FDA: Stick with Approved EUAs for COVID-19 Vaccines

Amid pressure to get more vaccines administered faster, FDA pushes back against changes in dosing regimens.

FDA leadership is pushing back against calls to alter the dosing regimens for COVID-19 vaccines approved by the agency under emergency use authorizations in an effort to accelerate the pace of inoculations.

The US Centers for Disease Control and Prevention (CDC) reported that as of Jan. 4, 2021, more than 15.4 million vaccine doses had been delivered but only 4.6 million had been administered, falling short of the goal of 20 million vaccinations by the end of 2020.

Public and policymaker frustration with a slower-than-expected rollout of COVID-19 vaccines from Pfizer–BioNTech and Moderna has prompted requests to extend the time between the first and second shots or reduce the size of the dose administered, or mixing and matching vaccines in an effort to have more doses available for more people.

Medical leaders have criticized the United Kingdom’s announced 12-week delay for the second dose of the Pfizer–BioNTech and Oxford–AstraZeneca vaccines; FDA issued a statement on Jan. 4, 2021, urging that the approved dosing schedule be followed.

“As the first round of vaccine recipients become eligible to receive their second dose, we want to remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large, randomized trials supporting their effectiveness,” wrote FDA Commissioner Stephen M. Hahn and Peter Marks, director, FDA Center for Biologics Evaluation and Research in a statement.

While changes to the dosing schedules are “reasonable” to consider for clinical trials, they wrote, “However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19.”

Data from clinical trials are needed to understand how much protection a vaccine provides, they wrote. “If people do not truly know how protective a vaccine is, there is the potential for harm because they may assume that they are fully protected when they are not, and accordingly, alter their behavior to take unnecessary risks.”

Following criticism in early 2020 about perceived political pressure on FDA to approve vaccines prematurely, the agency has reiterated its commitment to science-based decision making.

“We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine,” the statement concluded.

Sources: CDC and FDA