FDA is poised to make final decision before the end of the year following vaccine panel’s favorable vote.
The European Commission has cleared Pfizer’s pneumococcal conjugate vaccine, Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]). The vaccine, acquired by Pfizer through its recently completed $68 billion takeover of Wyeth, is indicated for active immunization to prevent invasive pneumococcal disease, pneumonia, and acute otitis media caused by 13 streptococcus pneumonia serotypes in infants and children from six weeks to five years of age.
Prevenar 13 comprises the same seven serotypes found in the company’s existing pneumococcal conjugate vaccine, Prevenar, plus six additional serotypes: 1, 3, 5, 6A, 7F, and 19A. Pfizer claims the new vaccine represents the broadest serotype coverage of any pneumococcal conjugate vaccine.
The vaccine is given in multiple, staged doses under the European marketing authorization. Pfizer notes it has also been recommended that children up to five years of age who have already been vaccinated using Prevenar should be offered coverage against the additional serotypes covered by Prevenar 13.
FDA’s Vaccines and Related Biological Products advisory committee has voted in favor of clearing Prevenar 13, and the agency is due to make its final decision on December 30. Regulatory filings for pediatric use of Prevenar 13 are in progress in a number of other countries.
The vaccine is separately being investigated in global Phase III trials in adults. Pfizer says that it expects to make regulatory submissions for the adult indication during 2010.
Prevenar was Wyeth’s second biggest-selling product in 2008, with sales of $2.7 billion. Sales in the first quarter of 2009 were $603 million.