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Merck's (MRK) Pneumococcal Vaccine Vaxneuvance Gets EU Nod

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Merck (MRK - Free Report) announced that the European Commission has approved Vaxneuvance, its 15-valent pneumococcal conjugate vaccine for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes in adults 18 years of age and older. The FDA approved the vaccine in July.

The approval for Vaxneuvance in Europe was based on data from seven clinical studies that evaluated the vaccine candidate in 7,438 individuals in a variety of populations who are at increased risk of pneumococcal disease.

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) in Europe. Vaxneuvance elicited a strong immune response to the above three pneumococcal serotypes in clinical studies while also showing non-inferior immune responses for the 13 shared serotypes included in the currently licensed 13-valent conjugate vaccines.

Merck’s stock has declined 0.1% this year so far against an increase of 20.3% for the industry.

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In October, the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) unanimously voted to provisionally recommend Vaxneuvance either with a sequential regimen of Vaxneuvance followed by Pneumovax 23, Merck’s 23-valent pneumococcal polysaccharide vaccine, or with a single dose of 20-valent pneumococcal conjugate vaccine in certain adults.

Pfizer’s (PFE - Free Report) Prevnar-20, a 20-valent pneumococcal conjugate vaccine, was also approved in the United States this year in June.

Prevnar 20 includes all the 13 serotypes contained in Pfizer’s popular 13-valent pneumococcal conjugate vaccine, Prevnar 13 along with seven additional serotypes. Pfizer’s Prevnar-20 is under review in the EU.

Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Some better-ranked large drug stocks are Glaxo (GSK - Free Report) and Roche (RHHBY - Free Report) , which carry a Zacks Rank #2 (Buy).

Glaxo’s stock has risen 25.5% this year so far. Estimates for Glaxo’s 2021 earnings have risen 8.2% over the past 60 days while the same for 2022 are up 5.5% over the same timeframe.

Glaxo’s earnings surpassed estimates in two of the trailing four quarters, missed the same once and matched it once, delivering a beat of 15.28%, on average.

Estimates for Roche’s 2021 earnings have risen from $2.76 per share to $2.80 per share over the past 60 days while the same for 2022 have gone up from $2.79 per share to $2.87 per share over the same timeframe.

Roche’s shares are up 17.6% this year so far.

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