Merck’s Pneumococcal Vaccine Claims FDA Breakthrough Therapy Designation

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The U.S. Food and Drug Administration granted Merck’s investigational 21-valent pneumococcal conjugate vaccine (V116) Breakthrough Therapy Designation. The vaccine is for the prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia.

It is specifically designed to target 21 serotypes that cause more than 85% of all invasive pneumococcal disease cases in people 65 and over in the U.S. The designation is for adults 18 years of age and older.

The company plans to initiate Phase III trials for V116 later this year. The FDA made its decision based in part on data from the Phase I/II V116-001 trial that evaluated a single dose of the vaccine in pneumococcal vaccine-naïve adults 18-49 years of age (Phase I) and 50 years of age and older (Phase II). The company plans to present full results from those studies in June 2022 at the International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD).

The Breakthrough Therapy Designation was developed to expedite the development and review of drugs and therapies for serious or life-threatening conditions. The preliminary data must show the product is substantially better over currently available options for at least one clinically significant endpoint.

“V116 is specifically designed to address strains of disease-causing pneumococcal bacteria that are most prevalent in adults, reflecting our population-specific approach to developing pneumococcal conjugate vaccines,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer of Merck Research Laboratories. “We look forward to discussing the ongoing development of this investigational vaccine, including the approach for Phase III studies, with the FDA and other regulatory agencies.”

On July 19, 2021, the FDA approved Merck’s Vaxneuvance, which is a 15-valent S. pneumoniae vaccine. Instead of the 21 serotypes in V116, it only had 15. Different strains or variants of the S. pneumoniae bacteria are linked to varying levels of disease. Invasive pneumococcal disease (IPD) occurs when the bacteria-infected organs or tissues are typically germ-free. IPD is most common in individuals 50 years of age and older. Serotypes 3, 22F and 33F are the most common causes, and serotype 3 is the leading cause of the disease in the U.S.

Vaxneuvance and V116, are pneumococcal conjugate vaccines, utilizing materials from 15 (or 21) different strains of the bacteria. The vaccines are built of purified capsular polysaccharides from the bacterial serotypes that are individually linked to a CRM197 carrier protein.

Vaxneuvance was approved in Europe on Dec. 15, 2021.

Although COVID-19 is viral and pneumococcal disease is bacterial, there are similar considerations in terms of developing vaccines that prevent multiple strains of the diseases. Currently, the FDA is considering a “multivalent” approach to COVID-19. On April 6, the FDA’s Vaccines and Related Biological Products Advisory Committee met to discuss a strategy for COVID-19, particularly in the context of including vaccines that target more than one strain of SARS-CoV-2 and possibly recommending the vaccine at the same time as an influenza vaccine, and the possibility of a vaccine that protects against both influenza and COVID is not out of the question.

One of the points of discussion was that the FDA doesn’t have a clear plan for approving vaccines targeting new SARS-CoV-2 variants or deciding when or if people will need yet another dose. They did express, however, concerns that a decision and actions needed to be taken prior to fall 2022 and winter 2023, when a surge of the disease is expected.