Posted on 10/31/2021 8:45:43 PM PDT by BlackFemaleArmyColonel
Moderna Inc (MRNA.O)said on Sunday it has been told that the U.S. Food and Drug Administration will require additional time to complete its assessment of the company's COVID-19 vaccine for use in adolescents aged 12 to 17 years.
The FDA informed Moderna that the review may not be completed before January 2022, the company said in a statement, dealing a potential setback to the timing of an emergency use authorization (EUA) for that age group.
Moderna Chief Executive Stephane Bancel told Reuters last week that based on conversations with the agency, he believed the vaccine would be authorized for those 12 to 17 in the next few weeks. read more
The U.S. biotech company said it was told late on Friday that the FDA needed the additional time to evaluate recent international analyses of the risk of a type of heart inflammation called myocarditis after vaccination, a rare side effect that has primarily affected young males.
Moderna said it is conducting its own review of new external analyses on the increased myocarditis risk in those less than 18 years of age as they become available.
Moderna applied for U.S. authorization of its shot for those aged 12 to 17 in June.
Americans of those ages are eligible for the similar COVID-19 vaccine from Pfizer Inc (PFE.N) and partner BioNTech SE after it was cleared by the FDA and Centers for Disease Control and Prevention in May. read more
Moderna also said it will delay filing its request for an EUA for a half strength 50-microgram dose of the vaccine for children ages 6 to 11 while the FDA completes its review of the 12-17 filing.
(Excerpt) Read more at reuters.com ...
PATRIOT PING
Curious timing.
The phoney-baloney PCR “test” will be decertified by the FDA on December 31.
Come January, a “miraculous” decrease in “infections”...ergo no “need” to jab the youngsters.
hasnt stopped them from jabbing a whole bunch of these kids so far
The worst part is that parents who voluntarily force their kids to get the “vaccine” are Low Information Voters who get ALL their information from the msm.
They’re so perfect that no questions about their safety are necessary, nor tolerated.
Alec Baldwin says..”Take the shot!”
Pfizer is just as bad or worse
Well, he took the shot, so maybe he wishes everyone would, to take some of the heat off him. 👍
TRANSLATION: We have not yet figured out a way to word our approval that will credibly sustain the narrative that we are completely and totally surprised by the coming spike in fatalities among 12 to 17 year olds.
None of these jabs are safe even the so-called traditional ones.
I am just blown away in what I saw in a social media site (I am sure if I can post the URL) about the people dying from the Chinese vaccines (Sinopharm and Sinovac).
I mean “I am NOT sure if I can post the URL”
Nah what they need is more former members on the FDA board like Pfizer.
Getting ready to experiment on kids now.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.