COVID Vaccines for Kids Under 6 Won’t Have to Meet Efficacy Standard
The U.S. FDA’s top vaccine official told a congressional committee on Friday that COVID-19 vaccines for kids under 6 will NOT have to meet the agency’s 50% efficacy threshold required to obtain Emergency Use Authorization.
The FDA is reviewing data from Moderna’s two-shot vaccine for infants and toddlers 6 months to 2 years old, and for children 2 to 6 years old.
The agency is awaiting data on Pfizer and BioNTech’s three-dose regimen for children under age 5 after two doses of its pediatric vaccine failed to trigger an immune response in 2-, 3- and 4-year-olds comparable to the response generated in teens and adults.
According to Endpoints News, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, told the House Select Subcommittee on the Coronavirus Crisis the agency would not withhold authorization of a pediatric vaccine if it fails to meet the agency’s 50 percent efficacy threshold for blocking symptomatic infections.
COVID-19 vaccines for adolescents, teens and adults had to meet the requirement.
“If these vaccines seem to be mirroring efficacy in adults and just seem to be less effective against Omicron like they are for adults, we will probably still authorize,” Marks said.
The FDA on June 30, 2020, issued guidance that in order for an experimental COVID-19 vaccine to obtain EUA, it must “prevent disease or decrease its severity in at least 50 percent of people who are vaccinated.”
The guidelines were issued during a briefing with the Senate Committee on Health, Education, Labor and Pensions, during which senators sought assurances from former FDA Commissioner Stephen Hahn, Dr. Anthony Fauci and other top health officials that the expedited speed of development of COVID-19 vaccines wouldn’t compromise the integrity of the final product.
All previously authorized COVID-19 vaccines and boosters for all age groups were required to meet the FDA’s 50 percent requirement prior to obtaining EUA.
Vinay Prasad, a hematologist-oncologist and associate professor of Epidemiology and Biostatistics at the University of California, San Francisco posted a video responding to the news the FDA would bypass its own standard to authorize pediatric COVID-19 vaccines for kids.
Prasad said:
“Peter Marks from the FDA — he’s the defacto regulator-in-chief when it comes to vaccines — is saying that kids’ vaccines don’t need to hit the target. They don’t need to hit the 50 percent vaccine efficacy against symptomatic SARS-CoV-2 target. That was the target that the FDA themselves came up with in the original pandemic.
“They came up with this target 50 percent point estimate above, and the lower bound to the 95 percent confidence interval has to be above 30 percent. That was their minimum efficacy standard for vaccination. That was the standard they themselves set and that was the standard initial vaccine trials did clear for adults.
“But the pediatric vaccine trials — both the Pfizer and Moderna — appear not to have cleared that bar, and Peter Marks is talking to congressional officials and he is saying that it’s okay, we’ll probably authorize it anyway.”
Prasad said it was “incredible” that Marks would sign off on a pediatric vaccine if it seems to be mirroring efficacy in adults but is less effective against Omicron.
“We have standards for a reason,” Prasad said. The standard chosen by the FDA was “arbitrary and if anything I’d argue it was on the low side — 50 percent isn’t as good as what we wanted,” Prasad said.
“Fifty percent is quite low, and if you have a very low vaccine efficacy […] you can have compensatory behavior that actually leads to a lot more viral spread,” he added.
Prasad said when it comes to kids, it’s “kind of a moot point” because estimates from the Centers for Disease Control and Prevention from a few months ago showed 75 percent of children had seroprevalence — and it’s “probably higher now.”
“Taking a child under the age of 5 who already had and recovered from COVID and trying to make them better off with a vaccine against the original Wuhan ancestral strain — that’s an uphill battle,” Prasad said.
“The absolute upper bound, absolute risk reduction, has got to be super super low because once kids have it and recover from it they generally do pretty well. If they get it again they do even better than the first time.”
Lowering the regulatory standards for vaccine products is not the direction FDA should go, Prasad said. “They need to be upholding the standards they’ve set and raising the standards.”
Prasad raised concerns over what the standard will be moving forward if the agency doesn’t abide by its own minimum requirement.
“At what point will vaccine efficacy arrive at something the agency doesn’t accept?” He asked.
Prasad said once the FDA does away with EUA, many preschools will immediately mandate COVID-19 vaccines, and they won’t make exceptions for natural immunity or provide any exceptions at all.
“And so what he’s talking about is authorizing a vaccine in a setting where you have 75 percent minimum seroprevalence and the vaccine efficacy could be less than 50 percent,” Prasad said. “How much less?”
Pointing to a Moderna press release stating one arm of its trial showed its pediatric vaccines were only 37 and 23 percent effective, Prasad asked, “How much lower can it go — 10 percent? How low before Peter Marks says that’s too low?”
Prasad said if the adult vaccine becomes less effective over time, “tell me why that means you should accept the less effective kids’ vaccine?”
Prasad explained:
“If a therapy loses efficacy over time, why does that mean the bar to be a therapy is lower? It should mean that we need new therapies. We need a new mRNA construct.
