MONDAY, JUNE 18, 2018

FDA says Prevnar 13 effective for adults over 50

Drug reviewers from the U.S. Food and Drug Administration recently announced that Pfizer's Prevnar 13 vaccine was effective for protecting adults over the age of 50 from pneumococcal infections.
According to documents posted on Monday, the reviewers said trials for the vaccine also showed it did not have more safety risks than an older vaccine. These findings may pave the way for a positive vote by outside experts later this week, Reuters reports.
The vaccine is being reviewed under the FDA's accelerated approval process, which means the agency believes the medicine represents an unmet medical need. A panel of experts outside the FDA will consider whether to recommend approval of the drug during a meeting on Wednesday. The FDA will make a final decision in January.
Two trials by Pfizer tested Prevnar 13 against the standard vaccine, Merck & Co's Pneumovax. Merck's vaccine is currently the only vaccine for pneumococcal bacteria approved for adults in the United States. The Prevnar vaccine is currently only approved for children, but Pfizer has said an expanded population of adults could generate more than $1.5 billion in sales for what is already one of the world's biggest selling vaccines, according to Reuters.
Prevnar 13 protects against 13 strains of streptococcus pneumonia, a bacterium responsible for multiple ailments, including meningitis, pneumonia and ear infections. The pneumococcal infection kills thousands of people in the United States each year, many of them 65 years of age or older, according to the Centers for Disease Control and Prevention.
The vaccine is on the brink of becoming one of Pfizer's biggest brands, especially after the $10 billion-a-year cholesterol fighter Lipitor begins facing U.S. generic competition at the end of the month.