FDA approves Prevnar 13; ACIP issues recommendations for use

The FDA today approved Pfizer’s Prevnar 13, indicated for the active immunization of children to prevent invasive disease caused by Streptococcus pneumoniae. Just hours after the approval, the Advisory Committee on Immunization Practices recommended changes to the immunization schedule to incorporate the newly approved vaccine.

Pekka Nuorti, MD, a CDC medical epidemiologist who spoke at the committee meeting Tuesday, said the vaccine is approved for use in children 6 weeks through 5 years and includes the seven serotypes in pneumococcal conjugate vaccine 7-valent — 4, 6B, 9V, 14, 18C, 19F and 23F — plus six additional serotypes — 1, 3, 5, 6A, 7F, and the virulent 19A — a growing health threat that accounts for about 10% of the bacterial diseases.

“The approval of Prevnar 13 means that infants and young children in the United States will have access to a pneumococcal conjugate vaccine that provides coverage against 13 serotypes that could potentially result in life-threatening illnesses,” Emilio Emini, PhD, chief scientific officer of vaccine research for Pfizer, said in a press release. “Together, these 13 serotypes are responsible for the majority of invasive pneumococcal disease in the United States. Notably, serotype 19A is now the most common invasive disease-causing serotype in young children.”

The approval of Prevnar 13 was based on the review of 13 phase-3 studies involving more than 7,000 infants and young children. Data from the phase-3 trials support the safety and efficacy of the newly approved vaccine for the prevention of invasive pneumococcal disease in infants and young children.

Prevnar 13 is recommended to be administered as a four-dose series at 2, 4, 6, and 12 to 15 months of age.

The ACIP recommended using Prevnar 13 to immunize infants and toddlers, as well as in children aged 60 through 71 months with underlying medical conditions. They also recommended a supplemental dose for children through 59 months of age who have completed the four-dose immunization series PCV7. In addition, the ACIP said children who have started their immunization series with Prevnar should complete the series by switching to Prevnar 13 at any point in the schedule.

The FDA twice extended its review time for Prevnar 13, after the agency’s Vaccines and Related Biological Products Advisory Committee voted in November to back the vaccine’s approval. Pfizer officials described PCV13 as the “most complex biological product ever submitted for approval,” noting that the agency needed more time to review the vaccine’s application.

Although Prevnar 13 — similar to Prevnar 7 — is currently only approved for use in children, Pfizer is testing the vaccine’s use in patients up to age 18 years, which ACIP members said would likely facilitate the vaccine’s use in older children with underlying conditions. In connection with the approval by the FDA, Pfizer has agreed to certain post-marketing commitments, which involve conducting a study to further evaluate the safety profile of Prevnar 13, a study to evaluate the prevention of overall invasive pneumococcal disease and various studies to evaluate reduction in otitis media. Trials are also ongoing in adults. – by Colleen Zacharyczuk

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