How Government Data Is Being Misused to Question COVID-19 Vaccine Safety – ConsumerReports.org

All vaccines, including those against COVID-19, undergo rigorous clinical trials, in some cases involving tens of thousands of people. But those trials might not involve enough people with a particular risk factor, meaning certain issues might not be noticed by researchers at the earlier stages. Moreover, any vaccine might cause rare side effects that emerge later on.

Launched in 1990, VAERS is used by the CDC and FDA to detect concerning patterns or unusual and unexpected changes that might indicate a safety problem once vaccines are on the market, according to a 2015 academic paper published by researchers at both agencies in the journal Vaccine.

VAERS is important because it can capture events that were not routinely collected in active surveillance in clinical trials, more rare than would have been observed in trials because of limited sample sizes, or occur in populations not adequately studied in clinical trials, says Steven J. Jacobsen, MD, interim executive director of the Marshfield Clinic Research Institute, a Wisconsin-based medical research institute, and former president of the American College of Epidemiology.

For example, government researchers investigated reports of myocarditis, or inflammation of the heart muscle, that were submitted to VAERS, and then alerted the public when they deemed that risk plausible. The CDC has said its continuing to monitor the development.

VAERS reports on their own communicate only that some sort of adverse event, minor or major, happened after someone received a vaccine. Additional work and information are needed to establish whether the vaccine was the cause.

Physicians, epidemiologists, and statisticians at the CDC and FDA assess the number of reports received, what sort of events are reported, and the number of doses distributed. Then they compare the rate an adverse event is reported in VAERS with the rate of the same adverse event with other vaccines.

So while the reports alone generally cant tie a vaccine to an adverse event, it can play an important role.

VAERS can often provide the earliest information on potential vaccine safety problems, the 2015 vaccine paper by CDC and FDA researchers says.

If it does detect potential safety issues, researchers at the CDC and FDA can then investigate further using other systems, such as the CDCs Vaccine Safety Datalink, which receives more specific data from nine major healthcare organizations and can help measure attributable risk, says Emorys Orenstein.

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How Government Data Is Being Misused to Question COVID-19 Vaccine Safety - ConsumerReports.org