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FDA Approves Vaccines for Upcoming Flu Season, CDC Updates Recommendations


The U.S. Food and Drug Administration (FDA) last week announced approval of a new vaccine formulation for the 2012-2013 influenza season. In related news, the Centers for Disease Control and Prevention (CDC) issued revised flu vaccine guidelines, keeping in place the recommendation that all people age 6 months and older should receive a vaccine for the upcoming flu season.

The CDC estimates that 5% to 20% of the U.S. population gets influenza each year, leading to more than 200,000 hospitalizations due to related complications. Flu seasons are unpredictable, and influenza-related deaths can range from a low of about 3000 to a high of about 49,000.

FDA Approval

According to an FDA press release, the agency has selected 3 influenza strains for inclusion in this season's trivalent (3 virus) vaccines:

  • A/California/7/2009 (H1N1)-like virus;
  • A/Victoria/361/2011 (H3N2)-like virus;
  • B/Wisconsin/1/2010-like virus.

While the H1N1 strain is the same as the one in the 2011-2012 vaccines, this year’s influenza H3N2 and influenza B strains are different from last season's, the FDA explained.

"Vaccination remains the cornerstone of preventing influenza, a contagious respiratory disease caused by different influenza viruses infecting the nose, throat and lungs," according to the press release. "This year’s seasonal vaccines will provide protection against the three influenza virus strains that global surveillance indicates are likely to be the most common strains circulating during the upcoming season."

"There is always a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness," the agency continued. "However, even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications."

For more information about influenza and vaccination, visit

CDC Recommendations

As it has since 2010, the CDC's Advisory Committee on Immunization Practices recommends that all children older than 6 months and all adults should received an annual influenza vaccination.

As described in the August 17, 2012, Morbidity and Mortality Weekly Report, children age 6 months to 8 years who are being vaccinated for the first time, or who have not been vaccinated since the 2010-2011 season, should get 2 vaccine doses administered 4 weeks apart.

People of all ages above 6 months can receive the trivalent inactivated vaccine, given as an intramuscular injection. Healthy people age 2 years to 49 years may alternatively receive the live-attenuated flu vaccine given by intranasal administration. People with compromised immunity, pregnant women, and older adults should not receive the live influenza vaccine.

"To permit time for production of protective antibody levels, vaccination optimally should occur before onset of influenza activity in the community," according to the recommendations. "Therefore, vaccination providers should offer vaccination as soon as vaccine is available. Vaccination should be offered throughout the influenza season (i.e., as long as influenza viruses are circulating in the community)."

The MMWR report also includes information about febrile (fever) seizures associated with administration of influenza and pneumococcal vaccines, vaccine recommendations for persons with a history of egg allergy (as the live vaccine is grown in eggs), and development of quadrivalent (4 virus) influenza vaccines for future use.



L Grohskopf, T Uyeki, J Bresee, et al. Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP) -- United States, 2012-13 Influenza Season. Morbidity and Mortality Weekly Report 61(32):613-618. August 17, 2012.

Other Source

Food and Drug Administration. FDA Approves Vaccines for the 2012-2013 Influenza Season. Press release. August 13, 2012.