The FDA announced two revisions to the Emergency Use Authorization (EUA) of Moderna’s COVID-19 vaccine, which it hopes will help speed up the rollout process. The update announced Thursday clarified that the number of extractable doses per vial in the currently available vials is 11, and also approved the use of another multi-dose vial, which can contain up to 15 doses.
The FDA pointed out that despite the update, depending on the type of syringe and needle used to extract each dose, there may not be enough capacity to extract more than 10 doses from a vial containing up to 11 doses, or the doses extracted from it. More than 13 kinds. The vial can hold up to 1
Therefore, the agency warns against combining the remaining vaccines in multiple vials to form a complete dose.
The National Institutes of Health said that early trials of the Moderna COVID-19 vaccine started for the African variant
The FDA warned: “If a vial is contaminated during use, then collecting a certain dose of the drug from multiple vials will spread the contaminants to other vials.” “Using a contaminated vial may result in vaccination. The individual caused a severe bacterial infection.”
The update also pointed out that the dosing schedule will remain unchanged, and the vaccine will continue to be administered in two doses of 0.5 ml in two doses with an interval of one month.
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“Both these amendments have had a positive impact on the supply of Moderna COVID-19 vaccine, which will help provide more vaccine doses to the community and make the injected vaccines more quickly put into use,” FDA Director Dr. Peter Marcks Biologics The Evaluation and Research Center said in a press release issued on Thursday. “Ultimately, more vaccines should be released to the public in a timely manner and should help to end the pandemic more quickly.”
According to the US Centers for Disease Control and Prevention (CDC), more than 71.3 million doses of Moderna vaccine have been delivered in the United States. This is the second such COVID-19 acceptance EUA in the United States after the authorization of Pfizer and BioNTech products.
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In addition, Moderna has also collaborated with the National Institutes of Health to start early trials of a preventive research vaccine against variants of the coronavirus in South Africa. The trial has begun its first phase of clinical trials in adult volunteers and is expected to recruit approximately 210 participants.