Two officials from the U.S. Food and Drug Administration (FDA) don’t recommend doses for the CCP virus vaccine to be cut in half in order to stretch the vaccine supply, according to documents.
Hahn and Marks wrote they want to remind people of the importance of receiving CCP virus vaccines according to how they’ve been authorized by the FDA, as Americans who have already been inoculated with the first dose against COVID-19 are now scheduled to receive their second round.
“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. “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.”
Moncef Slaoui, the head of Operation Warp Speed, told CBS' “Face the Nation” over the weekend they are in talks with Moderna and the FDA about the idea of cutting doses, as some data shows two half-doses of the Moderna vaccine might work.
Last week, health officials in the United Kingdom also decided that delaying the second dose as long as 12 weeks is fine. They said by postponing booster doses they could give more people at least some protection with a first shot. They said unpublished data from the AstraZeneca study suggested waiting a little longer between doses might be better in the long run, but provided no details.
Hahn and Marks said Monday they have followed the debate on changing the dosing schedule to get more vaccines to the public faster, adding that making such changes “are not supported by adequate scientific evidence” and could possibly end up being “counterproductive to public health.”
“What we have seen is that the data in the firms’ submissions regarding the first dose is commonly being misinterpreted. In the phase 3 trials, 98 percent of participants in the Pfizer-BioNTech trial and 92 percent of participants in the Moderna trial received two doses of the vaccine at either a three- or four-week interval, respectively,” they wrote.
“Those participants who did not receive two vaccine doses at either a three-or four-week interval were generally only followed for a short period of time, such that we cannot conclude anything definitive about the depth or duration of protection after a single dose of vaccine from the single dose percentages reported by the companies.”
Hahn and Marks ended the statement by saying they “strongly recommend” health care providers to follow the FDA-authorized dosing schedule for each CCP virus vaccine until vaccine manufacturers have the data and science that supports a change.
