Want to know where the money is going? Well, here's some of it. (Also, when they mention "no-preservative" doses, that means that all the others not noted as "no-preservative" have mercury in them. Great idea for your four-year-old, right?)

 

 

Sanofi Has Youngest Kids; Novartis Has Most Doses

Sanofi’s vaccine is approved for the youngest patient cohort (a 0.25 mL no-preservative dose for infants 6-35 months of age). The company will have an exclusive market for small children under 4. Sanofi also has a larger 0.5 mL dose for older children (two shots), adolescents and adults.

Novartis has doses for 4-year olds and up. Based on the dollar size of contracts from Health & Human Services to vaccine manufacturers for H1N1 antigens, Novartis appears to be the largest supplier for the effort to stave off the pandemic.

The emergence of Novartis as the top supplier is a dramatic sign of the impact of the government spending on the vaccine industry over the past six years, where its contracts for new manufacturing capacity, methods and doses against H5N1 (avian) and H1N1 have helped to rebuild vaccine capacity to supply the U.S. market.

Novartis took over the Chiron vaccine business. It was quality control problems at a Chiron UK manufacturing facility that caused the high-profile flu vaccine shortage situation in 2004 that helped focus government attention on rebuilding supply for flu vaccines.

Novartis was awarded about 44% ($496 million) of the HHS contract dollars this year to produce H1N1 antigen. Sanofi received about half that amount: 23% ($252 million) of the bulk antigen contract dollars. That indicates they will deliver about three quarters of the vaccine doses for the program.

GSK Not Among First Approved: Stressing Adjuvant

CSL, the recent entrant into the U.S. flu vaccine market from Australia, has a H1N1 product for adults 18 years and older. CSL received about 16% of HHS antigen contract dollars.

Medimmune’s intranasal, live-virus vaccine is approved in two-doses for children two to nine years of age and in one dose for adults. Medimmune got about 14% of HHS bulk antigen contract dollars.

GlaxoSmithKline did not receive approval with the first group on H1N1 suppliers in the U.S.

GSK said that it submitted a supplemental application to FDA Earlier this month. The company explained that the strain change supplement “is the same as what was granted for other manufacturers today.”

GSK says it is “working with the FDA and HHS to support the government's plans for vaccination in the US. for H1N1 vaccine.”

GSK, however, did not get large contracts from HHS for bulk antigen, only $38 million. GSK received $215 million for bulk adjuvant – when HHS was concerned that it might have to use adjuvanted vaccine to stretch a weak antigen. GSK is supplying H1N1 vaccine in other non-U.S. markets and continues to pursue primarily an adjuvant-oriented strategy. The company just got the first novel adjuvant vaccine (the human papillomavirus product, Cervarix) through an FDA advisory committee the week before.