Oct 5, 2004 -- The US. faces a significant shortage in flu vaccine. This became evident today after Chiron Corp., manufacturer of the influenza vaccine Fluvirin, announced it is unable to release flu vaccine for at least 3 months. Fluvirin, which is manufactured in England, accounts for almost half of the total US influenza vaccine supply.
It has been recommended that the available flu vaccine be reserved for the following high-risk groups, which are considered of equal priority:
- Children 6 months through 23 months of age.
- Adults 65 years of age and older.
- People with chronic medical conditions such as heart or lung disease.
- Women pregnant during the flu season.
- Residents of chronic care facilities.
- Children on chronic aspirin therapy.
- Healthcare workers with direct patient contact
- Anyone who cares for or lives with children 0-6 months of age
These guidelines have been jointly agreed upon by the CDC (Centers for Disease Control and Prevention), the AAP (American Academy of Pediatrics), and the AAFP (American Academy of Family Physicians).
The inhaled flu vaccine FluMist is appropriate for healthy people 5-49 years of age in close contact with infants 0-6 months of age and for health care workers who are not in contact with severely immunocompromised persons.
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On October 5, 2004, CDC was notified by Chiron Corporation that none of its influenza vaccine (Fluvirin®) would be available for distribution in the United States for the 2004-05 influenza season. The company indicated that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, where Chiron's Fluvirin vaccine is produced, has suspended the company's license to manufacture Fluvirin vaccine in its Liverpool facility for 3 months, preventing any release of this vaccine for this influenza season. This action will reduce by approximately one half the expected supply of trivalent inactivated vaccine (flu shot) available in the United States for the 2004-05 influenza season.
The remaining supply of influenza vaccine expected to be available in the United States this season is nearly 54 million doses of Fluzone® (inactivated flu shot) manufactured by Aventis Pasteur, Inc. Of these doses, approximately 30 million doses already have been distributed by the manufacturer. In addition, approximately 1.1 million doses of live attenuated influenza vaccine (LAIV/FluMist ®) manufactured by MedImmune will be available this season.
Because of this urgent situation, CDC, in coordination with its Advisory Committee for Immunization Practices (ACIP), is issuing interim recommendations for influenza vaccination during the 2004-05 season. These interim recommendations were formally recommended by ACIP on October 5, 2004, and take precedence over earlier recommendations.
Priority Groups for Influenza Vaccination
The following priority groups for vaccination with inactivated influenza vaccine this season are considered to be of equal importance and are:
- all children aged 6-23 months;
- adults aged 65 years and older;
- persons aged 2-64 years with underlying chronic medical conditions;
- all women who will be pregnant during the influenza season;
- residents of nursing homes and long-term care facilities;
- children aged 6 months-18 years on chronic aspirin therapy;
- health-care workers involved in direct patient care; and out-of-home caregivers and household contacts of children aged <6 months.
Other Vaccination Recommendations
- Persons in priority groups identified above should be encouraged to search locally for vaccine if their regular health-care provider does not have vaccine available.
- Intranasally administered, live, attenuated influenza vaccine, if available, should be encouraged for healthy persons who are aged 5-49 years and are not pregnant, including health-care workers (except those who care for severely immunocompromised patients in special care units) and persons caring for children aged <6 months.
- Certain children aged <9 years require 2 doses of vaccine if they have not previously been vaccinated. All children at high risk for complications from influenza, including those aged 6-23 months, who present for vaccination, should be vaccinated with a first or second dose, depending on vaccination status. However, doses should not be held in reserve to ensure that 2 doses will be available. Instead, available vaccine should be used to vaccinate persons in priority groups on a first-come, first-serve basis.
Vaccination of Persons in Nonpriority Groups
Persons who are not included in one of the priority groups described above should be informed about the urgent vaccine supply situation and asked to forego or defer vaccination.
Persons Who Should Not Receive Influenza Vaccine
Persons in the following groups should not receive influenza vaccine before talking with their doctor:
- persons with a severe allergy (i.e., anaphylactic allergic reaction) to hens' eggs and
- persons who previously had onset of Guillain-Barre syndrome during the 6 weeks after receiving influenza vaccine
Source: Centers for Disease Control (www.cdc.gov)
EMERYVILL, Calif., October 5, 2004 -- Chiron Corporation (NASDAQ: CHIR) announced that th UK regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA), has today temporarily suspended the company's license to manufacture Fluvirin® influenza vaccine in its Liverpool facility, preventing the company from releasing any of the product during the 2004-2005 influenza season. Chiron has not released any Fluvirin into any territory, and therefore there is no requirement to recall or withdraw any vaccine.
"Chiron deeply regrets that we will be unable to meet public health needs this season. We take our responsibility to protect human health very seriously," said Howard Pien, president and CEO of Chiron. "Chiron believes in the value of influenza vaccination, and we are committed to taking all necessary actions to ensure an adequate vaccine supply for the 2005-2006 influenza season."
As Chiron conducted its internal quality assurance confirmatory testing in recent weeks, MHRA, in its capacity as the Liverpool production
facility's local regulatory authority, reviewed the test data and the manufacturing processes at the facility. As noted in the company's September 28, 2004, press release, Chiron anticipated that the regulatory review process would be satisfactorily completed in time to allow release of Fluvirin in early October. However, MHRA has asserted that Chiron's manufacturing process does not comply
with UK Good Manufacturing Practices regulations and has suspended the company's Liverpool facility license to manufacture influenza vaccine for three months. Chiron has initiated discussions with MHRA to determine the appropriate corrective actions.
Source: Chiron press release, October 5, 2004