FDA Waited Months to Alert Public to Possible COVID-19 Vaccine Safety Issues, Researchers Disclose

FDA Waited Months to Alert Public to Possible COVID-19 Vaccine Safety Issues, Researchers Disclose
The Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. (Andrew Kelly/Reuters)
Zachary Stieber

The U.S. Food and Drug Administration (FDA) first identified possible issues with the most-used COVID-19 vaccine in early 2021 but waited months to disclose the discovery to the public, a new publication revealed.

FDA researchers saw safety signals for two serious conditions among elderly persons following vaccination with Pfizer's COVID-19 vaccine on Feb. 27, 2021, the researchers disclosed in a new study. The conditions were a lack of oxygen to the heart, or myocardial infarction, and a separate heart condition known as pulmonary embolism.

Two weeks later, the signal was triggered for disseminated intravascular coagulation, a rare form of blood clotting. And in April of that year, a fourth signal was raised, for a blood platelet disorder.

But it wasn't until July 12, 2021, that the FDA alerted the public to the signals.

In that unsigned statement, the FDA made it appear as if the signals had just been found.

Utilizing "near real-time surveillance," the FDA detected "four potential AEIs," or adverse events of interest, the agency said at the time. "These four events may not be true safety concerns, and the screening method cannot establish that the vaccine caused these AEI. FDA is sharing the initial findings of this safety study in the spirit of transparency but does not believe there is a cause for concern."

It's unclear why the FDA waited months to alert the public. The agency and the new study's corresponding author, the director of the FDA's Office of Biostatistics and Pharmacovigilance, did not return requests for comment.


Safety advocates said the delay was concerning.

"From day one, people over age 65 have been targeted for COVID shots and, to date, 95 percent of them in the U.S. have rolled up their sleeves and gotten vaccinated. The FDA is legally responsible for ensuring that vaccine products released for public use are safe. Why did FDA officials wait for five months to come clean with the public about a suspected increased risk of blood clots that could lead to death for seniors who get the Pfizer/BioNTech COVID vaccine and then wait 10 more months to submit a study for publication?" Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times via email.

"How many seniors have suffered a pulmonary embolism or heart attack or developed a bleeding disorder after getting the Pfizer product but doctors wrote off those life-threatening adverse events as just a “coincidence” and not related to the shot because it took almost two years to publish this critically important information in a medical journal?" she added. "A congressional investigation into exactly what government health officials knew about serious health problems following COVID shots and when they knew it is long overdue."

Kim Witczak, another vaccine safety advocate, noted that the FDA authorized the Pfizer and Moderna vaccines shortly after receiving clinical trial information but took much longer to analyze the safety signals.

"This is not, as FDA claims, to be 'rapidly' working to identify potential new and important safety concerns," Witczak, who runs the group Woodymatters, told The Epoch Times via email.

In the new paper, FDA researchers said that the monitoring "complements other FDA and US Government vaccine safety surveillance systems by rapidly detecting safety concerns that may not have been voluntarily reported to passive surveillance systems such as Vaccine Adverse Event Reporting System."

Witczak called on the FDA, which has consistently promoted the vaccines, "to react faster and with unbiased attitude towards safety" while saying there should be an independent safety review of the vaccines with no agenda besides monitoring safety.

A brief timeline of the FDA's surveillance of COVID-19 vaccines among the elderly: February 2021: FDA identifies first safety signals. March 2021: FDA identifies another signal. April 2021: FDA identifies another signal. July 2021: FDA issues a statement about the signals, revealing their existence to the public for the first time. May 2022: FDA submits study to journal Vaccine. November 2022: FDA revises paper, possibly due to feedback from the journal. December 2022: The study is published following peer review.

New Study

The new paper provided the first follow-up to the public since the July 2021 statement.

Anderson and other researchers with the FDA or the U.S. Centers for Medicare and Medicaid (CMS) reported on results from safety monitoring of vaccines among people aged 65 and older through analyses of data from CMS records. CMS provides health insurance for many elderly Americans.

The researchers confirmed that the primary analysis detected signals for all four conditions listed in the statement, but said three of them—disseminated intravascular coagulation; the platelet disorder, which is known as immune thrombocytopenia; and myocardial infarction, or the lack of oxygen to the heart—no longer met the signal thresholds after certain, more in-depth analyses.

Pulmonary embolism, on the other hand, continued to meet the threshold.

Researchers stressed that just because a condition triggers a signal does not mean it is related to a vaccine and said they believe the vaccine's benefits still outweigh its risks.

Dr. Peter McCullough, chief medical adviser for the Truth for Health Foundation, differed, telling The Epoch Times that the new paper “corroborates the concerns of doctors that the large uptick in blood clots, progression of atherosclerotic heart disease, and blood disorders are independently associated with COVID-19 vaccination.”

Pfizer did not respond to a request for comment.

No signals were triggered for the vaccines made by Moderna and Johnson & Johnson.