)." Access to the two articles (research and commentary) can be done by going to http://www.lancet.com/journals/laninf/onlinefirst.

11/1/09: The CDC and others concerned about vaccines in children again indicated that the millions of children who are already battling other diseases -- including asthma, rheumatoid arthritis, HIV, irritable bowel disease (IBD), and other digestive disorders such as Crohn's disease -- can receive the H1N1 vaccine when already taking an immunosuppressant medication that weakens the immune system but controls their disease. The family members of such children should also obtain the vaccine to reduce any chance of exposure to the virus. However, the nasal spray vaccine, which contains live attenuated virus, is not to be used in patients taking any immunosuppressants.

The Strategic Advisory Group of Experts (SAGE) that provides advice to WHO on H1N1 indicated that, worldwide, teenagers and young adults continue to account for the majority of cases, with hospitalization highest in very young children. About 1%-10% of patients with clinical illness require hospitalization, while 10%-25% of those hospitalized require admission to an intensive care unit. About 2%-9% die. Approximately 7%-10% of all hospitalized patients are pregnant women in their second or third trimester. According to their report, pregnant women are 10 times more likely to need care in an intensive-care unit when compared with the general population. Although the SAGE group has begun to evaluate the several types of vaccines available to countries outside the U.S., including vaccines made with adjuvants, most of the recommendations parallel those made by the CDC for age, dosage, and susceptible groups. One recommendation that does not follow the CDC recommendations is the use of nasal (live, attenuated virus) in pregnant individuals. Based on animal studies and data suggesting the high risk of a poor outcome in pregnant individuals, SAGE advised the WHO to recommend that any (including the live, attenuated virus in the nasal mist) approved vaccine available to pregnant females should be used, providing no specific contraindication is present.

10/30/09: Dr. Frieden of the CDC gave an update on H1N1 and said that 48 states now had widespread flu, and in the last two months, more people have been hospitalized under the age of 65 than the number seen in a conventional flu season. Although a few areas were reporting a reduction in flu cases, overall the numbers of cases in the U.S. continue to increase. He also reported a high number of deaths (total 114, last week, 19) in children. Because of the high death rate in children, he said, "On Oct. 1, we released 300,000 (Tamiflu) courses from the strategic national stockpile (SNS). We are now releasing an additional 234,000 courses of liquid Tamiflu from the strategic national stockpile. That is the entire supply from the SNS." In addition, he mentioned that qualified pharmacists can now use adult capsules of Tamiflu to compound the lower pediatric fluid doses. He expressed concern that high-risk people are not seeking medical care in a timely manner and this could increase hospitalizations and deaths. He said vaccine availability was less than demand for both the conventional and H1N1 flu vaccine and said supplies were constantly being increased, although it would likely take time (weeks to months) to begin to meet demand.

News on research findings done to diagnose and treat H1N1 flu was announced today. In an article that will be published in the November 2009 print issue of the FASEB Journal (http://www.fasebj.org), Dr. Matalon and colleagues from the University of Alabama showed that the flu virus damages lungs through its "M2 protein," which attacks the cells that line the inner surface of lungs (epithelial cells). Specifically, the viral M2 protein disrupts lung epithelial cells' ability to remove liquid from the lungs, which often allows pneumonia and other lung problems to develop. The research shows, in the laboratory, that viral M2 protein can be markedly inhibited by antioxidants, thus potentially providing another method to treat severely ill flu patients. In another study done by investigators at Translational Genomics Research Institute (TGen), a new test was developed that can detect not only the strain of flu (for example, conventional or novel H1N1 flu) but also whether or not the strain may be resistant to oseltamivir (Tamiflu). The company is applying to the FDA for approval for use in human testing.

In world-related novel H1N1 news, the WHO is planning new recommendations for vaccinations to be announced next week. Because of reduced vaccine production, there are likely to be shortages of doses available to other countries that have little or no vaccine production. This availability reduction is exemplified by the following statement from HHS Secretary Kathleen Sebelius, "As vaccine becomes more available, I think evaluation will be made as to when it's appropriate for donation (to other countries) to begin, but I can tell you at this point the priority is getting the vaccine to citizens in this country, and that's what we're working on 24/7."

HHS Secretary Kathleen Sebelius visits H1N1 vaccination clinics at McKinley High School in Washington, D.C. Photo courtesy of Pierre Paret/Flu.gov

10/29/09: The CDC has contracted with GE Healthcare to obtain surveillance data for both H1N1 and seasonal influenza. GE healthcare can gather information from about 14 million patient records. The CDC will use the data to track H1N1 spread and get information on areas where outbreaks occur. The data will also help the CDC to better determine population susceptibilities to the virus. The data is updated daily, which allows the CDC to quickly adapt and provide guidelines and responses to counter the H1N1's rapid advance.

10/28/09: The government said it is dependent on the approved suppliers of H1N1 vaccines to provide the estimate of vaccine availability, and it is clear the suppliers overestimated the availability of H1N1 vaccine doses. Eventually, enough vaccine will be available for those who want it. Dr. Anne Schuchat, head of the CDC's National Center for Immunization and Respiratory Diseases, said, "It's hard to predict how long the H1N1 wave will continue, so even getting vaccinated a few months from now -- when vaccine supplies are more plentiful -- won't be too late." Meanwhile, some hospitals have reported an increased number of people who require extended care for H1N1. Doctors at Johns Hopkins and other physicians (for example, in Denver, Seattle, and San Diego) are concerned that increasing numbers of H1N1 patients who require intensive care may force some hospitals to cancel elective surgery cases.

Researchers (University of Alabama, Birmingham) claim that a combination of Tamiflu, Symmetrel, and ribavirin (Rebetol, Copegus) showed excellent ability to stop viral growth, even with drug-resistant H1N1 virus. However, this research was done in lab tests only and has not been tried in vivo or approved for human use. Such research offers a new approach for potential treatment methods.

10/26/09: The first IV drug to treat certain individuals with H1N1 infection has been approved by the FDA. Peramivir is approved for limited uses. The parameters for adults and pediatric patients are as follows:

1. The patient is not responding to either oral or inhaled antiviral therapy



2. When drug delivery by a route other than an intravenous route (for example, enteral [absorbed by the intestines] or inhaled) is not expected to be dependable or feasible



3. For adults only, when the clinician judges IV therapy is appropriate due to other circumstances

10/25/09: Friday night, President Obama declared the H1N1 flu a national emergency; the declaration was announced Saturday. The declaration will allow medical facilities to waive some federal requirements to allow a more rapid handling of flu patients. President Obama said the pandemic keeps evolving, the rates of illness are rising rapidly in many areas, and there's a potential "to overburden health-care resources." With the declaration, Health and Human Services Secretary Kathleen Sebelius now has authority to bypass federal rules when opening alternative care sites, such as off-site hospital centers at schools or community centers if hospitals seek permission to do this. Now hospitals could modify patient rules; for example, people would be required to give less information during registration to speed patient care. The declaration also addresses a financial question for hospitals. For example, federal rules do not allow hospitals to put up treatment tents more than 250 yards away from the doors and get payment for patient care. The declaration would now allow sites further away, and the hospitals would still be able to apply for patient-care payment. Part of the problem is the lack of available H1N1 flu vaccine, due to the low yield of the virus grown in chicken eggs. With low yields, fewer viruses are available to be made into vaccine. Now the government projection is for about 50 million doses available by mid-November, far fewer than the 45 million originally projected by Oct. 15. CDC Director Dr. Thomas Frieden said, "We are nowhere near where we thought we'd be by now. We share the frustration of people who have waited in line or called a number or checked a web site and haven't been able to find a place to get vaccinated. Since the beginning of the pandemic, we've seen more than 1,000 deaths and 20,000 hospitalizations. We expect it to occur in waves, but we can't predict when those waves will happen."

10/23/09: In an article published online in the Journal of Heart and Lung Transplantation, physicians representing the International Society for Heart & Lung Transplantation's (ISHLT) Infectious Disease Council issued an advisory for all programs in cardiothoracic transplantation related to novel H1N1 concerning donor tissue and recipients. The article reemphasizes that all donor recipients are likely high-risk individuals because of immunosuppressive drug treatments and that donors' tissue records should be searched for H1N1 vaccination information. They also suggested that the donor or tissue be rapidly tested for H1N1 infection before the transplant is utilized. This is a safety procedure that may be useful in other transplant patients and their donors or donor's tissues.

At the CDC press conference, Dr. Frieden reported that novel H1N1 flu was widespread in 46 states, estimated that "many millions" have been infected, and stated that he expects many more to become infected. He indicated production of the injectable vaccine is far less than was previously projected (45 million doses by Oct. 15) because to date, only 16 million are available and about 11 million were sent out to the 50 states. This large shortfall is due to the less-than-predicted output by vaccine companies which, in turn, was related to less H1N1 growth in eggs than predicted. He also noted that the conventional (seasonal) flu vaccine was beginning to experience some shortfalls but is encouraged by the demand. The following is what he said about pregnant individuals and H1N1: "Pregnancy is a risk factor for influenza each year. It's also a risk factor for serious illness and death from H1N1 influenza; you are about six times more likely to die from H1N1 influenza if you're pregnant. So, women who are pregnant are a high priority for the vaccine. There is no evidence that thimerosal increases the risk of problems, but we would like a thimerosal-free vaccine for those who want it. The challenge is that it is used for multi-dose vials and you may have more of that product. So, finding that vaccine for those who want it may be a challenge."

