Companies struggling to get H1N1 vaccine to U.S.

Tue Oct 27, 2009 3:01pm EDT

By Maggie Fox, Health and Science Editor
WASHINGTON (Reuters) - GlaxoSmithKline has yet to get U.S. government approval for its swine flu vaccine, the company said on Tuesday, while Novartis said it was still struggling to make vaccines.

A U.S. senator accused the Health and Human Services department of over-promising how many and how quickly H1N1 vaccines could be delivered, as disgruntled people lined up outside clinics across the United States seeking immunization.

The United States has contracted with its five suppliers of seasonal influenza vaccine to also deliver H1N1 vaccine, but has sharply cut initial estimates of how much will be delivered this month and next. HHS says companies are having more trouble than anticipated making the vaccine, which is grown in chicken eggs using 50-year-old technology.

Glaxo, which signed a broad agreement earlier this year with HHS for $250 million of pandemic products including vaccines, says its vaccine has yet to be approved by FDA, although it submitted it in September.

"We are working with the HHS to determine how we can best meet their needs and final shipping dates will not be known until these discussions and the regulatory approval process have been completed," said Glaxo spokeswoman Claire Brough.

Australian vaccine maker CSL said it had a new "seed" strain -- the virus sample sent to companies to make vaccine with -- that grows better in eggs.

"This is helping CSL produce more vaccine antigen more quickly than before," a spokeswoman said. She said a new U.S. facility in Illinois got FDA approval in September and was now packaging vaccines.

Novartis was also struggling.

"Yes the yields are lower than initially expected, with delays to the volume available," said spokesman Eric Althoff, adding that the Swiss group had informed the U.S. government about the lower yields through the whole process.

HHS initially predicted it would have distributed 40 million doses of vaccine by the end of October, but only 16 million have been parceled out.

On Tuesday CDC director Dr. Thomas Frieden said 22.4 million doses were now available to states, which can get them a day after they order them.

"It's quite likely that that too little vaccine is one of the things that's making people more interested in getting vaccinated, frankly," Frieden told reporters.

"We think it will get easier to find vaccine in the weeks that come."

AstraZeneca's MedImmune unit has had no trouble producing nasal spray vaccine, which was the first available to the U.S, market, while Sanofi-Aventis said on Friday it was on track to deliver more than 75 million doses.

Maine Republican Senator Susan Collins asked why the estimates were so far off.

"I am troubled that HHS has assured the public since August that the government would have enough vaccine to meet demand," she said in a letter to Health and Human Services Secretary Kathleen Sebelius, released late on Monday. "It now appears that much of the vaccine could arrive only after many people have already been infected with H1N1," she added.
"It seems that HHS gave its assurance of sufficient supply in August without adequate information to make such a commitment."

An HHS spokesman had no immediate comment.