FDA Approves Merck's Pneumococcal Vaccine As First Shot Designed For Adults

Monday, the FDA approved Merck & Co Inc’s (NYSE: MRK) Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) to protect against 21 strains of bacteria to prevent a severe form of pneumococcal disease.

It’s the first pneumococcal conjugate vaccine specifically designed to protect adults from a bacteria known as pneumococcus that can cause serious illnesses and a lung infection.

Merck currently has two approved pneumococcal shots:

• Vaxneuvance is given to individuals six weeks or older.
• Pneumovax 23 for adults 50 years and older as well as two-year-olds and above who are at an increased risk of the disease.

The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is expected to meet later this month to discuss and make recommendations for using Capvaxive in adults.

In adults 50 years of age and older, Capvaxive covers the serotypes responsible for approximately 84% of invasive pneumococcal disease (IPD) cases, compared to approximately 52% covered by Pfizer Inc’s PFE Prevnar 20 (PCV20), which is allowed in children and adults.

In adults 65 years of age and older, Capvaxive covers the serotypes responsible for approximately 85% of IPD cases, compared to approximately 51% covered by PCV20.

Capvaxive includes eight unique serotypes not covered by other currently approved pneumococcal vaccines; based on the same CDC data, those serotypes were responsible for approximately 27% of IPD cases in adults 50 years of age and older and approximately 30% in adults 65 years of age and older.

Among the clinical data supporting the approval are results from the pivotal Phase 3 STRIDE-3 trial, which evaluated CAPVAXIVE compared to PCV20 in adults 18 and older who had not previously received a pneumococcal vaccine.

The approval is also supported by results from the Phase 3 STRIDE-5 and STRIDE-6 trials evaluating Capvaxive in vaccine-naïve and vaccine-experienced adults.

Reuters noted that the vaccine has a wholesale acquisition price of $287 per dose. Most individuals will likely have access to it at no out-of-pocket cost if it gets a routine recommendation from the CDC’s advisers.

Concurrently, the FDA also approved Merck’s Keytruda (pembrolizumab) in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for primary advanced or recurrent endometrial carcinoma.

This approval marks the third endometrial carcinoma indication and the 40th indication overall for Keytruda in the U.S.

The approval is based on data from the Phase 3 NRG-GY018 trial (KEYNOTE-868), in which Keytruda combo regime followed by Keytruda alone reduced the risk of disease progression or death by 40% in patients whose cancer was mismatch repair proficient and by 70% in patients whose cancer was mismatch repair deficient, compared to placebo with carboplatin and paclitaxel followed by placebo alone.

Price Action: MRK shares closed at $127.50 on Monday.