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During an FDA meeting Thursday to discuss granting Emergency Use Authorization for COVID vaccines for children under 12, several experts spoke out against the plan, saying the benefits don’t outweigh the risks for young children.
While some advisors said it’s too soon to rush the use of vaccines in the pediatric population because kids are at such low risk from the virus, most argued that it’s important to have authorizations on hand should there be a resurgence of the virus in the fall and winter.
The members of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) were not asked to provide specific advice or to vote during the meeting.
The role of the FDA is to advise companies on what kind of clinical trials and data the agency wants to see before extending Emergency Use Authorization (EUA) or full approval of drugs, including vaccines, for use in new age groups.
The following issues were discussed during the meeting:
- What’s needed in terms of data — including safety data, database size and duration follow-up — to support EUA and licensure for COVID vaccines for pediatric age groups 6 to 12 years, 2 to 6 years and 6 months to 2 years of age.
- Provided there is sufficient evidence of effectiveness to support the benefit of a COVID preventive vaccine for adolescents 12 to 18 years old, safety data, including database size and duration of follow-up, would be needed to support licensure of the vaccine.
- Studies following licensure and/or issuance of an EUA needed to further evaluate safety and effectiveness of COVID vaccines in different pediatric age groups.
Pfizer’s COVID vaccine is currently authorized for emergency use in people as young as age 12. Moderna is authorized for people 18 and older, although the company has asked the FDA to authorize its use in children as young as 12. Johnson & Johnson’s vaccine is authorized in people 18 and older.
Both VRBPAC members and public health experts and scientists expressed concerns about using COVID vaccines in the pediatric population.
Peter Doshi, Ph,D, associate professor University of Maryland School of Pharmacy and senior editor of The BMJ, said during the open public hearing session, there is no emergency that would warrant using EUA to authorize COVID vaccines for children.
Pointing to Pfizer’s trial of 12- to15-year-olds which supported the recent EUA, Doshi said the harms outweighed the benefits and those who had the placebo were “better off” than those who received the vaccine.
[…]
Via https://childrenshealthdefense.org/defender/kids-benefits-covid-vaccine-dont-outweigh-risks/
The Most Revolutionary Act 
They’re STILL LYING TO US ABOUT EVERYTHING.
Why? Because it’s not about a virus & our health, but about total control.
They’ve absolutely no intention of “giving us back our freedoms”. What an absurd concept, anyway.
All around the world, hidden from many of us by the LYING MASS MEDIA, people in other places are living entirely normal lives, forgetting about Covid19.
We get one chance to wrest back self determination: DO NOT TOLERATE A DAY LONGER OF THIS OFFENSIVE, ROAD MAP BS.
If you meekly comply with any further restraints, you’re telling government & their advisors that THEY CAN DO DO TO US WHATEVER THEY WANT.
It’s down to us. Please take everything back on June 21st, if you haven’t already.
Dr Mike Yeadon
https://wearethene.ws/notable/221656
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Thanks for the link, Leland. Is there some organized event the 21st?
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Thanks for asking Stuart. I was a little CV slow on that as well as I forgot Dr. Yeadon is British😜
Here’s our answer:
Says June 21st date can only be met if two groups are treated differently
By Paul Joseph Watson | Summit News | June 11, 2021
Former British Prime Minister Tony Blair implied that those who choose not to be vaccinated should be discriminated against by remaining under lockdown restrictions if the UK’s June 21st “freedom day” is to be accomplished.
During an interview with ITV News, Blair was asked if he would delay the June 21st deadline, when all social distancing, mask mandates and other lockdown rules are supposed to come to an end.
Blair said that if the data suggested the June 21st date was at risk, the government should “look again at distinguishing between those people who are vaccinated and those people who aren’t because it really makes no sense to treat the two groups as if they’re the same.”
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