Fact check: It is standard practice that vaccine safety monitoring continues after approval

Social media users have asked why clinical trials for COVID-19 vaccines will continue for several years if the sting is safe.

Reuters fact check. REUTERS

Examples can be seen (here) and (here).

“COVID-19 vaccine trials continue. What does this mean for those taking the vaccine? Ask for a post shared on Facebook.

The report correctly notes that the Pfizer-BioNTech coronavirus vaccine was given an “estimated date for completion of the study” on January 31, 2023 (here). For the COVID-19 vaccine created by Moderna, studies are expected to end on October 27, 2022 (here).

However, it is standard practice for safety monitoring to continue after a vaccine has been approved for use.

After the final Phase III clinical trials were cleared, the Pfizer-BioNTech vaccine was approved for emergency use by U.S. regulators in December 2020 (here).

Pfizer reported that the safety monitoring of the participants in the Phase III thesis will continue. (here).

This means that “all participants in the trial continue to be monitored to assess long-term protection and safety for another two years after their second dose” (here).

Similarly, Moderna said he will participate in the Phase III trial for the next two years (here).

Additional data collected include a long-term safety follow-up, protection period against COVID-19, and efficacy against asymptomatic SARS-CoV-2 infection.

How vaccines are tested, licensed and monitored for safety is set out in the University’s University’s Vaccine Knowledge Project (here).

Vaccinations are also monitored by government agencies as they roll out, with the UK using the yellow card scheme (here) and the US government running VAERS (vaers.hhs.gov/reportevent.html).

Although the vaccines completed the necessary steps of each trial, the health and economic impact of COVID-19 meant that the process was expedited.

Efforts have been made worldwide to pool resources to accelerate the development and production of vaccines (here).

In addition, unprecedented financial investment and scientific collaboration have made it possible for some steps in research and development to take place “in parallel” (here).

For example, some clinical trials evaluate multiple vaccines at the same time, although clinical and safety standards are maintained despite the acceleration.

VERDICT

Missing context. This is the standard safety monitoring procedure to proceed after vaccines have been approved for use.

This article was produced by the Reuters Fact Check team. Read more about our work to actually check social media posts.

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