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