FDA approves Merck vaccine designed to protect adults from bacteria that can cause pneumonia, serious infections
On what date will the advisory panel to the Centers for Disease Control and Prevention discuss the eligibility criteria for the newly approved vaccine?
The advisory panel to the Centers for Disease Control and Prevention will discuss the eligibility criteria for the newly approved vaccine on June 27.
What are the potential business implications for Merck with the approval of this new vaccine, especially in relation to its cancer drug Keytruda?
The approval of Merck's new pneumococcal vaccine, Capvaxive, has significant business implications for the company. Some analysts view Capvaxive as a key growth driver for Merck as it prepares to offset losses from its blockbuster cancer drug Keytruda, which will lose exclusivity in the U.S. in 2028.
The market for pneumococcal conjugate vaccines is currently around $7 billion and could grow to be worth more than $10 billion over the next several years, according to a November note from Cantor Fitzgerald analysts. Merck's newly approved shot could boost its competitive edge in that space, which includes drugmaker Pfizer.
Merck currently markets two pneumococcal shots, but neither is specifically designed for adults. The company's existing shot Vaxneuvance is approved in the U.S. for patients 6 weeks of age and older. Pfizer's single-dose pneumococcal vaccine, Prevnar 20, is the current recommended product for adults. However, Merck expects its new shot to capture the majority of the market share among adults.
The FDA's approval is partly based on Merck's late-stage trial called STRIDE-3 that pitted the vaccine against Pfizer's Prevnar 20 in adults 18 and up who had not previously received a pneumococcal vaccine. Merck's shot, Capvaxive, specifically protects against 21 strains of pneumococcus bacteria to prevent a severe form of pneumococcal disease that can spread to other parts of the body and lead to pneumonia. It's the first pneumococcal conjugate vaccine designed specifically for adults and aims to provide broader protection than the available shots on the market.
In summary, the approval of Capvaxive could significantly boost Merck's revenue and market share in the pneumococcal vaccine market, helping to offset potential future losses from its cancer drug Keytruda.
How does Capvaxive differ from other pneumococcal vaccines currently available on the market?
Capvaxive, Merck's newly approved pneumococcal conjugate vaccine, differs from other vaccines currently available on the market in several ways. First, it is the first pneumococcal conjugate vaccine specifically designed for adults, providing broader protection against the bacteria. The vaccine protects against 21 strains of pneumococcus, including eight strains not covered by any other approved vaccine. These eight strains account for roughly 30% of invasive pneumococcal disease cases in patients 65 years and older. In comparison, Pfizer's Prevnar 20, the current recommended vaccine for adults, targets strains that account for roughly 52% of cases.
The 21 strains covered by Capvaxive account for approximately 85% of invasive pneumococcal disease cases in adults 65 years and older, making it a significant development in the prevention of pneumococcal disease. Moreover, Capvaxive has shown in clinical trials to elicit immune responses to the serotypes responsible for the majority of adult invasive pneumococcal disease, demonstrating its potential to become an important new preventative option for adults.
In summary, Capvaxive stands out from other pneumococcal vaccines due to its specific design for adults, broader protection against pneumococcal strains, and the number of strains it covers, which is higher than any other currently approved vaccine.