Meningococcal groups A, B, C, W, and Y vaccine (Pfizer)

Dive Brief:The Food and Drug Administration on Friday approved a new meningococcal vaccine, clearing Pfizers 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 Pfizers infectious disease portfolio, joining the companys recently approved vaccine for respiratory syncytial virus, or RSV. Yet the company is also adjusting to sharp sales declines for its COVID-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 shots 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. '

The FDA on Friday approved Pfizer's pentavalent meningococcal vaccine Penbraya for adolescents and young adults ages 10 through 25 years. Penbraya, which combines the components of Pfizer's Trumenba (meningococcal group B vaccine) and Nimenrix (meningococcal groups A, C, W-135, and Y conjugate vaccine), becomes the first vaccine cleared to prevent the five most common serogroups causing meningococcal disease."In a single vaccine, Penbraya has the potential to protect otherwise healthy adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots," commented Annaliesa Anderson, Pfizer's head of vaccine R&D.The company's submission was supported by results from a randomised Phase III trial comparing Penbraya against currently licensed meningococcal vaccines in more than 2400 participants. Last year, Pfizer reported that the trial succeeded on all of its primary and secondary endpoints. Specifically, Penbraya was found to be non-inferior to licensed vaccines in the US for all five of the serogroups that cause the majority of invasive meningococcal disease. A single dose of Penbraya also met non-inferiority criteria for serogroups A, C, W and Y compared to one dose of GSK's Menveo.Earlier this year, GSK reported that its own pentavalent meningococcal vaccine candidate met all primary endpoints in a Phase III study, including non-inferiority to Menveo, which protects against meningococcal groups A, C, Y and W-135, and the company's licensed meningococcal B vaccine Bexsero.An advisory panel to the US Centers for Disease Control and Prevention (CDC) is set to meet on October 25 to discuss recommendations for the appropriate use of Penbraya in adolescents and young adults.