After Delay, FDA Approves GSK's Pandemic Flu Vaccine

A GSK version of the pandemic H1N1 vaccine has now been approved by the FDA, says a company press release dated yesterday. The US DHHS has ordered 7.6 million doses of the vaccine to supplement the approximately 250 million doses of vaccine already obtained by the US government. GSK will produce multidose vials of the vaccine, which are expected to begin shipping in December.

The pandemic flu vaccines of 4 companies—CSL, MedImmune, Novartis, and sanofi pasteur—were approved by the FDA in mid-September. GSK's vaccine was delayed by a US government decision to omit immunity-boosting adjuvant (eg, aluminum salts) from all available pandemic flu vaccines, reports the LA Times. (GSK also announced yesterday that it will be donating 50 million doses of its adjuvant-containing pandemic flu vaccine to WHO for use in developing countries.) 

As of November 4, more than 26 million doses of pandemic flu vaccine have been shipped throughout the United States and its territories, according to the CDC. The top 10 recipients have received about half of the supply.

California	2,953,000
Texas	2,092,700
New York and New York City	1,687,100
Florida	1,495,700
Illinois	1,096,600
Ohio	983,500
Pennsylvania	948,600
Michigan	819,100
New Jersey	795,700
Virginia	781,800
Total	13,653,800

According to the HHS, the latest US government spend on pandemic H1N1 vaccines is $2,255,120,945, or about $8.75 per vaccine dose.

Novartis	$979,144,920
MedImmune	$446,668,000
sanofi pasteur	$395,908,025
GSK	$253,400,000
CSL	$180,000,000
Total	$2,255,120,945

DHHS = Department of Health and Human Services.

N.B.--GSK also makes Relenza (zanamivir), an anti-influenza treatment.