Hoping to boost its chances of FDA approval early next year, Pfizer has unveiled results from a Phase II clinical trial for its meningitis B vaccine, showing that the jab is safe and effective in adolescents when given alongside a licensed vaccine for human papillomavirus.
After initially leaving Novartis' meningitis B jab, Bexsero, off its national immunization program, the British government is now negotiating with the Swiss pharma over price--a series of events that's led a top Novartis Vaccines employee to tab the U.K. vaccination assessment system "flawed."
Pfizer and Novartis are in a dead heat to become the first vaccinemaker to roll out a meningitis B vaccine for the U.S. market. But the New York pharma giant just became the first of the two to snag a decision date from the FDA, which says it will have an answer on Pfizer's candidate within the next 6 months.
Let the negotiations begin. After pushing back on the price of Novartis' meningitis B vaccine, Bexsero, the U.K. is coming to the table with the Swiss drugmaker to see if it can haggle down the cost to its health system.
With Novartis and Pfizer racing for approval in a wide-open U.S. market, the Swiss pharma is taking the opportunity to expand its lead elsewhere, where its vaccine, Bexsero, has an expansive patient pool all to itself. And so far, it's going well, Novartis says.
Stellar Phase II data has helped Pfizer's breakthrough-designated meningitis B candidate surge ahead on its regulatory pathway to catch up with Novartis' Bexsero. And now, with the two companies submitting applications for approval on the same day, whether Pfizer's jab reaches the market first will be up to the FDA to decide.
Novartis' Bexsero, approved in 34 countries, was the world's first marketed vaccine to protect against the deadly meningitis B. And now, it's one step closer to becoming the first in the U.S.--that is, if a Pfizer candidate doesn't beat it to the finish line.
Australian survivors of the deadly meningococcal B strain are mounting pressure on the country's Pharmaceutical Benefits Advisory Committee to include Novartis' Bexsero, the only approved vaccine for the disease, on its national immunization plan when it meets next month.
Last March, Pfizer announced it would file for approval for its meningitis B candidate. Now, it has positive results from a pair of midstage trials for the jab that will keep it on track for expedited approval--and a showdown with Novartis' Bexsero.
Dr. John Porter, formerly the U.K. medical team lead for Pfizer, will become Novartis' medical affairs director for Northern Europe.