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Merck's (MRK) Pneumococcal Vaccine Succeeds in Pediatric Trials

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Merck & Co., Inc. MRK announced that its 15-valent pneumococcal conjugate vaccine candidate, V114, met primary endpoints in two clinical studies — PNEU-DIRECTION and PNEU-PLAN — under the phase III pediatric clinical program. Data from the studies supported its potential use in healthy infants and children who were previously inoculated with a lower valency pediatric pneumococcal conjugate vaccine. The vaccine candidate also demonstrated its effectiveness in pneumococcal vaccine-naïve children.

Please note that a biologics license application (BLA) seeking approval for use of V114 in adults is under review with the FDA. A regulatory update on its potential approval is expected by Jul 18, 2021.A regulatory application seeking its approval in Europe is also under review.

The vaccine candidate enjoys Breakthrough Therapy designation for the prevention of invasive pneumococcal disease in pediatric patients aged 6 weeks to 18 years and adults 18 years of age and older.

Merck’s shares have declined 2.6% so far this year against the industry’s 6.7% increase.

The PNEU-DIRECTION study evaluated complete four-dose regimens of V114 or a 13-valent pediatric pneumococcal conjugate vaccine (PCV13) in healthy infants aged 42-90 days. The study also evaluated mixed four-dose regimens where infants received some doses of PCV13 followed by remaining doses of V114. The PNEU-PLAN study evaluated a complete regimen of V114 or PCV13 in children aged 7 months to 17 years who were either pneumococcal vaccine-naïve or who previously received a partial or full regimen of licensed pediatric PCV.

In the PNEU-DIRECTION study, infants who received complete PCV13 regimen or a mixed dose schedule of PCV13 followed by V114 elicited comparableimmune responsesfor the 13 serotypes, or strains of pneumococcal disease, targeted by both vaccines. While immune responses were generally comparable to PCV13 for the 13 shared serotypes and higher for serotypes 22F and 33F included only in V114 in the PNEU-PLAN study.

We note that V114 includes pneumococcal serotypes 22F and 33F, which are not included in the currently licensed conjugate vaccines and are commonly associated with invasive pneumococcal disease worldwide.

Merck has a strong vaccine portfolio led by its human papillomavirus vaccine, Gardasil. The company’s vaccine portfolio also includes a 23-valent pneumococcal conjugate vaccine, Pneumovax 23. 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 shingles vaccine, Shingrix

We remind investors that Pfizer PFE has also developed a 20-valent pneumococcal conjugate vaccine, which is under priority review with the FDA. The FDA’s decision is expected in June 2021.

Merck & Co., Inc. Price

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

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Zacks Rank & Stock to Consider

Merck currently has a Zacks Rank #3 (Hold).

BioNTech SE BNTX is a better-ranked large biotech,sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

BioNTech’s earnings per share estimates have improved from $18.39 to $29.44 for 2021 and from $7.55 to $21.34 for 2022 in the past 30 days. The company delivered an earnings surprise of 70.52%, on average, in the last four quarters. The stock is up 149.9% so far this year.

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