By David Brown
Washington Post Staff Writer
Thursday, May 7, 2009
Although no final decision has been made to produce a vaccine against the new strain of swine flu, officials at the World Health Organization say they are aware of "pre-production contracts" by wealthy countries that may lay claim to substantial quantities of any that is made.
The worldwide capacity for making a pandemic vaccine is 2 billion doses at the most and possibly as little as 1 billion doses, depending on the uncertainties involving production and dosage. Of that total, the United States has preexisting contracts that would allow it to buy at least 600 million doses.
" 'Claim' is a hard word for me to swallow," said Robin Robinson, head of the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services, which is responsible for much of the nuts-and-bolts planning for a flu pandemic in the United States.
"We have the contractual mechanisms to purchase pandemic or other influenza vaccines," Robinson said yesterday. "We believe the U.S. needs could be satisfied by the capacity that is out there from these contracts."
Robinson said HHS orders could go as high as two doses of vaccine for the entire U.S. population of about 305 million. Two shots may be needed to stimulate immunity against the newly emerged swine-origin H1N1 strain.
The contracts are with Sanofi Pasteur, GlaxoSmithKline and Novartis, all of which make the traditional flu-shot vaccine, which takes four to six months from start to finish. HHS has a contract with MedImmune, which makes smaller amounts of vaccine a different way.
Sanofi Pasteur has two vaccine plants in Swiftwater, Pa. An older one makes about 50 million doses of seasonal vaccine each year, and a new one, which got final approval yesterday from the Food and Drug Administration, has a capacity of about 100 million doses. Both could potentially be used to make a pandemic vaccine, company spokeswoman Donna Cary said this week. Capacity to make pandemic vaccine could potentially be significantly higher at those plants, because a pandemic vaccine contains one-third of the ingredients of a seasonal flu shot, which protects against three flu strains.
Several vaccine makers queried this week were not willing to name the countries or organizations that have pre-booked orders. The exception is Baxter International, which makes relatively small amounts of flu vaccine. A spokesman said this week that it has contracts with Britain and Austria.
GlaxoSmithKline, which makes about 75 million doses of seasonal vaccine in plants in Canada and Germany, is "committed to doing what we can to assist the developing world," spokeswoman Sarah Alspach said yesterday. She cited a donation of 50 million doses of H5N1 "bird flu" vaccine to the WHO in recent years.
In an e-mail exchange earlier in the week, Marie-Paule Kieny, the WHO's director for vaccine research, said: "We don't know who the purchasers are, and I'm not sure this will be publicly available soon." She added, however, that "we are confident that they will be willing to free up supply for WHO, in order to help us assist developing countries."
In a news conference from Geneva headquarters yesterday, she said that a panel of scientific experts will meet next Thursday to provide advice to the organization about whether it should ask manufacturers to start large-scale production. She said that on May 19, WHO Director General Margaret Chan, U.N. Secretary General Ban Ki-moon and executives of the vaccine companies will meet to consider ways "to ensure more equitable access to developing countries, should this vaccine be available."
The potential shortage of vaccine for use in poor countries has some people worried. "If you impose this kind of restriction to equitable access, then it's going to be a tremendous burden on how we control this outbreak," said Jon K. Andrus, an expert in immunization at the Pan American Health Organization, the WHO's office for the Americas.
Even if the new strain continues to cause relatively mild illness, it may be important to vaccinate certain segments of the population, such as pregnant women, who are at higher risk of severe illness and death.