Pfizer wins FDA approval of new meningococcal vaccine

23 Oct 2023
www.biopharmadive.com
Drug ApprovalVaccinePhase 3Phase 2
Dive Brief:
The Food and Drug Administration on Friday approved a new meningococcal vaccine, clearing Pfizer’s shot Penbraya in teenagers and young adults for protection against the five most common disease-causing serogroups.
Penbraya is the first vaccine available that can provide such broad protection, which may make it more convenient than current options. While meningococcal disease is rare, it can be serious and even deadly.
Penbraya adds to Pfizer’s infectious disease portfolio, joining the company’s recently approved vaccine for respiratory syncytial virus, or RSV. Yet the company is also adjusting to sharp sales declines for its COVID-19 vaccineCOVID-19 vaccine and antiviral drug.
Dive Insight:
Two types of meningococcal vaccines are already available in the U.S. Some protect against serogroups A,C, W and Y, while other shots, like Trumenba, protect against serogroup B.
The Centers for Disease Control and Prevention recommends children aged 11 or 12 receive a MenACWY conjugate vaccine, followed by a booster at age 16. People 10 years or older who are at higher risk of meningococcal disease should receive a vaccine against serogroup B, according to the CDC.
The multiple shots and spaced-out vaccination regimens leave room for a shot like Penbraya, which is approved for use among people ages 10 through 25.
“Nearly 9 out of 10 adolescents have incomplete protection against invasive meningococcal disease caused by the leading serogroups,” said Jana Shaw, a pediatrics infectious disease specialist at Upstate Golisano Children's Hospital in Syracuse, New York, in a statement provided by Pfizer.
Pfizer said the routine use of Penbraya could reduce cases of invasive meningococcal disease as well as deaths and long-term effects from the infection.
The FDA approved the shot based on positive results from Phase 2 and Phase 3 trials run by Pfizer.
The pharmaceutical giant has continued to focus on its infectious disease business, even as demand for its COVID products has slumped, leading it to cut in revenue forecasts this year by $9 billion.
Pfizer expects its RSV vaccine, Abrysvo, to become a major product in the coming years. Initial signs from the shot’s launch appear promising, company executives have said recently.
“It is a little bit early to see the dynamics of the RSV market, but it looks like it's a really strong demand right now for RSV vaccines,” said Pfizer CEO Albert Bourla at an investment bank conference in late September. “Vaccinations are very, very high — higher than what we thought it would be.”
Abrysvo was first approved in older adults earlier this year. In August, the FDA cleared the shot for use protecting newborns via vaccination of their mothers during pregnancy.
Pfizer is also testing a combination influenza and COVID vaccine, which the company expects could become a regular option for fall vaccinations in the future.
“Clearly, combinations are going to unlock a lot of potential because the convenience of getting one shot in one visit, zero co-pay and full protection of respiratory vaccines is very, very compelling proposition,” Bourla added.
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