Lawmakers Clash Over COVID Vaccine Safety at House Hearing

Is the CDC’s Vaccine Adverse Event Reporting System (VAERS) a reliable way to document potential problems with the COVID-19 vaccine and other vaccines? Members of a House committee disagreed on that and other issues at a hearing Thursday on vaccine safety.

“Some people are trying to belittle these reports, but these reports come from people — people that died, people that got injured,” said Rep. Marjorie Taylor Greene (R-Ga.), a member of the House Select Subcommittee on the Coronavirus Pandemic. “In 2021, there were 706,767 reports on VAERS for vaccine injuries and deaths, in 2022 it was 206,676 … it was going down because the [vaccine] mandates stopped.”

She called it “shameful” that one of the witnesses — Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, had authorized the vaccine for use in children as young as 6 months old.

But Rep. Deborah Ross (D-N.C.) had a different view of those numbers. “In listening to today’s hearing, one might be led to believe that reports submitted to VAERS are the most meaningful measure of adverse health events and should be the sole basis for evaluating whether the COVID vaccines are safe,” she said. “However, my understanding is that VAERS is just one surveillance program within a multilayered vaccine system that CDC operates, and that submissions to VAERS, which are unverified, can be submitted by anyone, regardless of how likely a vaccine is to have created an adverse event, and can act as early warnings to prompt deeper investigations through these other surveillance programs.”

Hearing witness Daniel Jernigan, MD, MPH, director of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, agreed. “VAERS is a system for getting information in and quickly identifying trends, but it’s not the dataset we use to determine causality or the impact of the vaccine,” he said. “Over the last several years, there have been over 676 million doses of vaccines administered, and an exceedingly rare number of adverse events reported; there’s an even lower number of serious adverse events. Each of those serious adverse events does have a follow-up; they ask for medical records and autopsy records.”

Subcommittee Chairman Brad Wenstrup, DPM, a podiatrist, asked Marks whether the FDA was truly prepared to process the number of VAERS reports that have been submitted on the COVID-19 vaccine.

“We tried to be prepared for that, but the avalanche of reports was tremendous, and required retasking people on the fly,” Marks said. “What the public sees on the VAERS page is a small fraction of the information we sift through.”

Rep. Robert Garcia (D-Calif.) apologized to the witnesses for having to listen to Greene’s remarks. “I’m sorry you had to go through that,” he said. “It’s really unfortunate that we’re having this hearing trying to poke holes and cause more vaccine hesitancy among the public. We’re here because these members demanded we have this hearing, and we’ve continued to cave and give those members everything they want.”

The federal government’s program for compensating victims of medical injury related to the COVID-19 vaccine also came under fire at the hearing. Cdr. George Reed Grimes, MD, MPH, director of the Division of Injury Compensation Programs at the Health Resources and Services Administration (HRSA), explained that COVID-related vaccine injuries are not compensated under the HRSA’s Vaccine Injury Compensation Program but instead are compensated through another program known as the Countermeasures Injury Compensation Program (CICP).

That program, which came out of a law passed by Congress in 2005, is administered by HRSA, the Justice Department, and the Court of Federal Claims. The program has received about 9,600 injury claims related to the COVID vaccine, “representing a small fraction, less than 0.001% of all COVID-19 vaccine administrations in this country,” Grimes noted.

When Grimes became director of the program in 2021, the program had only four staff members, but thanks to a direct appropriation from Congress in fiscal year 2022, the program was able to hire more staff and now has 35 people processing claims. “In 2023, we averaged more than 90 claims resolved each month, which is up from zero per month the year before I started in this role,” he said.

Rep. Mariannette Miller-Meeks, MD, (R-Iowa) said that the CICP program wasn’t designed for a pandemic as large as COVID-19, and asked the rate of denial of the claims submitted. Grimes said he didn’t have the rate but that the program has adjudicated 2,214 claims. Miller-Meeks said she understood the denial rate was about 98%, and asked why there was a claims backlog. Grimes said it was due to the small staff that the program had had until 2022.

Rep. Michael Cloud (R-Texas) criticized the multiple functions the federal government was undertaking related to the vaccine. “We have the same agency funding the research, approving, and mandating, and finally adjudicating the COVID-19 [injury claims],” he said. “It concentrates too many government functions in the same unaccountable hands.”

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