A pediatric pneumococcal vaccine has been approved for use in adults aged 50 years and older for preventing pneumonia and invasive disease caused by Streptococcus pneumoniae, the Food and Drug Administration announced last week.
The approval of Prevnar 13, a pneumococcal 13-valent conjugate vaccine, "provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group," Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement announcing the approval, issued on Dec. 30. Pneumococcal disease is "a substantial cause of illness and death," and about 300,000 adults aged 50 years and older are hospitalized for pneumococcal pneumonia annually in the United States, she added.
Prevnar 13, manufactured by Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer, was approved in 2010 for children aged 6 weeks through 5 years for the prevention of invasive disease caused by 13 serotypes of S. pneumoniae, and for the prevention of otitis media caused by seven S. pneumoniae serotypes.
The approval in adults is an accelerated approval, which is used to approve products that have meaningful clinical benefit over existing treatments for serious and life-threatening illnesses, based on studies using surrogate effectiveness end points considered reasonably likely to predict clinical benefit. A product can be approved under the accelerated approval regulation if a follow-up clinical study confirming the anticipated clinical benefits is conducted.
The accelerated approval was based on randomized studies comparing immune responses to Prevnar 13 or Pneumovax 23 (a 23-valent pneumococcal vaccine approved in 1983 for children and for adults aged 50 and older) in more than 2,000 patients aged 50 and older in the United States and Europe.
"The studies showed that for the 12 common serotypes, Prevnar 13 induced antibody levels that were either comparable to or higher than the levels induced by Pneumovax 23," according to the FDA statement. Pain, redness, and swelling at the injection site; fatigue; headache; chills; and generalized muscle pain were among the common adverse reactions associated with Prevnar 13; these were similar to those with Pneumovax 23, the FDA statement said.
To meet postmarketing requirements, the manufacturer is conducting a study of more than 84,000 people aged 65 years and older who have not received Pneumovax 23. The goal is to evaluate whether Prevnar 13 is effective in preventing the first episode of community-acquired pneumonia caused by the 13 serotypes in the vaccine, according to the Dec. 30 statement issued by Pfizer announcing the approval. The company is also conducting a study to evaluate the concomitant use of Prevnar 13 and the annual influenza vaccine in adults aged 59 years and older who have previously received the conventional pneumococcal polysaccharide vaccine.
At a meeting on Nov. 16, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 14-1 that the immunogenicity data on the vaccine supported its effectiveness in preventing pneumococcal disease caused by the serotypes contained in the vaccine in people aged 50 and older and that the available data supported its safety in this older age group. At the meeting, Pfizer officials presented data that found that concomitant administration of Prevnar 13 with the trivalent influenza vaccine did not affect responses to the antigens in the influenza vaccine, but immune responses to Prevnar 13 were lower when the two vaccines were coadministered than when Prevnar 13 was given alone.
Now that it has been approved, the vaccine is expected to be on the agenda of the February meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.