Novel H1N1 Vaccine Approval for 4 of 5 Companies
Four vaccines against the novel (2009) H1N1 virus are now approved, said the US FDA yesterday. Initial lots of the vaccines—which will be made by CSL Biotherapies, MedImmune, Novartis, and sanofi pasteur—are expected to be available within the next 4 weeks. MedImmune is producing a nasal-mist spray vaccine, while the other companies are churning out the conventional shot vaccine.
Last week's late-breaking data indicated that 1 vaccine dose (15 micrograms), instead of the originally anticipated 2, will be sufficient to induce a "robust" immune response in most adult recipients. The optimal dose in children, however, has not been confirmed.
The vaccines are produced by using the same methods as those for seasonal flu vaccines, including viral cultivation in chicken eggs. (WHO nicely explains the vaccine-manufacturing process here.) Consequently people with "severe or life-threatening" allergies to chicken eggs should not receive the vaccine. Vaccines will also be available in preserved (ie, thimerosal containing) and nonpreserved formulations.
Side effects of the injected and nasal-mist vaccines are anticipated to be similar to those seen with the seasonal flu vaccines.
Five companies contracted with the US Department of Health and Human Services (HHS) to create and manufacture a vaccine against the novel H1N1 virus; only GlaxoSmithKline failed to receive vaccine approval yesterday. Reasons for the delayed or deferred approval of GSK's vaccine were not provided by the FDA or the company.
According to a cached version of the web page detailing HHS's contracting activities, the following government orders for novel H1N1 vaccines were made in May and June.
|
Novartis |
$979,144,920 |
|
GSK |
$253,400,000 |
|
sanofi pasteur |
$252,425,000 |
|
CSL Biotherapies |
$180,000,000 |
|
MedImmune |
$96,100,800 |
HHS = Health and Human Services.
Addendum: An updated HHS web page reveals that MedImmune received a total of $151,008,000 in contracts for May and June. The cumulative government spend is therefore $1,815,977,920. With an order of 195 million doses, that's $9.31 per vaccine dose.
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Wow---those order statistics at the end. That's nearly a billion bucks to Novartis alone, and that's just the US market, right? Pre-paid? Wonder what the per-injection price works out to be.
Yes, just the US market.
Dunno the payment specifics, except for the fact that I will see none of the money.
HHS ordered 195 million doses, which works out to $9.03 per shot. The actual vaccine will be "free" (although its development is funded by our tax dollars). The govt will spend another $1.5 billion to facilitate vaccine administration on the local level.