Moderna seeks COVID-19 vaccine authorization for teens

Moderna announced on Thursday that it had requested the FDA grant emergency use authorization for its COVID-19 vaccine in adolescents. Currently, the two-dose vaccine is authorized for use in the U.S. for those 18 years and older. 

"We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States," Stéphane Bancel, Chief Executive Officer of Moderna, said in a statement. "We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents. We have already filed for authorization with Health Canada and the European Medicines Agency and we will file with regulatory agencies around the world for this important younger age population. We remain committed to helping to end the COVID-19 pandemic."

The request follows promising data from a Phase 2 /3 TeenCOVE study involving 3,732 teens ages 12 to 18 that found the vaccine produced immune responses similar to those observed in adults. Additionally, Moderna said that no cases of COVID-19 were observed in participants who had received two doses of the jab. 

WHY DO SOME PEOPLE GET SIDE EFFECTS FROM COVID-19 VACCINES?

If authorization is granted, it would mark the second COVID-19 vaccine made available to younger teens. Pfizer-BioNTech received expanded authorization for use in adolescents ages 12 and older in May. 

CLICK HERE FOR COMPLETE CORONAVIRUS COVERAGE

Earlier this month, Moderna had announced that it had begun the process of seeking full FDA approval for its vaccine in adults ages 18 and older. 



TAGS: Moderna seeks COVID19 vaccine authorization for teens


10 Jun 2021 20:42   |    211

Source: www.foxnews.com


Alif. Lam. Mim.This is the Book; in it is guidance sure, without doubt, to those who fear Allah;Who believe in the Unseen, are steadfast in prayer, and spend out of what We have provided for them;And who believe in the Revelation sent to thee, and sent before thy time, and (in their hearts) have the assurance of the Hereafter   (The Cow   1-4 )


POPULAR NEWS

Ohio police rescue missing 4-year-old child found unresponsive, floating in pond
Good Samaritan swept away while trying to rescue doomed Florida father, boy
Debbie Reynolds was always determined to give back to those in need despite stardom, pal Ruta Lee says
Biden to designate Pulse nightclub as national memorial, renews gun control calls on mass shooting anniversary
Masks no longer required on House floor, after GOP outrage over continued requirement
Nevada seeking to be first-in-the-nation primary with new law
Drop in routine childhood vaccinations during coronavirus may spur increase in preventable illness, CDC warns
Moderna seeks COVID-19 vaccine authorization for teens
George P. Bush responds to media criticism in bid for Texas Attorney General: ‘I’m my own man’
2021 CMT Music Awards red carpet fashion
Jack Ciattarelli wins the New Jersey Republican gubernatorial nomination
North Carolina police officers hailed as heroes after rescuing woman from overturned, submerged vehicle
Pfizer lowers COVID-19 vaccine doses for younger kids in clinical trial
Clay Travis rips ex-ESPN host Jemele Hill’s ‘clown take’ for attacking Democrat Joe Manchin over election bill
Texas woman arrested for posing as 13-year-old daughter to prove point on school shootings
Texas woman arrested for posing as 13-year-old daughter to prove point on school shootings
Donald Trump endorses NC Rep. Ted Budd for Senate as Lara Trump stands down
GOP effort to kill Capitol riot probe could be beginning of end for filibuster
Teens’ coronavirus hospitalization rates 3 times higher than flu: CDC study
Heart inflammation following COVID-19 vaccine in teens being investigated

Email subscription:

Related Health News