FDA approvals clear way for flu vaccine marketing

Editor's note: This story was updated Aug 7 to include information about the start of influenza vaccine shipments by Novartis.

Aug 6, 2008 (CIDRAP News) – The six companies that make influenza vaccine for the US market have won federal approval for their version of this year's vaccine, in which all three flu strains used in last year's product have been replaced, the Food and Drug Administration (FDA) announced yesterday.

The FDA announcement clears the way for marketing of the vaccines. At least three vaccine makers have begun shipping vaccine to distributors and providers, according to recent company announcements.

The six manufacturers and their vaccines are CSL Limited, Afluria; GlaoxSmithKline Biologicals, Fluarix; ID Biomedical Corp. of Quebec (a unit of GlaxoSmithKline), FluLaval; MedImmune, FluMist; Novartis Vaccines and Diagnostics, Fluvirin; and Sanofi Pasteur, Fluzone.

In the wake of a relatively poor match between the vaccine and circulating flu strains last season, experts at the World Health Organization and the FDA in February recommended changing all three strains of virus used in the vaccine. In most years only one or two of the three strains are changed.

"One of the biggest challenges in the fight against influenza is producing new vaccines every year," Jesse Goodman, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research, said in a news release. "There is no other instance where new vaccines must be made every year."

Two of the three strains in the 2008-09 vaccine are included in vaccines now being used in the Southern Hemisphere, where the flu season is under way, the FDA noted.

The decision to change all three strains in the vaccine had generated some concern about possible production delays or low yields of the viruses, which are grown in eggs. But Curtis Allen, a spokesman for the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention (CDC) in Atlanta, said today he hasn't heard of any problems growing the strains.

"Vaccine production is always fraught with risk and anywhere along the line things can go wrong, but so far they have not, and we're looking forward to a season with adequate supplies of vaccine," Allen told CIDRAP News.

At a meeting in May, manufacturers estimated they would produce a record total of 143 million to 146 million doses of flu vaccine for the US market this year. Allen said the estimates of vaccine production have not changed since then. Last year 140 million doses were produced.

Allen listed the manufacturers' production estimates as follows: Sanofi Pasteur, 50 million doses; GlaxoSmithKline (including ID Biomedical), 35 million to 38 million; MedImmune, 12 million; Novartis, 40 million; and CSL, 6 million.

Sanofi announced Aug 1 that it had begun shipping the first 1.3 million doses of Fluzone. "Vaccine shipments to healthcare providers and to the [CDC] for distribution through the Vaccines for Children Program will continue through the fall and are planned to be completed in October," the company said in a news release.

The statement indicated that replacing all three strains of virus has not caused any major production problems.

"Introduction of three new strains for the influenza vaccine was unprecedented and could have resulted in a low yield or delay given our tight production timeline. Despite these challenges, we are pleased that once again Sanofi Pasteur has demonstrated its reliability in supplying Fluzone vaccine to the US market," said Wayne Pisano, the company's president and chief executive officer, in the news release.

MedImmune announced yesterday that shipments of FluMist, a nasal-spray vaccine that uses a weakened form of live virus, had begun on Jul 31. In a news release, the company affirmed that it plans to produce about 12 million doses, a record number.

FluMist will be available at some retail pharmacies and supermarkets and in nearly 200 school-based vaccination programs and university health centers, the company said. In addition, the federal government, as in past years, is buying some doses for use in military personnel, officials said.

Novartis announced Aug 7 that it has begun shipping Fluvirin to US healthcare providers. The company said it expects to deliver 20 million doses by the end of September and aims to deliver the remaining 20 million by Oct 31. Officials said the company has added a second manufacturing facility, located in Rosia, Italy, to help supply flu vaccine earlier in the season. The firm's other facility is in Liverpool, England.

"Despite the new composition [of the vaccine], Novartis made sure we were able to deliver a timely and robust supply of influenza vaccine this year," said Rajiv De Silva, president of Novartis Vaccines in the US, in a news release.

This is the first year the CDC is formally recommending flu shots for school-age children, adding about 30 million people to the ranks of those targeted for vaccination. Allen said the total number of those targeted for vaccination—including people at risk for serious flu complications and their close contacts—is about 258 million, or roughly 84% of the population.

See also:

Aug 5 FDA news release
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116933.htm

FDA page with chart of vaccine lot releases
http://www.fda.gov/cber/flu/flu2008.htm

Aug 4 MedImmune news release

Aug 1 Sanofi Pasteur news release
http://www.vaccineplace.com/docs/first_shipment_release.pdf

May 13 CIDRAP News story "Flu experts try to ensure record vaccine doses get used"

Feb 22 CIDRAP News story "FDA endorses overhaul for 2008-09 flu vaccine"

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