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After six people who received the Johnson & Johnson one-dose COVID-19 vaccine developed a type of rare and severe blood clot, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention on Tuesday each said they will seek a "pause" in use of the shots as they review the data.
The six cases involved what's known as a cerebral venous sinus thrombosis (CVST), a rare type of clot "seen in combination with low levels of blood platelets (thrombocytopenia)," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research and Dr. Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement.
"All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination," they said.
According to The New York Times, in one case a woman died and a second woman in Nebraska is in hospital in critical condition.
The agency officials stressed the rarity of the cases: Over 6.8 million doses of the Johnson & Johnson vaccine have so far been put into Americans' arms, their statement noted.
Still, out of "an abundance of caution," the CDC is convening a meeting of its Advisory Committee on Immunization Practices (ACIP) on Wednesday to "further review these cases and assess their potential significance," the statement said. Experts at the FDA will then review the ACIP findings.
As Marks and Schuchat explained, the clots, while "extremely rare," do pose complications in treatment when they arise.
"Treatment of this specific type of blood clot is different from the treatment that might typically be administered," they said. "Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given."
One major reason a data review is needed is so that physicians can be alerted to the potential issue "and can plan for proper recognition and management due to the unique treatment required with this type of blood clot," the two officials said.
In the meantime, "People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider," Schuchat and Marks said.
Such cases have not been reported in the two other vaccines being delivered to Americans, two-dose shots from Pfizer-BioNTech and Moderna. According to the Times, over 23 million doses per week of those shots are now being distributed across the United States.
In a statement, Johnson & Johnson said that "we are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines," the Times reported, and "at present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine." Janssen is the name of the division of Johnson & Johnson that developed the vaccine.
The news came as another blow to vaccination efforts worldwide. In Europe, concerns have been raised over AstraZeneca's COVID-19 vaccine, after 222 similar cases of clotting occurred, out of the 34 million shots administered to people in Britain and the European Union, the Times noted. The AstraZeneca vaccine is not being used in the United States.
The CDC/FDA decision on Tuesday marks another recent setback for Johnson & Johnson's vaccine in the United States.
Before the pause announced Tuesday, the federal government announced that Johnson & Johnson would allocate 86 percent fewer doses of its coronavirus vaccine across the United States this week.
The slowdown came days after federal officials learned that Emergent BioSolutions, a contract manufacturer that has been making both the Johnson & Johnson and the AstraZeneca vaccines in a Baltimore plant, had mixed up ingredients from the two and ruined up to 15 million doses of the Johnson & Johnson vaccine. How big a role that problem has played in Johnson & Johnson distribution woes is hard to determine, the Times said.
Antibody cocktail offers protection
People living with someone who has COVID-19 appear to get powerful protection against infection when they are given Regeneron's antibody cocktail, a new study shows.
The findings suggest that beyond preventing the worst outcomes for coronavirus infection when given early enough, the cocktail could also prevent people from getting sick in the first place, the company said Monday.
"With more than 60,000 Americans continuing to be diagnosed with COVID-19 every day, the REGEN-COV antibody cocktail may help provide immediate protection to unvaccinated people who are exposed to the virus, and we are also working to understand its potential to provide ongoing protection for immunocompromised patients who may not respond well to vaccines," Dr. George Yancopoulos, president and chief scientific officer at Regeneron, said in a statement.
In its statement, Regeneron said it would ask the U.S. Food and Drug Administration to expand the drug's emergency authorization use -- for high-risk people who already have COVID-19 but are not hospitalized -- to allow it to be given for preventive purposes in "appropriate populations."
There's "a very substantial number of people" in the United States and globally who could be a good fit to receive these drugs for preventive purposes, Dr. Myron Cohen, a University of North Carolina researcher told The New York Times. He leads monoclonal antibody efforts for the Covid Prevention Network, a U.S. National Institutes of Health-sponsored initiative that helped oversee the Regeneron trial.
"Not everyone's going to take a vaccine, no matter what we do, and not everyone's going to respond to a vaccine," Cohen noted.
The new data on Regeneron's antibody cocktail comes from a clinical trial that enrolled more than 1,500 people who lived in the same house as someone who had tested positive for the virus within the previous four days. Those who got an injection of Regeneron's drug were 81 percent less likely to get sick with COVID-19 compared to volunteers who got a placebo, the company said.
Dr. Rajesh Gandhi, an infectious diseases physician at Massachusetts General Hospital who was not involved in the study, told the Times that the data were "promising" for people who have not been vaccinated. But he noted that the type of patients that would be needed to determine whether the drug should be used preventively for immunocompromised patients were not included in the trial. "I would say we don't yet know that," Gandhi said.
Regeneron's cocktail, a combination of two drugs designed to mimic the antibodies generated naturally when the immune system fends off the virus, was given to President Donald Trump after he got sick with COVID-19 last fall.
The treatment received emergency authorization last November. Doctors are using it, as well as another antibody cocktail from Eli Lilly, for high-risk COVID-19 patients, to guard against severe disease and hospitalization.
But many hospitals and clinics have not made the treatments a priority because they are time-consuming and difficult to administer, mostly because they must be given via intravenously. Regeneron plans to ask the FDA to allow its drug to be given via an injection, as it was in the latest study, which would allow it to be given more quickly and easily.
COVID cases climb in Midwest as British variant takes hold
As new coronavirus cases soared across the Upper Midwest last week, a top health official said that a highly infectious variant first discovered in Britain has now become the most common source of infections in this country.
"Based on our most recent estimates from CDC surveillance, the B.1.1.7 variant is now the most common lineage circulating in the United States," CDC Director Dr. Rochelle Walensky said during a White House media briefing. There are now nearly 21,000 confirmed cases of the B.1.1.7 variant in the United States, according to the CDC.
Scientists and federal health officials have warned repeatedly that a fourth wave of coronavirus cases could arise in the United States this spring because of the emergence of more contagious variants and the easing of social distancing measures.
In the Upper Midwest, Michigan has been slammed: New cases and hospitalizations there have more than doubled in the last two weeks, and the six metro areas in the United States with the greatest number of new cases relative to their population are all in Michigan, the Times reported.
Several other states in the Upper Midwest have also reported significant increases in new infections and hospitalizations. In Illinois, the daily average for new cases has jumped about 56 percent in the past two weeks, to about 2,832 a day, the Times reported. Hospitalizations have risen about 28 percent from two weeks ago. Meanwhile, Wisconsin and North Dakota have seen their average case counts jump 50 percent or more in the last two weeks.
Nationally, new cases have stalled overall, while hospitalizations have leveled off and deaths remain near an average of about 800 a day, according to the Times.
The U.S. coronavirus case count passed 31.2 million on Tuesday, while the death toll passed 562,000, according to a Times tally.
Worldwide, nearly 137 million cases had been reported by Tuesday, with over 2.9 million dead from COVID-19.
The U.S. Centers for Disease Control and Prevention has more on the new coronavirus.
SOURCES: The New York Times; Associated Press
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