10/22/09: Many physicians would have difficulty in searching their medical records to identify high-risk patients in their practices. However, Practice Fusion Inc., a free, web-based electronic health record system for physicians, today implemented a first-of-its-kind tool that allows its physician users to quickly and accurately identify all high-risk candidates for H1N1 vaccination from their patient populations using criteria published by the Centers for Disease Control and Prevention (CDC). Dr. Tamara Cheney, a family practice physician, requested Practice Fusion to provide information to Dr. Cheney that could be used to identify her high-risk patients. Practice Fusion used CDC criteria as a screen to identify high-risk patients and took an extra step and released the high-risk information to every physician in the Practice Fusion system, benefiting the entire patient community. About 300,000 individuals were identified and their respective physicians then notified.

10/21/09: Aethlon Medical, Inc., announced that a new instrument, Hemopurifier, is the first-in-class medical device able to selectively remove infectious viruses and immunosuppressive proteins from the bloodstream. During in vitro research studies, the Hemopurifier removed 68% of H1N1 virus from blood plasma in 30 minutes, 80% of the virus in two hours, and a 96% reduction of H1N1 was observed at six hours. The studies were performed by third-party researchers approved by the United States Department of Health and Human Services (HHS) to house and conduct research on the current pandemic strains of H1N1 virus. The report does not document use with human patients but is a new research tool that may be useful in treatment methods in the future.

Today, the American Journal of Roentgenology placed three articles online at http://www.ajronline.org because they show the differences that can be seen with CT as compared to chest X-rays in high-risk patients with novel H1N1 infections. They suggest that CT scans are the best way to evaluate high-risk patients. The articles will be published in the December issue, but because of the current pandemic, the journal wanted to make the findings widely available to health-care providers now.

10/20/09: At the WHO conference in Washington, D.C., WHO experts now recommend that anyone with symptoms of the flu or pneumonia be immediately treated with antiviral drugs. One reason for this recommendation is that apparently in those few susceptible people who develop viral (H1N1) pneumonia have the novel H1N1 viruses penetrating deeply into lung tissue where it seems to cause more problems than the conventional or seasonal flu viruses.

10/19/09: Florida state health officials are reported to be establishing guidelines on which patients will get ventilators if a huge number of patients with H1N1 overwhelm the hospital system. Reportedly, terminal cancer and end-stage multiple sclerosis patients would not be put on ventilators, and terminally ill patients on ventilators may be removed from them to allow others who have a better chance of survival to use the machines. Fortunately, this dire situation has not developed in the U.S., but it seems likely that other health officials are considering similar situations as they must plan for disaster situations even if they do not develop.

The USDA (U.S. Department of Agriculture) announced confirmation that a pig at the Minnesota State fair has caught swine flu. This is the first reported case in the U.S. Canadian officials had reported a similar infection in pigs over a month ago that apparently occurred when a person who got the H1N1 flu during a trip to Mexico came in contact with the Canadian pigs. This transfer of the H1N1 flu to pigs shows the relative ease of cross-species infection with this virus. Australia, Argentina, Ireland, the United Kingdom, and Norway have also reported cases of pigs catching the H1N1 flu after exposure to infected people. However, people cannot get the H1N1 flu from eating properly processed pork products.

10/16/09: At the CDC's press conference today, Dr. Schuchat indicated the novel H1N1 was widespread in 41 states with a total of 86 deaths in children under age 18. She said, "About half of the deaths that we've seen in children since Sept. 1 have been occurring in teens between the ages of 12 and 17. These are very sobering statistics, unfortunately, they are likely to increase." She indicated that H1N1 vaccine production was not as high as predicted so the availability of the vaccine will not be as widespread in October as previously predicted (shortage is about 10-12 million doses) but hopes by the end of October or early November the supply will be widespread. She also commented on the shortage of conventional or seasonal flu vaccine and believes that it will be more available over time. She commented on a question about ICU availability and said that about 15%-20% of hospitalized H1N1 flu patients need ICU support but says she is not aware of any ICU bed shortages to date. The CDC will investigate this potential problem. Again she tried to reassure those who are concerned about the safety of the injectable H1N1 vaccine. "It's important for people to know that the H1N1 influenza vaccine is being made exactly the same way that the seasonal flu vaccines are made...100 million people get those every year and we believe there's a very strong safety record for them including many, many pregnant women who get those vaccines every year and many, many children who get those vaccines every year. We have increased our safety monitoring efforts here to be aware and ready and able to investigate any problems or rumors that emerge so that we, although we're all expecting a very safe vaccine, we're not taking that for granted. No shortcuts are being taken at all in the way this vaccine is being produced. And that's very important for people to know."

The Society for Healthcare Epidemiology of America (SHEA) had urged the CDC, based on clinical experience and scientific evidence, to remove the use of N95 respirators from its recommendations for routine care in favor of the first-line use of surgical masks. SHEA suggests that N95 respirators should be reserved for procedures associated with a higher risk of aerosolization of the H1N1 virus.

The Japanese government (Ministry of Health, Labor and Welfare) today announced that about 6480 schools in Japan have been closed because of the H1N1 swine flu.

Current CDC statistical data shows that about 45% of adults hospitalized with H1N1 had an underlying illness before catching the new strain of flu. Asthma was the most common illness (26%), followed by diabetes (10%). Also, 8% had other chronic lung diseases and 7.6% had immunosuppressive disorders. About 6.1% of those hospitalized were pregnant women.

Today the FDA (Food and Drug Administration) warned that a number of Web-based businesses are selling products (including products that claim to be Tamiflu) that do not work or that are not what they represent to be in the ads. The FDA urged consumers to only purchase FDA-approved products from licensed pharmacies located in the United States for treatment of the flu.

10/14/09: The CDC held a brief press conference yesterday. Dr. Schuchat said the following about the individuals who needed hospitalization with H1N1 flu: "In adults, the most common underlying conditions were asthma and chronic lung disease, chronic heart disease, and immunosuppression. And in children, the most common underlying conditions were asthma and chronic lung disease, neurologic or neuromuscular diseases, and sickle cell or other blood disorders." In about 45% of adults hospitalized, no clear underlying condition was present, but the data are still preliminary, and the CDC is looking into obesity as being a possible high-risk factor for H1N1. Although about 9.8 million doses of H1N1 vaccine are available to be ordered this week, only about 5.8 million doses have been requested. Dr. Schuchat said that distribution and ordering problems are being addressed and she would likely have data on doses released to individual states during a press conference planned for Friday, Oct. 16.

Researchers suggest that CT scanning may be useful in detecting H1N1 infections, possibly leading to earlier diagnoses of severe cases and complications (pulmonary emboli) in the future, according to a study published online in the American Journal of Roentgenology. The study will be published in the December issue. Since the northern hemisphere is entering the flu season, and the H1N1 flu is causing some younger people to have severe disease, there have been editorials in journals (Journal of the American Medical Association or JAMA) and several research papers (for example, New England Journal of Medicine [NEJM] on 10/08/09) that have mentioned the potential problems with intensive-care bed availability due to an influx of patients. For example, "In Winnipeg -- site of the largest cohort of pandemic patients in Canada -- all intensive-care beds were occupied with H1N1 flu patients when the outbreak peaked in June…And, in Mexico City, six major hospitals were so busy that admission to intensive care was delayed, and four patients died in the emergency department before they could get to the ICU," according to the Associated Press. ICU bed availability is a concern among many emergency medicine and intensive care doctors because even without H1N1 flu infections, many hospitals in the U.S. often have few or no ICU beds immediately available for patients.

10/12/09: The Journal of the American Medical Association announced, in a Web format, findings that will be published soon in JAMA describing 68 patients with severe influenza-associated (mainly novel H1N1 flu) ARDS that were treated with ECMO (extracorporeal membrane oxygenation). These infected patients were often young adults, pregnant or postpartum, obese, and required mechanical ventilation support. These patients had a median age of 34.4 years and had developed severe respiratory failure before ECMO treatment. The median duration of ECMO support was 10 days. At the time of reporting, 54 of the 68 patients had survived and 14 (21%) had died. Since many of these patients often die, the authors concluded: "This information should facilitate health-care planning and clinical management for these complex patients during the ongoing pandemic."

Two related articles, also to be published in the same JAMA issue as above, conclude: Critical illness from 2009 influenza A (H1N1) in Mexico and Canada occurred in young individuals, was associated with severe acute respiratory distress syndrome and shock, severe hypoxemia, multisystem organ failure, a requirement for prolonged mechanical ventilation, and the frequent use of rescue therapies and had a high case-fatality rate (17.3% in the Canadian study and 41.4% in the Mexico study).

