FDA to weigh Moderna half-dose COVID-19 vaccines: Operation Warp Speed ​​manager



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U.S. Food and Drug Administration discussing initiative to deliver Moderna coronavirus vaccines in half doses to distribute vaccine more widely across the population, senior Operation Warp Speed ​​official says (OWS).

Comments from Dr Moncef Slaoui, the director of operations of OWS, emerged on Sunday telling Margaret Brennan of CBS that halving the dose volume in vaccines given to people aged 18 to 55 results in a Entire “identical immune response” Dose of 100 micrograms.

Dr. Moncef Slaoui, chief advisor to Operation Warp Speed, speaks in the Rose Garden of the White House, Friday, November 13, 2020, in Washington.  (AP Photo / Evan Vucci)

Dr. Moncef Slaoui, chief advisor to Operation Warp Speed, speaks in the White House rose garden, Friday, November 13, 2020, in Washington. (AP Photo / Evan Vucci)

The plan would inoculate twice as many people, Slaoui said, calling it “a more responsible approach based on facts and data.”

“We are in discussions with Moderna and with the FDA, of course, it will ultimately be a decision by the FDA to speed up the injection to half the volume,” he continued.

Slaoui’s comments surfaced after being pressed to detail how the federal government is taking action to help states administer doses to Americans, a slow effort plagued by logistical hurdles such as staffing and funding.

A former FDA chief later agreed that the change in dosage would speed up vaccination efforts.

“They can move on to this,” former FDA Commissioner Dr. Scott Gottlieb told CNBC co-hosts Monday, talking about cutting Moderna’s dose volumes in half. “It would certainly extend the offer.”

As of Monday morning, the federal government had distributed at least 13 million doses, and more than 4.2 million vaccines entered the arms of Americans, according to figures from the Centers for Disease Control and Prevention. Officials, however, said there were likely delays in reporting.

While UK officials back the decision to space inoculations 12 weeks between the first and second dose, Slaoui and Dr Anthony Fauci, the country’s leading infectious disease specialist, have rejected the approach.

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“I think it’s not reasonable, when vaccines have been developed with two doses given 21 days apart, or 28 days apart and we have the data on their safety and effectiveness,” said declared Slaoui. “We don’t have data on a dose if we leave people one month, two months, three months with maybe incomplete immunity, waning immunity, maybe even the wrong kind of induced immune response that is. then corrected by a second dose.

As Americans seem to gain confidence in the vaccine, tampering with the process can threaten to destroy the newly gained confidence.



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