Health and Science News for Parents
Jan
16

FDA approves a new flu vaccine – with no eggs or virus

written by Tara Haelle

A quickie with more great news related to the flu vaccine – the FDA just approved a new flu shot without eggs or the virus itself in the vaccine. The new vaccine is called Flublok (which made me giggle when I first read it as Flub-lok instead of Flu-block), and it’s a “trivalent” vaccine. Trivalent means it protects against three flu strains, in this case two influenza A vaccines (H1N1 and H3N2) and one influenza B strain.

The vaccine has only been approved today for adults aged 18 to 49, based on two safety and effectiveness studies. In the effectiveness study, 2,300 people received Flublock, and a control group of a similar number received a placebo. The Flublok recipients experienced 44.6% protection against all flu strains during the study, including influenza strains that were not specifically included in the vaccine production.

In the safety study, which included approximately 2,500 people vaccinated with Flublok, the most common side effects were soreness at the injection site, headache, fatigue and muscle aches. These are the same side effects typically seen with other flu vaccines.

What makes this flu vaccine unique from other approved influenza vaccines available in the U.S. is that it doesn’t use egg proteins or even part of the influenza virus itself to trigger antibodies in your body. Instead, it was made with an insect virus called baculovirus whose DNA scientists genetically manipulated.

The vaccine does include an influenza virus protein called hemagglutinin (HA). HA is already in all inactivated flu vaccines because it’s the specific protein that most of our immune system’s antibodies attack when they go after the flu. It’s their primary target because it’s the protein in the flu virus that allows the virus to enter cells during an active flu infection.

Aside from removing the virus and egg proteins (which have raised concerns about individuals with egg allergies) from the vaccine, manufacturing a vaccine with the insect virus and HA can also be faster to produce in the event of a shortage or pandemic. Flu vaccine shortages or overall production can be slowed if eggs or flu vaccines aren’t available in large enough supply. This situation is less likely with the new vaccine.

The FDA reported that Flublok has a 16-week shelf life from its manufacturing date. Protein Sciences Corporation in Meriden, Conn. manufactures the vaccine.

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4 Responses to “FDA approves a new flu vaccine – with no eggs or virus”

  1. I’m excited about this, but it is going to muddle the decision making process a bit. I believe this next season we’ll see the first of the quadravalent (four strain) influenza vaccines. It will be interesting to see how all the new flu vaccines sort themselves out.

  2. Jack Malone

    I have just finished taking part in a clinical trial for the Flublok vaccine to test its safety in ages 50 and older. The vaccine is made from the outer coat of the flu virus called the hemagglutinin or HA protein. The HA protein in the vaccine was produced using recombinant DNA techniques and is designed to match the HAs of specific seasonal flu viruses. It was given as a single IM injection just as other common flu vaccines are given. In my case, there were no side effects whatsoever. Hopefully this vaccine will be available to those 50 and older very soon.

  3. Tara Haelle

    Thanks for the info, Jack, and thanks for participating in the trial for the rest of us :)

  4. Darwy

    Even better; since the baculovirus can be produced in a disposable bioreactor, the time for development, processing, etc is significantly reduced. This means that there’s a better chance that the flu vaccine with match the circulating strains. The old vaccine took months to grow in the egg culture, and then there was the proteins, antibiotics, etc. None of those are needed with the new technology.



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