By Jefferey Jaxen

In what is becoming a common occurrence, the U.S. Food and Drug Administration (FDA) has omitted convening their Vaccines and Related Biological Products Advisory Committee (VRBPAC) to weight the data and vote on its recent approval of a Pfizer booster for children 12-15 years old.

The move was not lost on members of the scientific community. Surgical oncologist and chief of the Johns Hopkins Islet Transplant Center Marty Makary, MD, MPH wrote on Twitter:

Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research was quoted in the FDA’s recent press releases stating:

“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the delta and omicron variants. In particular, the omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines,”

However, on August 18, 2020 in an article written by Marks in HealthAffairs.org he, along with then acting FDA commissioner Stephan Hahn, claimed “[the] FDA has committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public.

They also wrote, “By convening VRBPAC, FDA will ensure public transparency around discussions of vaccine safety and effectiveness to provide a window into its decision-making process and help address potential concerns from vaccine-hesitant populations.

In addition to not convening their VRBPAC committee, the FDA’s recent ‘science by press release’ statement made no mention of new trials. In fact, they appear to be basing their EUA extension in children based on “real-world data from Israel”.

Senator Rand Paul wrote:

Meanwhile, overall data analysis continues to show that the danger to children of SARS-COV-2 and its recent omicron variant, is low compared to older populations and especially those with comorbidities.

Even Dr. Tony Fauci himself was forced to admit what had been known for nearly a year during a recent interview.

Speaking to MSNBC, Fauci suggested that some of the children currently being treated at medical facilities were hospitalized with COVID as opposed to “because of COVID.”

He added some children who are currently listed as being in the hospital with COVID may actually be receiving treatment for “a broken leg or appendicitis,” rather than for a severe reactions to the virus.

Yet with each injection, children are asked to take on a risk profile that is still not fully understood. Emerging data continues to point to the increased risks of myocarditis after COVID vaccination in younger populations.

A new study looked at 12 to 39 years old patients insured by Kaiser Permanente Northwest who received at least one dose of an mRNA vaccine (Pfizer-BioNTech or Moderna) between December 2020 and October 2021. The researchers concluded “The true incidence of myopericarditis is markedly higher than the incidence reported to US advisory committees.” How much higher? 1 in 2700 Boys 12-17 1 in 1860 for Men 18-24

Cardiologist Ramin Farzaneh-Far MD commented on Twitter stating:

https://twitter.com/rfsquared/status/1477692351434960896?s=20

While Vinay Prasad, MD MPH wrote:

The FDA also suffered recent two black eyes it hopes the public didn’t see. Presumably because of the agency’s rush to authorize boosters against a backdrop of missing data and uncertain safety outcomes, its two senior vaccine regulators stepped down in unison.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause will exit the agency in October and November, respectively.

At the time in late August 2021 Politico reported:

“…the agency is facing a potential mutiny among its staff and outside vaccine advisers, several of whom feel cut out of key decisions and who view the plan to offer boosters to all adults as premature and unnecessary.

The wrote further that “The tension within the administration plus open skepticism from outside experts has fueled finger-pointing and divisions among health agencies. Career scientists in particular have been confused and surprised by the process...

Jefferey Jaxen

Jefferey Jaxen is a health journalist and featured in his weekly segment, ’The Jaxen Report’, on The HighWire. As an investigative journalist, researcher, and compelling writer, Jefferey serves as Lead editor of The HighWire News and Opinion Team.

Other Headlines

Coronavirus

ICAN Releases Recordings of FDA’s Peter Marks; Vaccine Official Dismissed Vaccine Injuries

The Informed Consent Action Network (ICAN) and REACT 19 held a joint press conference today to reveal a trove of secret recordings and FOIA documents of Peter Marks, the former Director of the Center for Biologics Evaluation and Research. The press conference included ICAN Founder Del Bigtree, Attorney Aaron Siri, and REACT 19’s Brianne Dressen.Continue reading ICAN Releases Recordings of FDA’s Peter Marks; Vaccine Official Dismissed Vaccine Injuries

More news about Coronavirus

Health & Nutrition

FDA Begins Process to Remove Unapproved Fluoride Drugs for Children

The FDA has begun the process of removing “concentrated ingestible fluoride prescription drug products for children” from the market. The press release said these products are intended to be swallowed by infants and toddlers, but have never been approved by the FDA. The announcement also said ingesting fluoride alters the gut microbiome, “which is ofContinue reading FDA Begins Process to Remove Unapproved Fluoride Drugs for Children

More news about Health & Nutrition

Vaccines

The FDA Will No Longer Routinely Approve COVID-19 Vaccinations for Healthy Individuals Under Age 65

The U.S. Food and Drug Administration (FDA) announced that it will no longer routinely approve COVID-19 vaccinations for healthy individuals under the age of 65. Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), and Dr. Marty Makary, FDA director, co-wrote a paper for the New England Journal of MedicineContinue reading The FDA Will No Longer Routinely Approve COVID-19 Vaccinations for Healthy Individuals Under Age 65

More news about Vaccines

Science & Tech

Humanoid Robots Malfunction and Attack; Sparks Debate Over AI Safety and Liability

A viral video released from an undisclosed Chinese factory shows a humanoid robot malfunctioning and attacking the factory workers. The Unitree H1, a product of the Chinese company Unitree Robotics, can be seen flailing its arms as workers move away to protect themselves. The robot was hung on a crane, and the workers were notContinue reading Humanoid Robots Malfunction and Attack; Sparks Debate Over AI Safety and Liability

More news about Science & Tech

Environment

BioLab Ends Manufacturing in Conyers After Chemical Fire Exposed Thousands to Toxic Contamination

BioLab announced it will not restart manufacturing at the Conyers, Georgia, facility where a major chemical fire occurred last fall. The company will continue to use the facility as a distribution center with 100 employees. The HighWire reported about the September fire, which included 17,000 evacuations and 90,000 ordered to shelter in place. Last month,Continue reading BioLab Ends Manufacturing in Conyers After Chemical Fire Exposed Thousands to Toxic Contamination

More news about Environment

Policy

Senate Hearing Alleges Government and Industry Corruption Over COVID-19 Vaccines

Corruption of government officials and pharmaceutical companies was revealed during a Senate Subcommittee on Investigations hearing on Wednesday. The hearing was titled “The Corruption of Science and Federal Health Agencies: How Health Officials Downplayed and Hid Myocarditis and Other Adverse Events Associated with the COVID-19 Vaccines,” and it was chaired by Senator Ron Johnson. SeveralContinue reading Senate Hearing Alleges Government and Industry Corruption Over COVID-19 Vaccines

More news about Policy