10/10/09: Yesterday afternoon, CDC official Dr. Schuchat stated, "The H1N1 virus is in virtually the entire country. Unfortunately, we're seeing more illnesses, more hospitalizations, and more deaths from it. Flu is widespread in 37 states. That's up from 27 states last week. Unfortunately, 19 more pediatric deaths from influenza got reported to us this past week. We're now up to 76 children having died from the 2009 H1N1 virus. To put that in context, the past three years, the total pediatric influenza deaths ranged from 46 to 88. We have had 76 children dying from the 2009 H1N1 virus. And it's only the beginning of October. Of course, the flu season often will last all of the way until May." They go on to say that next week the injectable vaccine should be shipped and start to be available, but there will not be enough available for everyone immediately. However, weekly shipments should eventually supply enough doses for all that request vaccine. "Vaccine against flu is the best way to protect yourself from the influenza and those around you," said Dr. Schuchat. She further tried to reassure those people who hear rumors about the vaccine that it is safe and that it was produced by the same companies and methods used for the safe flu vaccines produced over many years. Dr. Fauci, from the NIH, reported that clinical trials have now shown that it is safe and effective to get both the conventional and H1N1 flu vaccine shots at the same time. He reiterated that data shows a single shot of both vaccines produces an effective immune response in the majority of people. He indicated that current clinical trials were still ongoing with patients in several high-risk groups such as HIV-positive individuals and those with severe asthma.

10/8/09: WHO officials expressed confidence in novel H1N1 swine flu vaccines as being safe. They considered data from about 39,000 people who have obtained the vaccine and very few had any side effects such as muscle cramps or headaches. WHO official G. Hartl said, "The vaccine is the single most important tool that we have against influenza."

10/6/09: As of yesterday and today, a number of states have obtained the first vaccine shipments for H1N1 swine flu. Most states have obtained a fraction of what was requested, but the CDC has indicated as supplies become available, the vaccine will be shipped. The bulk of these first shipments are of the nasal spray form of the vaccine that can only be administered to healthy individuals 2-49 years of age. For many states and cities, the distribution of such small amounts is a problem as the initial demand volume outstrips the supply. For example, San Antonio, Texas, with a population of about 1.9 million, obtained only 500 nasal spray doses.

10/5/09: The Washington Post reported that recent analysis of data showed that by the end of August 2009, more than 100 pregnant women have been hospitalized in intensive-care units and 28 have died from novel H1N1 flu. They quoted the CDC official, Dr. Schuchat, saying that anecdotal reports find "…doctors around the country...have never seen this kind of thing before." Further, Dr. Schuchat called the novel H1N1 vaccine "an important way to protect yourself" and encouraged pregnant women to get vaccinated as soon as possible, adding that "no corners have been cut" in testing it.

There is a new test for novel H1N1 swine flu. Kirk Ririe, chief executive officer of Idaho Technology, announced that Idaho Technology's Joint Biological Agent Identification and Diagnostic System (JBAIDS) has been approved by the military to run tests for the H1N1 virus. The JBAIDS instrument will be used to test military personnel and their families all over the world at military installations for influenza A, swine flu A, and H1 swine flu in less than an hour. These test kits were manufactured by the Centers for Disease Control (CDC), and initial data from the United States Army Medical Research Institute for Infectious Diseases (USAMRIID) at Fort Detrick, Maryland, showed accurate identification of the H1N1 virus on the JBAIDS instrument. Currently, there is no indication when and if this quick and apparently accurate test will be available to the public.

New flu guidelines are available from the government. Officials from the U.S. Department of Health and Human Services (HHS) and the White House Office for Faith-based and Neighborhood Partnerships began distributing a new flu response guide. The document, titled "H1N1 Flu: A Guide for Community and Faith-Based Organizations," provides information about 2009 H1N1 swine flu. The new guide is available for download at http://flu.gov and http://www.hhs.gov/partnership or in hard copy from the Department of Health and Human Services.

10/4/09: The Journal of the American Medical Association (JAMA) announced that it is publishing a study that shows that surgical masks protect health-care providers from novel H1N1 flu viruses about as well as the more expensive N95 masks. "Surgical masks appear to be no worse than, and nearly as effective as, N95 respirators in preventing influenza in health-care workers, according to a study released early online today by JAMA." Out of over 200 nurses in each group wearing masks, 50 got the flu wearing a surgical mask while 48 got the flu wearing the N95 masks. The authors conducted the study because of the short supply of N95 masks worldwide. However, the authors caution use as follows: "Our findings apply to routine care in the health-care setting. They should not be generalized to settings where there is a high risk for aerosolization, such as intubation or bronchoscopy, where use of an N95 respirator would be prudent. In routine health-care settings, particularly where the availability of N95 respirators is limited, surgical masks appear to be non-inferior to N95 respirators for protecting health-care workers against influenza."

10/2/09: Sanofi Pasteur's influenza A (H1N1) 2009 monovalent vaccine trial in adults 18-64 years of age and over the age of 65 years, administered to adults, including the oldest study participants, was announced today. The company said data shows the vaccine induces a robust antibody response 21 days post-vaccination that is considered protective. These data from a placebo-controlled study of 849 adults help confirm preliminary NIH data from a few vaccine recipients. In the 18-64-year-old group, 98% of the vaccinated people developed a protective level of antibodies in 21 days, while in the older group (over 65), 93% developed protective levels. Both groups obtained a single 15 mcg dose of the vaccine. They further announced, "No serious adverse events have been observed to date in this clinical trial. Local injection site redness, swelling, and pain and systemic complaints of mild fever, headache, and fatigue were reported. Overall, the safety profile observed to date is very similar to that of the seasonal influenza vaccine."

9/30/09: Once again, the CDC and other health officials are urging people, especially parents, to avoid establishing or attending "swine flu parties" for themselves and their children. The idea of the parties is to get exposure to a person with the novel H1N1 swine flu so that uninfected people can get the disease and then recover and avoid vaccinations. This is considered risky behavior since the individual's response to the flu, especially in some individuals such as young children and individuals with known or unknown underlying disease, may be poor and could require hospitalization.

National news (NBC) has reported a death in a previously healthy teen whose doctor followed the current CDC guidelines for observation and nontreatment. The press speculates that this case may cause the CDC to modify again its recommendations for treatment by encouraging more people get antiviral drugs.

9/29/09: As stated yesterday, the CDC plans to closely monitor the novel H1N1 swine flu vaccine for any adverse effects. One of the major ways they will monitor for side effects will consist of evaluating any increases in the normal rates for major health problems such as miscarriages, heart attacks, strokes, and other problems. Although the vaccines have been tested on a relatively healthy population and no major adverse problems have been identified (otherwise they would not be approved for distribution), the goal is to immunize over half the U.S. population, many of whom are not classified as "relatively healthy." Consequently, monitoring of the vaccine for potential problems is warranted.

In a separate vaccine issue, the WHO announced that in addition to the nine countries that have agreed to share about 10% of their purchased novel H1N1 vaccine with underdeveloped countries, other countries now are planning to donate 10% of their vaccine stock. This should help the approximately 85 underdeveloped countries that otherwise would have no vaccine to distribute to their people, according to U.N. official David Nabarro.

9/28/09: CDC officials expressed concern about the role of rumors and press coverage of them as the new vaccination efforts start in October. Because of the Internet and immediate access to TV news by the public, CDC official have realized they must be prepared to reassure the public quickly when rumors of "problems with the vaccines" become widespread. For example, in the U.S., there are about 2,400 miscarriages, 3,000 heart attacks, 2,200 strokes, and 550 new seizure patients a day, so the CDC suspects that a few individuals are likely, simply by coincidence, to develop a serious health problem after getting a novel H1N1 swine flu shot. Such incidences may be sensationalized by some people and cause others to avoid getting the vaccine. The CDC has established a "war room" to address these potential problems immediately and plan to have live updates and updates available at the Web site http://flu.gov, as well as on Facebook and Twitter sites. Further, the CDC has given assurances that the vaccine efforts will be closely monitored to determine if any problems develop.

9/26/09: Yesterday, Dr. Thomas Frieden from the CDC gave a press conference update on the novel H1N1 swine flu. He reviewed the current situation and said the vaccines being produced against the novel H1N1 virus should be very effective. He again encouraged people in the high-risk groups to get vaccinated early and reiterated that people age 10 and older will need only one shot of vaccine. He further stated that although a Canadian study (not yet published) suggested that vaccination against the conventional flu makes some people more likely to be susceptible to the novel H1N1flu, the CDC had no information that this was happening. Although Dr. Frieden said he would study the Canadian data when it was available, he indicated that all of the Australian and U.S. data do not indicate that the conventional flu vaccine make people more susceptible to getting novel H1N1 flu.

9/25/09: Recently, the Food and Drug Administration (FDA) established an approved method for compounding Tamiflu in capsules (pills), creating a liquid mixture that ensures the most effective and proper dosing in a liquid form. The liquid Tamiflu is most often used to treat children. Because the Roche commercially prepared supplies of Tamiflu of liquid are low, Walgreens pharmacies across the nation are now beginning to produce Tamiflu Oral Suspension from the capsules according to the FDA recommendations for compounding. This will make liquid Tamiflu more available to the pediatric population. This was announced on Sept. 24 by the Walgreens senior vice-president of pharmacy.

9/23/09: An early review of an article scheduled to be published in the October 2009 Lancet medical journal suggests that vaccination against the novel H1N1 swine flu will help reduce cardiac deaths. The authors reviewed data collected from the 1930s to present about cardiac deaths and their relation to flu epidemics/pandemics and found that when effective vaccines were used against the flu, there were fewer cardiac deaths. They recommend that patients with cardiac problems obtain the flu vaccine.

9/21/09: Dr. A. Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), announced that children 10 years old and older will need only one shot to be vaccinated against novel H1N1 swine flu. Children 6 months to 9 years of age will need two shots, about 21 days apart, of both the conventional and novel H1N1 flu vaccines to establish a good immune response to the viruses. Data suggests that the novel H1N1 vaccine is about 76% effective in producing protection against swine flu. This percentage is considered "not bad at all" in protecting people from the flu.

