FDA statement on following the authorised dosing schedules for COVID-19 vaccines

FDA

4 January 2021 - Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 disease in adults. 

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 authorised by the FDA in order to safely receive the level of protection observed in the large randomised trials supporting their effectiveness.

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 immunise 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 authorised 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.

Read FDA Statement

Michael Wonder

Posted by:

Michael Wonder

Posted in:

US , Vaccine , Registration , COVID-19