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Merck (MRK) Gets FDA Nod for Pneumococcal Vaccine Vaxneuvance

Merck & Co., Inc. MRK announced that the FDA has approved its 15-valent pneumococcal conjugate vaccine (PCV), Vaxneuvance (V114), for the prevention of invasive pneumococcal disease in adults 18 years and older caused by 15 serotypes. The vaccine includes pneumococcal serotypes 22F and 33F, which are not included in the currently licensed 13-valent conjugate vaccines. These two serotypes, along with the leading serotype 3, contribute significantly to the burden of invasive pneumococcal disease (IPD).

A regulatory application seeking approval for V114 is also under review in the EU.

The FDA approval was based on data from several phase II and III studies. Merck’s phase III clinical development program for Vaxneuvance included 16 late-stage studies that evaluated the vaccine candidate in a variety of populations who are at increased risk of pneumococcal disease.

Vaxneuvance was earlier granted Breakthrough Therapy designation by the FDA for the prevention of invasive pneumococcal disease in pediatric patients aged 6 weeks to 18 years and adults 18 years of age and older. The vaccine is contraindicated for adults who have previously had severe allergic reaction to any component of the vaccine or to diphtheria toxoid.

The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is likely to meet in October to discuss and make recommendations on the use of Vaxneuvance in adults.

Last month, the FDA approved Pfizer’s PFE 20-valent PCV, which includes the pneumococcal serotypes, 22F and 33F.

Merck’s shares have declined 4.6% so far this year against the industry’s 9.8% increase.


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In May, the company successfully completed two clinical studies — PNEU-DIRECTION and PNEU-PLAN — evaluating Vaxneuvance 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. The company plans to a supplemental regulatory licensure application to the FDA for use of Vaxneuvance in pediatric patients by the end of 2021.

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.

Apart from Vaxneuvance, Merck has a strong vaccine portfolio led by its human papillomavirus vaccine, Gardasil. However, its shingles vaccine, Zostavax, is facing stiff competition from Glaxo’s GSK Shingrix.

Zacks Rank & Stock to Consider

Merck currently has a Zacks Rank #5 (Strong Sell).

Bayer BAYRY is a better-ranked pharma company, carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Bayer’s earnings per share estimates have improved from $1.78 to $1.81 for 2021 and from $1.93 to $2.00 for 2022 in the past 60 days.


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GlaxoSmithKline plc (GSK): Free Stock Analysis Report
 
Pfizer Inc. (PFE): Free Stock Analysis Report
 
Merck & Co., Inc. (MRK): Free Stock Analysis Report
 
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