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Posted by on Nov 11, 2009 in FDA, Infectious diseases, Pharma

After Delay, FDA Approves GSK’s Pandemic Flu Vaccine

After Delay, FDA Approves GSK’s Pandemic Flu Vaccine

Vaccine.jpg

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 companiesCSL, MedImmune, Novartis, and sanofi pasteurwere 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.

bmartin (1130 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.