WHO officials have stated the amount of novel H1N1 swine flu vaccine available worldwide is not expected to reach the amounts first projected. Most of the first vaccine batches have been purchased by the more wealthy developed countries. However, at least nine countries (Australia, Brazil, France, Italy, New Zealand, Norway, Switzerland, Britain, and the U.S.) have pledged to donate vaccine to developing nations that have little or no access to the vaccine. These vaccine doses will be added to the 120 million vaccine doses that two pharmaceutical companies, GlaxoSmithKline and Sanofi-Pasteur, pledged to the WHO. U.S. officials suggest that about 10% of the U.S. vaccine supply will be donated to these underdeveloped countries.

9/18/09: The CDC announced the first vaccine released will be the nasal spray form of the novel H1N1 swine flu vaccine. The CDC estimates about 3.4 million doses will be released during the first week in October, with more releases scheduled in the following weeks. However, this vaccine is composed of live attenuated virus and should be given only to healthy people ages 2-49. People who have asthma or respiratory problems, and those that are immunocompromised or pregnant, should not get the nasal spray vaccine.

9/17/09: The FDA approved clinical studies of LEAPS technology (Ligand Epitope Antigen Presentation System) that allows the CEL-CSI company to direct an immune response against specific disease epitopes, which, for this clinical study, are the non-changing regions of H1N1 (and other flu viruses). This study is designed to help hospitalized patients overcome severe novel H1N1 infections.

9/15/09: Two studies suggest that blacks and Hispanics may be about four times more likely to be hospitalized than other races for the novel H1N1 swine flu. This statistic is likely due to the higher predominance of diabetes and asthma in these populations.

Today the FDA approved H1N1 novel swine flu vaccine from four vaccine suppliers, CSL, AstraZeneca, Novartis, and Sanofi-Aventis. This early FDA approval may allow distribution to occur earlier in October than thought previously. In addition, the vaccination process may require only one shot instead of two for the H1N1 swine flu. Health and Human Services Secretary Kathleen Sebelius said most adults produce a "robust" immune response to this vaccine in eight to 10 days. Pathology reports from autopsies on people who have died from H1N1 swine flu show that the virus penetrates deep into the lungs and disrupts the alveoli, where oxygen and CO₂ are exchanged. Over two-thirds of H1N1 deaths are attributable to the virus and about one-third due to secondary bacterial infections. Autopsy results show large amounts of virus in the blood, feces, and urine of infected individuals, which suggests these may be sources of infection for other people. Dr. Sherif Zaki from the CDC reported these findings at the U.S. Institute for Medicine this week.

9/14/09: Data from three different studies (from Canada, Mexico, and Singapore) reported at the American Society for Microbiology Meetings showed that H1N1 flu is still transmitted among humans even after fever is gone for 24 hours. The authors suggest that a better indicator may be the lack of coughing and that the infectious period may extend over a week longer than previously thought. The researchers do not know if the data will cause the CDC to modify its current recommendations about it being OK to resume work or school 24 hours after untreated fever stops.

9/10/09: Australian and U.S. researchers announced that 76%-96% of people who obtained a single dose of a novel H1N1 swine flu virus vaccine should be protected. U.S. data confirms the Australian data. The data is only for adults; the studies are not yet finished for children. This data may alter the current view that two doses (two shots) of the novel H1N1 vaccine will be needed to get a good immune response. This finding may effectively double the amount of available vaccine. In addition, researchers and other experts still encourage people to get the vaccine (one shot) for the conventional seasonal flu as soon as possible. The conventional flu vaccine is now available in many locations (clinics, stores) in the U.S.

A professor of biostatistics from the University of Washington reported that analysis of statistics predict that October vaccinations will be too late to curb the first wave of novel H1N1 swine flu but should help limit a second wave of the flu. He further suggested that vaccination of children is important, as every infected child statistically infects about 2.4 other people and that 30%-40% of all viral transmissions are from an infected person to others in the home.

9/8/09: The CDC had a press briefing today on interim guidelines for the use of antiviral medications. Dr. Schuchat indicated that three modifications were being suggested to the interim guidelines for use of Tamiflu and Relenza.

1. Patients with high risk factors should discuss flu symptoms and when to use antiviral medications; doctors should provide a prescription for the antiviral drug for the patient to use if the patient is exposed or develops flu-like symptoms without having to go in to see the doctor.

2. "Watchful waiting" was added as a response to taking antiviral medications, with the emphasis that those people who develop a fever and have a preexisting health condition should then begin the antiviral medication.

3. The antiviral drugs are the first-line medicines for treatment of novel H1N1 swine flu, and most current cases of flu are novel H1N1 and are, to date, susceptible to Tamiflu and Relenza.

9/7/09: During the weekend, colleges across the nation began to report their experiences with the novel H1N1 swine flu. Most cases seem mild to moderate, but many colleges report a large number of students affected. For example, Washington state officials estimate that about 2,100 students have the flu. Another school, Emory University, has opened a dorm on campus for students with the flu. The student's have nicknamed the dorm "Flu U."

9/4/09: The CDC published the guidelines for child-care providers and childhood care centers. The emphasis is on the following: "Importantly, infants less than 6 months of age represent a particularly vulnerable group because they are too young to receive the seasonal or 2009 H1N1 influenza vaccine; as a result, individuals responsible for caring for these children constitute a high-priority group for early vaccination." Details of the guidelines are provided in this lengthy document that can be found at http://www.flu.gov/professional/school/childguidance.html. The guidelines are very similar to those recently published for workplace prevention of flu and emphasize the need for caregivers to quickly separate sick children from others and delineate methods to follow for facility closures.

9/3/09: Today, a CDC official, Dr. Thomas Frieden, gave a briefing on the novel H1N1 swine flu. The good news is that swine flu cases here and in the southern hemisphere have not shown an enhanced severity or death rate; the vast majority of cases have been mild or moderate. However, the pattern of age groups has continued to be different from conventional flu in that a younger population, rather than the elderly, is most affected. Of specific concern is the numbers of children affected and who have died. Children with health or developmental problems seem to have more incidences of severe disease or death, said Frieden, "in most of the cases -- cerebral palsy, muscular dystrophy, long-standing respiratory or cardiac problems. So, most of the children who had fatal H1N1 infection this past spring had an underlying condition." Secondary bacterial infections caused severe disease or death in the few children that did not have known underlying problems. The CDC plans to monitor this trend closely and consult with pediatric physicians about reducing the numbers of these cases.

Vaccinations were discussed and reviewed; the CDC again emphasized the importance of vaccinations and stressed the need for children, pregnant women, and people with underlying health problems to get vaccinated as soon as the vaccine is available. The CDC has set aside about $1.5 billion for vaccines that are predicted to become available in mid-October. The CDC expects some adverse vaccine-related events and will modify recommendations if the situation warrants.

Concern was expressed about overwhelming the health-care system in the U.S.; consequently, Frieden stated that "There's no reason to see a doctor or go to the emergency department unless you're severely ill." He reiterated the CDC's published precautions that people with underlying diseases should take. People should stay informed because situations can change rapidly; "Flu is unpredictable. Flu season is just beginning."

8/28/09: From the CDC: Flu activity appears to be increasing in the Southeast based on influenza-like illness data reported by health-care providers. Below is a summary of the most recent key indicators:

• Visits to doctors for influenza-like illness (ILI) were highest in February during the 2008-09 flu season but rose again in April 2009 after the new H1N1 virus emerged. Current visits to doctors for influenza-like illness are down from April, but are higher than what is expected in the summer and have increased over the last two weeks.



• Total influenza hospitalization rates for adults and children are similar to or lower than seasonal influenza hospitalization rates, depending on age group.



• The proportion of deaths attributed to pneumonia and influenza (P&I) was low and within the bounds of what is expected in the summer.



• Most state health officials are reporting regional or sporadic influenza activity. Two states (Alaska and Georgia) and Puerto Rico are reporting widespread influenza activity at this time. Any reports of widespread influenza activity in August are very unusual.



• Almost all of the influenza viruses identified were the new 2009 H1N1 influenza A viruses. These 2009 H1N1 viruses remain similar to the viruses chosen for the 2009 H1N1 vaccine and remain susceptible to antiviral drugs (oseltamivir and zanamivir) with rare exceptions.

Today the WHO published a report that gives advice about preparations for the second wave of novel H1N1 swine flu, based on the current worldwide outbreaks. They suggest that now the predominant flu strain in the world is H1N1, that it has not markedly increased in its current ability to cause serious disease, and that although a few strains have been found to be resistant to antiviral drugs, the vast majority of tested strains remain susceptible. However, WHO officials say that vigilance is necessary to determine that resistant strains do not increase in number. Further, the pattern of susceptible people continues to be remarkably different from conventional flu in that the most vulnerable people are younger, have more deaths, have more respiratory problems, and are more likely to overburden intensive care facilities. They suggest that now is the time to plan for the second wave likely to occur in the northern hemisphere in the upcoming months.

8/27/09: Brazil has reported 552 deaths to date and now surpasses the U.S. as the country with the most deaths due to novel H1N1 swine flu.

