Meningococcal group B vaccine(Pfizer Inc.)

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.

While Pfizer’s approval has won Penbraya some time to its own on the market, GSK is close behind with its own pentavalent competitor. In the race to secure U.S. approval for the first five-pronged meningitis vaccine, Pfizer has eked out a regulatory win well ahead of its immunization rival GSK. Friday, the U.S. FDA gave a thumbs-up to Penbraya, the commercial moniker for Pfizer’s pentavalent vaccine defending against the most common serogroups behind meningococcal disease. The shot is approved for adolescents and adults between the ages of 10 and 25. Penbraya mixes components from two of the company’s other meningococcal vaccines—Trumenba and Nimenrix—which together tackle serogroups A, B, C, W and Y. Those serogroups account for nearly all invasive meningococcal disease. Prior to Pfizer’s Penbraya approval, protection from all five groups required four injections from two separate vaccines. Chief to Pfizer’s marketing pitch for Penbraya is that the shot needs only be administered twice. The company figures this feature will streamline standard of care and potentially boost the number of people who get vaccinated. The FDA handed Pfizer its regulatory win based on results from the company’s phase 2 and phase 3 trials, which included a late-stage study pitting Pfizer’s pentavalent shot against other meningitis vaccines currently approved in the U.S. Besides Pfizer, GSK’s Bexsero has competed with Trumenba for the meningococcal B vaccine market. GSK also makes Menveo, a vaccine against meningococcal groups A, C, W-135 and Y. Sanofi separately markets its own MenACWY vaccines called Menactra and MenQuadfi. Now, though, Pfizer is poised to disrupt the market with a shot that protects against the serogroups A, B, C, W and Y. Beyond the shot’s approval, the Centers for Disease Control and Prevention’s advisory committee on immunization practices is set to weigh in on how Pfizer’s vaccine should be used on Oct. 25. While Pfizer’s approval has won Penbraya some time to its own on the market, GSK is close behind with its own pentavalent competitor, coded MenABCWY. In May, GSK unveiled study results pitting the investigational MenABCWY vaccine against a combination of Bexsero and Menveo. GSK found its vaccine candidate was noninferior to the Bexsero-Menveo combination in people aged 10 to 25 years across all five of the targeted serotypes.