The FDA Just Ruled You Can't Do These 4 Things With the COVID Vaccines
After some debate, the experts are laying out the ground rules around the new vaccines.
As the rollout of the COVID-19 vaccine gathers pace across the United States, there has been debate over the most efficient way for the medication to be administered to the population. With both the vaccines from Moderna and Pfizer-BioNTech showing a reassuring 95 percent effectiveness, some public health officials have suggested that more of the public may be protected faster if the drugs were administered in different doses or on a revised schedule. But on Monday night, the U.S. Food and Drug Administration (FDA) poured cold water on these suggestions in a statement by Stephen M. Hahn, MD, and Peter Marks, MD. "We have been following the discussions and news reports," they said, before expressly ruling against the following suggestions regarding the COVID vaccines. Read on to find out what they said, and for more COVID news, check out Dr. Fauci Just Said He's Worried About This One State.
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Taking two half-doses
In an interview with Face the Nation on Jan. 3, Operation Warp Speed Chief Advisor Moncef Slaoui, PhD, said that, in an effort to get the most people vaccinated in the shortest amount of time with the limited number of vaccines currently available, U.S. officials were in talks with Moderna and the FDA to potentially give younger, healthier individuals just half the recommended dose of Moderna's COVID vaccine. But in an interview with Today, Anthony Fauci, MD, expressed hesitance to halve the doses. "We know from the clinical trial that the optimal time is to give it on one day and then for Moderna, 28 days later, and for Pfizer, 21 days later," Fauci said. "That's what the data tells us is the best way to do it."
Ultimately, the FDA seemed to agree with Fauci. "These are all reasonable questions to consider and evaluate in clinical trials. 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," they wrote. And for states going against the CDC's rollout recommendations, check out These 2 States Are Going Against the CDC's Vaccine Recommendations.
Only taking one dose
Like Fauci, the FDA particularly stressed the need for the follow-up dose of either vaccine. "Using a single dose regimen and/or administering less than the dose studied in the clinical trials without understanding the nature of the depth and duration of protection that it provides is concerning," the FDA wrote. "There is some indication that the depth of the immune response is associated with the duration of protection provided. 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." And for more on what you shouldn't do post-vaccination, check out You Shouldn't Do This Right After Getting a COVID Vaccine, Expert Warns.
Delaying the second dose
The two vaccines operate on slightly different schedules. The Pfizer-BioNTech vaccine has an interval of 21 days between the first and second doses, while the Moderna equivalent is administered with a 28-day waiting period between doses. While Ashish Jha, MD, dean of the Brown University School of Public Health, and Robert Wachter, MD, chair of the department of medicine at the University of California at San Francisco, wrote an op-ed for The Washington Post calling to delay the second dose to give more people the first, the FDA ultimately disagreed.
"The available data continue to support the use of two specified doses of each authorized vaccine at specified intervals," the FDA ruled. "We cannot conclude anything definitive about the depth or duration of protection after a single dose of vaccine." And for more vaccine news delivered right to your inbox, sign up for our daily newsletter.
Mixing and matching vaccine
This subject has been particularly contentious after a New York Times report that the United Kingdom was recommending that different vaccines could be used in combination. However, a clarification issued by Mary Ramsay, MD, Head of Immunizations at Public Health England, explained that this was only an absolute last resort, on the "extremely rare occasions where the same vaccine is not available, or where it is not known what vaccine the patient received…it is better to give a second dose of another vaccine than not at all."
The FDA agreed that whichever vaccine is in your first dose should also be the one you receive as a follow-up: "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," they ruled. And for more on why one prominent figure hasn't been vaccinated, check out The Real Reason President Trump Hasn't Gotten the COVID Vaccine Yet.