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Merck's (MRK) 21-Valent Pneumococcal Jab Gets FDA Approval

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Merck (MRK - Free Report) announced that the FDA had granted approval to V116, its 21-valent pneumococcal conjugate vaccine (PCV), for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. For the prevention of pneumonia indication, the FDA granted accelerated approval.

The vaccine will be marketed by the trade name of Capvaxive. Capvaxive becomes the first PCV specifically designed for adults to be approved by the FDA. 

Capvaxive targets serotypes that account for approximately 84% of all invasive pneumococcal disease in older adults (50 years and older) in the United States, including eight serotypes not covered by currently licensed vaccines.

Capvaxive’s approval was based on data from four phase III studies conducted across a range of adult populations. In the studies, Capvaxive demonstrated robust immune responses in both vaccine-naïve and vaccine-experienced adult populations.

Merck’s stock has risen 17% so far this year against an increase of 20.2% for the industry.

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Merck has a 15-valent PCV called Vaxneuvance (V114) in its vaccine portfolio that was approved in 2021. Vaxneuvance generated sales of $665 million in 2023, down 2% year over year.

Pfizer (PFE - Free Report) markets a 20-valent PCV called Prevnar-20 (marketed as Apexxnar in the EU) for adults, as well as for infants and children aged six weeks through 17 years of age.

Prevnar 20 includes all the 13 serotypes contained in Pfizer’s 13-valent pneumococcal conjugate vaccine, Prevnar 13, along with seven additional serotypes. Pfizer is also conducting phase III studies to evaluate the co-administration of its Prevnar-20 vaccine with its COVID-19 vaccine.

GSK (GSK - Free Report) has a 24-valent PCV in its pipeline, which is currently in phase II development. The vaccine candidate was added to GSK’s portfolio with the acquisition of the Massachusetts-based privately held biotech Affinivax in August 2022. The vaccine is being developed using the Affinivax Multiple Antigen-Presenting System technology.

In a separate press release, Merck announced that the FDA had granted approval to its blockbuster PD-L1 inhibitor, Keytruda in combination with chemotherapy (carboplatin and paclitaxel), followed by Keytruda monotherapy, for treating adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status. The approval is based on data from the phase KEYNOTE-868/NRG-GY018 study. This marks Keytruda’s third indication of endometrial carcinoma. Keytruda is already approved for certain types of advanced endometrial carcinoma as monotherapy and in combination with Eisai’s Lenvima.

Earlier this week, the FDA approved another PD-L1 inhibitor, AstraZeneca’s (AZN - Free Report) Imfinzi (durvalumab), in combination with carboplatin and paclitaxel, followed by Imfinzi monotherapy for the treatment of adult patients with mismatch repair deficient advanced or recurrent endometrial cancer. The approval for expanded use of AstraZeneca’s Imfinzi was based on data from a prespecified exploratory subgroup analysis by MMR status in the phase III DUO-E study.

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Merck currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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