Kennedy is planning modifications to the Vaccines Adverse Event Reporting System to identify whether vaccines contribute to an unstated problem. The reporting system is at the heart of the departure of CBER head Peter Marks.
Health and Human Services Secretary Robert F. Kennedy Jr. is planning a suite of changes to the vaccines injury monitoring system, automating and boosting data collection to detect adverse events associated with immunization, according to a Tuesday report from STAT News.
Speaking at a Make America Health Again event, Kennedy said “it’s outrageous that we don’t have a surveillance system that functions,” as per STAT. Currently, the U.S. has the Vaccines Adverse Event Reporting System (VAERS) in place, which was established in 1990 and acts as a centralized repository of reports flagging potential safety concerns in patients who have received a vaccine.
Kennedy’s desire to alter VAERS was at the heart of the departure of Peter Marks, the former chief of the FDA’s Center for Biologics Evaluation and Research (CBER). Marks said he was forced out of the agency after denying Kennedy’s team access to the system.
“Why wouldn’t we [allow access]? Because frankly we don’t trust (them),” he said, according to the AP. “They’d write over it or erase the whole database.”
“VAERS is a passive reporting system,” according to the FDA’s website, which means that it relies on reports from individuals, healthcare providers or companies. The monitoring system, which is co-run by the Centers for Disease Control and Prevention and the FDA, is designed to detect unusual patterns in vaccine side effects. However, it cannot “determine if a vaccine caused a health problem.”
During the MAHA event on Tuesday, according to STAT, Kennedy pointed to a 2010 report from the Agency for Healthcare Research and Quality (AHRQ), which found that “adverse events from drug and vaccines are common, but underreported.” According to the report, “fewer than 1% of vaccine adverse events are reported” to the VAERS.
To remedy this, the AHRQ at the time recommended implementing an “automated adverse event reporting,” which it said could potentially “speed the identification of problems with new drugs” while also helping detect safety issues with older drugs. Kennedy on Tuesday said that under his leadership, the HHS would roll out such an automated system, while also promoting global data sharing regarding vaccine use.
The goal of these changes, according to Kennedy, is to find the “contribution” of vaccines to a yet unclear outcome, as per STAT’s reporting. Kennedy suggested that vaccines, along with mold, food and other exposures may be “culprits” leading to this outcome.
Kennedy has built his HHS leadership on the promise of addressing childhood conditions, such as autism. During his confirmation hearings, Kennedy promised to boost overall health in America, which at the time he claimed was “in a grievous condition,” noting the rise of cancer and obesity in children.
At a press conference at the HHS on Wednesday, Kennedy additionally flagged what he called the “unrelenting upward trend” of autism in the U.S., as per NPR. Citing figures from a recent CDC report, Kennedy said that autism had jumped from 1 in 36 children in 2020 to 1 in 31 children in 2022.
“The [autism] epidemic is real,” Kennedy said, adding that he will direct the HHS to investigate the so-called “environmental” causes of autism.
