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Pfizer, BioNTech Booster Gets FDA Nod for 12 to 15-Year Olds

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Pfizer (PFE - Free Report) and its partner BioNTech (BNTX - Free Report) announced that the FDA has extended the Emergency Use Authorization (EUA) for the booster dose of their COVID-19 vaccine to allow its use in adolescents 12 through 15 years of age. The third dose is the same as the previous two doses, 30-µg.

The decision comes as the Omicron variant of the virus is rapidly infecting children across the United States and the world. Health experts expect that the widespread use of booster shots can raise the level of protection and possibly lower the impact of Omicron.

Pfizer and BioNTech’s booster dose was granted emergency approval by the FDA last month for all adults 18 years of age and older, following the completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. Last month, the EUA was extended to allow its use in individuals 16 and 17 years of age.

Along with the approval for 12 to 15-year-olds, the FDA also amended the existing EUA to reduce the time between completion of primary series and booster dose for all eligible individuals to five months from six months previously set. The decision to reduce the time for the booster administration was based on real-world data from the Ministry of Health of Israel, which showed that a booster jab given after five months after the primary series raised no new safety concerns in adolescents 12 through 17 years of age.

The FDA also authorized a third primary series dose for children 5 through 11 years of age who are immunocompromised

The Centers for Disease and Control Prevention (CDC) has to recommend booster shots for 12- to 15-year olds in order to be widely available in the country.

Pfizer’s stock has risen 60% in the past year compared with an increase of 26% for the industry.

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Germany-based BioNTech’s shares have rallied 169.9% in the past year against the industry’s decrease of 21.3%.

 

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Pfizer’s COVID-19 vaccine booster is the only one approved for use in children.

The booster dose of Moderna’s (MRNA - Free Report) vaccine has been granted EUA for use in adults at least six months after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.

A booster shot of J&J’s (JNJ - Free Report) adenovirus-based single-shot COVID-19 vaccine was granted EUA by the FDA in October for adults aged 18 and older at least two months after the primary vaccination with its vaccine or with Pfizer or Moderna’s two-shot mRNA COVID-19 vaccine regimen.

Last month, the CDC recommended the use of Pfizer/BioNTech’s Comirnaty and Moderna’s mRNA-1273 over J&J’s single-shot COVID-19 vaccine. The CDC stated that J&J’s vaccine or its booster dose should be used only when mRNA-based vaccines are contraindicated for a person or are inaccessible. Data reviewed by the CDC demonstrated that the administration of the adenovirus-based COVID-19 vaccine like that of J&J could lead to a higher risk of fatal side effects, including rare cases of thrombosis with thrombocytopenia syndrome and even deaths compared to mRNA-based vaccines including Pfizer and BioNTech’s Comirnaty or Moderna’s mRNA-1273.

Both Pfizer and BioNTech have a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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