FDA Approves Expanded Age Indication for Prevnar 13

The United States Food and Drug Administration has recently approved the use of the Pfizer’s pneumococcal vaccine Prevnar 13 for people in the age group of 18 - 49. This approval is an addition to the already approved use of the vaccine to prevent pneumonia for people above the age of 50.//

Prevnar 13 is a pneumococcal polysaccharide conjugate vaccine which was first approved by the European Union (EU) in December 2009. Pneumonia mainly occurs due to the lung infection caused by streptococcal pneumonia bacterium.This vaccine is found to be effective against the 13 strains of the streptococcous pneumonia bacteria which is responsible for causing pneumonia and other diseases. Symptoms of the disease include fever, chills, cough, breathing difficulties and chest pain. The FDA approval for Prevnar 13 is mainly given to prevent pneumococcal pneumonia and invasive disease in adults above the age of 18 years. It is also approved for infants and children between 6 weeks to 17 years of age. This marks the use of Pfizer’s Prevnar 13 to be the only pneumococcal vaccine to be used across the lifespan.

Dr.Luis Jodar, Chief Medical and Scientific Affairs Officer, Pfizer Vaccines said that the expanded age indication for the pneumococcal vaccine will benefit the public to prevent the risk of pneumococcal disease including patients with immunocompromising conditions like HIV, cancer and chronic renal failure.

The expansion of the age indication for the vaccine was made after the decision based on the results of Phase 3 trial of Prevnar 13 in adults who were not previously vaccinated against the disease.

Common side effects of the vaccine were found to be redness, rash, swelling or pain at the injection site, chills, muscle pain, fatigue, vomiting and joint pain.

Source-Medindia