“You need to kind of aim at the thing that’s actually out there now and not the original thing from two years ago. Maybe you want to rejigger your process. Try something new but it doesn’t mean we keep lowering the bar. This is ridiculous.”
Moderna reports concerning efficacy data for pediatric COVID-19 vaccines
As The Defender reported, Moderna on April 28 asked the FDA to approve its COVID-19 mRNA-1273 vaccine for children 6 months to 6 years old, citing different efficacy numbers than it disclosed in March.
The company conducted separate trials for two versions of the vaccine, one for infants and toddlers aged 6 months to 2 years, and one for children 2 to 6 years, and claimed data showed “a robust neutralizing antibody response” and “a favorable safety profile.”
Yet, Moderna’s KidCOVE study showed the company’s COVID-19 vaccine failed to meet the FDA’s minimum efficacy requirements for EUA in the 2- to under-6 age group, and barely surpassed the agency’s 50% efficacy requirement in the 6-month to 2-year age group — even after the vaccine maker changed its analysis of the study to meet the threshold.
Moderna also did not follow trial participants beyond 28 days, so vaccine effectiveness after that time is unknown. Data from New York state show vaccine effectiveness for the 5-to-11 age group plummets within seven weeks to 12 percent.
“Here, we’re looking only at the first four weeks,” Dr. Madhava Setty told The Defender. “Although data from New York were in a different age group using a different mRNA vaccine, the effectiveness was remarkably similar after four weeks. Why wouldn’t we expect that the same thing is going to happen?”
The House Select Subcommittee on Coronavirus Crisis on April 26 asked the FDA for a status update on COVID-19 vaccines for children under 5.
The agency said it was considering holding off on reviewing Moderna’s request to authorize its COVID-19 vaccine for children under 5 until it has data from Pfizer and BioNTech on their vaccine for children, pushing the earliest possible authorization of a vaccine from May to June.
When asked on Friday whether the FDA’s vaccine advisors would slow-roll Moderna’s applications and wait to review Pfizer’s and Moderna’s applications together, Marks said the meetings set for next month could move up if necessary.
“Obviously if we get through reviews faster, then we will send them to committees sooner,” Marks said.
According to Rep. Jim Clyburn’s (D-S.C.) account of the meeting, Marks said the FDA’s vaccine advisory committee has reserved earlier dates, enabling the agency to potentially “move dates up even by a week for any of these reviews.”
“At the end of the day, we want people to have confidence in getting vaccinated,” Marks said. “We need to get more kids vaccinated, not just in the younger than 5 age range, but also older than 5.”
See more here: childrenshealthdefense.org
Bold emphasis added
Header image: PBS
Editor’s note: Anyone would think they are deliberately trying to kill children, or possibly make them incapable of reproduction which, of course, would help the globalists towards their population reduction goals.
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Lorraine
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Do not submit your children, nor yourselves, as test subjects.
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nafaho
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I make 85 dollars each hour for working an online job at home. dso I never thought I can do it but my best friend makes 10000 bucks every month working this job and she recommended me to learn more about it.
The potential with this is endless…>>>>>>https://t.ly/eGAt
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cn
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The murders continue .
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Saeed Qureshi
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@ “COVID Vaccines For Kids Under 6 Won’t Have To Meet Efficacy Standard”
As if vaccines met the efficacy criteria for the adults. Believe it or not, the efficacy of vaccines has never been determined, at least scientifically. No wonder they did not work and will never work. It is not an opinion but a scientific fact.
https://bioanalyticx.com/vaccines-efficacy/
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PGraham
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This goes against all logic and ethical laws and any parent that allows their child to receive this lethal jab should not be allowed to have children. Our government is trying to kill us and should not be trusted.
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Alcheminister
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All vaccines are toxic, based on fraud, comprised of toxins, provide no potential benefit and are used by an industry that relies on sickness and belief. Protocol (homogenization) is also inherently sub-optimal and failure (unless you’re a clone). No vaccines have ever been beneficial. Every vaccine administered to a child is essentially a form of child abuse, assault or attempted murder.
https://ghostofjfk.substack.com/p/behold-health-benefits-of-vaccines?s=r
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Russ D
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Most IDIOTS have no idea what’s in vaccines. They just believe what they are told like good little Sheeple!!!
Vaccine Ingredients and Vaccine Secrets
https://healthwyze.org/reports/60-vaccine-secrets
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Mark Tapley
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There is nothing unusual about any of this. Vaccination has never been anything but the injection of foreign proteins, nano particles and other garbage into the blood system. The idea that any one could get immunity from anything with this procedure is even more ridiculous than the antiquated idea of blood letting that used to be practiced. Viruses do not exist and after over 150 years of trying every conceivable means possible to prove pathogenic transmission, all have failed. Thats why the great allopathic icon of the world, the con medical con man Pasteur never in his 40 years of unmitigated fraud, never succeeded in transferring pathogens as has always been claimed. No problem, he just used arsenic and mercury.
After the wonderful beneficent Rockefeller’s and their dozen blood toxins that were the real cause of the 1918 “flu” everyone has been propagandized by the Zionist cartel to believe in vaccination so that now all that need be done is for the Jew MSM and puppet actor politicians to tell the herd there is new virus and the idiots line up for their own sterilization, debilitation and death. But after all what can be said for cucks that are that stupid? Read the real history of vaccination in Suzanne Humphries MD “Dissolving Illusions.”
