Sunday, August 1, 2021

FDA authorises 2 changes to Moderna’s vaccine – ET HealthWorld


The US Food and Drug Administration has authorised two changes to Moderna’s Covid-19 vaccine that can provide extra doses from each vial.

The agency said late on Thursday that it approved new vials from Moderna that can contain up to 15 doses each, compared with the original vials designed to hold 10 doses. Additionally, regulators said providers can safely extract up to 11 doses from the original 10-dose vials. Those changes will be added to instructions for health care workers.

The dosing updates should help bolster US supplies and speed vaccinations as the US nears 100 million inoculations against Covid-19. President Joe Biden has vowed to provide enough shots to vaccinate all US adults by late May and recently set a new goal of administering 200 million injections within his first 100 days in office.

Moderna said in a statement it plans to begin shipping the new 15-dose vials in the coming weeks. The company submitted updated data to FDA showing how many vaccines can be extracted from each vial using different types of syringes.

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