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Merck (MRK) Gets Priority Tag for Pneumococcal Vaccine BLA

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Merck & Co., Inc. (MRK - Free Report) announced that the FDA has accepted and granted priority review to its biologics license application (BLA) for V114, its investigational 15-valent pneumococcal conjugate vaccine for use in adults. The FDA’s decision is expected on Jul 18, 2021.

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. A regulatory application is also under review in the EU.

The regulatory filings are supported by data from several phase II and III studies. Merck’s phase III clinical development program for V114 included 16 late-stage studies that evaluated the vaccine candidate in a variety of populations who are at increased risk for pneumococcal disease.

V114 was earlier granted Breakthrough Therapy designation by the FDA for the prevention of invasive pneumococcal diseasein pediatric patients aged 6 weeks to 18 years and adults 18 years of age and older.

Merck’s shares have declined 7.2% in the past year against the industry’s 5.4% increase.

 

We remind investors that Pfizer (PFE - Free Report) 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 has a strong vaccine portfolio led by its human papillomavirus 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 - Free Report) shingles vaccine, Shingrix

Merck currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Another large drug/biotech stock with the same Zacks Rank as Merck is Alexion Pharmaceuticals (ALXN - Free Report) .

Alexion’s shares have gained 36.6% in the past year. Its earnings estimates for 2021 have risen 2.9% over the past 90 days.

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