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FDA Approves First GMO Vaccine

The Food and Drug Administration has approved a new influenza vaccine for sale in the United States containing genetically modified organisms. The vaccine, Flublok, includes recombinant DNA technology and an insect virus called baculovirus. Insect cells programmed to produce hemagglutinin, a flu virus protein necessary for entry of the virus into the body’s cells.

Flu vaccines have traditionally been made using egg cultures. The GMO ingredients will allow Flublok’s creator, Protein Sciences Corporation, to speed production of Flublok and similar vaccines in the event of a pandemic.

The capacity to quickly generate abundant amounts of vaccines may have drawbacks. Serious side effects potentially associated with GMO vaccines include the deadly nerve disease Guillain-Barre Syndrome.

Further, two test participants died during clinical trials for Flublok. Despite the risk of side effects, Protein Sciences claims the vaccine is safe for human consumption.

In fall 2012 the FDA also approved Novartis’ Flucelvax, a flu vaccine using cells from dog kidneys. The GMO technology behind such vaccines stems from a $1 billion Health and Human Services grant earmarked to examine speedier manufacturing methods.

Corporate media such as the New York Times, CNN, and Reuters also reported on Flublok. However, their reportage highlighted regulatory and corporate pronouncements emphasizing new manufacturing efficiencies and the anticipated safety and effectiveness of the vaccine, while downplaying the dangerous side effects.

Tara Dodrill, “New GMO Flu Vaccine Using Insect Proteins Approved by FDA,”, June 26, 2013,

Joseph Mercola, “First Genetically Energy Flu Vaccine Now on the Market”, Health Impact News, November 1, 2013,

Jonathan Benson,  “FDA approves first GMO Flu Vaccine Containing Reprogrammed Insect Virus,” Natural News, February 8, 2013,

Corporate Media Coverage:
JoNel Aleccia, “FDA Approves Next Generation, Bug Based Flu Vaccine,” NBC News, January 16, 2013, – .UucH0vYo5z8.

Jethro Mullen, “Regulators Approve New Insect-Based Flu Vaccine,” CNN, January 17, 2013,

Andrew Pollack, “Rapidly Produced Flu Vaccine Wins FDA Approval,” New York Times, January 16, 2013,

Julie Steenhuysen, “Insight: U.S. Government Investment Gives Flu Vaccines a Shot in the Arm”, Reuters, Jan 19, 2013
Student Researcher: Ryan Mackey (Florida Atlantic University)

Faculty Evaluator: James F. Tracy (Florida Atlantic University)

  • Aaron January 29, 2014

    You make a poor argument for why this drug is unsafe.

    Yes, 2 people died during the clinical trial. But the FDA website says the trial involved 2,300 people who received the vaccine. 2 people out of 2,300 is a fatality rate of only 0.09%. Even the seasonal flu can have a morbidity rate of 5-10%, and unusual strains like Swine flu can be higher. Please explain how this drug is unsafe.

    People who equate vaccines with being unsafe pose a serious public health problem. Cases of once-cured diseases are starting to rise again because people aren’t getting vaccinations. By spreading misinformation about the safety of vaccines, you are contributing to this problem.

    • Miriad January 30, 2014

      You have failed to understand the article, Aaron. The name of the organization should have given you a clue. ‘Project censored sets out to make available news that is not published by more mainstream sources. Corporate news organizations often have financial and political reasons for either not printing a story or being economical with the truth. The article stresses those pieces of important information that were not included in mainstream news reports. This allows people to make a more informed decision about the product. Nowhere in the article does it suggest the vaccine is inherently unsafe, simply that people should seek more information than is often made available to them by mainstream press.

      Burying the bad news is rife among corporate press sources. The practice is bad for consumers and ordinary citizens. Whether the mortality rate is acceptable or not is a decision people can only make when they know all the facts.

      If you disagree please highlight which parts of the article are, in your opinion, misinformation.

  • debris54 January 30, 2014

    I have never had ANY kind of flu vaccine … I have not been sick, either, in at least 20 years (since I was about 38). Being ill is not a bad thing.. it develops what the body needs to NOT get sick later. Whereas some types of vaccine are lifesaving .. flu is not one of them. The stats on who dies from flu are revealing (if my memory serves me properly)

  • Gary Evans January 31, 2014

    This article suggests that Guillain-Barre is uniquely (potentially) associated with this newly applied technology. It should be understood that Guillain-Barre is known to be associated (rarely) with both traditional influenza vaccination and influenza disease itself. Further, influenza can and does kill many people every year. Although I am not a fan of GMO foods, which are associated with many unanswered questions, the use of genetic technology to produce specific proteins that can be used as vaccines is another matter entirely. These new, specifically applied technologies should allow for much more rapid production of effective vaccines when the inevitable does happen and nature invents a new pandemic, killer strain of influenza.

  • naomi March 12, 2014

    there is also at least one type of insulin – Humalog- that is GMO (with a strain of E. Coli!)

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