8/25/09: The President's Council of Advisors on Science and Technology released a report on Monday that says swine flu could infect up to about 120 million people and cause about 1.8 million hospitalizations with up to 90,000 thousand deaths. The advisors base their numerical estimates on analysis of data from the spring-summer outbreak in the northern hemisphere and the current winter pandemic in the southern hemisphere. They suggest these numbers of patients would severely stress the current hospital system because there are only a finite number of intensive-care beds available in the U.S. The advisors warn that schools could be acutely affected and urges the release of vaccines and drugs in mid-September, in contrast to current thoughts that flu vaccines would only be available in the U.S. in October. One of the reasons to move up the timing is that most experts believe people will need two doses of the vaccine, delivered at least two weeks apart, to develop full immunity to the new H1N1 flu. In addition, people likely will need a vaccine for the conventional seasonal flu. The advisors also urged the U.S. Food and Drug Administration to quickly decide on the safety and efficacy of new intravenous (IV) formulations of flu drugs, such as Roche AG's Tamiflu, GlaxoSmithKline's Relenza, and BioCryst Pharmaceuticals' experimental drug, peramivir. IV formulations of these drugs may be the only way to administer antiviral agents to people severely ill with novel H1N1 swine flu. The advisors state that the current novel H1N1 swine flu is "a serious threat to our nation."

8/21/09: CDC recommendations for college students and the flu were published yesterday afternoon. Like the CDC recommendations for businesses and employers, the recommendations are voluminous and detailed. They can be found at http://www.cdc.gov/h1n1flu/institutions/guidance/. One of the main aims of the CDC is to facilitate self-isolation of students (and others) at higher education institutions to lessen the chance of individuals spreading the flu. Also, the CDC published a "toolkit" for educational institutions that provides fact sheets, templates, informational posters, and other items for use.

8/19/09: Today the CDC released guidelines for businesses and employers for the 2009-2010 flu season. It is an extensive document that covers many pages of recommendations. The document is published at the following Web site: http://www.cdc.gov/h1n1flu/business/guidance. Key aspects of the guidelines involve details about the following:

• Sick people should stay home.



• Sick employees at work should be asked to go home.



• Cover coughs and sneezes.



• Improve hand hygiene.



• Clean surfaces and items that are more likely to have frequent hand contact.



• Encourage employees to get vaccinated.



• Take measures to protect employees who are at higher risk for complications of influenza.



• Prepare for increased numbers of employee absences due to illness in employees and their family members, and plan ways for essential business functions to continue.



• Advise employees before traveling to take certain steps.



• Prepare for the possibility of school dismissal or temporary closure of child-care programs.

If the flu season becomes severe, the CDC recommends the following additional precautions:

• Consider active screening of employees who report to work.



• Consider alternative work environments for employees at higher risk for complications of influenza during periods of increased influenza activity in the community.



• Consider increasing social distancing in the workplace.



• Consider canceling nonessential business travel and advising employees about possible disruptions while traveling overseas.



• Prepare for school dismissal or closure of child-care programs.



• Other considerations

Each one of the above points is described in detail at the Web site. One important subset of recommendations that should be highlighted is as follows: "CDC recommends that workers who appear to have an influenza-like illness upon arrival or become ill during the day be promptly separated from other workers and be advised to go home until at least 24 hours after they are free of fever (100 F [37.8 C] or greater), or signs of a fever, without the use of fever-reducing medications."

8/16/09: Egypt and other countries have banned people under age 12 and over age 65 from going on pilgrimage to Mecca during Ramadan in an effort to prevent novel H1N1 swine flu spread. Apparently, not all of those planning a pilgrimage are aware of the restrictions that went into effect Sunday morning, as angry people reacted to the travel restrictions at the Cairo airport today. A number of people were removed after they had already boarded planes bound for Mecca.

8/14/09: The CDC reported today the total number of patients hospitalized (7,511) and total deaths (477) due to novel H1N1 swine flu. The mortality, or death rate, for hospitalized patients is about 6.7%. The CDC reported that as of 8/8/09, only two novel H1N1 strains out of 318 tested showed resistances to oseltamivir, and none were resistant to zanamivir.

8/11/09: Novel H1N1 swine flu vaccine trials began in the U.S. yesterday in St. Louis with several hundred volunteers obtaining the vaccine inoculation. Not all doctors think that starting school classes during this flu pandemic is a good idea. For example, a U.K. professor, Dr. Price, says, "There is no greater way of facilitating the spread of swine flu than allowing children to mix in schools. If we had a vaccine, it would be a different matter, but given we don't yet, it would in my view be foolhardy to allow children back to school. It's a discussion that needs to be had." Currently, the CDC and many other international health agencies recommend schools reopen, and any closures should be determined by local officials.

8/09/09: Several reports now have noted the presence of Tamiflu-resistant novel H1N1 virus. Some investigators have suggested the resistance is due to the production of H274Y, a new surface antigen that has reportedly been detected in several resistant flu isolates. Researchers suggest that resistant isolates may be more common than thought, since recent tests have detected a number of isolates with H274Y antigen.

8/7/09: The CDC has published extensive and technical recommendations for schools to consider during the upcoming 2009-2010 flu season. All of the details can be found at http://www.pandemicflu.gov/plan/school/schoolguidance.html. The following points are taken directly from the report and are presented in two parts that consider actions depending on the potential severity of the flu season:

CDC-recommended school responses for the 2009-2010 school year

Under conditions with similar severity as in spring 2009

• Stay home when sick: Those with flu-like illness should stay home for at least 24 hours after they no longer have a fever, or signs of a fever, without the use of fever-reducing medicines. They should stay home even if they are using antiviral drugs. (For more information, visit http://www.cdc.gov/h1n1flu/guidance/exclusion.htm.)



• Separate ill students and staff: Students and staff who appear to have flu-like illness should be sent to a room separate from others until they can be sent home. The CDC recommends that they wear a surgical mask, if possible, and that those who care for ill students and staff wear protective gear such as a mask.



• Hand hygiene and respiratory etiquette: The new recommendations emphasize the importance of the basic foundations of influenza prevention: Stay home when sick, wash hands frequently with soap and water when possible, and cover noses and mouths with a tissue when coughing or sneezing (or a shirt sleeve or elbow if no tissue is available).



• Routine cleaning: School staff should routinely clean areas that students and staff touch often with the cleaners they typically use. Special cleaning with bleach and other non-detergent-based cleaners is not necessary.



• Early treatment of high-risk students and staff: People at high risk for influenza complications who become ill with influenza-like illness should speak with their health-care provider as soon as possible. Early treatment with antiviral medications is very important for people at high risk because it can prevent hospitalizations and deaths. People at high risk include those who are pregnant, have asthma or diabetes, have compromised immune systems, or have neuromuscular diseases.



• Consideration of selective school dismissal: Although there are not many schools where all or most students are at high risk (for example, schools for medically fragile children or for pregnant students), a community might decide to dismiss such a school to better protect these high-risk students.

Under conditions of increased severity compared with spring 2009

The CDC may recommend additional measures to help protect students and staff if global and national assessments indicate that influenza is causing more severe disease. In addition, local health and education officials may elect to implement some of these additional measures. Except for school dismissals, these strategies have not been scientifically tested. But the CDC wants communities to have tools to use that may be the right measures for their community and circumstances.

• Active screening: Schools should check students and staff for fever and other symptoms of flu when they get to school in the morning, separate those who are ill, and send them home as soon as possible. Throughout the day, staff should be vigilant in identifying students and other staff who appear ill.



• High-risk students and staff members stay home: People at high risk of flu complications should talk to their doctor about staying home from school when an outbreak of flu is circulating in the community. Schools should plan now for ways to continue educating students who stay home through instructional phone calls, homework packets, Internet lessons, and other approaches.



• Students with ill household members stay home: Students who have an ill household member should stay home for five days from the day the first household member got sick. This is the time period they are most likely to get sick themselves.



• Increase distance between people at schools: The CDC encourages schools to try innovative ways of separating students. These can be as simple as moving desks farther apart or canceling classes that bring together children from different classrooms.



• Extend the period for ill people to stay home: If influenza severity increases, people with flu-like illness should stay home for at least seven days, even if they have no more symptoms. If people are still sick, they should stay home until 24 hours after they have no symptoms.



• School dismissals: School and health officials should work closely to balance the risks of flu in their community with the disruption dismissals will cause in both education and the wider community. The length of time schools should be dismissed will vary depending on the type of dismissal as well as the severity and extent of illness. Schools that dismiss students should do so for five to seven calendar days and should reassess whether or not to resume classes after that period. Schools that dismiss students should remain open to teachers and staff so they can continue to provide instruction through other means.

Reactive dismissals might be appropriate when schools are not able to maintain normal functioning; for example, when a significant number and proportion of students have documented fever while at school despite recommendations to keep ill children home.

Preemptive dismissals can be used proactively to decrease the spread of flu. The CDC may recommend preemptive school dismissals if the flu starts to cause severe disease in a significantly larger proportion of those affected.

