Merck's next-gen pneumococcal shot scores FDA nod, setting up high-stakes clash with rival Pfizer

Merck
Pfizer scored FDA approval for its next-gen pneumococcal vaccine a month ahead of Merck. But the New Jersey pharmaceutical giant leads in the race to reach the key market for children. (Merck & Co.)

Let the games begin. Yes, it's a signal for the start of the Olympics. But it's also a call to arms for the next-gen pneumococcal vaccine race.

A month after Pfizer gained an approval for its pneumococcal shot, Merck has done the same.  

With Friday’s FDA nod for Vaxneuvance, Merck has answered Pfizer, whose Prevnar 20 vaccine scored an approval from the U.S. regulator on June 8. Both approvals are for adults.

The companies are now set to embark on a high-stakes market clash, with billions of dollars on the line.

Both of the next-gen shots offer improved protection against bacteria that can cause pneumonia, meningitis and blood infections. While Vaxneuvance defends against 15 different strains of the bacterium, Pfizer’s shot targets 20, seven more than its current blockbuster Prevnar 13, which rang up $5.95 billion in sales in 2020. 

In phase 2 and 3 trials, Merck's Vaxneuvance delivered immune responses superior to Prevnar 13 in the shared serotype 3 and for the two serotypes Prevnar 13 doesn’t cover, 22F and 33F.

The three serotypes are “responsible for substantial disease burden in adults," Roy Baynes, Merck Research Laboratories’ chief medical officer, said in a statement.

In the other 12 shared serotypes, Vaxneuvance delivered comparable efficacy to Prevnar 13, the company said.

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

While Merck has high hopes for its new shot, the company didn't immediately reveal when it would launch Vaxneuvance.

Pfizer has ruled the pneumococcal vaccine market for more than a decade. Prevnar 13 scored approval in 2010 and four years later won the CDC’s backing in adults over age 65, fueling a massive sales surge. 

Looking ahead, Pfizer hopes to retain its dominance by testing Prevnar 20 along with its COVID-19 vaccine. That study, in adults 65 and older, began weeks before Prevnar 20’s approval.

But Merck has a chance to score big with Vaxneuvance as it leads in the race to reach children. Merck has completed a successful phase 3 trial for the shot in kids, and could get an FDA green light by the end of 2021. Children make up roughly 80% of the market for pneumococcal vaccines.

RELATED: Looking for an edge over Merck, Pfizer begins testing its COVID-19 vaccine and next-gen pneumococcal shot together

Merck has sold its Pneumovax 23 vaccine for nearly four decades. While it defends against 23 serotypes, it doesn’t produce as durable an immune response as Prevnar 13.