Fighting Back Against H1N1

Last week brought disappointing news in the fight against the novel H1N1 influenza virus. In anticipation of the winter flu season, U.S. health officials had planned to start vaccinating 160 million priority people in October, but they now say vaccine supplies will be limited.

“While we hoped to have had 120 million doses, if everything went well, we know we will have at least 45 million doses,” said Bruce Gellin, director of the National Vaccine Program Office at the Department of Health & Human Services, in a televised broadcast. The delay comes from a slow-growing virus used to make the vaccines. Although initial supplies will be low, the five major producers will continue to crank out 20 million doses per week, he pointed out.

And progress is being made in testing the needed vaccines. NIH is moving ahead with clinical trials in children, who, along with pregnant women and health care workers, are among the priority groups for immunization. The trials were started after safety data came in earlier this month from three adult trials using Sanofi Pasteur and CSL Biotherapies vaccines. Such trials are designed to give regulators the safety and dosage information needed for approval.

FDA has just licensed CSL’s Kankakee, Ill., vaccine packaging facility. Having enough capacity for the final formulation and packaging of pandemic flu vaccines is a top concern in the vaccine community.

Meanwhile, GlaxoSmithKline reports that it has started its first clinical trial of an H1N1 vaccine in Europe and that it will conduct 16 trials across Europe, Canada, and the U.S. Both Baxter International and Sanofi started H1N1 vaccine trials in early August.

Last week, China’s Sinovac Biotech completed its first trial. Positive results included good immunogenicity and protection after one dose. The company will apply to China’s FDA for a production license and hopes to deliver an initial order of 4 million doses to the government by September.

Novavax, in Rockville, Md., also announced positive results in animal studies for its H1N1 viruslike particle vaccine. Unless an emergency arises, however, new vaccine technologies such as Novavax’ may not be used to fight the current pandemic.