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 has approved a new Pfizer meningococcal vaccine whose simpler dosing schedule is expected to make it easier for children and young adults to get fully vaccinated to protect against a rare infection that can quickly become fatal within 24 hours. Five groups of Neisseria meningitidis bacteria are the most common cause of meningococcal disease, which causes infections of the lining of the brain and spinal cord as well as the blood. For those who survive serious cases of the infection, the effects can still be long lasting. Pfizer already had four of the culprit bacterial groups covered with a vaccine called Nimenrix. Another Pfizer vaccine called Trumenba covers the fifth group of bacteria. Penbraya, the meningococcal vaccine approved by the FDA on Friday, combines Nimenrix and Trumenba in a single shot. The regulatory decision covers use of this new vaccine in those ages 10 through 25. Penbraya is administered as two intramuscular injections given six months apart. Penbraya is a bacterial vaccine. It works by what’s called active immunization, in which the immune system is prompted to produce antibodies against target pathogens. FDA approval of the new Pfizer vaccine is based on the results of clinical trials that compared Penbraya to currently available meningococcal vaccines. Results showed this vaccine was “noninferior,” meaning it was not worse at eliciting an immune response versus the comparator vaccines. “In a single vaccine, Penbraya has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots,” Annaliesa Anderson, senior vice president and head, vaccine research and development at Pfizer, said in a prepared statement. The Phase 3 study for Penbraya enrolled more than 2,400 patients from the U.S. and Europe. The most common adverse reactions were pain at the injection site, fatigue, headache, injection site redness, muscle pain, injection site swelling, joint pain, and chills. The vaccine’s label also cautions that Guillain-Barré syndrome, an immune response that damages nerves, has been reported after dosing of other meningococcal vaccines. The next step for Penbraya is a recommendation from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. This vaccine is the first agenda item for the committee’s next meeting, scheduled for this Wednesday. Pfizer isn’t the only company trying to offer protection against meningococcal infection with fewer shots. GSK’s pentavalent meningococcal vaccine candidate is a combination of that company’s approved vaccines, Bexsero and Menveo. In March of this year, the British pharmaceutical giant reported Phase 3 results showing this vaccine candidate, administered as two doses six months apart, was non-inferior to the two approved GSK meningococcal vaccines.