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Merck (MRK) Vaxneuvance sBLA for Pediatrics Gets Priority Review

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Merck (MRK - Free Report) announced that the FDA has accepted its supplemental biologics license application for its recently approved 15-valent pneumococcal conjugate vaccine (PCV), Vaxneuvance (V114), and granted priority review to the same. The sBLA is seeking label expansion of the multi-valent PCV for the prevention of invasive pneumococcal disease in children aged six weeks through 17 years. A decision from the FDA on the potential approval of the expanded label of the vaccine is expected by Apr 1, 2022.

Vaxneuvance was approved by the FDA for use in adults in June this year. A marketing authorization application seeking approval for the use of the 15-valent PCV in adults is under review in Europe. In October, the Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion recommending approval of  the vaccine. A final decision from the European Commission is expected by the end of 2021.

The label expansion application of Vaxneuvance in pediatrics is supported by data from phase III and phase II studies that evaluated the vaccine in infants, children, and adolescents. The study evaluated the vaccine in a variety of clinical settings including special populations at increased risk for a pneumococcal disease like children with HIV infection or sickle cell disease. The sBLA is also backed by data for the use of the vaccine as part of a mixed dosing regimen, which includes immunization of children who are pneumococcal vaccine-naïve or have received a partial or full regimen of a lower-valency pediatric PCV.

Merck’s shares have declined 9% so far this year against the industry’s 11.8% increase.

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Apart from Vaxneuvance, Merck has a strong vaccine portfolio led by its human papillomavirus vaccine, Gardasil. The company also has a 23-valent PCV, Pneumovax 23, in its portfolio. It also has a commercialized shingles vaccine, Zostavax. However, the vaccine faces strong competition from the popular shingles vaccine, Glaxo’s (GSK - Free Report) Shingrix.

Glaxo received the first FDA approval for Shingrix in 2017. The approval was followed by multiple label expansions over the years., Glaxo recorded approximately $1.5 billion in sales from Shingrix in the first nine months of 2021.

We note that Merck was facing patent infringement litigations from another U.S. pharma giant, Pfizer (PFE - Free Report) , related to its PCV vaccines. In October, Merck and Pfizer entered into settlement agreements resolving all ongoing PCV-related litigations worldwide.

Per the settlement terms, Merck will pay royalties to Pfizer on net sales of all Merck PCV products till 2035.

Zacks Rank & Stocks to Consider

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

Sarepta Therapeutics (SRPT - Free Report) is a better-ranked stock from the pharma/biotech sector carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Estimates for Sarepta have narrowed from a loss per share of $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022.

Sarepta delivered an earnings surprise of 11.06%, on average, in the last four quarters.