Editor’s demonstrate: Gain the most modern COVID-19 news and guidance in Medscape’s Coronavirus Helpful resource Heart.
Pfizer asked the FDA on Thursday to lengthen emergency use authorization of its COVID-19 vaccine to formative years ages 5 to 11.
The set up a matter to comes after the drugmaker submitted scientific trial recordsdata to the FDA on Sept. 28. Pfizer acknowledged the secret agent of 2,268 formative years confirmed the vaccine became stable and produced a strong immune response.
Contributors within the overview received a lower dose of the vaccine, 10 micrograms. Their response 2 weeks after a 2nd dose became reportedly equal to the immune protection in a withhold an eye on neighborhood of 16- to 25-year-olds who received the fully authorized 30-microgram doses.
Currently, the Pfizer EUA applies to 12- to 15-year-olds and other folks eligible for a Pfizer booster shot. The drugmaker received full FDA approval for the vaccine for American citizens 16 years and older in August.
The filing for authorization in 5- to 11-year-olds comes as total cases of COVID-19 within the U.S. proceed to claim no. The decrease entails a drop in current cases in formative years for the fourth consecutive week, in accordance to prognosis of recordsdata from the American Academy of Pediatrics and the Kid’s Smartly being facility Association.
The next step is an FDA resolution on whether to lengthen the current emergency use authorization (EUA) for formative years to the younger age neighborhood.
Timing of any first payment observe from the company is unknown. But perchance in anticipation of this day’s filing, the FDA already scheduled a gathering of its Vaccines and Connected Organic Products Advisory Committee for Oct. 25.
Source
Twitter: @pfizer, Oct. 7, 2021.
Damian McNamara is a workers journalist primarily based in Miami. He covers a enormous fluctuate of scientific specialties, including infectious diseases, gastroenterology and neurology. Apply Damian on Twitter: @MedReporter.
