Novartis, Sanofi-Pasteur, CSL and Medimmune - with contracts to supply about 95% of the 195 million doses of vaccine for the upcoming H1N1 program - received simultaneous approvals from FDA on Sept. 15.

Health & Human Services Secretary Kathleen Sebelius announced the approvals at a House Energy & Commerce hearing on the status of the pandemic flu response.

Declaring that she saw responding to the H1N1 threat as her first duty at HHS and had gone to the "situation room" tracking the pandemic within an hour of being sworn in, Sebelius expressed confidence that there will be enough vaccine for a full immunization campaign. She noted that the department is now looking at balancing the need for one or two doses. Some age groups - young children - require two doses.

The first priority groups comprise 159 million individuals. HHS has already contracted for 195 million doses from five manufacturers.

The four companies with first approval will be providing a range of dosage forms aimed at different patient groups.

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.

Sebelius credited the speed of the H1N1 vaccine development to spending stretching back into the Bush Administration.

The fast development of an H1N1 vaccine was "possible due to the investments made through ASPR (the assistant secretary for preparedness and response) and BARDA (the Biomedical Advanced Research & Development Authority) over the past six years."

Novartis was awarded about 47% ($496 million) of the HHS contract dollars this year to produce H1N1 antigen. Sanofi received about half that amount: 24% ($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 17% 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 8% of HHS bulk antigen contract dollars.

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

GSK said th at 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 U.S. 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 (Also see "Cervarix Passes Safety Hurdles; FDA Ponders Breadth of Protection Claim" - Pink Sheet, 14 September, 2009.).

Distribution is a Critical Element of Supply

Sebelius also expressed confidence in the central distribution system patterned on the Vaccines for Children experience. The program calls for delivery through a central contractor to up to 90,000 sites, identified by states and local authorities.

The large number of administration sites for the shots include "traditional and non-traditional" providers, Sebelius noted.

The H1N1 vaccine distribution program may in fact expand the network for vaccinations of other products in the future.

The same day that Sebelius was testifying on Capitol Hill, local health representatives at a National Vaccine Advisory Committee meeting in Washington, D.C., said that the distribution of the free H1N1 vaccine was bringing in a broader range of practitioners (including Ob-Gyn doctors important for the vaccination effort for pregnant women). Some of these groups and individual practitioners had not previously participated as strongly in vaccination campaigns.

The local public health officials from Illinois and Colorado suggested that getting the names of these practitioners could help expand the reach of other vaccination programs in the future and could be a major long-term benefit of the H1N1 response.

Bipartisan Credit for Vaccine Rehabilitation

Sebelius made the same point about the long-term benefits of the H1N1 effort in an exchange with Rep. Jane Harmon, D-Calif.

Harmon asked Sebelius whether the H1N1 response "cold be applicable to a pandemic that is more severe, a biological attack or other huge health challenges."

Sebelius was delighted to get the question on the long-term lessons from the pandemic response. "That is a great question," she declared.

"No question that Congress working with the prior administration put in place steps that have been executed over the last six or seven years" that made the fast response this year possible. She praised the added resources within HHS and at the sate and local level.

The bipartisan nature of the support for rebuilding the ability to respond to a public health crisis was stressed as well by several Republican congressmen.

Committee Ranking Member Texas Republican Joe Barton noted that the ability to develop fast response vaccines and create an antiviral stockpile was "not breaking new ground." The work behind those efforts began in 2004, Barton said in his opening comments.

The rush on both sides to claim credit for the public health effort is important as a sign that the support for the vaccine industry may continue past the current pandemic threat. Both sides like to claim a piece of what looks to this point like a successful response.

"At a minimum," the HHS secretary said, "what is happening over the next several months will enhance our entire public health infrastructure."

California Democrat Anna Eshoo ended the hearing by asking Sebelius about progress toward a universal flu vaccine that could protect against various virus strains and the switch away from egg-based vaccine production.

Sebelius said that work on both projects remains underway but noted a universal flu vaccine is not imminent. Eshoo said Congress should continue hearings on the advances. Sebelius, welcoming the chance to keep the dialog with Congress going on support for new technologies, said HHS would be delighted to participate.

-Cole Werble (c.werble@elsevier.com)

FDA Approves Four H1N1 Vaccines: HHS Touts Fast Response and Improved Infrastructure

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