8/6/09: Controversy is brewing over the accuracy of tests that are used to rapidly detect influenza virus infection. Most of these tests are used in doctor's offices or urgent care and emergency centers and do not indicate if the person tested has novel H1N1 swine flu. These tests only indicate if flu virus is present or, in some tests, if the virus is type A or B (novel H1N1 swine flu is type A like most seasonal flu). Different studies suggest rapid tests many have only 20%-80% accuracy in detecting flu, depending on which test is used and the skill of the personnel running the test. The CDC is reportedly going to publish a study of these tests "soon." Meanwhile, Dr. Timothy M. Uyeki, a CDC official, says, "We're saying you need to understand the limitations of these tests. The clinician should not base a decision to treat or not treat on the basis of a negative result." Detection and identification of novel H1N1 swine flu virus is usually not done in doctors' offices or hospital labs, but in state labs usually with a sensitive and specific PCR test that most other labs do not use because of expense, training requirements, and time needed to run the test.

8/5/09: China closed summer camps in areas affected by swine flu (Beijing and Guangzhou) yesterday. Other areas in China that have swine flu may also be closed. China has reported 2,162 cases of swine flu but no deaths. In the U.S., physicians suggest that one of the major problems encountered with novel H1N1 swine flu is pneumonia. They suggest that another common vaccine, Pneumovax, may help prevent pneumonia in many patients that get the flu. Data presented to the CDC vaccine committee suggests that about one-third of all pneumonias associated with the flu may be prevented by Pneumovax. Unfortunately, there is no study that shows this effect, but some physicians plan to recommend the vaccine to patients with chronic lung problems.

8/3/09: The Pan American Health organization announced today that Tamiflu-resistant strains of novel H1N1 swine flu virus have been detected in the U.S. in El Paso and near McAllen, Texas, along the Texas-Mexico border. Other countries (Japan, Denmark, and Canada) have also detected similar resistant viral strains. Viral experts suggest the drug Tamiflu may be overused by people who take it "at the first sneeze," especially in countries where Tamiflu does not require a prescription (Mexico, Canada).

7/31/09: The WHO reported that several countries have noted an increased flu risk in pregnant women, particularly during the second and third trimesters of pregnancy in women infected with novel H1N1 swine flu. Also, an increased risk of fetal death or spontaneous abortions in infected pregnant women has been reported, which was noted in previous pandemics. WHO officials suggest pregnant females be given Tamiflu within 48 hours of developing flu symptoms for greatest benefits; they also suggest this treatment even after 48 hours as it may reduce the chance for pneumonia and hospitalization. The WHO suggests that other groups at increased risk of severe or fatal illness from novel H1N1 infection include people with underlying medical conditions such as chronic lung disease (including asthma), cardiovascular disease, diabetes, and immunosuppressed individuals. WHO officials say preliminary studies suggest that obesity, especially extreme obesity, may be a risk factor for more severe disease.

Novel H1N1 swine flu can progress rapidly. The following is a list of danger signs provided by WHO officials that may appear in infected individuals:

• shortness of breath, either during physical activity or while resting;



• difficulty in breathing;



• turning blue;



• bloody or colored (not clear) sputum;



• chest pain;



• altered mental status;



• high fever that persists beyond three days;



• low blood pressure; and



• in children, danger signs include fast or difficult breathing, lack of alertness, difficulty in waking up, and little or no desire to play.

Novel H1N1-infected people with any of these danger signs need to seek medical help immediately.

7/29/09: The CDC committee on vaccine use today published recommendations about who should get the novel H1N1 flu vaccines when vaccine is first available:

• pregnant women,



• people who live with or care for children younger than 6 months of age,



• health-care and emergency-services personnel,



• people between the ages of 6 months through 24 years of age, and



• people from ages 25 through 64 years of age who are at higher risk for novel H1N1 because of chronic health disorders or compromised immune systems.

The groups listed above total approximately 159 million people in the United States, so at least that number of doses of vaccine will be needed. It is possible that initially the vaccine will be available only in limited quantities. If this occurs, the committee recommended that the following groups receive the vaccine before others:

• pregnant women,



• people who live with or care for children younger than 6 months of age,



• health-care and emergency-services personnel with direct patient contact,



• children 6 months through 4 years of age, and



• children 5 through 18 years of age who have chronic medical conditions.

Current data suggests that the risk for infection among people age 65 or older for novel H1N1 flu is less than the risk for younger age groups, which is not the usual situation for seasonal flu. However, the CDC suggests people 65 and older get the seasonal flu vaccine as soon as it becomes available.

The CDC says that the novel H1N1 vaccine does not replace the conventional flu vaccine, so individuals still need to be vaccinated against the seasonal flu. The CDC indicated that when appropriate, an individual can get both vaccines administered on the same day.

7/28/09: Controversy continues about the safety of European fast-track novel H1N1 swine flu vaccines. WHO officials continue to caution against the fast-track approach because of safety concerns; they want more extensive testing done to avoid problems like those that occurred with the 1976 flu vaccine that resulted in hundreds of people getting Guillain-Barré syndrome (autoimmune-induced weakness or paralysis), other side effects, or dosage-related low or no immune response. The U.S. is not following a fast-track approach.

7/27/09: Several European countries (Britain, France, and Greece) indicated they will fast-track novel H1N1 swine flu vaccine trials. WHO officials warned officials about potential dangers (missed side effects and adequate vaccine dosage determinations) if a fast-track method is used. The European officials say the benefits outweigh the risks and will allow earlier vaccinations (within weeks) to be done. The U.S. is taking a more conservative approach and plans to have a vaccine campaign ready in October.

7/24/09: The WHO reported today that novel H1N1cases are increasing worldwide, with the median age of infected people being 12 -17 years of age. Because pandemics often run for about two years, the patient population and the most susceptible people may change as the disease progresses over time. The WHO suggests that although vaccine yields are not as high as hoped, they expect vaccines to be available during the month of September. The CDC press conference today released data indicating that 43,771 laboratory-identified cases with 302 deaths were due to the new novel H1N1 virus. The officials indicate several flu outbreaks have occurred at summer camps and cautioned that more outbreaks may occur in a similar fashion when schools open in September. Use of Tamiflu (and other antiviral medications) was not recommended for any flu prevention except in high-risk individuals (for example, pregnancy, asthma) and people were urged to go to CDC Web sites for guidelines. Currently, flu vaccines were not going to be mandated for school-aged children, but the CDC did recommend that all children between 6 months and 17 years of age be vaccinated against flu viruses. The CDC now reports that labs have detected about five novel H1N1 cases that are Tamiflu-resistant, but the vast majority of isolates is still susceptible to antiviral drugs. During the conference, several reporters tried to get Dr. Schuchat to estimate the death rate for novel H1N1, but Dr. Schuchat only indicated that overall rates from both the conventional flu and novel H1N1 flu are likely to be higher than the approximately 36,000 deaths per year seen with only the conventional flu. The CDC would not speculate about how much higher the expected death rates would be. New influenza vaccine recommendations were released today by the CDC and can be found at http://www.cdc.gov.

7/22/09: The National Institute of Allergy and Infectious Diseases (NIAID) is set to begin clinical trials of vaccines for novel H1N1 swine flu. Initial studies will try to determine if one or two doses of vaccine will be safe and generate a good immune response in normal adult volunteers and the elderly (age 65 and older). Another trial will determine if a mix (a single shot) of the seasonal flu vaccine and the novel H1N1 vaccine will provide a safe and good immune response to both viral strains in normal adult volunteers and the elderly (age 65 and older). First examinations of the results will occur about 21 days after immunization. If these trials initially show the vaccines are safe, other trials will be started on children (6 months to 17 years of age).

7/20/09: Transcripts from the CDC press conference on 7/17/09 indicate that planning is ongoing for the upcoming flu season. Both the novel H1N1 pandemic flu strain and the conventional flu strain are expected to be present during the upcoming flu season. Because the novel H1N1 strain continues to infect individuals, they expect the flu season to start early this year, especially when schools begin to open in September. On 7/29/09, planning for immunization will commence, to recommend which people should get vaccinated first. The CDC suggests that additions to the vaccines to make them more effective (adjuvants) are contingent upon showing that such additives are needed to boost vaccine immunogenicity. The studies are ongoing.

7/17/09: Today, the CDC reports a total of 40,617 suspected or proven cases of H1N1 swine flu with a total of 263 deaths in the U.S., with Wisconsin reporting the largest number of cases (6,031) and New York the largest number of deaths (57). As stated previously (6/29/09), the CDC suspects the bulk of cases (over 1,000,000) are not reported, and people have mild or moderate flu symptoms that resolve.

7/16/09: WHO officials have changed reporting practices for the pandemic H1N1 swine flu cases. The officials say that further spread is inevitable and suggest that only those that occur in newly affected countries need reporting. In addition, WHO officials request that unusual situations, such as clusters of severe or fatal cases, be reported.

7/13/09: WHO officials identified several objectives that countries could adopt as part of their pandemic vaccination strategy and published these current recommendations by their Strategic Advisory Group of Experts (SAGE) on the current H1N1 flu pandemic:

• All countries should immunize their health-care workers as a first priority to protect the essential health infrastructure. As vaccines available initially will not be sufficient, a stepwise approach to vaccinate particular groups may be considered. SAGE suggested the following groups for consideration, noting that countries need to determine their order of priority based on country-specific conditions: pregnant women; those over 6 months of age with one of several chronic medical conditions; healthy young adults 15-49 years of age; healthy children; healthy adults 50-64 years of age; and healthy adults 65 years of age and older.



