September 16, 2005
FLU VACCINE FOR 2005-2006 INFLUENZA SEASON
By: John Kasprak, Senior Attorney
You asked for information on vaccine supply for the 2005-2006 influenza season and recommended distribution to priority groups.
The following information derives from the Centers for Disease Control and Prevention (CDC) influenza website (September 7, 2005; http://www.cdc.gov/flu/about/qa/0506supply.htm).
How much vaccine will be available for the 2005-2006 flu season and which manufacturers will be providing it?
Because of uncertainties regarding the production of influenza vaccine, the exact number of available doses and the timing of vaccine distribution are not known at this time. Four manufacturers expect to provide flu vaccine to the U.S. market during 2005-2006. They are: (1) Sarnoff Pasteur, Inc. with projected production of up to 60 million doses of inactivated influenza vaccine (“flu shots”); (2) Chiron Corporation, 18 to 26 million doses; (3) GlaxoSmithKline, Inc., 8 million doses; and (4) MedImmune Vaccines, Inc., producer of the nasal spray influenza vaccine (also called live attenuated influenza vaccine or LAIV), approximately 3 million doses.
What about the problems Chiron faced last flu season?
Last year, Chiron Corp., one of only two manufacturers to produce flu vaccine for the U.S. market in the 2004-2005 flu season, had its license suspended by British regulators for manufacturing problems. The company's Liverpool, England plant experienced bacterial contamination. The three-month suspension effectively prevented the release of any vaccine from the company, thus cutting roughly in half the supply of injectable vaccine available to the United States.
On March 2, 2005, the British Medicines and Healthcare Products Regulatory Agency (MHRA) lifted its suspension of Chiron's license to manufacture flu vaccine (see http://www.fda.gov/bbs/topics/news/2005/new01160.html). Chiron announced on August 31, 2005 that it had passed U.S. Food and Drug Administration (FDA) inspections of its Liverpool facility. As a result, Chiron can produce influenza vaccine for the upcoming flu season. It will be able to deliver the vaccine to this country upon successful production, final testing, and release of the vaccine by FDA to the U.S. market.
Does CDC recommend the distribution of flu shots to “priority groups”?
CDC recommends that certain priority groups receive flu shots until October 24, 2005 to ensure that people who are at highest risk of complications from influenza have access to the vaccine. After that date, all persons will be eligible for vaccination.
The priority groups which should be targeted to receive flu shots prior to October 24, 2005 are:
1. persons aged 65 years and older, with and without chronic health conditions;
2. residents of long-term care facilities;
3. persons aged 2 to 64 years with chronic health conditions;
4. children aged 6 to 23 months;
5. pregnant women;
6. healthcare personnel who provide direct patient care; and
7. household contacts and out-of-home caregivers of children under six months.
The CDC notes that vaccination with the live, nasal-spray flu vaccine is always an option for healthy persons aged 5 to 49 years who are not pregnant. This vaccine is not subject to prioritization and can be given to healthy 5 to 49 year olds at any time, according to the CDC.
Why was the October 24, 2005 date chosen?
According to the CDC, last year the lack of specific guidance on when influenza vaccine could be made more widely available caused confusion and contributed to millions of doses going unused. As a result, CDC heard form state and local health officials, vaccine manufacturers, community vaccinators, and physician groups on the need to provide a clearer, more specific time frame for 2005-2006. CDC worked with these groups to develop a time frame that (1) recognizes the need to make the first doses of vaccine available to people at the highest risk of complications as well as health care workers and those in close contact with children under 6 months of age and (2) ensures that providers can effectively plan and deliver vaccine to others in a timely manner.
Demand for flu shots falls off quickly after November, even when there is a shortage, according to CDC. Its planning team tried to balance two competing priorities: (1) ensuring an ample opportunity to vaccinate those at highest risk for complications from influenza, providers caring for them, and close contacts for children under 6 months old, and (2) allowing ample time to vaccinate other priority groups and those wanting vaccination before demand declines. Community vaccinators and health officials generally need 4 to 5 weeks for optimal planning. The 2005-2006 influenza planning team concluded that October 24, 2005 was the best date to meet these objectives.
What about individuals displaced by Hurricane Katrina?
The CDC recommends influenza vaccination for all people 6 months of age and older who have been displaced by the hurricane and are living in crowded group settings.