Merck's Capvaxive to challenge Pfizer's Prevnar with CDC panel support

Merck's Capvaxive, the first pneumococcal disease vaccine designed specifically for adults, has achieved significant strides in its competition against Pfizer's Prevnar franchise. Recently, the CDC's Advisory Committee on Immunization Practices (ACIP) cast a nearly unanimous vote, with one abstention, advocating for the vaccine's use in millions of adults.

The ACIP's endorsement outlines that Capvaxive should be administered to adults aged 65 and older who have not yet received a pneumococcal conjugate vaccine. Additionally, it is recommended for adults between the ages of 19 to 64 who have specific underlying medical conditions or other risk factors. This decision also includes individuals aged 19 and older who began their pneumococcal vaccination series with Pfizer’s Prevnar 13 but have not completed all the recommended doses of Merck’s Pneumovax 23.

Eliav Barr, M.D., Chief Medical Officer at Merck, remarked that the ACIP vote validates the clinical advantages of Capvaxive for U.S. adults and expressed anticipation for the CDC's final published guidelines.

Capvaxive provides protection against 21 serotypes of the bacterial infection, which account for 84% of pneumococcal disease cases in adults aged 50 and above, based on CDC epidemiologic data. In comparison, Pfizer’s leading pneumococcal vaccine, Prevnar 20, covers 20 serotypes responsible for 52% of the disease within the same demographic.

Despite Capvaxive’s broader coverage, analysts from Leerink highlight that Merck still faces challenges in surpassing Pfizer’s dominant position. The ACIP’s recommendation for both vaccines places them on a level playing field, making it critical for Merck to capitalize on its differentiated coverage to attract purchasers and prescribers.

During the ACIP meeting, extensive discussions led to a postponement in voting on Capvaxive’s recommendation for all adults aged 50 to 64. The committee decided to defer this decision to their next session in October to allow for further analysis. Analysts at Leerink predict that the ACIP will eventually lower the recommended age to 50 and endorse both Capvaxive and Prevnar 20, once again positioning the two vaccines equally.

In the midst of this, Vaxcyte is developing another promising candidate designed to provide the broadest serotype coverage yet, with a 24-valent shot. This development could potentially disrupt the existing competition between Merck and Pfizer.

Merck's Capvaxive joins its 15-valent pneumococcal shot, Vaxneuvance, which yielded $665 million in sales last year. On the other hand, Pfizer's Prevnar generated a remarkable $6.4 billion in revenue in 2023. This significant difference underscores the challenge Merck faces in catching up to Pfizer's longstanding market leadership.

By securing the ACIP’s recommendation, Merck has taken a crucial step forward in the pneumococcal vaccine market. However, the company must continue its efforts to distinguish Capvaxive from Prevnar and leverage its broader serotype coverage to gain a competitive edge. As the landscape evolves with new entries and ongoing evaluations, both Merck and Pfizer will need to strategically navigate to maintain and expand their market positions.

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