FDA: COVID-19 vaccine needs to be administered as authorized

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Jan. 5 (UPI) -- Those who who receive the COVID-19 vaccine must get two full doses, the U.S. Federal Drug Administration said amid reports concerning altering how the drug can be administered.

The FDA issued the warning in a statement on Monday, stating it has been following reports about reducing the number of doses, extending the length of time between injections and reducing the size of each dose in order to inoculate more people, warning doing so may "run a significant risk of placing public health at risk."

"These are all reasonable questions to consider and evaluate in clinical trials," Stephen Hahn, commissioner of Food and Drugs at the FDA, and Peter Marks, director of the Center for Biologics Evaluation and Research, said in the 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."

The two medical experts said they lack appropriate data to support changing how the vaccines were authorized to be administered.

The statement was issued a day after Moncef Slaoui, chief scientific adviser for the Trump administration's Operation Warp Speed vaccine program, told CNN on Sunday that the FDA was considering halving doses of Moderna's COVID-19 vaccine for those between the ages of 18 to 55 to increase the number of people who can be inoculated against the virus.

Hahn and Marks said the public needs to receive the vaccine as it was authorized by the FDA, stating researchers during clinical trials followed those who failed to receive their second shot only for a short period of time so there is not enough data to understand the depth or duration of protection one receives from a single dose of the vaccine.

"If people do not truly know how protective a vaccine is, there is the potential for harm because they may assume that they are fully protected when they are not, and accordingly, alter their behavior to taken unnecessary risks," they said.

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