• Since new technologies are involved in the production of some pandemic vaccines, which have not yet been extensively evaluated for their safety in certain population groups, it is very important to implement post-marketing surveillance of the highest possible quality. In addition, rapid sharing of the results of immunogenicity and post-marketing safety and effectiveness studies among the international community will be essential for allowing countries to make necessary adjustments to their vaccination policies.



• In view of the anticipated limited vaccine availability at a global level and the potential need to protect against "drifted" strains of virus, SAGE recommended that promoting production and use of vaccines, such as those that are formulated with oil-in-water adjuvants and live attenuated influenza vaccines, was important.



• As most of the production of the seasonal vaccine for the 2009-2010 influenza season in the northern hemisphere is almost complete and is therefore unlikely to affect production of pandemic vaccine, SAGE did not consider that there was a need to recommend a "switch" from seasonal to pandemic vaccine production.

7/11/09: U.S. government agencies (CDC, Homeland Security, Health and Human Services and others) begin a joint meeting to determine plans to respond to the upcoming flu season.

7/8/09: Denmark, Japan, and the Special Administrative Region of Hong Kong, China, have informed WHO officials that they have detected a few novel H1N1 viruses which are resistant to the antiviral drug oseltamivir (Tamiflu). Currently, these strains have shown resistance when tested under laboratory conditions, and the vast majority of tested novel H1N1 swine flu strains still show sensitivity to oseltamivir. There is no change in recommendations about antiviral drug use from WHO officials. Argentina and Australia report the highest number of new cases in this reporting period (898 and 730, respectively) as the southern hemisphere continues its flu season.

7/3/09: The WHO has reported 77,201 cases worldwide with 332 deaths; Chile and the United Kingdom reported the highest increases in new cases since the last reporting period.

6/30/09: Today, CDC flu experts recommended that children, pregnant women, the elderly, and people with chronic diseases should avoid the hajj pilgrimage when asked for advice from the Saudi government about how to avoid H1N1 swine flu problems. The CDC suggested the people would be at highest risk for getting flu complications. The pilgrimage attracts about 3 million people to Mecca and Medina. The Saudi government said they recommend pilgrims get flu shots, once they are available, at least two weeks before leaving their country before they go on pilgrimage.

6/26/09: Dr. Anne Schuchat, a CDC administrator, indicated today that the U.S. is still reporting increasing numbers of H1N1 flu cases even though the routine flu season is essentially over. She indicates the unique situation in which the U.S. is seeing increases while decreases in cases should be happening. About 99% of all isolates are the new (or novel) H1N1 influenza A virus. The CDC investigators estimate that over 1 million people have been infected in the U.S., based on the reported number of cases. Currently, the most cases occur in people under age 25 with deaths averaging at age 37. Outbreaks have been noted in several summer camps across the nation; guidelines for campers have been issued at http://www.cdc.gov. She commented about the increases in cases in the southern hemisphere, since it is their winter season, and thinks many more cases will occur. She states that about 75% of deaths associated with novel H1N1 flu occur in individuals with underlying health problems or conditions. She indicated that five vaccine manufacturers should have clinical trials beginning later this summer and that the CDC has not yet established who should get the vaccine(s) first when they become available. The logistics of vaccinations could be complex if about 600 million doses need to be administered (about two doses for most of the U.S. population).

6/22/09: The WHO reports 52,160 cases of H1N1 swine flu with 231 deaths. The country with the most reported cases (21,449) is the U.S.

6/19/09: Recommendations for health-care personnel were published today by the CDC to help prevent flu spread to health-care workers. The following is quoted from the CDC press release: "Probably the single most important thing is that infectious patients be identified at the front door. Whether these patients are coming in through the emergency department or the ambulatory care clinic, identifying them up front is essential so health-care personnel know that they should be doing the things that we recommend; that consistent application of precautions is important to make sure that there isn't occupational exposure."

The current recommendations include using a single patient room for infectious individuals and have them cover their cough. And use respirators, gloves, eye protection when they're with a patient with probable H1N1. As always, careful attention to hand hygiene is part of standard precautions that continue to be recommended. For novel H1N1 we currently also recommend that special procedures that might generate a fine aerosol be performed in a special room with negative pressure air handling so other parts of the hospital aren't exposed to potentially infectious material."

6/18/09: Venezuela authorities have quarantined 1,219 cruise ship passengers and 460 crew members when three ship crew members tested positive for swine flu during the cruise. The quarantine will last 10 days, and the passengers and crew will remain on the ship.

6/17/09: The CDC just published two major articles on research results about H1N1 swine flu in the New England Journal of Medicine (360:2605 and 2616, 2009). The articles are written for researchers and clinicians and summarize the basic genetic and clinical data accumulated as of June 3, 2009. Two new terms are introduced that may be seen in future articles on the flu. The first is S-OIV (Swine-Origin Influenza Virus) and refers to the novel Swine-Origin Influenza A (H1N1) that is causing the first pandemic flu in 41 years. The second term is "triple-reassortant." Triple-reassortant means the virus has a mix of eight RNA strands (genes) from three sources: avian, human, and swine viruses. They further identify S-OIV, the novel H1N1 virus, as being a triple-reassortant strain that differs from other triple-reassortant strains such as other H1N1 by having only three classic North American swine RNA strands, two Eurasian swine RNA strands, two avian RNA strands, and one human flu RNA strand instead of five classic North American swine RNA strands, two avian, and one human flu RNA strand found in the current H1N1 flu. They provide data that indicate the majority of cases of S-OIV (novel H1N1) occur in people aged 10-18 years old (40%). Diarrhea and vomiting, symptoms not usually seen in flu patients, are reported in 25% of S-OIV patients. Patients that required hospitalization were 9% of the total number of detected cases and showed a death rate of about 5% (2/36) of hospitalized patients. Anyone who wants a detailed explanation, with data, about the current pandemic viral strain of flu should read these two papers.

6/15/09: The WHO reports 76 countries with a total of 35,928 cases and 163 deaths of H1N1 influenza A swine flu.

6/11/09: WHO director Dr. Margaret Chan announced a level 6 pandemic for H1N1 2009 influenza A swine flu. The decision to declare a pandemic was reached after widespread human-to-human transmission was reached in another WHO-designated region of the globe (Australia), thus fulfilling the WHO level 6 pandemic criteria. However, officials reminded everyone that declaration of a pandemic for H1N1 flu does not indicate any major change in either the way countries respond to the disease or that the H1N1 flu has any major change in its characteristic presentation, it just indicates there is worldwide spread. The WHO suggests there is no increase in severity of symptoms of the 2009 H1N1 flu. The WHO has also not suggested any travel restrictions due to the level 6 pandemic. The WHO said that H5N1 flu is still at WHO level 3 and remarks how unusual it is to concurrently have two types of flu at these two levels. They also express caution because the H1N1 can change, and although it seems relatively stable, they express concern that it might change when the northern hemisphere enters flu season this fall. Today, the WHO reports about 28,744 H1N1 infections in 74 countries with 144 deaths around the world. The first cases on the African continent have been detected in Egypt. In a related news release, four major vaccine producers are in the early stages of H1N1 vaccine development.

6/9/09: WHO administrator Dr. Keiji Fukuda said the WHO is close to announcing a level 6 pandemic alert because of the rapid spread (over 1,000 cases reported with about 125 new cases daily) of H1N1 in Australia. The WHO has been criticized by some flu experts who think countries have pressured the WHO not to declare a pandemic. WHO officials say they are waiting to verify case reports in several countries before they declare level 6 (pandemic). The WHO has not declared a level 6 pandemic in the last 41 years.

6/7/09: The WHO reports 21,940 cases and 125 deaths worldwide.

6/5/09: Wisconsin continues to report the highest number of confirmed and suspected cases in the U.S. (2,217, an increase of 603 cases in four days). Total U.S. cases are 13,217 with 27 deaths.

6/3/09: The WHO reports that the U.S. and Australia reported the highest number of new cases in the last reporting period (1,078 and 204, respectively).

6/1/09: The CDC reports that to date there are 10,053 confirmed and probable cases of H1N1 swine flu in the U.S. with Wisconsin having the most cases (1,641). The CDC estimates that only about one in 20 cases are reported, so the CDC suggests the actual number of U.S. cases is about 200,000 cases. There have been 17 deaths reported in the U.S. Most of the cases of H1N1 currently produce mild flu symptoms. The WHO reports H1N1 swine flu in 62 countries with a total of 15,410 cases and 115 deaths. There are no cases reported on the African continent to date. Public-health officials have dropped the term "swine flu" and now use "2009 H1N1 flu" since pigs are not transmitting the disease.

5/29/09: The WHO reports that a total of 53 countries now have confirmed a total of 15,510 cases of H1N1 swine flu with a total of 99 deaths. As of today, 8,975 cases have been confirmed in the U.S. with 15 deaths. The U.S. has the highest number of confirmed cases and Mexico the highest number of deaths (85). The high number of confirmed U.S. cases may be due to testing methods available in almost every U.S. state. Today, Chinese officials released 21 U.S. students after five days of quarantine when an individual on their flight developed swine flu.

5/28/09: Australia advises about 2,000 passengers on a cruise ship docked in Sydney to quarantine themselves after at least nine confirmed cases of swine flu were found.

5/26/09: Sanofi Pasteur announces it has obtained a $190 million contract from the U.S. government to produce a swine flu vaccine. In Kuwait, 18 U.S. soldiers are reported to have swine flu.

