May 11, 2011 (CIDRAP News) – Influenza vaccine production for the US market is likely to head into record territory again this year, with manufacturers' estimates indicating that up to 173 million doses could be made.
On the basis of company projections, the Centers for Disease Control and Prevention (CDC) said the total number of doses is expected to range from 166 million to 173 million. By comparison, 163 million doses were distributed for the 2010-11 season, the agency reported this week.
CDC spokesman Tom Skinner, saying the projected total would be a new record, listed the following production estimates from the five companies making vaccine for the US market:
- Sanofi Pasteur, 70 million doses
- GlaxoSmithKline (GSK), 35 million to 37 million
- Novartis, 30 million to 35 million
- MedImmune, 16 million
- CSL, 15 million
Sanofi, the largest flu vaccine producer for the US market, is aiming at about the same number of doses as it made last year.
"Last year we planned to produce 70 million doses for the US and exceeded this a bit [at] about 71 [million]," company spokeswoman Donna Cary told CIDRAP News.
She said she couldn't give any estimates yet for Sanofi's high-dose vaccine for elderly people, Fluzone High-Dose, or its new intradermal vaccine, just approved by the Food and Drug Administration. As reported previously, only limited amounts of the intradmeral vaccine will be made this year, she noted.
Novartis's projection of 30 million to 35 million doses for 2011-12 signals a decrease from 2010-11. "Last year we shipped approximately 40 million doses," said Liz Power, director of media relations for Novartis Vaccines and Diagnostics. "That was consistent with our projection at last year's Flu Vaccine Summit, 35 to 40 million."
Power said the new projection is based on anticipated demand for the coming season.
This year's vaccine will target the same three flu strains as last season's. Cary and Power said this theoretically should reduce the risk of production problems and delays, but cautioned that there are no guarantees in vaccine production.
"Theoretically [using the] same strains means all manufacturers should be well prepared," said Cary. "One would assume with no strain change that vaccine would be available early. But one never knows what might happen. Production and delivery of more than a hundred million doses of vaccine each year within a few short weeks is a tremendous undertaking, and not all factors are within [the] control of manufacturers."
As an example of how things can go wrong, she noted that last year there was a problem with the documentation for the latex-free status of syringe tip caps, which delayed the shipping of some single-dose, preservative-free vaccine products by several weeks.
Power commented that using the same strains as last year means "we have a good understanding of the strains we're working with and of things like growth characteristics and yields. So it does help us anticipate what's going to be required in terms of production."
But she added, "I'm not sure if that means we'll be ahead of schedule. We were ahead of schedule last year. We plan to start shipping in August and will be shipping through October."
Additional information from the other three manufacturers—GSK, MedImmune, and CSL—was not immediately available today.
Company officials contacted today said they couldn't give any information on how many flu vaccine doses produced last year went unused.
Earlier this week the CDC estimated from its National Flu Survey that 42.3% of the US population received a flu vaccination for the 2010-11 season. Given a US population of about 309 million in 2010, that suggests that roughly 131 million doses were administered. This implies, in turn, that if 163 million doses were distributed, around 32 million doses were not used.
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