On January 4th, 2021, the U.S. Food and Drug Administration (FDA) released a statement reiterating the importance of following the authorized dosing schedules for both approved COVID-19 vaccines. Efforts to increase the number of individuals immunized against COVID-19 by changing the doses or dosing schedules are said to run the risk of being counterproductive to public health. The FDA is urgently reminding the public to follow their guidance, based on data and science:
“We have been following the discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19. 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. 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….
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, as 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.”Commissioner of Food and Drugs – Food and Drug Administration
Stephen M. Hahn M.D.
Director – Center for Biologics Evaluation and Research (CBER)
Peter Marks M.D., PhD.
Remember to follow all FDA guidelines when you begin to administer vaccines to your facility, even if you hear stories of alternative dosing ‘strategies.’ The FDA is committed to making decisions based on the most current data and science, and right now the scientific data does not support making changes to either the dose or dosing schedule.
Stay the course, stay strong, stay well, mask up, and stay tuned!