The U.S Centers for Disease Control and Prevention (CDC) endorsed the safety and efficacy of
Pfizer ( PFE Quick Quote PFE - Free Report) / BioNTech ( BNTX Quick Quote BNTX - Free Report) two-shot vaccine for COVID-19, BNT162b2 for use in adolescents aged 12-15 years old.
The CDC’s Advisory Committee on Immunization Practices’ (ACIP) unanimously voted to recommend the vaccine for use in adolescents after reviewing study data. The CDC’s director approved the committee’s recommendation, thereby opening up vaccination to approximately 17 million adolescents in the United States
Earlier this week, the FDA expanded BNT162b2’s Emergency Use Authorization (EUA) to allow vaccinating the adolescent patient population. The EUA was originally issued on Dec 11, 2020 for vaccinating individuals 16 years of age and older. This was the first COVID-19 vaccine authorized in the United States for this age group. Vaccinations have already begun in some states. A similar application seeking a variation to the European Conditional Marketing Authorization (CMA) for Comirnaty (BNT162b2’s brand name in Europe) was filed in late-April.
The FDA decision was based on data from a phase III study,which enrolled 2,260 adolescents in the United States. The study data showed that BNT162b2 was 100% effective in preventing COVID-19 in adolescents aged 12-15 years old. Moreover, in the pivotal phase III study the candidate demonstrated robust antibody levels, exceeding those in participants aged 16-25 years old in another study. The vaccine was also well tolerated.
BNT162b2/Comirnaty was developed in record time and is now approved for emergency/temporary use in 91 countries worldwide. As of May 3, 2021, Pfizer/BioNTech had shipped approximately 430 million doses of the vaccine to 91 countries.
Meanwhile studies are ongoing to expand the authorization of BNT162b2 to additional population groups, such as children from 6 months to 11 years of age. The companies are also evaluating the administration of a single booster dose five to seven months after receiving the second dose of BNT162b2 mainly with the aim of protecting against the emerging variants of concern.
Pfizer’s stock has risen 7.8% this year so far compared with an increase of 4.9% for the
BioNTech’s shares are up 128.3% this year so far against the
industry’s decrease of 6.5%.
Other marketed COVID-19 vaccines are
Moderna’s ( MRNA Quick Quote MRNA - Free Report) mRNA-1273, J&J’s ( JNJ Quick Quote JNJ - Free Report) single-shot COVID-19 vaccine and AstraZeneca’s ( AZN Quick Quote AZN - Free Report) COVID-19 vaccine. Moderna is currently evaluating its vaccine in a phase II/III study for adolescents.
Pfizer has a Zacks Rank #3 (Hold) while BioNTech sports a Zacks Rank #1 (Strong Buy). You can see
the complete list of today’s Zacks #1 Rank stocks here. Zacks' Top Picks to Cash in on Artificial Intelligence
In 2021, this world-changing technology is projected to generate $327.5 billion in revenue. Now Shark Tank star and billionaire investor Mark Cuban says AI will create ""the world's first trillionaires."" Zacks' urgent special report reveals 3 AI picks investors need to know about today.
See 3 Artificial Intelligence Stocks With Extreme Upside Potential>>