FDA Set to Authorize New COVID Boosters Before Human Trials Completed

A vial of Pfizer's COVID-19 vaccine in Seattle, Wash., on June 21, 2022. (David Ryder/Getty Images)

The U.S. Food and Drug Administration (FDA) is expected to clear new boosters this week for the Moderna and Pfizer-BioNTech COVID-19 vaccines, even though the companies have not completed trials on human subjects and without the vaccine going before an advisory panel of doctors.

The process of approval was set in motion on June 28 when the panel of doctors that advises the FDA on vaccines met virtually and voted to allow the vaccine-makers to modify their already-approved vaccine boosters to add an Omicron component to target the variant of the virus that is now dominant in the United States.

When reached by The Epoch Times, the acting chairman of that committee, Dr. Arnold Monto, defended the panel’s decision.

“The problem is, it takes a long time to pull together an advisory [meeting],” said Monto, a professor of epidemiology and global public health at the University of Michigan. He added that there is no requirement that the advisory committee meets on requests for clearance.

“The conclusion of FDA was that the data were clear enough and based on what we had recommended, they were moving ahead,” Monto said.

The vote came after the head of the FDA’s vaccine unit, Dr. Peter Marks, said that the vaccines had “undoubtedly saved many lives,” but that “their effectiveness does appear to wane over time” and don’t “hold up quite as well” in the face of new variants.

Signage outside of the Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. (Andrew Kelly/Reuters)

Omicron emerged in late 2021, and has proven better able to evade vaccine-bestowed protection than earlier strains. BA.5, a subvariant of Omicron, is currently dominant in the United States.

The FDA had said it wanted new boosters for the latest variant going into the fall and winter, when cases of COVID-19 are expected to rise again as people gather more indoors after falling during the summer months.

Pfizer and Moderna have already reported data from clinical trials with modified vaccines containing an Omicron BA.1 component, and in June, following the committee’s vote, were instructed to begin testing the modified vaccines containing a BA.4/5 component.

But those tests won’t be finished by the time the new boosters are approved.

Dr. Pierre Kory, president and chief medical officer of the Frontline COVID-19 Critical Care Alliance and a former head of critical care at the University of Wisconsin hospital, criticized the pending authorization.

“Rushing this new combo vaccine out without proper testing or convening the vaccine advisory committee only serves to fatten big pharma’s bottom line,” Kory told The Epoch Times via email. “These companies are completely absolved of responsibility for the harm these vaccines will inevitably cause as they continue to rake it profits. The FDA is needlessly putting Americans in jeopardy and must be stopped.”

Life Insurance Data

A recent report on group life insurance data published by the Society of Actuaries shows a 200 percent increase in deaths for people ages 35-44 in the third quarter of 2021, nine months after the vaccine was introduced and around the same time many large corporations imposed a vaccine mandate. The report used data submitted by 20 of the top 21 group term life insurance companies in the United States.

When asked why deaths from all causes among Americans would rise after a vaccine has been introduced, Dr. Monto declined to answer.

“I think I’m not going to be able to comment any further,” he said. “I believe these vaccines are life-saving, and that’s why it’s important to get them out with appropriate review.”

Serious adverse events have been linked to the COVID-19 vaccines, including severe allergic shock, heart inflammation, and blood clotting. Additionally, in July of 2021, the FDA released results of a safety screening for the Pfizer-BioNTech vaccine that detected four potential adverse events of interest: pulmonary embolism, acute myocardial infarction, immune thrombocytopenia, and disseminated intravascular coagulation.

“These four events may not be true safety concerns, and the screening method cannot establish that the vaccine caused these,” the FDA said at the time, adding that these had not been identified as concerns in the Vaccine Adverse Event Reporting System (VAERS).

VAERS, a passive reporting system run by the FDA and the U.S. Centers for Disease Control and Prevention, shows 30,479 reported deaths following vaccination with the COVID-19 vaccines, and more than 1 million adverse events as of Aug. 19.

Patients, family members and health care providers are able to submit information to VAERS describing what they believe may be a side effect from a vaccine. Only a fraction of all side effects are thought to be reported to the database, with a 2007-2010 study showing just 1 percent were reported.

The FDA did not return calls for comment for this story.