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Merck's (MRK) Pneumococcal Jab Gets CHMP Endorsement for Kids

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Merck (MRK - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (“CHMP”) recommended the use of Vaxneuvance, its pneumococcal 15-valent conjugate vaccine, in children six weeks through 17 years of age.

A final decision by the European Commission (EC) on this filing is expected by year-end. Vaxneuvance was approved for use in adults aged 18 years and older in Europe last December to protect against invasive pneumococcal disease.

The CHMP decision is based on data from eight clinical studies which evaluated Vaxneuvance in infants, children and adolescents. Combined, these studies enrolled nearly 8,400 individuals.

In the year so far, shares of Merck have risen 14.5% against the industry’s 3.3% decline.

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Merck’s Vaxneuvance is already approved in the United States for use in individuals aged six weeks and older. While the FDA initially approved the vaccine for use in adults in July 2021, it received label expansion for use in infants and adolescents in June 2022.

A pneumococcal infection is caused by the bacterium Streptococcus pneumoniae (S. pneumoniae). While there are more than 100 different types of S. pneumoniae serotypes, only a few of these are responsible for the majority of the pneumococcal infections.

Vaxneuvance is approved in the United States and Europe to prevent invasive pneumococcal disease caused by 15 S. pneumoniae serotypes.

Another large-cap pharma giant which markets its pneumococcal vaccine is Pfizer (PFE - Free Report) . Prevnar-20 is a 20-valent pneumococcal conjugate vaccine, which the FDA approved in June 2021 for use in adults. Earlier this February, the vaccine was approved for adults in the European Union and is being marketed by Pfizer under the brand name Apexxnar. The Pfizer vaccine is yet to be approved for use in individuals aged under 18 years.

Pfizer also markets another pneumococcal vaccine, Prevnar 13, which contains 13 S. pneumoniae serotypes and is approved for use in individuals aged six weeks and older. During second-quarter 2022, Pfizer recorded $1.4 billion from combined sales of Prevnar 13 and Prevnar 20.

 

Zacks Rank & Stock to Consider

Merck currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stock in the overall healthcare sector are Kamada (KMDA - Free Report) and Morphic (MORF - Free Report) , which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Kamada’s 2022 earnings per share have risen from 1 cent to 26 cents. Shares of Kamada have lost 27.7% in the year-to-date period.

The earnings of Kamada missed estimates in three of the last four quarters and beat the mark just once, witnessing a negative surprise of 212.50%, on average. In the last reported quarter, KMDA’s earnings beat estimates by 450%.

In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.47 to $1.80. Loss estimates for 2023 have narrowed from $3.96 to $3.62 during the same period. Shares of Morphic have lost 39.8% in the year-to-date period.

Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.


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