Flu vaccine makers begin shipments for US market

Aug 1, 2012 (CIDRAP News) – Over the past few weeks the three companies that make the lion's share of influenza vaccine for customers in the United States have started shipping their first doses for the 2012-13 season.

The vaccines will contain new H3N2 and influenza B components. Some flu vaccine companies are working on quadrivalent vaccines that contain viruses from both influenza B lineages rather than just one, but they are not expected to be available for the 2012-13 flu season.

Flu vaccine makers have projected that they will make up to 149 million doses for the upcoming US flu season.

Yesterday GlaxoSmithKline announced that it has begun shipping its first lots of FluLaval, indicated for people age 18 and older, and Fluarix, approved for those ages 3 and older. The company said in a statement that the first shipments will go to Centers for Disease Control and Prevention (CDC) distribution centers and to healthcare providers.

Earlier, Sanofi Pasteur and Novartis announced that they had started shipping their first doses—Sanofi on Jul 16 and Novartis on Jul 26.

Sanofi, in its announcement, said the shipments were the first of more than 60 million doses of seasonal flu vaccine it planned to deliver to US healthcare providers this season. The company makes Fluzone, approved for use in people age 6 months and older. Besides standard intramuscular injectable vaccine, Sanofi also makes a high-dose version aimed at adults age 65 and older and an intradermal option for adults ages 18 though 64.

The company said it shipped the first doses to Alaska, Hawaii, and the CDC for use in the Vaccines for Children program. Direct shipments to healthcare providers and vaccine distributors will be ongoing, and healthcare providers who have placed reservations will start receiving their first shipments in August, with orders completed by the end of September, Sanofi said.

Chad Hoover, Sanofi's vice president and chief commercial officer, said in the statement that the company realizes the tall challenge providers have in trying to immunize everyone age 6 months and older before flu season starts. "With the confidence of early vaccine delivery, healthcare providers can start immunizing sooner and commit to scheduling immunization clinics throughout the season," he said.

Novartis's announcement said the company started shipping the first of more than 30 million doses of seasonal flu vaccine to US customers. Its vaccine Fluvirin is approved for people ages 4 and older.

Brent MacGregor, Novartis's president of US vaccines and head of Region North America, said, "The influenza vaccine will arrive in time to help meet a significant public health need and allow healthcare professionals to start administering vaccines in the lead up to the influenza season."

Representatives from the two other companies that make flu vaccine for the US market—MedImmune and CSL—told CIDRAP News recently that they are on track with production.

Melissa Garcia, a spokeswoman for MedImmune, said the company is on schedule with production and shipping of 13 million to 14 million doses of FluMist, indicated for those ages 2 through 49. Deb Wambold, a spokeswoman for Merck, which markets CSL's Afluria vaccine, said the company is on track for meeting its delivery obligations, involving up to 13 million doses for the US market.

Afluria is approved for use in people ages 5 and older, but CDC vaccine advisors have recommended that it not be used in children ages 6 months through 8 years because of increased reports of febrile reactions in this age group. However, the advisors said it can be used if no other age-appropriate vaccine is available for kids those ages who are at increased risk for flu complications.

Last October a meta-analysis published in Lancet Infectious Diseases raised questions about the effectiveness of standard flu vaccines. The strict meta-analysis of high-quality randomized controlled trial placed seasonal flu vaccine efficacy at 59% for adults younger than 65, which was lower than commonly cited 70% to 90% estimates.

Despite this, the authors said existing vaccines are the best weapons for protection against flu and should be used until more effective ones are available.

The timing of the Northern Hemisphere flu season varies, and flu outbreaks can occur as early as October, according to the CDC. Flu activity often peaks in January or later and can continue as late as May. The 2011-12 flu season started unusually late and was mild compared with past seasons.

The CDC recommends that everyone age 6 months and older get a flu vaccine each year.

See also:

Jul 16 Sanofi Pasteur press release

Jul 26 Novartis press release

Jul 31 GlaxoSmithKline press release

May 31 CIDRAP News story "Early flu-vaccine production forecast: up to 149 million doses"

CDC 2012-2013 flu season Q and A

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