Pandemic Influenza Vaccine Production
By Gigi Kwik Grönvall, PhD, October 13, 2005 [download PDF]
Why Influenza Vaccine Production Takes So Long
At present, it takes nearly 9 months to produce currently licensed influenza vaccines. About 6 months before influenza vaccine production starts, manufacturers order specially grown, clean chicken eggs. Millions of 11-day-old fertilized eggs are injected with the influenza seed strains, and, after several days of incubation, multiplying virus fills the eggs. Machines open the eggs and harvest the contents, and the influenza virus is purified several times to separate the virus from the egg proteins. The virus is chemically inactivated so it will not cause influenza. Then the virus is “split” or broken into fragments, which reduces side effects in the people who get the vaccine. The vaccine is then packaged into vials and distributed to vaccine providers in time for September vaccination campaigns. A problem or accident in any step of vaccine production can lead to significant delays. Vaccine production depends on how early the vaccine seed strains are selected for production, how well the strains grow in the fertilized chicken eggs, and whether the production process and the vaccine meet FDA approval. There is little room for manufacturing errors and no potential to scale up the process if there is increased demand. There is now no possibility of developing and producing an effective pandemic influenza vaccine for the 2005-2006 flu season. The production of an effective pandemic vaccine could be possible in 15 to 18 months, if the following actions are taken immediately: - Launch a crash program to develop and manufacture an effective pandemic flu vaccine in quantities sufficient to immunize all Americans and to export (or give away) a significant amount to countries that lack the capacity to make their own vaccine.
- Increase vaccine supply through adjuvants. Adjuvants are immune boosters, which improve the body’s response to vaccines and could dramatically increase the supply of pandemic influenza vaccine. Adjuvant vaccines are licensed in Europe but not in the U.S.
- Clarify Reverse Genetics (RG) intellectual property issues, so that a vaccine seed strain can be readied for production in 10 to 15 days, versus weeks or months. Patents for RG are held by MedImmune and by the Mount Sinai Medical Center in NYC. The World Trade Organization, World Intellectual Property Organization, and/or OECD should be engaged to rapidly resolve these issues so that vaccines can be used worldwide.
- Address liability and regulatory issues for pandemic flu vaccines.
- Improve the demand for influenza vaccine production in normal times, which provides surge capacity in influenza crises.
- Seek advance purchase commitments from countries who will seek to buy vaccine in the midst of a pandemic.
Research Priorities for Pandemic Influenza Vaccine - Increase funding for modern vaccine production. The current method of making influenza vaccines in fertilized chicken eggs is an outdated technology. More modern tissue culture vaccines are being pursued, but results are not expected until 2009—this work should be accelerated.
- Aggressively fund research on broad-range influenza vaccines to provide one-dose, lifelong protection against Type A influenza.
Prepared by the Center for Biosecurity of UPMC, for a briefing on Capitol Hill, October 12, 2005, co-sponsored by Trust for America's Health (TFAH), Senator Barack Obama (D-IL), Senator Olympia J. Snowe (R-ME), Congresswoman Nita M. Lowey (D-NY), the Infectious Diseases Society of America (IDSA), and the Center for Biosecurity of UPMC.
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