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Andy
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Every comment from you is about the Jews. For God sake give it a rest!!
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Mark Tapley
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Hello Andy:
All I stated in the entire comment was the phrase Jew MSM. Check out who controls all of the MSM including almost all top positions All MSM are in the Black Rock – Vanguard investment interlock.
All of Biden’s top cabinet positions.are Zionist Jews but I guess that is a coincidence to huh Andy? All 4 of Trumps top campaign donors in 2016 were Zionist Jews. Zionist Jews are the top campaign donors for both the fake Dem. and the fake Rep. parties. While they are less than 2% of the population. How about explaining that to us Andy. Also need you to explain to us why the ADL is the official censor for JewTube. PSI was started because real science is suppressed by this same network but you don’t like to mention that because it would be anti semitic. The ?Zionists favorite tactic for silencing their opponents. Need you to explain why not one member of the puppet congress will vote against the aIPAC agenda. And why the U.S. gives 11 million per day to Israel not including other huge benefits. Not every comment I make makes reference to Zionists. For instance the one I made a little while ago as to the real reason for Alzheimers. I just mention them when the situation merits it.
https://www.bitchute.com/video/xMkxPAmyfOOj/
https://www.bitchute.com/video/7DMlgBGbqDkr/
The following 27 Jews are in Creepy Joe’s Cabinet and most important Administrative positions.
1) Doug Emhoff, Jewish Husband of Kamala Devil Harris
2) Janet Yellin, Jewish Secretary Treasury
3) Anthony Blinken, Jewish Secretary of State
4) Ron Klain, Jewish Chief of Staff
5) Merrick Garland, Jewish Attorney General
6) David Cohen, Jewish Deputy Director CIA
7) Alejandro Mayorkas, Jewish Secretary Homeland Security
8) Avril Haines, Jewish Director National Intelligence
9) Rochelle P. Walensky, Jewish CDC Director
10) Victoria Nuland, Jewish Secretary State Political Affairs
11) Eric Lander, Jewish Office of Science Technology
12) Jeffry Zeints, Jewish Covid Czar
13) Rachel Levine, Jewish Assistant Health Secretary
14) and 15) Cass Sunstein, Jewish Senior Counselor at the Department of Homeland Security, and his wife, Samantha Power, Head of USAID
16) Dana Stroul, Jewish Pentagon Senior Policy Official on the Middle East
17) Wendy Sherman, Jewish Deputy Secretary of State
18) Anne Neuberger, Jewish Director of Cybersecurity at NSA
19) Chanan Weissman, Jewish Director of Technology at National Security Council
20) Avril Haines, Jewish Director of National Intelligence
21) Polly Trottenberg, Jewish Deputy Secretary of Transportation
22) Jessica Rosenworce,l Jewish Acting Chairwoman FCC
23) Jennifer Klein, Jewish Co-Chair of the Gender Policy Council
24) Jared Bernstein, Jewish Member of Council of Economic Advisers
25) David Kessler, Jewish Chief Science Officer of COVID Response
26) Stephanie Pollack, Jewish Deputy Administrator Federal Highway Administration
27) Gary Gensler, Jewish Chairman of the Securities and Exchange Commission
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bmatkin
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The problem with your “zionist” , “Jew” schtick is that only a very few of those of the tribe of Judah part of these world wide problems. Zionists, technically, are those that want to unite the “13” tribes of Israel or a lest find them. Another definition are those Jews who wanted their own homeland. However, your definition is one that means the small group of Jews in the One World Government cabal. It’s just not accurate and may reflect your bias or bigotry to people of Judah not associated with the monsters you pointed out.
We’re tired of this and it makes this website look like silly people are the only ones that read it.
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Alcheminister
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Something Mark doesn’t mention often enough.
Souled out shit is souled shit. Don’t care about your ethnicity, if you’re an asshole, fuckoff.
Mark Tapley
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Hello Bmatkin:
I have stated many times on PSI that the great majority of Jews have nothing to do with the Zionist conspiracy that also includes many gentiles. In fact the mass of Jews have many times been used as cannon fodder by their leaders at the top.
Tom
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The injection horror show continues with absolutely no need of ever proving safety and efficacy. This is the ultra corrupt FDA in action with the determination to murder as many humas as they can. Next you will hear that mRNA gene therapy injecions will become part of the regular chilhood vaccine schedule, which has never been proven to actually help children to be healthier. In fact, quite the opposite occurs.
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Alcheminister
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I’m gonna say it straight. Anyone manufacturing, promoting, administering vaccines probably deserve Darwin awards, are unfit to be parents and I’m a genocidal eugenicist now. I don’t think it’s reasonable to entertain or tolerate their BS (nor any aspect of what enables that).
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VOWG
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Question. Just what is the efficacy standard when none of the vaxxes are in any way efficacious?
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Alcheminister
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Exactly. And even more importantly, what are the enabling fundamentals, “justification” or beliefs?
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