Genetically Modified Flu Vaccine: Flublok

By

Home / Genetically Modified Flu Vaccine: Flublok
If we're hit by another Spanish Flu pandemic, health officials would prefer a vaccine that manufacturers can produce quickly. Image by the U.S. CDC

If we’re hit by another Spanish Flu pandemic, health officials would prefer a vaccine that manufacturers can produce quickly. Image by the U.S. CDC

GMO Vaccine – Is It Safe?

Flublok has been tested in two clinical trials with 2,497 adults aged 18 through 49 years. The most common adverse reactions in participants were pain around the injection site, headache, and fatigue. Serious adverse events (SAE) were collected for six months post-injection. Two participants died during the trial, one in the Flublok group and one in the placebo group. Both deaths occurred more than 28 days after injection and neither was found to be related to the vaccine.

Another safety concern that some people may have is that this is a genetically modified vaccine. Like genetically modified foods, there is limited information about how a GMO vaccine reacts with our own cell structure in the long term. In a study conducted in 1998 by the United States Army Medical Research Institute of Infectious Diseases researchers conclude, “It is unlikely that a recombinant vaccine will be developed to replace an existing licensed human vaccine with a proven record of safety and efficacy.” 

The paper explains that this is due to the high cost of producing the vaccine and the extensive testing by the FDA it would require.  FluBlok was tested in 2 clinical trials, one of which only included a few hundred people; serious adverse events were reported for six months after receiving the vaccine. The FDA approved the vaccine, however, so perhaps the U.S. government didn’t require as much ‘extensive’ testing as expected.

BEVS Technology: Vaccines

This technology, although new for the influenza virus, is not new in science. It has been used for other infectious disease vaccines, such as the human papillomavirus (HPV) vaccine, and vaccinations for SARS, and Ebola. The BEVS technology has also been successfully used to develop therapeutic vaccines for prostate cancer, breast cancer, and diabetes, and has even been used in wound healing, tissue repair, anti-inflammatory diseases, Alzheimer’s disease, and Parkinson’s disease.

Insect Cells, Human Vaccines, and GMO Viruses

Although it may seem strange to use a vaccine grown in insect cells, this process does provide a vaccine for people who are allergic to eggs, and for those who want to avoid preservatives such as mercury in vaccines. This method of making a vaccine is also much faster than growing the virus in chicken eggs, which is a lengthy process – the speed of production could be very helpful in epidemics and pandemics, when vaccines are in high demand and needed quickly. Although there weren’t extensive clinical trials, the vaccine will now be tested in a much larger trial pool – the American public – so more data on the safety and efficacy of the vaccine should emerge over time.

Resources

Pollack, A. Rapidly Produced Flu Vaccine Wins FDA approval. (2013). The New York Times. Accessed February 13, 2013.

Protein Sciences Corporation. FluBlok. Accessed February 13, 2013.

Protein Sciences Corporation. BEVS Platform Technology. Accessed February 13, 2013.

United States Food and Drug Administration. FDA approves new seasonal influenza vaccine made using novel technology. (2013). Accessed February 13, 2013.

Dertzbaugh, MT. Genetically engineerined vaccines: an overview(1998). Plasmid. 39 (2) 100-13. Accessed February 13, 2013.

Leave a Comment

Close Bitnami banner
Bitnami