Sanofi’s New Four-Strain Flu Vaccine is approved by the FDA

Every year in the United States, influenza poses problems by causing approximately 226,000 hospitalizations. Sanofi Pasteur, the vaccines division of the French Sanofi pharmaceutical company, has the broadest range of available vaccines for 20 infectious diseases. On Monday, June 10, 2013, the company announced that its new four-strain influenza vaccine, Fluzone Quadrivalent, recently obtained its license from the FDA. The license was established for children 6 months of age and older, adolescents, and adults. The vaccine is the newest addition to the Fluzone family of influenza vaccines. The Fluzone vaccines are usually administered to more than 50 million people in the US every year.

The special fact about the new vaccine, Fluzone Quadrivalent, is that it will be the first intramuscular vaccine to give protection against four strains, two A strains and two B strains. Until this year, flu vaccines have only included one B strain. Since the 2001-2002 flu season, two influenza B types perpetrated into the general population infected with the virus. The Influenza B strain is very dangerous, as seen in recent years where up to 44% of pediatric deaths were ascribed to this strain. Therefore, scientists have been trying to come up with a vaccine with two B strains for additional protection. Fluzone Quadrivalent vaccine will be the only one available for the most susceptible of children – 6 months of age.

The Vice President of the United States Scientific and Medical Affairs branch of Sanofi Pasteur, David Greenberg, MD, publicly stated, “Protection against the type B flu strain may be an especially important factor that healthcare providers consider when immunizing children since influenza B causes a substantial number of illnesses, hospitalizations and deaths in the pediatric population.”

Fluzone Quadrivalent will be available for the 2013-2014 influenza season. It will be administered through pre-filled syringes and single-dose vials. It will not contain any preservatives and will not be made with natural rubber latex.

Sanofi has also released safety information for the vaccine. Clinical studies were done nation-wide with the involvement of the Senders Pediatric Clinic in South Euclid, Ohio. The clinical studies, which compared the trivalent form to the new quadrivalent form, showed that the new vaccine was generally safe. However, the most common adverse effects of the vaccine include pain, redness and swelling at the vaccination site, myalgia (muscle ache), malaise, headache, and fever, especially in young children. Sanofi made sure to state that the vaccine does not protect all individuals, and also that the decision to administer the vaccine to any individual should be based on the weighted benefits and risks.

Last December, rival drugmaker, GlaxoSmithKline, won the FDA approval for the first four-strain vaccine, Fluarix Quadrivalent. However, the GSK vaccine was for children 3 years and older. Sanofi’s new vaccine is making waves because of the capacity of the vaccine to act in children as young as 6 months.

The U.S. Centers for Disease Control and Prevention recommends vaccination for all individuals aged 6 months of age and older in the United States.

References:
1. New Four-Strain Influenza Vaccine from Sanofi Pasteur Now Licensed by FDA for Broad Age Range of Children and Adults. Sanofi Pasteur Multimedia Press Release Website. http://www.multivu.com/mnr/61694-sanofi-pasteur-fluzone-quadrivalent-influenza-virus-vaccine-fda-approval
2. U.S Food and Drug Administration. Fluarix Quadrivalent [Internet]. Updated 2013 Mar 11. Available from: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm342391.htm