Notes from BIO: Vaccine Applications to FDA Booming

The Food & Drug Administration expects to receive as many biological license applications for new vaccine products in a four-month period later this year as the agency has ever received in a full year.

The onslaught of applications suggest a big year for vaccine approvals in 2010.

“It is going to be a busy year” for the agency’s Center for Biologics Evaluation & Research, the head of the agency’s biologics review management, Robert Yetter, told an FDA Town Hall meeting here at BIO. FDA is planning for the uptick in applications based on conversations with sponsors and indications from the sponsors of projected filing dates.

The ramp up in applications is tangible evidence of the past five years of accelerated activity in the vaccine field. In 2008, FDA approved three new vaccines: two were new mutli-component products Kinrix (DTaP with polion from GlaxoSmithKline) and Pentacel (DTaP with polio and Haemophilus B from Sanofi-Pasteur); GSK also received approval for its rotavirus product (Rotarix).

The bolus of review applications will hit FDA at an awkward time as FDA deals simultaneously with efforts to support the preparations for a potential return of the H1N1 flu with the next northern hemisphere flu season.

Yetter reported that CBER is already looking at ways to move license applications and supplements for pandemic vaccines “as quickly as we can.” He noted that the agency has developed experience with dealing with emergency licensing procedures for vaccines in recent years. FDA licensed a Sanofi-Pasteur avian flu vaccine in 2007 to allow the federal government to purchase it for the national stockpile. Yetter said that the agency will “use every pathway” to speed vaccines for the H1N1 outbreak.

Yetter pointed out, however, that FDA is patently aware that it cannot take risks or appear to take short-cuts on vaccine approvals in an emergency. He noted that the agency has to be able to convince the public that a vaccine is safe or they went take it even if FDA gets it out for use.

At least two major vaccine manufacturers, Novartis and Wyeth, have important vaccine projects under review which also could get caught up in the increase of workflow at CBER. Novartis has its first meningitis application for Menveo for people 11-55 pending from last August. Wyeth has the key generation shift for the pneumoccoal conjuate franchise active at FDA in a BLA for Prevnar-13 since March 31. The application was okayed for a priority review in early May.