FDA Has Authority to Recall COVID Vaccines — A Growing Number of Scientists Are Demanding the Agency Take Swift Action

A growing chorus of voices among public health officials, scientists and researchers say there is sufficient scientific evidence to support an FDA Class I recall of COVID-19 vaccines.

by Brenda Baletti, Ph.D.

“It’s time for a recall” of the COVID-19 vaccines, epidemiologist Nicolas Hulscher argued on a recent episode of “Brannon Howse Live.” The mounting evidence that the COVID-19 vaccines caused death and other serious injuries are grounds for “Class I recall” by the U.S. Food and Drug Administration (FDA), Hulscher said.

Hulscher is one of the growing chorus of voices among public health officials, scientists and researchers demanding public health officials hit the pause button on the shots until definitive safety studies are performed.

The latest round of calls began in January when Florida Surgeon General Joseph Ladapo called for a “halt in the use of COVID-19 mRNA vaccines” over safety concerns that the mRNA technology is delivering DNA contaminants into people’s cells.

A few weeks later, the journal Cureus published the first peer-reviewed paper to call for a moratorium on the COVID-19 vaccines. The paper included a sweeping review of “lessons learned” from the clinical trial data and the many adverse events associated with the shots.

Just last week, elected officials, organizations — including the World Council for Health and Door to Freedom — and hundreds of doctors and researchers sent a letter to the heads of state of 10 European countries calling for a suspension of the “modified mRNA vaccines,” citing serious health concerns associated with the shots.

Calls for a moratorium or a recall have been widely controversial. Ladapo was accused by The New York Times of peddling “misinformation.” The Washington Post said he had a pattern of making “debunked claim[s],” and FactCheck.org accused him of relying on “faulty science.”

Cureus retracted the “lessons learned” paper in what co-author Dr. Peter McCullough called, a “stunning act of scientific censorship.” The paper was later republished in two parts in a different peer-reviewed journal.

Despite efforts to censor and discredit medical professionals and researchers who draw attention to the harms associated with the vaccines, even mainstream publications have conceded that the COVID-19 vaccines can cause serious injuries and that vaccine-injured people have been ignored. Yet, they continue to push the shots.

Hulscher told The Defender that the mainstream media’s refusal to seriously report on calls to pull the vaccines from the market has serious implications for public health. It’s “a contributing factor to excess mortality” among global populations, he said.

“The FDA has failed to protect Americans from unsafe products because they suffer from corporate capture,” he added.

M. Nathaniel Mead, lead author of the “Lessons Learned” paper, told The Defender the FDA never should have authorized the vaccines in the first place. The “usual safety testing protocols and toxicology requirements were bypassed” and a reanalysis of the trial data showed serious adverse effects. “The ‘safe and effective’ narrative has always been a farce,” he said.

Freedom of Information Act requests have uncovered evidence that top officials at the FDA and Centers for Disease Control and Prevention knew about COVID-19 vaccine injuries early in 2021 — long before making the information public.

Still, U.S. public health agencies continue to authorize and recommend new boosters.

The FDA could easily respond to calls to halt vaccination, Hulscher said, by issuing a Class I recall, where a drug is recalled because it is likely that its use will cause serious health consequences or death — which he said nine studies and the Vaccine Adverse Event Reporting System (VAERS) data show.

“Because criteria for a Class I recall have been far exceeded, it should be an easy and effective way to halt the COVID-19 injection program and begin the process of compensating those who were harmed.”

Hulscher said he expects that calls will grow to withdraw the vaccines from the market until the regulatory authorities finally take action.

How does a Class I recall work?

Drug recalls are mechanisms to remove or amend pharmaceutical products that violate laws under the purview of the FDA.

Recalls range from minor to serious. In a minor case, companies issue a public alert that a medical device may cause harm in some situations or temporarily withdraw a product from the market while addressing a rule violation.

More serious recalls come into play in the case of pharmaceutical products that may, or likely will, cause harm to human health. A Class I recall, the most serious type, typically involves withdrawing a drug from the market completely.

In most cases, the FDA doesn’t recall the product, the company does — either by its own initiative or at the FDA’s recommendation — and the FDA oversees the recall process.

In the case of vaccines and other biologics, medical devices and controlled substances, the FDA has the authority to compel a company to recall a drug.

If a determination is made that a batch, lot or other quantity of a product licensed under the Public Health Service Act presents an imminent threat to public health, the FDA can issue an immediate recall.

However, for most drugs, the FDA doesn’t have the authority to force a company to recall products that violate FDA rules — it can only recommend the drugmaker recall its product.

Federal lawmakers have periodically introduced legislation to provide the FDA with mandatory recall authority for any and all faulty or unsafe prescription and over-the-counter drugs. However, Congress has not yet passed a bill giving the FDA that authority.

