In the phase 3 LIBERTY study, the investigational monoclonal antibody, VYD2311, had significantly fewer adverse events than an mRNA COVID-19 vaccine, and it did not blunt vaccine-induced neutralizing titers when the two were given together.
|Articles|April 2, 2021
Revisions to Moderna COVID-19 Vaccine EUA Aim to Increase Available Doses
Author(s)Killian Meara
The 2 revisions made to the EUA pertain to the number of doses allotted to the current vials containing the vaccine, and allow a new vial that has a maximum of 15 doses.
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On Thursday, The US Food and Drug Administration announced that they will be making 2 revisions to the Emergency Use Authorization (EUA) issued to Moderna’s
“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. “Ultimately, more vaccines getting to the public in a timely manner should help bring an end to the pandemic more rapidly.”
The first revision clears up the information regarding the number of doses per vial, for the vials that are currently being used. The number of doses that can be extracted from these vials has a range of 10-11, with 11 being the maximum amount allotted.
The second revision authorizes the use of a new vial presentation, which allows for a maximum of 15 doses per vial. Moderna expects to start shipping the new vials in the coming weeks.
Each dose extracted from a vial is dependent on the type of syringe and type of needle used. There may not be sufficient volume in a vial to extract the maximum number of doses the vial allows. For example, an 11 dose vial may only get 10 doses extracted, and a 15 dose vial may only get 13 extracted.
The FDA evaluated data submitted by Moderna that showed the number of does that could be extracted from the vials and on the fill volumes for both vials to support the changes made to the EUA.
The dosing regimen remains the same, at 2 doses of 0.5 mL, 1 month apart and the FDA has updated its fact sheet to reflect the new changes.
“We are committed to constantly learning and improving to facilitate easier administration of our COVID-19 vaccine for medical staff and accelerate immunization programs. Thank you to the U.S. FDA and CDC for their ongoing collaboration,” Stéphane Bancel, Chief Executive Officer of Moderna said. “We remain focused on doing all that we can to help end the COVID-19 pandemic with a vaccine.”
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