#Moderna second dose timing uk trial#
In the phase 3 trials, 98% of participants in the Pfizer-BioNTech trial and 92% of participants in the Moderna trial received two doses of the vaccine at either a three- or four-week interval, respectively. What we have seen is that the data in the firms’ submissions regarding the first dose is commonly being misinterpreted. And for the Moderna COVID-19 vaccine, the interval is 28 days between the first and second dose. For the Pfizer-BioNTech COVID-19 vaccine, the interval is 21 days between the first and second dose. The available data continue to support the use of two specified doses of each authorized vaccine at specified intervals.
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. 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. These are all reasonable questions to consider and evaluate in clinical trials. 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. 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.
Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 disease in adults. Director - Center for Biologics Evaluation and Research (CBER) Commissioner of Food and Drugs - Food and Drug Administration For Immediate Release: JanuStatement From:
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