Coronavirus: Thread

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Republicans Press FDA On Why COVID-19 Vaccines Would Be Authorized For
Young Children

https://www.theepochtimes.com/exclusive-congress-presses-fda-on-why-covid-19-vaccines-would-be-authorized-for-young-children_4519179.html
https://www.theepochtimes.com/us-regulators-prepared-to-clear-covid-19-vaccine-for-young-children-despite-substandard-efficacy-lawmaker_4454398.html

A group of members of Congress is pressing the U.S. Food and Drug
Administration (FDA) for answers before the regulator decides whether
to authorize COVID-19 vaccines for young children.
Sen. Ted Cruz (R-Texas) speaks to reporters in Washington on April 7,
2022. (Drew Angerer/Getty Images)

All Americans aged 5 and older can get a COVID-19 vaccine. The FDA is
scheduled to meet with its advisory panel on June 15 to discuss
whether to grant emergency use authorization (EUA) for the Moderna and
Pfizer vaccines for children aged 6 months to 4 years old.

A bicameral group of members of Congress, led by Sen. Ted Cruz
(R-Texas) and Rep. Bill Posey (R-Fla.), are questioning whether an EUA
makes sense, given how little risk COVID-19 poses to young children
and how the vaccines have plunged in effectiveness against infection
as new virus variants have emerged during the pandemic.

“The broad approach of the CDC and FDA to date has been a one-size
fits all policy—get the vaccine regardless of age, risk factors, the
underlying health of the individual, or previous infection,” the
members wrote to FDA Commissioner Robert Califf and members of the
advisory panel in a June 7 letter obtained by The Epoch Times. “Yet,
to date there remain many unanswered questions about these
EUA-approved COVID-19 vaccines and only a small percentage of the
safety data about these vaccines that are in the possession of the FDA
and the manufacturers has been released for review.”

The members noted that nearly 70 percent of children aged 1 to 4 have
recovered from COVID-19, according to the Centers for Disease Control
and Prevention (CDC). That recovery gives the children a level of
protection against re-infection that studies show is better than the
protection from the vaccines. The members also pointed out that
children who contract COVID-19 have a high survival rate and have
little risk of experiencing severe disease.

The group asked the FDA to answer a series of questions before issuing
its decision on the EUA requests from Moderna and Pfizer. They want to
know, among other details, the cardiac risk factor for children
getting the vaccines; whether the FDA will commit to sticking with a
50 percent effectiveness threshold it outlined in 2020; and whether
there is a possibility children who get the vaccines will face higher
risk from future variants of the virus that causes COVID-19.

“The data show that the risks of serious adverse outcomes for COVID
for children five and under is very low and as such the standard for
evaluating EUA interventions must be very high,” the group wrote. “We
believe each question raised above is not just important, but
essential questions for the FDA, VRBPAC and the CDC when it comes to
doing a thorough job of evaluating the potential benefits and
potential risks of the vaccines for which you have been asked to
consider granting an Emergency Use Authorization.”

VRBPAC stands for the Vaccines and Related Biological Products
Advisory Committee. It is the FDA’s advisory panel on vaccines.

The group who wrote the letter also includes Sen. Ron Johnson
(R-Wis.), Rep. Louie Gohmert (R-Texas), Rep. Ralph Norman (R-S.C.),
Rep. Mary Miller (R-Ill.), Rep. Andy Biggs (R-Ariz.), Rep. Chip Roy
(R-Texas), Rep. Dan Bishop (R-N.C.), Rep Lauren Boebert (R-Colo.),
Rep. Andrew Clyde (R-Ga.), Rep. Thomas Massie (R-Ky.), Rep. Warren
Davidson (R-Ohio), Rep. Jeff Duncan (R-S.C.), Rep. Diana Harshbarger
(R-Tenn.), Rep. Matt Rosendale (R-Mont.), Rep. Vicky Hartzler (R-Mo.),
and Rep. Bob Good (R-Va.).

The FDA did not respond to a request for comment.

“I am concerned that in a rush to mandate a ‘one-size-fits-all’
policy, the FDA is failing to consider that this age group is least at
risk for complications from COVID and that the CDC estimates 68% of
those under five have already had COVID. Common sense would suggest
that VRBPAC members have already asked these questions, so we would
expect a response by the time they meet. If we don’t receive answers,
it is right to assume they haven’t asked basic benefit and risk
questions about using this vaccine for millions of children who are at
very little risk from COVID,” Posey said in a statement.

“We are in our third year with COVID-19, and we know vastly more about
the virus now than we did in 2020. One of the most important things we
know is that this virus poses minimal risk for children. Before the
FDA approves an Emergency Use Authorization for a children’s vaccine,
parents should be able to see the data and paperwork they would use to
justify this decision. This is the least the FDA can do for families
in Texas and across the country so parents can make the best decisions
for their children,” Cruz added.
Food and Drug Administration (FDA) Commissioner Robert Califf
testifies during a Senate Agriculture, Rural Development, Food and
Drug Administration, and Related Agencies Subcommittee hearing on
Capitol Hill in Washington on April 28, 2022. (Kevin Dietsch/Getty
Images)

Given the high survival rate of children, the unknown long-term side
effects of the shots, and the post-vaccination heart inflammation
cases that were only detected after the vaccines were authorized, “the
push for vaccine approval seems absolutely reckless,” Gohmert said.

“Just last month, the FDA essentially announced that people should no
longer take the Johnson and Johnson vaccine due to dangerous blood
clotting side effects. This, after telling us the J&J vaccine was safe
and effective for over a year. As Americans, we have every right to
demand that the utmost safety and efficacy standards be implemented
and rigorous studies and testing be performed before these injections
are approved for anyone, especially innocent children,” he added.

After Rep. James Clyburn (D-S.C.) reported being told by Dr. Peter
Marks, a top FDA vaccine official, in May that the agency would not
withhold authorization solely because a vaccine was not at least 50
percent effective. An FDA spokesperson told The Epoch Times in an
email that the agency “will evaluate any data submitted in the context
of the ongoing public health emergency and will only authorize
vaccines for the youngest children that meet our standards and for
which the known and potential benefits outweigh the known and
potential risks.”

Experts and parents are divided on whether vaccines are needed for
children, especially healthy children.

Based on research and the effect of COVID-19 on youth, “childhood
vaccination should not be considered unless a child has significant
co-morbidities like cystic fibrosis, severe Type I diabetes, etc.,”
Dr. Steven Hatfill, a virologist, told The Epoch Times in an email.

Dr. Moira Szilagyi, president of the American Academy of Pediatrics,
said in a statement that U.S. authorities should “move with all
possible speed” to review the data on vaccines for young kids, adding,
“Children are not immune from COVID, which can cause severe and
long-term illness, hospitalizations and even death.”