The Food and Drug Administration has plans to authorize the emergency use of Pfizer Inc PFE 0.01% and BioNTech SE’sBNTX 17.88% jointly-developed COVID-19 vaccine in adolescents aged between 12 to 15 years, the New York Timesreported Monday.
What Happened: The move means that the campaign to vaccinate against COVID-19 will potentially expand to millions more, as per the Times.
The FDA could reportedly give its go-ahead early next week. Subject to clearance, the U.S. Centers for Disease Control and Prevention’s vaccine advisory panel is likely to meet the following day to take stock of both the clinical trial data and make recommendations of use in the adolescent age group.
“We can assure the public that we are working to review this request as quickly and transparently as possible,” a spokeswoman for the FDA told the Times. She declined to comment on the timing of the agency to the Times.
BioNTech shares closed 10.95% higher in Monday’s regular session to $208.90 and rose another 3.35% to $215.89 in after-hours trading. On the same day, Pfizer shares also gained 3.05% in the regular session to $39.83. The shares rose 0.38% in after-hours trading.
Why It Matters: Pfizer announced positive results related to the Phase 3 trial evaluating its BNT162b2 vaccines in 2,260 adolescents aged 12 to 15 years on Mar. 31.
The results indicated 100% efficacy and substantial antibody responses and showed that the vaccine was well tolerated.
At the time, Pfizer CEO Albert Bourla said that the drugmaker plans to submit data to the FDA as a “proposed amendment” to the company’s existing Emergency User Authorization for the vaccine.
Cantor Fitzgerald analyst Louise Chen said Pfizer’s stock is underappreciated, after the adolescent data was released.
The FDA authorization will ease the worry of middle and high school administrators planning for the fall should all students be vaccinated by that time, as per the Times.
As per the CDC, 312.5 million doses of COVID-19 vaccines have been delivered in the U.S. and 246.8 million have been administered.
Both Pfizer and Moderna’s vaccines require administration of two doses, while Johnson & Johnson’s requires a single shot.