On a vaccine roll, Pfizer scores FDA nod for Prevnar 13 follow-up ahead of rival Merck

BD vaccine syringe
With an approval in hand for its next-gen pneumococcal vaccine, Pfizer has a leg-up on rival Merck, whose next-gen shot is up for review next month. Merck, however, is further in its development timeline for the shot’s use in children. (Fierce Biotech)(BD)

Another year, another major vaccine approval for Pfizer.

With Tuesday’s FDA nod 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 bacterium, is approved for adults 18 and over. It was fast-tracked for approval in December when the FDA not only accepted Pfizer’s application but set it up for priority review.

Meanwhile, Merck is hammering away at approval for its own next-gen pneumococcal conjugate vaccine, V114, a 15-strain shot. The vaccine scored priority review in January and its action date comes next month. Plus, because of its early study in youngsters, it could follow up with an approval in children a year ahead of Pfizer's.

RELATED: Pfizer’s ‘Prevnar 20’ gets in FDA fast lane as next-gen pneumococcal vaccine race heats up with Merck

Tuesday's Pfizer approval comes on top of its raging success with Comirnaty, its BioNTech-partnered COVID-19 vaccine. While competing COVID shots have struggled with safety concerns and supply issues, Pfizer and BioNTech have become the world’s most reliable and prolific supplier of coronavirus vaccines. Their shot won emergency authorization from the FDA in December and has since won additional nods to expand its use.

Tuesday’s approval strengthens Pfizer’s hold on the pneumococcal vaccine market. Its Prevnar 13 generated sales of $5.95 billion last year, continuing its run as the world’s top-selling vaccine, at least until 2021's COVID revenues are tallied. Prevnar 13 scored FDA approval in 2010, and in 2014 it won the CDC's backing in adults over 65. That CDC decision fueled a blockbuster sales increase during the subsequent years.

Prevnar 20 will tackle the same 13 serotypes included in Prevnar 13, plus seven serotypes associated with high fatality rates, antibiotic resistance and meningitis, the drugmaker says.

In a phase 3 trial of 902 adults who had never had a pneumococcal shot, the next-gen vaccine met its safety objectives across all age groups and most of its immunity objectives. The exception was one of the seven new serotypes, Serotype 8, which narrowly missed its target.

“Today's approval of Prevnar 20 marks a significant step forward in our ongoing fight to help address the burden of pneumococcal disease, including pneumonia in adults, and broadens global protection against more disease-causing serotypes than any other pneumococcal conjugate vaccine,” said Kathrin Jansen, Pfizer’s 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  pneumococcal vaccine use in adults.

RELATED: Ready to square off with Pfizer in next-gen pneumococcal vaccines, a Merck exec says competition’s a good thing

“Adult vaccinations play a pivotal role in helping protect our health and wellness, especially as we age and our immune systems begin to naturally weaken,” said Jane Barratt, secretary general of the International Federation on Aging.

While Pfizer's next-gen shot has the edge over Merck—in both timing and in targeting more serotypes—there still is work to do as it trails Merck in the much-larger pediatric market.

Merck’s V114, based on the same conjugate technology that allows Prevnar 13 to reach children, is further along in its development timeline for kids. The company expects to file that approval late 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 on the market for kids a year before Pfizer. Children make up roughly 80% of the market for pneumococcal shots.

Much is at stake for Pfizer and Merck, according to RBC Capital Markets' Wednesday note to investors.

"The evolution of the pneumococcal vaccine market could have important implications for both companies as Pfizer looks to preserve its nearly $6 billion global Prevnar franchise and with Merck looking for V114 to serve as an important non-oncology growth driver," read the report.