(Reuters) – The U.S. Food and Drug Administration (FDA) has approved Pfizer Inc’s next-generation vaccine to prevent pneumococcal disease in children aged six weeks to 17 years, the company said late on Thursday.
The vaccine, Prevnar 20, offers more protection against the disease versus the company’s widely-used Prevnar 13 vaccine, by targeting seven more serotypes of the streptococcus pneumoniae bacteria that causes those infections.
The pneumococcal disease can lead to infections in several parts of the body including the lungs, where they can cause pneumonia.
Prevnar 20 has also been approved to prevent a type of ear infection known as otitis media in infants six weeks through five years of age, the company said.
The approval is based on results from mid-stage and late-stage studies that showed the vaccine’s safety and tolerability was similar to Prevnar 13.
About 2,000 cases of the disease occur each year in children under 5 years of age in the United States, according to the Center for Disease Control and Prevention.
(Reporting by Sriparna Roy in Bengaluru; Editing by Subhranshu Sahu)
