FDA Statement on Adherence to Authorized Dosage Schedules for COVID-19 Vaccines

Two different mRNA vaccines have now shown remarkable efficacy of approximately 95% in preventing COVID-19 infection in adults. As the first round of vaccine recipients are eligible to receive their second dose, we would like to remind the public of the importance of receiving COVID-19 vaccines, according to how they have been approved by the FDA to receive the protection level safely. observed in the large randomized trials supporting their effectiveness.

We followed the discussions and news reports about reducing the number of doses, extending the time between doses, changing the dose (half-dose), or vaccinating and mixing vaccines to immunize more people against COVID-19. These are all reasonable questions to consider and evaluate in clinical trials. At this stage, however, it is premature to suggest that changes to the FDA-authorized dosage or schedules of these vaccines should continue and not be thoroughly rooted in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of endangering public health, undermining the historic vaccination efforts to protect the population against COVID-19.

The available data still support the use of two specified doses of each authorized vaccine at specific intervals. For the Pfizer-BioNTech COVID-19 vaccine, the interval is 21 days between the first and second dose. And for the Modern COVID-19 vaccine, the interval is 28 days between the first and second dose.

What we have seen is that the information in the companies’ submissions on the first dose is usually misinterpreted. In the Phase 3 trials, 98% of the participants in the Pfizer BioNTech trial and 92% of the participants in the Moderna trial received two doses of the vaccine respectively. The participants who did not receive two vaccines with an interval of three or four weeks were generally only followed for a short period of time, so that we could not find anything definitive about the depth or duration of protection after a single dose of vaccine. do not infer. of the single dose percentages reported by the companies.

The use of a single dose regimen and / or administration of less than the dose studied in the clinical trials, without understanding the nature of the depth and the duration of protection it provides, as there is an indication that the depth of the immune response is associated the duration of protection. If people do not really know how protective a vaccine is, they can be harmed because they accept that they are fully protected if they do not, and thus change their behavior to take unnecessary risks.

We know that some of these discussions about changing the dosing schedule or dose are based on the belief that changing the dose or dosing schedule can help get more vaccinations available to the public faster. Making such changes that are not supported by sufficient scientific evidence can ultimately be counterproductive to public health.

We have repeatedly committed to making decisions based on data and science. Until vaccine manufacturers have data and science that supports a change, we recommend that healthcare providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine.

The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of food supply, cosmetics, nutritional supplements, products that emit electronic radiation and for the regulation of tobacco products in our country.

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