FDA Officials: Thousands of Excess Deaths Likely if More People Don’t Get Vaccinated

Officials make unsupported claims in new editorial.

Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the US Food and Drug Administration (FDA), testifies to a Senate panel on Capitol Hill in Washington on May 11, 2021. Jim Lo Scalzo/Pool/Getty Images

Two top U.S. Food and Drug Administration (FDA) officials are urging Americans to get vaccines, including COVID-19 shots, warning that there will likely be thousands of excess deaths over the winter if they do not.

Dr. Peter Marks and Dr. Robert Califf wrote in the editorial, published by the Journal of the American Medical Association, that vaccination rates may be approaching a “dangerous tipping point” because of the growing number of people opting against the influenza, COVID-19, and other vaccines.

“The situation has now deteriorated to the point that population immunity against some vaccine-preventable infectious diseases is at risk, and thousands of excess deaths are likely to occur this season due to illnesses amenable to prevention or reduction in severity of illness with vaccines,” they wrote.

Dr. Marks, listed as the contact for the editorial, referred a request for data supporting the warning to the FDA’s media office.

A spokesperson declined to offer any data outside of that cited in the editorial.

Exemptions for childhood vaccine mandates reached the highest level ever in the United States in the 2022-23 school year, according to federal authorities, while resistance to influenza and COVID-19 vaccines has been rising among healthcare workers and other populations.

Just under 19 percent of adults have received one of the new COVID-19 vaccines, which were introduced in 2023 with clinical study data from just 50 humans and no efficacy estimates.

Dr. Marks and Dr. Califf said that they want to “counter the current trend” in lagging vaccination rates.

“We urge the clinical and biomedical community to redouble its efforts to provide accurate plain-language information regarding the individual and collective benefits and risks of vaccination. Such information is now needed because vaccines have been so successful in achieving their intended effects that many people no longer see the disturbing morbidity and mortality from infections amenable to vaccines. For example, smallpox has been eradicated, and polio has been eliminated from the US, through effective vaccination campaigns,” they wrote.

Measles was also officially eliminated, but unvaccinated people have been responsible for multiple U.S. outbreaks, including one in Ohio, the officials said, citing a U.S. Centers for Disease Control and Prevention (CDC) study on the outbreak.

They added later, “In addition to making a difference regarding childhood immunization, communication regarding the potential benefits of vaccination can hopefully also improve the number of individuals accepting vaccination to protect against COVID-19, influenza, and respiratory syncytial virus disease.”

The officials provided just six citations, one of which outlined the FDA’s top surveillance system, which was recently revealed to be incapable of assessing one of the major side effects of COVID-19 vaccines.

Another outlined the outbreak in Ohio, which included some vaccinated patients, and the third linked to a review of why parents don’t get their children vaccinated against measles. The three others went over COVID-19 vaccines, including one that used modeling to estimate that the shots prevented millions of hospitalizations and deaths.

The editorial did not involve any discussion of side effects, such as heart inflammation, but did feature the officials decrying what they described as the “large volume of vaccine misinformation.” The best way to respond to the misinformation, they said, “is to dilute it with large amounts of truthful, accessible scientific evidence.” They said later that healthcare workers should “focus at every appropriate opportunity on helping to ensure that individuals have the necessary information to make informed choices regarding vaccination, considering the benefits and risks.”

Several experts who reviewed the editorial said they found it lacking, in part because it did not acknowledge the blunders public health officials made during the COVID-19 pandemic.

“Public health now is discussing how the public has lost trust in them and their recommendations, blaming ’misinformation' only without looking at actions they performed during the pandemic that may have reduced trust. Prolonged school closures, lockdowns, and extended mask mandates (even after vaccines were available for COVID) reduced trust in the American public in our public health officials,” Dr. Monica Gandhi, an infectious disease expert at the University of California, San Francisco, told The Epoch Times via email, pointing to a 2022 survey that found low levels of trust in public health agencies.

The distrust will “spill over [to] the vaccine recommendations,” especially when the U.S. recommendations for COVID-19 vaccines differ from most of the rest of the world, Dr. Gandhi added. “If public health spent some time addressing mistakes they made during the pandemic, they may get the public to trust them more on vaccine recommendations.”

The FDA cleared a new round of COVID-19 vaccines from Moderna, Pfizer-BioNTech, and Novavax in 2023 despite there only being animal data available for two of the shots and data on just 50 human volunteers for the Moderna jab. The U.S. Centers for Disease Control and Prevention (CDC) then recommended virtually all Americans aged 6 months and up receive one of the vaccines, with limited exceptions. Many other countries don’t currently recommend COVID-19 vaccination for most people, in light of high levels of prior vaccination and infection.

An FDA spokesperson claimed that the COVID-19 vaccines dramatically reduce death, hospitalization, and severe illness. The spokesperson said the agency “continues to work with partners to gather data to further document the safety and effectiveness of the current formulations of the COVID-19 vaccines,” adding, “we anticipate information being published in the coming months.”

Dr. Marty Makary, a professor at Johns Hopkins School of Medicine, said that the editorial ignored the reality that the risk-benefit calculation for vaccines is different for different people.

“The big hole in the argument put forth by FDA leaders is that the risk-benefit calculation is not the same for an 80-year-old obese woman as it is for a healthy 19-year-old male,” Dr. Makary told The Epoch Times in an email. “FDA refuses to customize the risk of myocarditis, for example, and the benefit by age group because they don’t believe the public can handle a nuanced message. They believe the public is too dumb to digest a tailed vaccine recommendation and therefore insists on one simple message on vaccine boosters.”