US Flu Vaccine Manufacturers: Not Enough Quadrivalent Vax Supply

12-Sep-2013 - Last updated on 13-Sep-2013 at 13:52 GMT

New alternative flu vaccines don't have to use eggs or the live virus.

Related tags Flu vaccine Influenza Influenza vaccine

The US FDA approval of the new quadrivalent flu vaccine in June has not quite given manufacturers enough time to meet demand expectations, as production time can take up to about six months.

Sanofi Pasteur said it has completed all of its bulk manufacturing at its Swiftwater, Pennsylvania-based facility and that it expects to release 60 million doses and ship them all out by the end of October, spokeswoman Donna Cary told BioPharma-Reporter.

“This is the first year that the quadrivalent is available in the US and there isn’t that much supply of it,” Cary said, noting that the timing of its approval was the cause rather than a more difficult manufacturing process.

She added that Sanofi could not switch all of its manufacturing processes to support the quadrivalent vaccine and that the supplies for the vaccines with the additional B strain of the virus should be prioritized for children.

Sanofi also produces a standard trivalent vaccine and an intradermal vaccine that Cary said is produced here and then put into its injector at a plant in France.

Another quadrivalent producer, GlaxoSmithKline, said it is releasing eight million doses of quadrivalent vaccine in the US and will be able to ship two million more in October, according to the Wall Street Journal. Spokesman Robert Perry told the Journal that the company expects to increase its manufacturing capacity to as many as 35 million doses of the vaccine for next year’s flu season.

Novartis is also a major producer of the flu vaccine in the US.

No Egg Flu Vaccine

This year will also bring another option for patients and healthcare workers who need the vaccine but might be allergic to the eggs that are required to grow the vaccine in for producing it.

Approved last January, Protein Sciences’ Flublok vaccine, unlike the others, does not use the influenza virus or eggs in its production.

A spokeswoman for Protein Sciences who requested to remain anonymous told us that the company expects to ship 200,000 doses this year from its Meriden, Connecticut facility. However, the company expects to expand its manufacturing capacity to provide between one and five million doses next year after its second facility in Pearl River, NY, is approved by the FDA, she said. That facility was leased from Pfizer.

She noted that one of the main advantages of this manufacturing process is that it’s much faster to produce the vaccine when compared with the standard process.

“We can get product to the fill finish company in about two months,” she said.

Ten percent of all hospitals across the US have placed an order with Protein Sciences for its vaccine though the company said it’s still waiting on the FDA to approve or release this year’s lot. She said that approval should come in October but they haven’t provided a specific date, although there’s "no concern" that they won’t approve the lot.