In the past, drugmakers have initiated vaccine recalls and informed distributors and facilities that may have purchased a vaccine about issues with the product.

In 2007, Merck recalled 1.2 million doses of Haemophilus influenzae type B (Hib B) vaccines due to concerns the vaccine was contaminated with the Bacillus cereus bacterium. The CDC analyzed VAERS from April 2007 to February 2008 and identified 75 reports related to the Hib B vaccines, including five deaths. The agency said the deaths weren’t related to the reported B. cereus.

Merck also recalled one lot of Gardasil in 2013 because it contained glass.

In 1999, the FDA-approved RotaShield vaccine, meant to prevent rotavirus gastroenteritis, was found to be causing intussusception in infants, an often excruciating and potentially fatal condition in which part of the intestine telescopes into itself.

The CDC withdrew its recommendation after identifying more than 100 reports in VAERS of intussusception following vaccination with RotaShield. Wyeth, now Pfizer, withdrew the vaccine from the market.

The FDA had approved that vaccine as safe, even though the clinical trials showed increased incidences of intussusception in vaccinated infants.

A congressional investigation showed that many of the FDA and CDC advisers who recommended the vaccine had financial ties to pharmaceutical companies developing rotavirus vaccines.

Thousands of FDA-approved drugs and devices are recalled each year, and the number of Class I recalls has been trending upward. Details of each recall are listed on an obscure FDA “enforcement report” website.

There have been some limited recalls for vaccines in 2024, including for COVID-19 vaccines, but these have been Class III recalls of limited lots, and in those cases, the product was deemed unlikely to cause harm.

For example, in November, Pfizer issued a Class III recall of four lots of its Comirnaty vaccine that were shipped at temperatures exceeding refrigeration requirements. The lots went to Alaska and U.S. Pacific island territories.

McKesson Medical Supply issued Class III recalls for lots of polio, Tdap, Hepatitis A and B, shingles, flu and other vaccines after their walk-in refrigerator failed.

The FDA did not respond to The Defender’s request for comment on calls for a Class I recall of COVID-19 vaccines.

Researchers say evidence supports Class I recall of COVID vaccines

Last week, two new peer-reviewed studies presented evidence supporting a moratorium or recall for the mRNA COVID-19 vaccines.

A study published in Science, Health Policy and the Law detected DNA contamination in the COVID-19 vaccines, at levels three-to-four times higher than regulatory limits. The study added to previous findings by other researchers that were also the basis for Ladapo’s concerns. Such contamination could be grounds for a recall.

“The recent paper by Kammerer et al. is another in a series of papers that show very high levels of DNA contamination in modified mRNA vaccines,” Children’s Health Defense Chief Scientific Officer Brian Hooker told The Defender.

“In light of this and the already exhaustive body of literature on the toxicity of these jabs, they need to be recalled as soon as possible and the myriad injuries caused by the shots need to be addressed,” he added.

Another study published last week analyzed COVID-19 vaccine and booster safety data. The authors concluded that “at minimum,” health officials should institute a moratorium on the shots. “But ideally, they should be removed from the market and their use in humans should be stopped.”

In addition to the 38,190 deaths after the COVID-19 vaccine reported to VAERS as of Nov. 29, Hulscher also pointed to recent studies that taken as a whole he said provides enough evidence to trigger a recall.

Analyses have linked 3.1 million excess deaths to vaccines and lockdowns in 47 countries between 2020 and 2022, and 17 million excess deaths globally from vaccines and other pandemic response measures.

A 2023 article in BMC Infectious Diseases, later retracted by the journal, estimated that 278,000 Americans may have died from the COVID-19 vaccine by December 2021. Similarly, Pantazatos and Seligman estimated between 146,000 and 187,000 possible vaccine-associated deaths by August 2021.

Another 2023 study published in the Asian Pacific Journal of Health Sciences found that higher COVID-19 vaccine uptake was associated with increased all-cause mortality. Another recent study published in Bulgarian Medicine found a positive correlation between COVID-19 vaccination rates and excess mortality.

A recent study published in Microorganisms found that all-cause death risk was higher among people who had received the COVID-19 vaccine than those who hadn’t.

Hulscher and colleagues also recently published a study estimating 49,240 excess cardiac deaths possibly due to the COVID-19 vaccination in the U.S. from 2021-2023.

Hulscher and co-authors published a systematic review in Science, Public Health Policy and the Law on Nov. 17 of autopsy-related literature following COVID-19 vaccination. They found that 73.9% of the 325 deaths were linked to the shots, suggesting “a high likelihood of a causal link” between the shots and death.