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Pfizer (PFE) Gets EU Nod for Expanded Use of Pneumococcal Jab
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Pfizer (PFE - Free Report) announced that the European Commission (EC) approved the label expansion of its 20-valent pneumococcal conjugate vaccine for use in infants, children and adolescents aged six weeks through 17 years of age.
Following this decision, infants and children aged under 18 years can now be immunized with the Pfizer vaccine for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae (S. pneumoniae).
A pneumococcal infection is caused by the bacterium 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 pneumococcal infections.
Please note that the vaccine was approved by the EC in 2022 for active immunization of adults (aged 18 years and older) to prevent invasive disease and pneumonia caused by S. pneumoniae. The vaccine was being marketed under the trade name Apexxnar.
Following the label expansion, Pfizer has now changed/updated the brand name to ‘Prevenar 20’ to include the younger age group.
Shares of Pfizer have lost 2.0% in the year against the industry’s 14.3% rise.
Image Source: Zacks Investment Research
The EC approval was expected as the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending this label expansion in January.
Both the EC and CHMP decisions are based on data from four pivotal late-stage clinical studies, which exhibited the safety, tolerability and immunogenicity of Prevenar 20. Collectively, all four studies enrolled more than 4,700 infants and, 800 toddlers and children of all ages.
In the United States, Pfizer markets this vaccine under the trade name Prevnar 20 which is the current standard of care in the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. The FDA approved the Pfizer vaccine for use in individuals aged six weeks and older last year in April.
The approval of Pfizer’s Prevenar 20 will provide stiff competition to Merck (MRK - Free Report) , which markets Vaxneuvance, its own pneumococcal 15-valent conjugate vaccine, which contains 15 S.pneumoniae serotypes. Merck’s Vaxneuvance is approved in the EU and United States for similar use in individuals aged six weeks and older.
Pfizer also markets another pneumococcal vaccine, Prevnar 13/Prevenar 13, which contains 13 S. pneumoniae serotypes and is approved for use in individuals aged six weeks and older. In 2023, Pfizer recorded $6.4 billion from combined sales of Prevnar 13 and Prevnar 20.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. Meanwhile, during the same period, estimates for 2025 EPS have improved from 32 cents to 50 cents. Year to date, shares of ADMA have risen 38.5%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting once, the average surprise being 85.00%.
In the past 60 days, estimates for GSK’s 2024 EPS have risen from $3.87 to $4.03. Meanwhile, during the same period, estimates for 2025 EPS have improved from $4.20 to $4.39. Year to date, shares of GSK have risen 17.0%.
GSK's earnings beat estimates in three of the trailing four quarters while missing the mark once, the average surprise being 7.59%.
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Pfizer (PFE) Gets EU Nod for Expanded Use of Pneumococcal Jab
Pfizer (PFE - Free Report) announced that the European Commission (EC) approved the label expansion of its 20-valent pneumococcal conjugate vaccine for use in infants, children and adolescents aged six weeks through 17 years of age.
Following this decision, infants and children aged under 18 years can now be immunized with the Pfizer vaccine for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae (S. pneumoniae).
A pneumococcal infection is caused by the bacterium 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 pneumococcal infections.
Please note that the vaccine was approved by the EC in 2022 for active immunization of adults (aged 18 years and older) to prevent invasive disease and pneumonia caused by S. pneumoniae. The vaccine was being marketed under the trade name Apexxnar.
Following the label expansion, Pfizer has now changed/updated the brand name to ‘Prevenar 20’ to include the younger age group.
Shares of Pfizer have lost 2.0% in the year against the industry’s 14.3% rise.
Image Source: Zacks Investment Research
The EC approval was expected as the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending this label expansion in January.
Both the EC and CHMP decisions are based on data from four pivotal late-stage clinical studies, which exhibited the safety, tolerability and immunogenicity of Prevenar 20. Collectively, all four studies enrolled more than 4,700 infants and, 800 toddlers and children of all ages.
In the United States, Pfizer markets this vaccine under the trade name Prevnar 20 which is the current standard of care in the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. The FDA approved the Pfizer vaccine for use in individuals aged six weeks and older last year in April.
The approval of Pfizer’s Prevenar 20 will provide stiff competition to Merck (MRK - Free Report) , which markets Vaxneuvance, its own pneumococcal 15-valent conjugate vaccine, which contains 15 S.pneumoniae serotypes. Merck’s Vaxneuvance is approved in the EU and United States for similar use in individuals aged six weeks and older.
Pfizer also markets another pneumococcal vaccine, Prevnar 13/Prevenar 13, which contains 13 S. pneumoniae serotypes and is approved for use in individuals aged six weeks and older. In 2023, Pfizer recorded $6.4 billion from combined sales of Prevnar 13 and Prevnar 20.
Pfizer Inc. Price
Pfizer Inc. price | Pfizer Inc. Quote
Zacks Rank & Stocks to Consider
Pfizer currently carries a Zacks Rank #3 (Hold). A couple of better-ranked large-cap stocks in the overall healthcare sector include ADMA Biologics (ADMA - Free Report) and GSK plc (GSK - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. Meanwhile, during the same period, estimates for 2025 EPS have improved from 32 cents to 50 cents. Year to date, shares of ADMA have risen 38.5%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting once, the average surprise being 85.00%.
In the past 60 days, estimates for GSK’s 2024 EPS have risen from $3.87 to $4.03. Meanwhile, during the same period, estimates for 2025 EPS have improved from $4.20 to $4.39. Year to date, shares of GSK have risen 17.0%.
GSK's earnings beat estimates in three of the trailing four quarters while missing the mark once, the average surprise being 7.59%.