FDA approves new type of flu shot
November 21st, 2012
12:34 PM ET

FDA approves new type of flu shot

The Food and Drug Administration has approved a new flu vaccine for adults that is not egg-based, although it hasn't yet been tested on people with egg allergies.

The manufacturing process for the vaccine, called Flucelvax, is similar to the egg-based production method, but the virus strains included in the new vaccine are "grown in animal cells of mammalian origin instead of in eggs," the FDA says.

"The cell-based vaccine is as safe and effective as traditional egg-based vaccine and the technology used to manufacture it is more flexible and reliable than the traditional technology," said Health and Human Services Secretary Kathleen Sebelius in a statement Tuesday.

It is, however, only approved for adults 18 and older, according to the FDA.

The vaccine will not only add to the number of ways to prevent getting the seasonal flu, but provide a weapon should a new flu pandemic emerge.

Even though Flucelvax is the first cell-based flu vaccine approved in the United States, it's been around for five years already. The European Medicines Agency approved the same vaccine, called Optaflu, in 2007.

It's also not the first-ever cell-based vaccine approved in the United States, according to the FDA; polio, smallpox, hepatitis A, rotavirus, rubella, and chickenpox vaccines are produced using cell lines.

The benefit of using the cell-based production method is that is vaccines can be produced much more quickly, within weeks, according to the manufacturer Novartis. Traditional flu vaccine production takes months using specialized eggs.

Having a faster way to manufacture the flu vaccine is especially important when a brand new virus appears that can quickly develop into a pandemic, as seen in 2009 when the H1N1 influenza virus emerged.

That H1N1 pandemic made it even more urgent for health officials to have access to a more quickly produced flu vaccine. Having access to this technology is a big enough deal that the U.S. government has entered into a public/private partnership with the manufacturer, says Dr. William Schaffner, chairman of the Department of Preventive Medicine at Vanderbilt University Medical Center and past president of the National Foundation for Infectious Diseases.

In 2009, a division of HHS joined forces with Novartis to build a state-of-the-art vaccine production facility in Holly Springs, North Carolina, so this cell-based flu vaccine can eventually be manufactured in the United States. That facility is expected to become operational next year.

This is one of three partnerships HHS has established to build facilities that "will use modern cell- and recombinant-based vaccine technologies that have the potential to produce vaccines for not only pandemic influenza but also other threats more quickly and in a more affordable way," according to an HHS statement earlier this year.

While Flucelvax is not produced in eggs, it doesn't automatically mean that it's suited for people with egg allergies; it hasn't been studied in this group of people.

According to FDA spokeswoman Rita Chappelle, the influenza virus reference strains that are adapted for use in manufacturing Flucelvax are obtained from the WHO Collaborating Center, which are grown in eggs. Therefore, she says, "Flucelvax may not be described as completely egg-free."

soundoff (34 Responses)
  1. test


    November 21, 2012 at 15:07 | Report abuse | Reply
  2. pam levy

    Is it true that these cells are manufactured in Dog kidneys?

    November 21, 2012 at 15:17 | Report abuse | Reply
    • Shane

      I can't say for sure, but I'd be more willing to bet it would be pig than dog, since we are more closely related to pigs.

      November 21, 2012 at 17:42 | Report abuse |
    • andrew

      The cell line originates from canine (dog) kidney cells. However, you should not think that dogs are being used in the manufacturing process. It is a cell line that is perpetually maintained and grown in flasks and bioreactors.

      November 22, 2012 at 12:57 | Report abuse |
  3. Shane

    Very good to know. Hopefully it proves to be extremely safe.

    Faster turnaround for vaccine development = fewer deaths in a pandemic.

    November 21, 2012 at 17:41 | Report abuse | Reply
  4. Darlene Buckingham

    Get the vaccine – forget about fresh clean water, clean air, nutritious food, sunshine, exercise – just get a needle and you can drink contaminated water, breath in car exhaust, eat twinkies and never get the flu. Modern medicine is wonderful!

    November 21, 2012 at 17:58 | Report abuse | Reply
    • charleen gillaspie

      You are sick!!!! Don't put anything you don't need into your body...research what is contained in this injection before geting it administered to you or your children.....flu doesn't start until fu shots start .....think about it!!!!

      January 4, 2013 at 12:25 | Report abuse |
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    November 23, 2012 at 01:26 | Report abuse | Reply
  6. Becky

    What are the long term effects? 5, 10, 30 years down the road? Is it possible this could create more health problems rather than be a benefit? Does it really work or is it another medical scheme to trick people into thinking they need it to make the medical community more money? Perhaps we should question and research this stuff rather than taking it as fact.

    December 2, 2012 at 23:07 | Report abuse | Reply
    • charleen gillaspie

      I believe if flu vaccine is not introduced to patients the influenza would not be an issue......The influenza doesn't start until flu shots are given...stop the shots...get rid oif the flu ...That's why Drs are not giving shot any longer...it's government...stop encouraging innoculations to our Americans!!! If you agree start writing to our government!!!!! We are not guinea pigs!!!!

      January 4, 2013 at 12:20 | Report abuse |
  7. registered voter

    Even flu vaccine without mercury preservative, contains elements such as Triton-10, a substance used in industry detergent. These elements are certainly toxic, with them directly injected into bloodstream, even at minute amount, the long term damage to health is unknown or unstudied.

    December 10, 2012 at 17:36 | Report abuse | Reply
  8. hillemanlabs

    Hilleman Laboratories will invest the majority of its resources in the research and clinical assessment of vaccines against strains of diseases prevalent in the developing world, which bears 90% of the global burden of disease.

    December 19, 2012 at 02:16 | Report abuse | Reply
    • charleen gillaspie

      Is this government money...stop with flu vaccines we are not guinea pigs...stop with toxic abuse to humans...We need to being guinea pigs...get to Washington to stop this toxic abuse to Americans and all other humans!!!

      January 4, 2013 at 12:30 | Report abuse |
  9. petercha

    It's about time. Our medicine/vaccine/etc approval systems are far too slow. People die while waiting for things that could save their lives.

    January 9, 2013 at 17:05 | Report abuse | Reply
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  13. Concerned RN

    Flucelvax is NOT an "eggless" flu vaccine. It contains 1% egg. Evidently this is just small enough for the manufacturer to get away with calling it egg-free. I attempted to get this vaccine at my local Walgreen's and was turned away by the pharmacist because I have a severe egg allergy. He stated the vaccine does in fact contains eggs and is not recommended for me. I contacted the manufacturer, Novartis, at 877-683-4732 and this info was confirmed. Go figure. Just trying to get the word out to others.

    November 3, 2013 at 12:33 | Report abuse | Reply
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