Home / Health / Pfizer (PFE) COVID-19 vaccine gets the nod for adolescents in the EU

Pfizer (PFE) COVID-19 vaccine gets the nod for adolescents in the EU



Pfizer PFE /BioNTech BNTX has announced that the Conditional Marketing Authorization (CMA) for a two shot vaccine for COVID-19, Comirnaty in the European Union (EU) has been extended to allow vaccination of teenagers aged 12 to 15 years. -19 The first to be allowed in Europe for this age group.

The approval follows a previous positive opinion received by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) to expand the CMA in the EU. The CMA was originally issued Dec. 21. 2020 for vaccinating individuals aged 16 and over.

Please note that in the United States The vaccine was approved for this age group earlier this month. The US Centers for Disease Control and Prevention (CDC) also certifies the safety and efficacy of Comirnaty/BNT1

62b2 For use in adolescents aged 12-15 years. Full vaccination in the country

Approval for the adolescent age group is based on data from a phase 3 study that enrolled 2,260 adolescents. The study data showed that BNT162b2 was 100% effective in preventing COVID-19 in adolescents aged 12-15 years. Phase 3 pivotal. Candidates show strong antibody levels. than among participants aged 16-25 in another study. The vaccine is also well tolerated.

BNT162b2/Comirnaty It was developed in record time and is now approved for emergency/temporary use in 91 countries worldwide as of May 3, 2021. Pfizer/BioNTech It has shipped approximately 430 million doses of the vaccine to 91 countries.

meanwhile Studies are ongoing to expand BNT162b2 authorization to additional population groups, such as children aged 6 months to 11 years and pregnant women. Companies are evaluating possible doses of stimulants and improved vaccine versions.

Pfizer’s stock is up 5.2 percent this year, compared with a 5.7 percent gain for the industry.

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BioNTech shares are up 290% this year, compared to an 8% industry decline.

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Other COVID-19 vaccines marketed are: modernMRNA mRNA-1273 of not a wordVaccines against COVID-19 One shot of JNJ and AstraZeneca(AZN)’s (AZN) vaccine, Moderna is currently evaluating the vaccine in a Phase II/III study for adolescents. last week The study found a primary endpoint, demonstrating non-inferior immunization compared to the COVE study evaluating vaccines in adults.

Pfizer has #3 Zacks (Hold) while BioNTech has #1 Zacks (Strong Buy). The complete list of today’s Zacks #1 stocks can be found here..

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