Most of Novartis AG’s swine flu vaccine may not reach the U.S. until the first quarter of 2010, almost at the end of flu season, Chief Executive Officer Daniel Vasella said today in an interview on CNBC.
“I feel compassion for those people who are waiting,” he said.
The Basel, Switzerland, drugmaker is the biggest U.S. supplier of the new vaccine, and U.S. health officials have reported the country’s overall supply will reach 28 million doses by the end of the month after previously projecting 40 million to 50 million by mid-October. H1N1 is widespread in 41 states, has hospitalized more than 5,000 and has caused the deaths of 292 people since Sept. 1, 90 percent of whom were younger than 65, the U.S. Centers for Disease Control and Prevention reported Oct. 20.
Production at Novartis is not being held up now, Vasella said today. The initial problem was the lack of antigen, the key ingredient that induces immunity, he said.
“There was one-fifth of the normal yield,” Vasella said.
Novartis received the first seed strains from the CDC and Geneva-based World Health Organization and was forced to go back and get others, Sarah Coles, a spokeswoman for the company, said in an e-mail.
Half the Yield
All the other vaccine makers with contracts to supply to the U.S. -- Paris-based Sanofi-Aventis SA, London-based GlaxoSmithKline Plc and AstraZeneca Plc, and CSL Ltd. based in Melbourne -- received seed strains at the same time to develop the shots, CDC officials have said. The strains yielded half as much antigen as that for a typical seasonal flu, Aphaluck Bhatiasevi, a WHO spokesman, said Sept. 18.
Novartis is moving swiftly to increase the pace of its output including transferring 300 workers to the swine flu vaccine production lines, Vasella said.
U.S. Health and Human Services Secretary Kathleen Sebelius said yesterday there were “manufacturing glitches” because new production lines were set up to accommodate the swine flu vaccine. Sebelius didn’t specify which companies had the glitches. Novartis is contracted to deliver about 35 percent of the 250 million doses ordered by the U.S. government, according to statements from HHS.
Novartis Statement
“Novartis has taken steps to accelerate the post- production process and delivery of vaccine,” according to a statement from the company released after Vasella’s interview. “Among other things, we have prioritized production of pre- filled syringes despite substantially slower filling rates. Along with the low yields, these efforts have led to delays in vaccine supply.”
Novartis began a large-scale fill-and-finish operation on the swine flu vaccine in early September after completing its seasonal flu campaign, the company said in its statement.
AstraZeneca’s MedImmune Inc., producer of a nasal spray version of the vaccine, was about 300,000 doses behind in its production, Karen Lancaster, a company spokeswoman, said Oct. 20. MedImmune, based in Gaithersburg, Maryland, had shipped at least 6.5 million doses to the U.S. government and planned to send a total of 11 million by the end of October, she said.
Sanofi said it began shipping its vaccine on Sept. 29, “a little bit earlier than anticipated,” and was tracking “pretty much on schedule,” Donna Cary, a spokeswoman, said Oct. 20.
CSL was “on schedule” to delivery its 36 million doses, Sheila Burke, a spokeswoman, said Oct. 20.
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