COVID-19 vaccine is expected to receive FDA emergency approval for ages 12-15 next week
By Shivdeep Dhaliwal
The Food and Drug Administration has plans to approve the emergency use of Pfizer Inc. PFE 0.01% and BioNTech SE’sBNTX 17.88% Co-developed COVID-19 vaccine in teenagers between the ages of 12 and 15, the New York Times reported on Monday.
What happened: The move means the COVID-19 vaccination campaign may expand to millions more, according to the Times.
Photo by Gustavo Fring via Pexels
The FDA could give its approval early next week. Subject to clearance, the U.S. Centers for Disease Control and Prevention Advisory Board is expected to meet the next day to take stock of clinical trial data and make recommendations for use in the adolescent age group.
“We can assure the public that we are working to investigate this request as quickly and transparently as possible,” an FDA spokeswoman told the Times. She declined to comment on the Times at the time of the agency.
The BioNTech share closed on Monday 10.95% higher to USD 208.90 and rose a further 3.35% to USD 215.89 after close of trading. On the same day, Pfizer stock also gained 3.05% to $ 39.83 in the regular session. The share rose 0.38% in after-hours trading.
Why it matters: On March 31, Pfizer announced positive results related to its Phase 3 study evaluating its BNT162b2 vaccines in 2,260 adolescents aged 12 to 15 years.
The results showed 100% effectiveness and significant antibody responses, indicating that the vaccine was well tolerated.
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At the time, Albert Bourla, CEO of Pfizer, said the drug company plans to submit data to the FDA as a “proposed change” to the company’s existing emergency user approval for the vaccine.
Photo from CDC via Unsplash
Pfizer, Moderna Inc.MRNA 6.64%, and Johnson & JohnsonJNJ 0.52% COVID-19 vaccines are also approved for use in adult emergencies in the United States
Cantor Fitzgerald analyst Louise Chen said Pfizer stock has been underestimated following the youth data release.
FDA approval will ease the worries of middle and high school administrators planning this fall if all students are vaccinated by that time, according to the Times.
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According to the CDC, 312.5 million doses of COVID-19 vaccines have been dispensed and 246.8 million have been given in the U.S.
Both Pfizer and Moderna vaccines require the administration of two doses, while those of Johnson & Johnson require a single shot.
This article originally appeared on Benzinga and was republished with permission.