5/23/09: CDC researchers suggest that analysis of over 50 strains of H1N1 are closely related and suggest that a single flu vaccine will likely target most, if not all, of the currently detected strains. They further suggest these findings would facilitate making an effective vaccine. The Department of Health and Human Services set aside about $1 billion for vaccine development on Friday. The WHO reports 43 countries with a total of 12,022 confirmed H1N1 cases and 86 deaths.

5/22/09: The CDC reports that only 1% of the reportedly confirmed H1N1 swine flu cases have occurred in people older than 65 years of age, while the majority of cases occurred in people 5-24 years of age. The officials speculate that older people may have been exposed to viruses in the 1930s-1950s that share some antigenic similarity to H1N1 strains and thus may provide some resistance to the virus.

5/20/09: The WHO reports 11,034 confirmed cases worldwide with a total of 85 deaths from H1N1 swine flu. To date, the WHO has not upgraded to a level 6 (pandemic); it is still at a level 5. Although CDC officials consider H1N1 to be widely spread in the U.S., WHO officials are waiting to see if H1N1 flu becomes widespread in other countries before raising the level to 6.

5/19/09: New York increases its school closings to 17 due to the numbers of suspected cases of H1N1 swine flu. WHO Director-General Dr. M. Chan addressed World Public Health Representatives today and said that the current pattern of mild illness with few deaths continues for H1N1. She cautioned the officials that because influenza viruses change rapidly, the viruses may have given everyone a "grace period" of time to better understand and treat the disease. She is concerned that the virus may interact with the H5N1 avian influenza virus populations that are "firmly established in poultry in several countries." CDC officials have estimated that about 100,000 people in the U.S. are infected with the flu virus and about half that number is infected with H1N1 swine flu; the confirmed case numbers are much smaller (5,123 cases as of May 19).

5/18/09: New York closes 11 schools after a school administrator died after getting H1N1 swine flu. The WHO is starting a conference today (World Health Assembly) about key public-health issues; the flu is likely to be a major topic of this conference. The WHO reports 40 countries are now positive for H1N1 swine flu (as compared to 29 countries reported by the WHO on May 10), with a total of 8,829 confirmed cases and 74 deaths.

5/17/09: The CDC publishes figures on the types of flu viruses reported from May 2 to May 9; the majority of isolates were novel influenza A H1N1 (34.3%) and influenza A viruses that were either unsubtyped or unsubtypable (total 40.2%). The unsubtypable viruses are thought to be variations of the novel influenza A H1N1 virus. They further report that novel influenza H1N1 virus is "antigenically and genetically unrelated to seasonal influenza A (H1N1)" and suggest that little or no protection would be afforded by current seasonal influenza vaccines. They do report some good news; to date, all tested isolates (96) of novel influenza A H1N1 are susceptible to both oseltamivir and zanamivir. However, the CDC reports that seasonal influenza A H1N1 is only sensitive to zanamivir. For more details about these reports, see http://www.cdc.gov/flu/weekly/pdf/External_F0918.pdf; data and graphs are available.

5/15/09: The WHO reports, to date, that 34 countries have officially reported a total of 7,250 cases of H1N1 swine flu worldwide. The CDC reports H1N1 has been detected in 47 states, with a total of four deaths. Confirmed and "probable" cases are totaled at 4,714 in the U.S. Several schools were closed for one week in New York when many students and some adult staff developed flu symptoms.

5/13/09: The CDC reports that a new PCR test kit (a test that detects the genetic material of the virus) for H1N1 swine flu has been produced and is being shipped to all U.S. states and also internationally. The CDC reports that a number of novel H1N1 and "unsubtypable" viruses are being detected. Novel H1N1 viruses cause a wide range of clinical symptoms such as fever, cough, sore throat, body aches, headache, chills, and fatigue and often have accompanying nausea, vomiting, or diarrhea. The CDC considers "unsubtypable" virus to be antigenic variations of the novel H1N1 virus. Some investigators suggest that H1N1 mutates rapidly because there are numerous "unsubtypable" viruses.

5/12/09: Dr. A. Schuchat, interim deputy director with the CDC, says the CDC is focusing on the coming fall flu season and that the current numbers of flu cases are increasing so fast they may consider stopping counting cases. The counted cases may only represent the tip of the iceberg for the actual number of cases. Other investigators have revised the H1N1 swine flu mortality rate to be 0.4%-1.4% of cases but reiterate that the data is still incomplete.

Interim Deputy Director for Science and Public Health Program Rear Admiral Anne Schuchat, MD, speaks during a CDC press briefing. Photo by James Gathany/CDC

5/10/09: The WHO reports, to date, that 29 countries have officially reported a total of 4,379 cases of H1N1 swine flu worldwide, and the infection has reached another continent -- Australia.

5/8/09: Mexico reopens all high schools and universities today after a two-week closure. Although two more deaths were reported in Mexico (revised total number of deaths in Mexico now at 44), Health Minister Jose Angel Cordova said the flu cases were declining. Argentina, Brazil, and Colombia are the first South American countries to report H1N1 swine flu cases. World Health Organization (WHO) authorities say that up to 2 billion people could be infected if the H1N1 swine flu becomes a two-year pandemic. Confirmed H1N1 cases have been detected in two more U.S. states for a total of 43 states.

5/7/09: Currently, at least 41 U. S. states have reported confirmed cases of H1N1 swine flu. The southern hemisphere is beginning the fall/winter season, and epidemiologists and other researchers plan to closely monitor this area of the world to see if H1N1 swine flu increases in numbers of cases and severity. Some investigators suggest that how H1N1 infects populations in southern hemisphere countries (for example, New Zealand) over the next few months will help predict what N1H1 will do in the upcoming flu season of the northern hemisphere. The WHO has reported H1N1 swine flu cases confirmed in 23 countries with a total of 2,099 cases. The WHO published revised case and death numbers in Mexico to 1,112 cases and 42 deaths; this shows a marked reduction in both cases and deaths from the numbers reported by Mexico about one week ago.

5/6/09: An announcement from vaccine producers and U.S. government sources suggests that a vaccine is being developed for the more common seasonal flu virus strain and that a second vaccine is being made specific for the H1N1 2009 swine flu virus. Authorities suggest that this second vaccine is likely to require an initial injection followed by another injection at a later date. They project this requirement because people have not been exposed to H1N1 and to get a good immune response, people will need a "booster shot" (a second immunization) to enhance a person's immune response to the new H1N1 virus. Consequently, a total of three vaccine shots for the 2009-2010 flu season will likely necessary to provide an immune response that may protect individuals from the various flu viruses. Many doctors think that obtaining three, instead of one, vaccine inoculations will hamper attempts to vaccinate the general population. The WHO said about 1,600 cases of H1N1 are confirmed in about 23 countries worldwide.

5/5/09: The first U.S. death reportedly due to H1N1 virus was reported in Texas in a 33-year-old woman with multiple health issues. Over 400 schools are closed nationwide, but investigators suggest this has not been effective and suggest schools be opened since the virus is already being passed person-to-person in over 35 U.S. states. Mexico today began reducing restrictions on businesses and allowing shops to open because flu cases have begun to decline and the severity of the disease seems much less than first thought.

5/4/09: The U.S. reports a total of over 200 cases of H1N1 swine flu confirmed in about 31 states; currently, there have been no fatalities other than one child (with additional health issues) in Texas that got the disease while in Mexico. CDC officials have cautious optimism that this epidemic may not cause as many severe cases as first thought.

5/3/09: Reports from Egypt indicate many pig farms are killing off their pigs in an effort to prevent spread of "swine flu." Most investigators think this drastic step is not warranted. Canadian officials suggest a pig farm in Alberta was exposed to H1N1 virus when a farmer who visited Mexico returned. The officials say that pigs that test positive for H1N1 are being isolated. This is the first report of H1N1 infection transferred from an infected human to pigs.

5/2/09: The WHO and others jointly put out a notice that said to date there is no evidence N1N1 swine flu virus is transmitted by food, and properly handled and cooked pork or pork products will not be a source of infection.

5/1/09: Pork producers agree with U.S. researchers that "swine flu" should be renamed H1N1 2009 flu because the flu cannot be caught from eating properly cooked pork products. Virus researchers agree that no flu viruses are passed to humans through processed pork products.

Editorial note by Dr. Charles P. Davis:

After about one week, several significant things have occurred with H1N1 influenza A 2009 swine flu virus infections. First, the virus has been documented to spread rapidly from Mexico to the majority of U.S. states and now across borders to Europe, Asia, and South America; it has taken only about one to two weeks to accomplish this. This is good evidence that the virus spreads rapidly from person to person and that a large number of people may develop the disease. Second, with revised data from Mexico about mortality (deaths), the disease may not be nearly as deadly as first speculated. Third, most countries' health authorities are closely monitoring the disease on a daily basis, and the WHO and other national organizations worldwide are sharing data and opening up supplies (antiviral medications). This international cooperation helps everyone to understand and treat this disease. Finally, joint efforts between government agencies and pharmacological companies have already begun to work on producing a vaccine to prevent or reduce the effects of this disease. These efforts and findings that have occurred over such a short period of time should reassure people that although they should be vigilant about ways to avoid getting this disease (especially hand washing), there is no reason to be obsessively protective or to panic about H1N1 influenza A swine flu.

Next: CDC on Swine Flu (H1N1) »

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