FDA To Consider Giving Half-Doses Of Moderna’s COVID-19 Vaccine To Speed Distribution

 

The Food and Drug Administration (FDA) is set to meet this week to decide whether to give just half-doses of Moderna’s COVID-19 vaccine to people aged 18 to 55.

Distribution of the two vaccines approved for emergency use in the U.S. has been slow, so halving the dose would make the vaccine available to twice as many people in an age group that is not as endangered of those over 55, according to Moncef Slaoui, chief scientific adviser of Operation Warp Speed, a vaccine program established by President Donald Trump.Slaoui said on CBS’ “Face the Nation” on Sunday that half a dose is just as effective as a full dose. “We know that for the Moderna vaccine, giving half of the dose to people between the ages of 18 and 55, two doses, half the dose, which means exactly achieving the objective of immunizing double the number of people with the doses we have,” Slaoui said.

“We know it induces identical immune response” to the full dose, he added.

With vaccines in short supply, Slaoui said cutting the vaccine doses in half was “a more responsible approach that would be based on facts and data.

Slaoui later said on CNN that the FDA will decide if the current 100-microgram dose will be cut in half, with another half-dose following 28 days after the first.

The U.S. Centers for Disease Control and Prevention (CDC) on Saturday said it had administered more than 4.2 million first doses of COVID-19 vaccines and distributed more than 13 million, but initial goals from the federal government estimated 20 million would be available before the end of 2020.

Pfizer’s COVID-19 vaccine, the first in the U.S., was approved by the FDA for emergency use authorization (EUA) on Dec. 11. The FDA on Dec. 18 also approved Moderna’s EUA request. Both are already being distributed. Moderna said its data showed their vaccine was 95% effective in its late-stage clinical trial, the same as Pfizer’sThe Moderna vaccine was developed in conjunction with the Trump administration’s Operation Warp Speed. A key advantage of Moderna’s vaccine is that it does not need sub-zero storage like Pfizer’s, which needs to be stored at -94 degrees.

A third vaccine, one developed by AstraZeneca and researchers at Oxford University, was approved Dec. 30 for emergency use in Britain.

Britain on Monday became the first country in the world to begin administering the AstraZeneca/Oxford’s vaccine.The CDC’s Advisory Committee on Immunization Practices (ACIP) on Dec. 2 voted to direct that healthcare workers and residents of long-term care facilities will be the first to get the shots in the initial rollout once federal regulators authorize use of a vaccine. The recommendation was approved CDC Director Robert Redfield, but governors will eventually have the final say on who gets the vaccine first.

So far, though, thousands of health care workers across the U.S. have refused to get COVID-19 vaccines. “Up to half of health care workers in one California county and a Texas hospital say they will not get the shot, 60 percent of nursing home staff in Ohio are turning down the jab and 40 percent of frontline workers in Los Angeles won’t get it either, polls reveal,” the Daily Mail reported..

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