Companies struggling to get H1N1 vaccine to US

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 the FDA had released five lots of its vaccine. “In terms of H1N1 vaccine production, CSL is working as quickly and efficiently as possible to manufacture H1N1 vaccine antigen and is making good progress,” a spokeswoman said in an e-mail.

Part of the problem is the “seed” strain - the virus sample sent to companies to make vaccine with - did not grow particularly well in eggs.

NEW STRAIN

“The company is using a new H1N1 virus seed strain which is providing better yields than the original seed strain that all manufacturers were given back in May. This is helping CSL produce more vaccine antigen more quickly than before,” the 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.

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 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.”

Collins cited a Purdue University study that predicted that nearly 60 percent of the American population would be infected with H1N1, of whom a third would fall ill, and that last week would see the peak of infections.

“It seems that HHS gave its assurance of sufficient supply in August without adequate information to make such a commitment,” she said.

An HHS spokesman had no immediate comment.

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* Glaxo has yet to get FDA approval for vaccine

* Senator asked why HHS made promises

* Novartis, CSL working to improve production

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters)