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You are here: Home » News » Jesuit Agendas » Health Care News » Vaccines » For Kids, Benefits of COVID Vaccine ‘Don’t Outweigh Risks,’ Experts Tell FDA

For Kids, Benefits of COVID Vaccine ‘Don’t Outweigh Risks,’ Experts Tell FDA

June 11, 2021 11:26 AM By Children's Health Defense Leave a Comment

Originally published by Childrenshealthdefense.org.


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An advisory committee to the U.S. Food and Drug Administration (FDA) held a virtual meeting Thursday to discuss what data would be needed to vaccinate children under 12 against COVID.

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:

  1. 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.
  2. 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.
  3. 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.

In terms of the benefits, Doshi said “the reported 100% efficacy in Pfizer’s trial was based on 16 COVID cases in the placebo group versus none in the fully vaccinated group. But there were about 1,000 placebo recipients so just 2% got COVID. Put another way, 2% of the fully vaccinated avoided COVID, whereas 98% of the vaccinated wouldn’t have gotten COVID anyway. “

On the other side of the ledger, Doshi said, side effects were common:

“Three in 4 kids had fatigue and headaches, around half had chills and muscle pain, around 1 in 4 to 5 had fever and joint pain. The list goes on. In sum, all the fully vaccinated 12- to 15-year-olds avoided symptomatic COVID but most wouldn’t have gotten COVID even without the vaccine. So, the benefit is small but it came at the price of side effects that were mild to moderate in severity and lasted a few days.”

Doshi said few children in Pfizer’s trial benefited because they didn’t get COVID, already had COVID or were asymptomatic. Doshi pointed to data from the Centers for Disease Control and Prevention (CDC) showing 23% of 0- to 4-year-olds and 42% of 5- to17-year-olds have already had COVID and have robust natural immunity.

As for long-term side-effects, Doshi said many severe side effects occur beyond six weeks after dosing, specifically referencing a quote by top FDA advisor Dr. Paul Offit who stated otherwise.

Vaccinating children for the benefit of adults is an “unproven hypothetical benefit,” Doshi said. He reminded the FDA they cannot authorize or approve a medical product in a population unless the benefits outweigh the risks in that same population.

“If the FDA does not have a high bar for EUAs and licensing, the point of regulation is lost,” Doshi said.

Kim Witczak, an FDA consumer representative, expressed great concerns over the premature approval of COVID vaccines for children. Witczak said data shows children are neither in danger or dangerous and questioned the timing of last Friday’s CDC announcement of the rise in children being hospitalized with COVID.

“The media ran with it and more fear was stirred — perfectly timed in advance of this meeting,” Witczak said.

“The truth is we don’t really know that much about these vaccines,” Witczak said. “The ‘safe and effective’ messaging is being thrown around by everyone from government officials to media, community, religious leaders, to Hollywood celebrities. Then you add in all the promotions like multimillion dollar lotteries, free donuts, free shots at the local bar and so on. This subconsciously creates the illusion that there are no downsides whatsoever, nothing to weigh or consider.”

Witczak added: ”We simply cannot ignore the growing evidence of harm and just accept the narrative that adverse reactions are a good thing — and that means the shot is working.”

Witczak and Doshi were two of 27 researchers and clinicians around the world who launched a citizen’s petition demanding the FDA withhold full approval of COVID vaccines until efficacy and safety measures are met.

Some VRBPAC members expressed concern about reports of heart inflammation potentially linked to COVID vaccines.

Dr. Cody Meissner, director of pediatric infectious diseases at Tufts University School of Medicine, said children are at low risk of severe disease from the virus and more study is needed about safety in younger age groups.

“Before we start vaccinating millions of adolescents and children, it’s important to find out what the consequences are,” Meissner said, noting a low COVID hospitalization rate among children.

“As more people are immunized and become immune from infection, I think it’s likely that we are going to get this pandemic under pretty good control,” he said. “I do not feel we can justify an EUA. The burden of disease is so small and the risks are just not clear.”

But other members of the committee sharply disagreed.

“I think we need these vaccines sooner rather than later in children,” said Dr. Mark Sawyer, a pediatrics professor at the University of California San Diego School of Medicine.

“It just seems silly to think that we’re not going to have to include children as part of that,” said Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, co-inventor of Merck’s lucrative rotavirus vaccine and advisor to the FDA. “They can suffer and be hospitalized and occasionally die.”

“The notion that we are not going to have to vaccinate children going forward I think is wrong,” Offit added.

“I think that we need to have EUA ready to go if we start to see an upsurge of cases in the fall,” said Dr. Stanley Perlman, professor of pediatrics at the University of Iowa.

Risk of heart inflammation

Dr. Tom Shimabukuro, deputy director of the CDC’s Immunization Safety Office, said during the meeting “there are ‘very few’ reports of myocarditis or pericarditis in 12- to 15-year-olds who have been given coronavirus vaccines.”

However, the CDC data Shimabukuro presented showed a higher-than-expected number of cases of heart inflammation among young people recently vaccinated with their second doses of mRNA vaccine. The agency identified 226 reports that might meet the agency’s “working case definition” of myocarditis and pericarditis following the shots.

Among 16- to 17-year-olds through May 31, 79 cases of myocarditis and pericarditis were reported. The expected rate among people in this age group is between two and 19 cases, Shimabukuro said during his presentation.

CDC data also showed that among 18- to 24-year-olds, there were 196 reports of myocarditis and pericarditis. The expected rate is between eight and 83 cases.

The CDC’s Advisory Committee on Immunization Practices scheduled an emergency meeting for June 18 to update data and further evaluate myocarditis following vaccination with Pfizer and Moderna vaccines.

The FDA’s meeting ended with remarks by Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“I also want to take a moment to remember all the children who have died of COVID-19 in this pandemic, because that should not be forgotten here,” Marks said. “I just want to reiterate something here — this is an illness that takes the lives of children. We know that over 300 children have died in the pandemic so far.”

As Dr. Sidney Wolf, founder and senior advisor of Health Research Group, pointed out during the FDA meeting, CDC data from Jan. 1 to March 31 showed only 204 hospitalizations and 0 deaths in the 12- to17-year-old age group due to COVID.

As The Defender reported May 26, two papers recently published in the journal of Hospital Pediatrics, found pediatric hospitalizations for COVID were overcounted by at least 40%, carrying potential implications for nationwide figures used to justify vaccinating children.

Author: Children’s Health Defense

The mission of Children’s Health Defense is to end childhood health epidemics by working aggressively to eliminate harmful exposures, hold those responsible accountable, and to establish safeguards so this never happens again. CHD was founded by Robert F. Kennedy, Jr. and he serves as Chairman. For over three decades, he has been one of the world’s leading advocates of humanitarian and environmental causes. He is also founder and president of Waterkeeper Alliance, the umbrella group for 300 local waterkeeper organizations, in 34 countries, that track down and sue polluters. His father, Robert F. Kennedy, served as United States Attorney General (1961-1964) and United States Senator from New York (1965-1968).

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  • Fionnola Morris on “They’re preparing us for civil war.”Actions taken to provoke a civil war is probably a fair summation. However, the Lord also has His plans which aren’t simply reactive. Many of us can clearly see the hand of God in all this, especially…
  • Edg on “They’re preparing us for civil war.”Yes OUR Mighty Lord planned to Stop the curse on America with these abortions and YES our Lord's will and HE is never Late Pray for Peace for America and Peace for Israel
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  • Nora on “They’re preparing us for civil war.”I agree. This reminded me of David Wilkerson's book The Vision (1973). In the vision God gave him, New York City is on fire > he didn't know why, it could be a celestial event, an attack, or civil…
  • Kris L on “They’re preparing us for civil war.”The paths of the two eclipses also crisscross over southern Illinois, an area that used to be call Little Egypt.
  • Derek on Recent prophetic dreams show prices for Electroneum (ETN)I don't think its a negative sentiment. Many lost 99% of their monies and it can drop more from here. It's only when you see things as is, you learn and grow, not by blind faith.
  • James - Lincoln on “They’re preparing us for civil war.”Couldn't agree more with this, Mena! May you be blessed for sharing!!
  • Ant 🐜 on Recent prophetic dreams show prices for Electroneum (ETN)Wow, given this negative sentiment regarding RDD and ETN from once committed diehards who once believed, I would suggest that this week is now the absolute bottom and both cryptos are on their way up…
  • Bill F on Recent prophetic dreams show prices for Electroneum (ETN)Thanks for sharing that mem. "Not by might , nor by power....nor by excellent TA skills...nor by intellectual prowess...but by My Spirit sayeth the Lord!"
  • mem on Recent prophetic dreams show prices for Electroneum (ETN)I was the opposite. Didnt give rdd the time of day, because from the fundamentals it was a no go. No dream or vision needed to pass on a bad altcoin Then i had a dream where a person i havent seen sin…
  • Derek on Recent prophetic dreams show prices for Electroneum (ETN)Yes, that's why I stay away from all these SHIB and LUNC $1 dreams. There is no way the crypto market would reach quadrillion dollars market cap anytime soon, we may hit those probably during financia…
  • faith on Recent prophetic dreams show prices for Electroneum (ETN)Hi Bill, thanks for your reply. One thing I can share with you and others is from the RDD dreams I read most people do not see a warning when they get it. Bathroom/toilet dreams, anything medical (drs…
  • Edg on Prophetic dream warns of trouble ahead at Coinbase crypto exchangewell coinbase STOCK has LOST around 75 % of its value since a year ago and they will manipulate the SMALL coins, meme , to be able to keep afloat , or they will o anything to keep them from getting Hi…
  • Edg on Prophetic dream warns of trouble ahead at Coinbase crypto exchangeLMA O the world's STRONGEST currency . . . nice joke it is also been Manipulated to be where it is as of today
  • Just Another Brother on Prophetic dream warns of trouble ahead at Coinbase crypto exchangeBut this is artificial because the west stops them from paying in the bond denominated western currency, instead they pay in ruble. It might be considered a technical default, but it's imposed on them…
  • Just Another Brother on Recent prophetic dreams show prices for Electroneum (ETN)Thank you Bill for your encouraging post. I too have been around since back when ETN became hot and I bought at 6 pence. I've been in and out multiple times since then, and likewise with RDD. I have m…
  • MattNZ on Prophetic dream warns of trouble ahead at Coinbase crypto exchangeJUST IN: Russia has defaulted on its foreign debt for the first time since 1918. @GeneralMcInerney
  • Phil - Sydney on Recent prophetic dreams show prices for Electroneum (ETN)Good post . Yes. It’s a long hard road RDD has been a very slow ride down. Too late to sell so I’m in for another 2 years if it takes that long to reach $1 or $2.10. God bless everyone. Instant riches…
  • Two cents worth on Rockefeller Medicine: A Poisonous Illusion?Allopathic medicine is "Rockefeller" Medicine. Here's a humorous video about allopathic medicine, though the reality is very dark... In a time when US citizens are spending far more for "healthcare" t…
  • Bill F on Recent prophetic dreams show prices for Electroneum (ETN)Thanks for this input Faith and good to hear from you. I too am a veteran and have been around Z3 since the RDD revelation and before. It has been an "interesting" process indeed. And I also lost mone…
