FDA Authorizes Pfizer/BioNTech Covid-19 Vaccine For Teens

On Monday , the Food and Drug Administration announce it would authorize the emergency use of the extremely effective Pfizer / BioNTech covid-19 vaccine for children between the ages of 12 to 15 . The vaccinum is the first to be made useable to the years group , though both it and Moderna ’s similar mRNA vaccine are being tested for teens and unseasoned small fry as well .

“ The FDA ’s expansion of the emergency brake manipulation authorisation for the Pfizer - BioNTech covid-19 vaccinum to include adolescents 12 through 15 year of age is a significant stride in the fight against the covid-19 pandemic , ” allege Acting FDA Commissioner Janet Woodcock in astatementreleased by the representation . “ Today ’s activeness let for a younger universe to be protected from covid-19 , play us closer to come back to a sense of normalcy and to cease the pandemic . parent and guardians can catch one’s breath assure that the agency undertook a strict and thorough review of all available data , as we have with all of our covid-19 vaccine pinch use authorizations . ”

The clinical trial used to stop up this new exigency use sanction involve 2,260 children ages 12 to 15 in the U.S. , who were randomly give two doses of the vaccine or a placebo . In total , 18 volunteers have tested positive for the viral unwellness during the ongoing study so far , all of whom were unvaccinated . In other words , the vaccine was find to be 100 % good at preventing illness and other issue like hospitalization in these children . The vaccine also appeared to be well - tolerated , with no reported major differences in side effects compare to what ’s already been document with people ages 16 to 25 .

A vial of the Pfizer/BioNTech vaccine

A vial of the Pfizer/BioNTech vaccinePhoto: Jessica Hill (AP)

The vaccine probably does n’t entirely protect teens from covid-19 , given the relatively small sample size . But it does trace up with the clinical and genuine - reality data collected on the Pfizer and Moderna mRNA vaccinum to date , which has found that both bring home the bacon substantial protection against unwellness and infection . Last week , Modernaannouncedthe preliminary results of their ongoing tribulation involving 12 to 17 year - olds ; the data evidence that their vaccine had 96 % efficacy at forestall unwellness 14 twenty-four hours after the first dose .

Children are much less likely to have serious sickness and death from covid-19 than other age groups . But older teens are thought to spread the computer virus to others as expeditiously as adult , while even young children are still susceptible torare but serious complications . fry may also be at higher risk oflingering symptomsafter the initial illness has passed , much like adults who educate “ long covid . ” allot to CDC data , an calculate 190,000 children have beenhospitalizeddue to covid-19 as of December 2020 — a turn far higher than the calculate 50,000hospitalizedfor the seasonal grippe annually .

Some experts have also warn thatherd immunityagainst covid-19 in the U.S. will be much harder to get to if children do n’t have the opportunity to get vaccinated as well . And it ’s look almost certain that both teens and younger nestling will be give that guess . Prior to its annunciation today , the FDAannouncedthat it would bear an consultive meeting on June 10 to discuss a potential emergency use authorization of covid-19 vaccines for children jr. than 12 geezerhood one-time . Both Moderna and Pfizer are presently conducting trials with nestling in that age mathematical group .

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