December 1, 2023

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Merck 21-valent Pneumonia vaccine received FDA breakthrough therapy designation

Merck 21-valent Pneumonia vaccine received FDA breakthrough therapy designation


Merck 21-valent Pneumonia vaccine received FDA breakthrough therapy designation


On April 14, Merck announced that one of its next-generation pneumococcal vaccines, V116, has been granted Breakthrough Therapy Designation by the FDA.


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V116 can be used in adults 18 years of age and older to prevent invasive pneumococcal disease (IPD) and pneumococcal pneumonia caused by 21 S. pneumoniae serotypes, including 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F and 35B.


It is reported that the serotypes targeted by V116 cover 85% of people aged 65 years and older with invasive pneumococcal disease in the United States, including 8 serotypes not covered by any currently licensed vaccines. Merck will begin a Phase III clinical trial later this year.


The FDA’s decision is based on data from the two-part randomized, comparative controlled, double-blind Phase I/II study V116-001 (NCT04168190) . This study evaluated the safety, tolerability and immunogenicity of a single dose of V116 in pneumococcal vaccine-naïve adults 18-49 years ( Phase I) and 50 years and older (Phase II) Expand the test.


Full results from the V116-001 study will be presented at the International Symposium on Pneumococcus and Pneumococcal Disease (ISPPD) in June .


In a statement, Eliav Barr, Merck’s senior vice president and global head of clinical development and chief medical officer, said: “V116 specifically targets the most prevalent type of pathogenic pneumococcal strain in adults, reflecting our efforts to develop a pneumococcal conjugate vaccine for the population. strategy. We look forward to discussing the continued development of this investigational vaccine with the FDA and other regulatory agencies, including the approach to the Phase III study.”


Merck’s other pneumococcal vaccine, V114, did not lose out when it went head-to-head with Pfizer’s “blockbuster” Prevnar 13. Merck has a series of development plans for the V114 to show that the V114 is a better choice than the Prevnar 13. V114 targets 13 serotypes already covered by Prevnar 13 and 2 other serotypes.


V114 received FDA approval for use in adults in July last year, and a few months later in December, it received a priority review from the FDA for its sBLA for use in minors and infants. The PDUFA time was originally set for this month 1, but the FDA did not make a decision as scheduled, but pushed the date back to July 1 this year.


Analysts estimate that peak sales of the V114 could reach $1 billion. At the JP Morgan conference in January, Merck Chief Executive Ken Frazier called V114 a key driver of the company’s late-stage portfolio, part of an upcoming “vaccine kit” to prevent pneumonia.


The struggle with Pfizer is not only that, but in the pediatric market, Merck hopes that the third vaccine V117 will become a key player in the competition with Pfizer.










Merck 21-valent Pneumonia vaccine received FDA breakthrough therapy designation

(source:internet, reference only)

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