  • faith on Recent prophetic dreams show prices for Electroneum (ETN)I was around Z3 when the plethora of RDD dreams occurred during the time frame you mentioned. At first, like many others, I bought the coin. Shortly thereafter, the Lord warned me away from it. Prophe…
  • Glenn Clark on Prophetic dream warns of trouble ahead at Coinbase crypto exchangeThanks Derek for those details. Yeah I think the increased fees are almost certain which will turn a large number of users away. Their current fees aren't exactly the lowest of exchanges so I'm guessi…
  • Derek on Prophetic dream warns of trouble ahead at Coinbase crypto exchangeCoinbase made huge profits in 2021, and last quarter earnings were really bad. They laid off 20% staff, rescinded offers. They will layoff 30% more by EOY. Coinbase charges 3% fee, where as pro charge…
  • Glenn Clark on Prophetic dream warns of trouble ahead at Coinbase crypto exchangeI wonder if the sunsetting of Coinbase Pro is any kind of indicator of trouble within Coinbase. Sounds like Coinbase pro becomes "Advanced Trade" within Coinbase. It's supposedly just a migration and…
  • James Bailey on America blindly trusting two Jesuits to lead our nation through the coronavirus pandemic.Thanks for letting me know the video was deleted on YouTube. I had downloaded it so I uploaded it to Brighteon.com, a site that believes in freedom of speech. Here's the link: https://www.brighteon.co…
  • James Bailey on Prophetic chart could be showing macro view of crypto winter aheadI’m expecting SPX to return to 4160 within the next week or two and then drop a little before moving above 4200 soon afterwards. I'm expecting another big wave down starting in late July possibly trig…
  • James Bailey on Prophetic dream warns of trouble ahead at Coinbase crypto exchangeI'm expecting SPX to return to 4160 within the next week or two and then above 4200 by the middle of July. The May 4 top reached 4307 so it might return close to that level before the next wave down b…
  • Derek on Recent prophetic dreams show prices for Electroneum (ETN)Based on dreams of one of the brother in christ, bitcoin will take 10 years to recover after the crash. It's been 5 years since the recommendation for ETN and REDD was made. Unless you've the stomach…
  • Raven0777 on Prophetic dream reveals food shortageAntichrist, disaster I was at the doors of death back in 2010, I had dreams not of this world after that!! .About 2014, or 2015, I dreamed I was watching breaking news. The reporter had a map of the U…
  • Marcio on I HEARD THE LORD SAY “DAUGHTERS OF GOD, RECEIVE MY FIRE! RUN! RUN! RUN! RUN!”Heaven Land Devotions - Jesus Christ - Master Of Time And Eternity By Joanie Stahl https://www.youtube.com/watch?v=BWWH6cEFsGw
  • David on America blindly trusting two Jesuits to lead our nation through the coronavirus pandemic.Thank you for this. Is there anyway to get that deleted video?
  • William on Encounter with a soldierUnless you were absolutely sure these soldiers were Japanese, you should not of said that they were. You need to be more guarded in what you share.
  • Fionnola Morris on The Coming Healing of the Land & NationsThank you, Pastor Thomas, there is much too encourage us from the scriptures in your post. However, I am concerned about the fact we cannot have a move of God with so much bloodshed of whatever kind b…
  • Fionnola Morris on Encounter with a soldierThank you again, Caroline for faithfully bringing that warning to the people of God. Who knows, if we are praying and repenting on behalf of our land (2 Chron 14:7), God will certainly heal our land a…
  • Bernie on Encounter with a soldierThe soldiers could be North Korean.
  • Bob on Encounter with a soldierLeaked China Meeting Reveals Plans to Attack USA. https://rupreparing.com/news/2022/5/20/sources-china-preparing-for-d-day-invasion-of-the-continental-united-states-with-forces-to-land-on-the-beaches-…
  • Thomas NoDoubt on I HEARD THE LORD SAY “DAUGHTERS OF GOD, RECEIVE MY FIRE! RUN! RUN! RUN! RUN!”I’ve been waiting on this word from Him for about 44 years now Ever since I heard this prophetic word spoken over my life, “New things, New things, new things! God is going to do a new thing through y…
  • christian on Disturbing facts about the Ukraine war and their President Volodymyr Zelensky that western news sources refuse to reporthttps://www.youtube.com/watch?v=vl3QUlED-jc I asked God about Russia & Ukraine and He spoke to me CLEAR AS DAY
  • Geo Washington on The Federal Bureau of Tweets: Twitter Is Hiring an Alarming Number of FBI AgentsWhen social media started many years ago I had a premonition that the technology would one day be used by the Antichrist. People mocked me. Later on the prophet John Paul said. "Technology is not your…

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