The FDA has approved a novel pneumococcal 20-valent conjugate vaccine capable of protecting against 20 serotypes implicated in most cases of invasive pneumococcal disease (IPD) and pneumonia. The new vaccine, dubbed PREVNAR 20, includes an additional seven serotypes responsible for just under half of all US cases of pneumococcal disease and related deaths.
The new FDA approval was based on positive data from three late-stage trials that demonstrated the vaccine's safety and immunogenicity (NCT03760146, NCT03828617, and NCT03835975). More than 6000 vaccine-naive adults as well as adults with prior pneumococcal vaccination participated in these trials.
Prior to the most recent approval of PREVNAR 20, the only available pneumococcal vaccines for use in US adults were the 13-valent pneumococcal conjugate vaccine (PCV13) and 23-valent pneumococcal polysaccharide vaccine (PPSV23).
Compared with PCV13, the new FDA-approved PREVNAR 20 vaccine protects against seven additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, and 33F. These additional serotypes were selected based on a generalized geographic distribution of IPD and the association these serotypes have with patterns of antibiotic resistance as well as disease severity. Overall, the seven additional serotypes in PCV20 account for up to 40% of all pneumococcal disease cases and deaths in the US.
Glen Chun, MD, clinical director of the Mount Sinai National Jewish Respiratory Institute, New York City, told Medscape Medical News in an email that the PCV20 vaccine has the potential to have a significant impact on disease rates and associated morbidity and mortality.
Chun, who wasn't involved in the clinical trials on the vaccine, explained that there are currently over 90 distinct pneumococcal capsular serotypes that have been identified to date. "In the US, more than half of all of the cases of IPD are caused by the 20 serotypes in the new PCV20 vaccine," he added.
"In my experience, there are patients who have received both the PPSV23 and PCV13 and still are affected by IPD and pneumonia," explained Chun. "The severity of disease has been variable in these patients with breakthrough infections. Broadening the coverage based on geographic distribution for IPD only improves protection and coverage against additional pneumococcal disease serotypes."
Panagis Galiatsatos, MD, MHS, assistant professor in the Division of Pulmonary & Critical Care Medicine at Johns Hopkins School of Medicine, Baltimore, Maryland, said in an email to Medscape Medical News he believes the new FDA approval is a smart move, considering the vaccine's breadth of serotype coverage. "But it's not just the quantity of coverage, but also the quality of coverage," he said. "For instance, it covers versions of Streptococcus pneumoniae that are responsible for almost half of all pneumonia cases."
Galiatsatos added that the approval is also a significant development that will likely affect more vulnerable populations, including immunocompromised patients and the elderly. "As a lung doctor and a critical care doctor, I have seen this bacteria ravage vulnerable populations who have never been vaccinated," he said. "I'm very hopeful and excited about the vaccine, because honestly I think it's a game-changer for our most vulnerable adults."
Chun and Galiatsatos have disclosed no relevant financial relationships.
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Cite this: FDA Approves 20-Valent PneumococcalVaccine (Prevnar) - Medscape - Jun 14, 2021.