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Another year, another major vaccine approval for Pfizer.
With FDA nod on Tuesday for its next-gen pneumococcal vaccine Prevnar 20, the pharmaceutical giant scored its second major vaccine win in seven months as it crossed the finish line ahead of rival Merck.
The shot, which attacks 20 different strains of the bacteria, is approved for adults 18 years and older. It was accelerated for approval in December, when the FDA not only accepted Pfizers’ application but also set it up for priority review.
Meanwhile, Merck is pushing for approval for its own next-gen pneumococcal conjugate vaccine, V114, a 15-strain shot. The vaccine scored a priority rating in January and the action date is next month. In addition, because of its early study in young people, it could gain approval in children a year earlier than Pfizer’s.
RELATED: Pfizer’s Prevnar 20 enters FDA fast lane as next-generation pneumococcal vaccine race heats up with Merck
Tuesday’s Pfizer approval comes on top of roaring success with Comirnaty, the BioNTech-partnered COVID-19 vaccine. While competing COVID injections have struggled with safety and delivery issues, Pfizer and BioNTech have become the world’s most reliable and prolific supplier of coronavirus vaccines. Their gunshot wound license from the FDA in December and has since gotten additional nods to expand its use.
Tuesday’s approval strengthens Pfizers’ grip on the pneumococcal vaccine market. The Prevnar 13 generated $5.95 billion in sales last year and continued its run as the world’s best-selling vaccine, at least until 2021’s COVID revenues add up. Prevnar 13 achieved FDA approval in 2010 and in 2014won the CDC’s support for people over 65. That decision by the CDC fueled a surge in blockbuster sales in subsequent years.
Prevnar 20 will target the same 13 serotypes as Prevnar 13, plus seven serotypes associated with high death rates, antibiotic resistance and meningitis, the drugmaker says.
In a Phase 3 study involving 902 adults who had never received a pneumococcal shot, the next-gen vaccine met its safety goals for all age groups and most of its immunity goals. The exception was one of seven new serotypes, Serotype 8, which narrowly missed its target.
The approval of Prevnar 20 today marks a significant step forward in our ongoing battle to tackle the burden of pneumococcal disease, including adult pneumonia, and broadens global protection against more disease-causing serotypes than any other pneumococcal conjugate vaccine, said Kathrin Jansen, Pfizers . head of vaccine R&D.
The CDC Advisory Committee on Immunization Practices (ACIP) is expected to meet in October to discuss and update its recommendations on the use of pneumococcal vaccines in adults.
RELATED: Ready to Deal With Pfizer in Next-Generation Pneumococcal Vaccines, a Merck Exec Says Competitions Are a Good Thing
Adult vaccinations play a vital role in protecting our health and well-being, especially as we age and our immune systems begin to weaken naturally, said Jane Barratt, secretary general of the International Federation on Aging.
While Pfizer’s next-gen shot has an edge over Merckin in both timing and targeting more serotypes, there’s still work to be done as it follows Merck into the much larger pediatric market.
Merck’s V114, based on the same conjugate technology that allows Prevnar to reach 13 children, is further along the child development timeline. The company expects to submit that approval by the end of this year, while Pfizer’s application for children is unlikely to come until late 2022.
That difference could allow Merck to get its next-gen shot to the kids’ market a year ahead of Pfizer. Children make up about 80% of the pneumococcal injection market.
According to RBC Capital Markets’ Wednesday note to investors, the stakes are high for Pfizer and Merck.
“The evolution of the pneumococcal vaccine market could have important implications for both companies as Pfizer aims to maintain its nearly $6 billion global Prevnar franchise and seeks with Merck for V114 to serve as a major non-oncology growth engine,” read the report.
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