# 3338
This afternoon the news wires are abuzz with word that Baxter, International Inc. will have a `commercially available swine flu vaccine’ available next month.
By using `cell-based’ technology, they claim to have cut the production time of making a vaccine in half, to just 13 weeks.
First the article making the rounds, then some questions that really ought to be asked, and answered, before we all start rolling up our sleeves.
Swine flu vaccine available next month
June 14, 2009 - 5:29AM
Specialty drug maker Baxter International Inc says it's in "full scale" production of a swine flu vaccine that will be commercially available in July.
The company based in Deerfield, Illinois, made its announcement on Friday, a day after the World Health Organisation (WHO) declared swine flu a global pandemic.
Baxter has said that its patented technology cuts in half the usual time it takes to develop a vaccine - to about 13 weeks instead of 26.
The US Centres for Disease Control and Prevention has reported 45 swine flu deaths nationwide.
It sounds very cut & dried. A commercially available pandemic vaccine in July. Hooray and happy days!
But, is it true?
Without taking anything away from what would be a terrific accomplishment by Baxter - producing a trial batch of H1N1 vaccine in 13 weeks instead of 26 - this article leaves a lot of unanswered questions.
First, this report appears to stem largely from a press release from Baxter International, which appeared on their website yesterday.
This press release has the usual caveats attached (emphasis mine).
This release includes forward-looking statements concerning the company's vaccines products, including with respect to potential delivery timelines. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: continued success in advancing a new technology through full-scale production, including with respect to steps required for finishing and release; remaining regulatory approvals; governments' decisions with respect to orders; and other risks . . . .
If you’ve followed the vaccine manufacturing story over the past few years you are aware that a great deal of hope has been pinned on new `cell-based’ technologies that don’t require the use of eggs to grow the virus.
This article and headline states that a vaccine would be `available next month’, yet I see no mention of animal testing or human clinical trials.
Without these trials (which can take weeks, or even months), we can’t know if this vaccine is safe or the answer to basic questions like - how much antigen will be required per shot, whether an adjuvant will be needed, or whether it will take 1 or 2 shots to convey immunity.
Also not mentioned is how much antigen Baxter will have produced in July, and how much would be coming off the manufacturing line in the weeks and months to follow.
If Baxter is able to deliver a trial lot of vaccine for testing and regulatory approval in July, it will have made an important advancement in the production of a vaccine. They should be congratulated.
But until we know the answers to these and other serious questions (like who will purchase this vaccine), I wouldn’t put too much faith in the idea that very many of us will rolling up our sleeves for a swine flu shot this summer.
Regardless of what you read in the papers.
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