FDA Must Immediately Dispel Uncertainty About Timely Availability of 2025-2026 COVID-19 Vaccine
WASHINGTON, D.C. – Recent statements from Trump administration officials hinting at new requirements for the approval of COVID-19 vaccines have created uncertainty about the timely availability of the updated 2025-2026 version of the vaccine later in the year. If the Food and Drug Administration (FDA) were to require COVID-19 vaccine manufacturers to conduct annual effectiveness studies prior to granting approvals, there would not be enough time to make and distribute updated vaccines before they were already obsolete.
Public Citizen Health Research Group Director Dr. Robert Steinbrook issued the following statement:
“The FDA should immediately dispel the uncertainty about the timely availability of the 2025-2026 COVID-19 vaccine and commit to the strain change approval process that it has been using. Tweaks to allow the vaccine to provide effective immunity are routine updates, not a new product that requires clinical trials.
“The COVID-19 vaccine saves lives every day. Breaking a system that is working well is nonsensical and would create a very dangerous situation. There are still hundreds of COVID-19 deaths and thousands of hospitalizations in the United States each week.
“If FDA Commissioner Dr. Martin Makary is serious about advancing the science of COVID-19 and other vaccines, he would allow the FDA’s Vaccines and Related Biological Products Advisory Committee to meet, so that independent experts can discuss the best path forward for vaccine safety and effectiveness. The committee has yet to meet in 2025 and no meetings are scheduled.”
Some background
“It’s now been years since COVID has presented the threat that it once did, and the urgency to rush approval of boosters without normal oversight no longer exists,” a Department of Health and Human Services spokesperson told STAT News.
The statement is very misleading. COVID-19 still poses a serious threat and timely approval of booster vaccines is urgent and not being rushed. From October 1, 2024 to April 19, 2025 there have been between 29,000 to 47,000 COVID-19 deaths in the US and 250,000 to 400,000 hospitalizations, according to preliminary estimates from the Centers for Disease Control and Prevention.
Regular COVID-19 vaccination and booster shots are particularly important for people at highest risk of severe COVID-19, including people ages 65 and older and people with underlying medical conditions.
COVID-19 and flu vaccines are routinely updated using the FDA’s “strain change rule,” under which updated vaccines are not considered new vaccines, which they are not. Because the changes are limited to the version or versions of the virus that are being targeted, the manufacturers are not required to conduct new effectiveness studies. There is a Vaccine Adverse Event Reporting System (VAERS) for adverse events.