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WASHINGTON, D.C. — Reports have indicated that the Food and Drug Administration is considering distributing half doses of the Moderna vaccine to younger patients in the hopes of inoculating more Americans.
Top officials in the FDA warn, however, that doing so could come with risks.
So far, just over 4 million Americans have received their first dose of a COVID-19 vaccine, which puts the U.S. far behind the 20 million dose schedule set for the end of 2030 by Operation Warp Speed.
The FDA said on Monday that considerations of altering the coronavirus vaccine schedule are “premature.”
The two coronavirus vaccines that have received emergency use authorization require two doses. For the Pfizer vaccine, the booster comes three weeks after vaccine administration. The Moderna vaccine requires the second dose four weeks after inoculation.
Data has shown that the two vaccines are at least 94 percent effective after the second dose is administered. To date, there is not enough data to estimate the effectiveness of a single dose, leaders from the FDA said.
“These are all reasonable questions to consider and evaluate in clinical trials,” FDA Commission Stephen Hahn and Center for Biologics Evaluation and Research Director Peter Marks said in a joint statement.
“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.”
As of Monday, there are 4.5 million Americans who have received their first dose of one of the two coronavirus vaccines. It was not until Monday that some Americans began receiving a second dose of the vaccine.
But Marks and Hahn caution that foregoing the second dose of the vaccine could cause more harm than good without data to backup the effectiveness of the first dose.
“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,” they said.


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