Have vaccines been studied post-licensure?

A new commentary has led to a number of claims that prominent scientists are admitting that no study of the safety of vaccines post-licensure exists and that vaccine injuries are less rare than people think,

The claim that Dr. Stanley Plotkin and his colleagues have admitted that vaccine safety is not properly studied is misleading and lacks context. The article doesn’t say vaccines aren’t studied for safety. Instead, it is a proposal to use surplus funds from the vaccine excise tax, which are not currently being used and as intended by the initial law to improve the detection, investigation, and prevention of vaccine adverse events after a vaccine is approved to enhance the current vaccine safety system.

Dr. Dan Salmon, the article’s primary author, says, “Mr. Siri is not portraying our NEJM article accurately. Available vaccines are highly safe and effective for the vast majority of people. Post-licensure studies exist abundantly to show vaccines are very safe and effective.”

Vaccines undergo extensive testing in preclinical and clinical trials before being approved by the FDA. This includes several phases of clinical trials with tens of thousands of participants to check for safety and effectiveness.

For example, the clinical trials for the Pfizer-BioNTech COVID vaccine included over 40,000 participants. But if a rare event happens once in a million cases, a trial of 40,000 might not catch it. That’s why post-approval monitoring systems like the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) are important. These systems help detect and study super rare events as millions of people get vaccinated.

The article acknowledges the need to keep improving vaccine safety monitoring to maintain public trust. It stresses the importance of strong safety monitoring to tackle new public health challenges. Their article aims to strengthen these systems and highlight the need for transparency and ongoing research to build confidence in vaccines.

When looking at the full context and evidence, it’s clear that the claim that vaccines are not properly studied is false. The scientific community always works to improve vaccine safety monitoring and transparency so that people can be confident in their decision to get vaccinated.