Pfizer ($PFE) posted positive results in a late-stage study of its Prevnar 13 vaccine. The study of the shot, known as Prevnar in the U.S. and Prevenar in other countries and used to prevent infection by streptococcus pneumonia, showed that the immune response to the vaccine in the 18- to 49-year-old age group was noninferior when compared to the response in the 60- to 64-year-old age group.
The objective was met for all 13 serotypes in Prevnar 13, and the data support a recent regulatory submission to expand the indication of Prevnar 13 in the EU to include adults between 18 and 49 years old. Pfizer will also use study results to support similar planned submissions in other countries.
"Prevenar 13 is the first and only pneumococcal conjugate vaccine for adults, and we continue to study the vaccine in new populations with the aim of broadening its availability," William Gruber, senior vice president of Vaccine Clinical Research and Development at Pfizer, said in a release.
The positive results come less than a month after the World Health Organization granted prequalification for the vaccine in adults over the age of 50, a decision that expanded the global market for the company's lead vaccine.
Prevnar 13 is already approved in 110 countries for infants and young children. But only about 70 countries, including the U.S., approve it for adults over 50.
- see the release
- get more from Reuters
Special Report: Prevnar 13 -- 20 Top-selling Vaccines -- H1 2012
Related Articles:
WHO injects Prevnar 13 with adult prequalification status
CDC delay could temper adult uptake of Pfizer's Prevnar shot
FDA approves Pfizer's Prevnar 13 for adults over 50
FDA experts back Pfizer's Prevnar 13 for older adults