H1N1 vaccine: low yield and FDA footdragging behind delays

Vaccine Output Falls Short - Less Than Half of Expected Supply Is Delivered


The U.S. has purchased H1N1 vaccines from Sanofi-Aventis SA, Novartis AG, CSL Ltd., GlaxoSmithKline PLC and and MedImmune, which is a unit of AstraZeneca PLC.

The process has been slower than usually seen with seasonal vaccines. Viruses for both vaccines go through a purification process after being grown in eggs.

One problem is that Glaxo, which has contracted to provide 7.6 million doses of vaccine to the U.S., has yet to get Food and Drug Administration approval for its vaccine.

A Glaxo spokeswoman said she couldn't speculate on the timing of approval. The FDA declined to comment.

Novartis, which contracted to make 90 million vaccine doses for the U.S., saw a yield just one-fifth of what was expected after working with the first H1N1 "seed" virus to grow the vaccine. Novartis and other manufacturers are now working with another seed virus that they hope will yield better results.

Novartis officials said they expect to be able to produce 90 million to 120 million doses by year end, suggesting the U.S. likely won't get its entire order filled until the first part of next year, as the company is also supplying vaccine to other countries.

The head of Novartis's vaccine business, Andrin Oswald, said the low yield was the main reason for production delays. But he also said the U.S. request for a greater amount of its vaccine order in single-dose syringes was slowing the process.

Comment: Is there a way to develop the vaccine without eggs?

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