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FDA adjusts Moderna authorization to permit more vaccine doses in each vial

FDA adjusts Moderna authorization to permit more vaccine doses in each vial
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The Food and Drug Administration (FDA) adjusted Moderna’s emergency use authorization on Thursday to permit more COVID-19 vaccine doses in each vial — a move expected to speed up deliveries and shipments. 

The FDA announced late Thursday that it will allow Moderna to include up to 50 percent more extractable doses in its vials in an amendment to its authorization. The increase would permit Moderna to put up to 15 doses per vial, instead of the previous 10 doses per vial. 

The federal agency also boosted the maximum number of doses allowed to be extracted from the already existing 10-dose vials to 11 doses, noting that the extra dose may only be available depending on the syringes and needles used. 

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In an updated fact sheet, the agency also said certain syringes and needles may not be able to produce more than 13 doses from the new vials. 

“Both of these revisions positively impact the supply of Moderna COVID-19 Vaccine, which will help provide more vaccine doses to communities and allow shots to get into arms more quickly,” Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said in a release.

“Ultimately, more vaccines getting to the public in a timely manner should help bring an end to the pandemic more rapidly,” he added. 

The FDA noted that the vaccine dose amount given to each person has not changed, as each will receive 0.5 mL in two separate doses one month apart. Those who administer the vaccine are instructed not to combine vials in order to create any extra doses.

Moderna’s CEO Stéphane Bancel released a statement in response to the decision, thanking the FDA and Centers for Disease Control and Prevention (CDC) for working with them on the update. 

“We are committed to constantly learning and improving to facilitate easier administration of our COVID-19 vaccine for medical staff and accelerate immunization programs,” Bancel said. 

The news comes as the U.S. continues to ramp up its vaccination campaign, with 30 percent of the population receiving at least one dose of the vaccine and nearly 17 percent being fully vaccinated as of Thursday morning, according to CDC data.  

President BidenJoe BidenVirginia GOP gubernatorial nominee acknowledges Biden was 'legitimately' elected BuzzFeed News finds Biden's private Venmo account Kid reporter who interviewed Obama dies at 23 MORE has upped his goal to administer 200 million vaccine doses in his first 100 days of office, which comes at the end of this month. The original goal of 100 million doses in that time period was surpassed last month.