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Merck (MRK) Pneumococcal Vaccine Meets Late-Stage Study Goals

Zacks Equity Research
·4 min read

Merck Co., Inc. MRK announced that two phase III studies evaluating its investigational 15-valent pneumococcal conjugate vaccine, V114, met their primary immunogenicity objectives. The candidate elicited strong immune response for all 15 serotypes included in it.

One late-stage study — PNEU-PATH (V114-016) — evaluated V114 compared to the currently available 13-valent pneumococcal conjugate vaccine (PCV13). Patients in both arms were administered Merck’s own Pneumovax 23, a 23-valent pneumococcal polysaccharide vaccine, one year later. Data showed that immune responses were comparable in patients receiving either V114 or PCV13 for 13 common serotypes of V114 and PCV13, and higher for serotypes 22F and 33F included only in V114. Moreover, immune responses were comparable in both arms for all serotypes following administration of Pneumovax 23.

Another late-stage study — PNEU-DAY (V114-017) — evaluated V114 in immunocompetent adults aged between 18 and 49 years with underlying medical conditions associated with increased risk for pneumococcal disease compared to PCV13. Data showed that immune responses were generally comparable in both arms for 13 shared serotypes with higher responses for serotypes 22F and 33F in V114 arm after one month of vaccination.

Data from these late-stage studies will be presented at a future scientific congress. Moreover, the company remains on track to file a regulatory application seeking approval for V114 in the United States by the year-end.

Please note that Merck’s phase III clinical development program for V114 includes 16 late-stage studies that evaluated the vaccine candidate in a variety of populations who are at increased risk for pneumococcal disease.

Last month, the company announced positive top-line results from two other late-stage studies — PNEU-AGE (V114-019) and PNEU-TRUE (V114-020) — evaluating the safety, tolerability and immunogenicity of V114. Data showed that V114’s immune responses were non-inferior to PCV13 in patients above 50 years of age. Moreover, data also showed that three different lots of V114 demonstrated equivalent immune response across all 15 serotypes in similar patient population.

Pneumococcal serotypes, which are not in the currently licensed conjugate vaccines, such as 22F and 33F, are commonly associated with invasive pneumococcal disease worldwide. Both these serotypes currently cause 13% of the invasive pneumococcal disease seen among adults aged 65 years and older in the United States and 7-12% of the adult cases seen across Europe. Hence, a potential approval of the vaccine will bode well for Merck, given the targeted patient population.

Merck’s shares have lost 13.9% this year so far against the industry’s 2.5% growth.

 

The company has a strong vaccine portfolio led by its human papillomavirus (“HPV”) vaccine, Gardasil. Apart from Gardasil and Pneumovax 23, the company has several marketed vaccines in its portfolio like ProQuad/M-M-R II/Varivax, RotaTeq, and Zostavax. However, Zostavax is facing stiff competition from Glaxo’s GSK Shingrix.

We remind investors that Pfizer PFE is also developing a 20-valent pneumococcal conjugate vaccine in late-stage studies.

Meanwhile, Merck is also engaged in developing vaccines to help combat COVID-19. The company acquired Themis, which has a COVID-19 vaccine candidate, V591, in June. Other companies in the race include Moderna MRNA, Pfizer, Glaxo, Sanofi and Novavax.

Merck Co., Inc. Price

Merck  Co., Inc. Price
Merck Co., Inc. Price

Merck Co., Inc. price | Merck Co., Inc. Quote

Zacks Rank

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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