Top 4 influenza vaccine FDA approvals

Influenza vaccine

Following a notably bad year for ‘flu in the US, I take a look at what I think are the top 4 influenza vaccines that recently gained FDA approval in the United States.

In January 2013, the FDA approved this trivalent seasonal influenza vaccine made by Protein Sciences Corp. The very exciting thing about this approval is that, unlike current ‘flu vaccines, Flublok does not use the influenza virus or eggs in its production. Instead, Flublok makes use of a novel recombinant technology to manufacture large quantities of the influenza virus protein, haemagglutinin. The vaccine is thus safe to use in individuals with egg allergies. The technology also harnesses the potential for the vaccine to be produced rapidly in the event of a pandemic.

Fluarix Quadrivalent
Fluarix Quadrivalent was the first intramuscular vaccine to protect against four influenza strains. Approved in December 2012, this four-strain vaccine can protect against the two most common A virus strains as well against both B virus strains. It's thought that the second B strain, which trivalent vaccines did not protect against, was responsible for a large proportion of the influenza cases in the US last year. GlaxoSmithKline (GSK), the manufacturers of the vaccine, say the four-strain shot should be available for the 2013-14 season. Quadrivalent ‘flu vaccines are set to be big news in the coming few years, with an FDA panel recently giving them the nod of approval.

MedImmune FluMist Quadrivalent
Approved by the FDA in February 2012, FluMist Quadrivalent is an upgrade of AstraZeneca's previous FluMist trivalent vaccine. The first quadrivalent vaccine to be approved, FluMist Quadrivalent protects against two A strains and two B strains. Another very clever part about FluMist Quadrivalent is it is inhalable through the nose, doing away with needles and painful arms.

This was the first seasonal influenza vaccine licensed in the US to be produced using cultured animal cells. This novel cell-based approach is different to the usual influenza vaccine manufacture process where virus strains are grown inside of fertilized chicken eggs. Using cell culture rather an egg-based process means that manufacturers are able to maintain an adequate supply of readily available frozen cells to ensure readiness of the vaccine in the event of a pandemic. The vaccine, manufactured by Novartis, was approved by the FDA in November 2012.

Do you agree with my list?

What other ‘flu vaccines do you think should be on the list?

Why not join our discussion on our LinkedIn discussion page.

If you'd like to hear more about strategy and innovation in vaccines, including several talks on the influenza vaccine landscape and influenza vaccine development, you might be interested in attending the World Vaccine Congress & Expo 2013, 16-18 April 2013, at the Gaylord National Hotel and Convention Center, Washington DC.

Comments 1

  1. Tammy Ben-Yedidia

    It seems that the regulatory authorities feel that a change is required in the field of influenza vaccines, they approve changes in manufacturing process and add a 4th virus antigen in the quadrivalent vaccines but the real change needed is approval of vaccine that induces cellular immunity one that is not strain dependent. you may find inteerst in a universal vaccine, based on conserved viral regions that is developed by our company BiondVax, see

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