Flu VaccinesIntroduction

Vaccines in the US are regulated under the FDA’s Center for Biologics Evaluation and Research (CBER). While vaccines have helped to significantly decrease the incidence of or eliminate diseases such as smallpox and polio from the US, in recent years, vaccines seem to have lost power to more mutant viruses such as the flu.


Currently, the FDA has guidelines on the approval of vaccinations. Guidelines include submission of clinical data such as immunogenicity, safety, and pediatric and post-marketing information. The approval process of a vaccine is similar to that of other biologics. The guidelines have served as tools to help guide the production of childhood and booster vaccines such as Tdap, MMR, and varicella. However, they are not sufficient enough to guarantee the production of vaccines for the more mutant diseases such as influenza.

CBER’s Vaccines and Related Biological Products Advisory Committee meets annually to discuss and vote on the next year’s influenza vaccine virus selection. According to the book Inside the FDA by Fran Hawthorne, “CBER was generally slower than CDER […] In 2003 the median review time for priority products at CBER was 12.1 months.” However, flu viruses are constantly changing. CBER’s decision and the flu season are one year apart. The flu virus could have mutated during that period of time to become unresponsive to the vaccine.


Should there be stricter regulations for the influenza vaccine?


There should be stricter regulations for the influenza vaccine if all of the following are true:

1)      The current process fails to produce vaccines that provide sufficient protection against the flu by proving to have consistently low vaccine effectiveness (VE)

2)      This lack of effectiveness has caused significant consequences.


1)      For argument’s sake, we are looking at multiple CDC-recommended vaccines as standards to compare the VE against. DTap is 95% effective in preventing all three diseases that it is immunized against. MMR is a live attenuated vaccine just like the influenza vaccine and is also 95% effective. Varicella, another live attenuated vaccine, is 85% effective. In 2013, the CDC reported an overall VE of 62% for the influenza vaccine. In 2012, the influenza vaccine had a VE of 52%. The lack of effectiveness is mainly due to slow response time to mutation, lack of regulatory data on effectiveness prior to marketing, and lack of regulatory efforts to change the vaccine once the virus has mutated.

2)      In 2013, influenza officially reached epidemic proportions in the US, causing more than 7.2% deaths. The general public has also expressed its disappointment in this year’s flu vaccine being only “moderately effective,” which means 4 out of 10 people who have received the vaccine are still catching the disease. The consequences from the lack of regulations and responses to change are serious for Americans.


Data shows the vaccine is lacking effectiveness and causing an increase in mortality rates. Therefore, there should be stricter regulations for the influenza vaccine.

For more information on this issue, contact the Kulkarni Law Firm.