Pfizer, Novartis push for approval of meningitis vaccines
- Pfizer’s rLP2086 and Novartis’s Bexsero are both designed to protect against the B strain of meningococcal bacterium. Both companies are seeking FDA approval for their vaccines for prevention in people between the ages of 10 and 25.
- Both vaccines are on the fast track for approval after receiving “breakthrough therapy” designations from FDA.
- The latest push comes in response to the outbreak of meningitis at Princeton University and the University of California at Santa Barbara (UCSB).
Although the B strain of meningococcal bacterium causes about 40% of all meningitis infections, there is no vaccine to protect against this strain. Clearly there is an unmet medical need. The respective vaccines that have been developed and are being tested by Pfizer and Novartis are both being fast-tracked because of the urgency associated with addressing this infectious disease, which in severe cases can lead to hearing loss, brain damage, kidney disease, amputation or death.
In fact, both vaccines have already been used. During the recent outbreak, Novartis provided almost 30,000 doses of Bexsero at Princeton and UCSB, while Pfizer’s vaccine is being evaluated in 20,000 people in clinical trials.
- www.sundiatapost.com Novartis, Pfizer seek U.S. approval of meningitis vaccines