Pfizer's MenB reach--and lead on Novartis--limited without ACIP nod
As Pfizer's ($PFE) meningitis B vaccine rolls out in the U.S., it may get a head start on Novartis' ($NVS) Bexsero, which is still awaiting FDA approval. But the drug giant still doesn't yet have what it needs to build a considerable lead: a recommendation from the CDC's Advisory Committee on Immunization Practices (ACIP).
After winning the agency's approval late last month for Trumenba, Pfizer has been "working around the clock" to supply the vaccine to the U.S., Susan Silbermann, president of Pfizer's vaccine unit, said in a statement, and as of Tuesday the vaccine is available for order by healthcare providers, retail pharmacies, hospitals and college health centers.
But while drugmakers are good to go once nabbing the FDA's green light, for vaccinemakers, an ACIP nod is key: Not only will physicians oftentimes not use vaccines until they get ACIP's blessing, but many payers won't cover them, either. Pfizer already well knows the value of an ACIP recommendation: In August, its best-selling Prevnar 13 scored a $2 billion boost when the panel endorsed its universal use in adults over 65.
|Pfizer Vaccines President Susan Silbermann|
Both Pfizer and Novartis have already begun making their case with the committee, presenting data at a meeting last year. Now, Silbermann told FierceVaccines in a statement, Pfizer looks forward to a discussion and vote at an upcoming meeting--the earliest of which is slated for February--"to help inform discussions and potential recommendations regarding prevention of meningococcal group B disease through vaccination."
As for Bexsero, which Novartis submitted for FDA consideration the same day Pfizer filed its Trumenba app, the vaccine is still under the FDA's priority review. And while it right now is the only meningitis B vaccine approved outside the U.S., it's been held up in the U.K.--a key market--as government officials and the Swiss pharma's execs haggle over price.
- read Pfizer's release
Pfizer beats out Novartis with FDA MenB nod
FDA sets decision date for Pfizer's MenB candidate
Pfizer's Prevnar gets $2B boost with CDC nod in older adults
Pfizer puts the heat on Novartis with FDA MenB filing
Pfizer prepares to file for approval with positive PhII MenB data
'Breakthrough' nod for Pfizer MenB candidate sets up showdown with Bexsero