Flu vaccine shipments start for US market

Jul 18, 2011 (CIDRAP News) – Companies that make flu vaccine for the US market announced that they have begun shipping their first doses for the 2011-12 flu season, according to statements from four of the five companies.

The flu vaccine for the upcoming season will contain the same three strains as the previous year, including the 2009 H1N1 strain. In May the US Centers for Disease Control and Prevention (CDC) projected that manufactuers will make a record 166 million to 173 million doses for the US market the upcoming season. Last year the companies distributed 163 million doses.

Also today, the US Food and Drug Administration (FDA) said in a statement that it has approved the flu vaccines made by the five companies.

Sanofi Pasteur, which supplies the largest portion of US flu vaccine, said today that it has started shipping two of the three vaccine products, Fluzone for adults and children and Fluzone High-Dose, which is targeted to those age 65 and older.

Distributors will be receiving regular shipments, and healthcare providers who have reserved vaccine will receive their first shipments by August, with orders completed by early October.

The company projected that shipping for its newest product, Fluzone Intradermal, won't start until late September in limited quantities. The intradermal vaccine was just licensed by the FDA in May. The vaccine features a novel microinjection needle that is 90% shorter than those for other flu vaccines. Sanofi says the product is designed to appeal to adults ages 18 through 64, a group that has the lowest immunization rates.

Last season Sanofi reported limited supplies of the high-dose version of Fluzone, which was also in its first year on the market. However, it expects the vaccine to be widely available to seniors this year.

The vaccine is formulated to increase antibody response to the vaccine in older adults, a group that is higher risk for flu complications and is known to have a lower antibody response following flu immunization. So far the CDC's vaccine advisors have not made a recommendation about the formulation.

Sanofi said it expects to make 70 million doses of seasonal flu vaccine for US customers.

MedImmune, the maker of FluMist, the intranasal live-inactivated virus vaccine, said today that it has begun shipping the first of its 15 million to 16 million doses to US distributors that supply healthcare providers.

Dr Steve Projean, MedImmune's senior vice president of researcher and development, said in a statement, "MedImmune is committed to supporting public health efforts to initiate seasonal influenza vaccination as early as possible each year, greatly widening the window of opportunity for vaccination."

Novartis, maker of Fluvirin, announced Jul 15 that it began shipping the first of its more than 30 million doses to US customers, which it said will help healthcare workers to vaccinate high-risk groups such as seniors and pregnant women early.

Dr Vas Narasimhan, president of Novartis' US vaccine division, said in a statement that vaccine shipments are well ahead of schedule and in ample supply. "The early arrival of the influenza vaccine will allow public health professionals to administer vaccinations weeks ahead of their normal schedule, meeting an important public health need to help protect as many individuals as possible."

On Jul 15 GlaxoSmithKline also announced that it had released its first lots of FluLaval, one of the two influenza vaccines it supplies to the US market. FluLaval is indicated for adults age 18 and older. It said in a statement that it anticipates that shipment of its other vaccine, Fluarix, approved for use in adults and children aged 3 and older, will begin in the next several days.

The company said it expects to supply the US market with 35 million to 37 million doses of seasonal flu vaccine.

CSL Biotherapies, maker of Afluria, is expected to make 15 million doses for the US market, according to an earlier estimate. Information about shipping projections for CSL's seasonal flu vaccine was not immediately available.

On Jun 22 the FDA issued the company a warning letter related to a March inspection of its flu vaccine facilities in Parkville, Australia. The FDA noted several deviations from good manufacturing practices, and questioned what it said was a lack of detail in CSL's response to the inspection report. CSL said it was in the process of preparing a more substantial response about the corrective actions it is taking to address the FDA's concerns.

See also:

Jul 18 FDA news release

Jul 18 Sanofi press release

Jul 18 MedImmune press release

Jul 15 Novartis press release

Jul 15 Glaxo press release

May 11 CIDRAP News story "Record flu vaccine production expected again this year"

Jun 22 CSL statement

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