When will the coronavirus vaccine Moderna become available? The FDA is expected to issue its approval.
According to preliminary research, the vaccine candidate may also prevent some asymptomatic cases.
By the end of this week, Americans may have received a second vaccine. The US Food and Drug Administration (FDA) has determined that Moderna’s coronavirus vaccine candidate is very successful in preventing proven cases of the illness, paving the way for regulatory approval. The two-shot regimen was 94.1 percent effective at preventing symptomatic disease in a trial of about 30,000 participants, according to a 54-page analysis published by the agency, with 11 cases in the vaccine group and 185 in the placebo group, meeting the “predefined success criteria” for emergency use authorization (EUA).
The vaccine candidate performed particularly well in cases of severe illness. In the clinical trial, there were 30 cases of severe coronavirus, but none of them were in the vaccine group. The researchers wrote, “The known benefits among recipients of the proposed vaccine relative to placebo are a reduction in the risk of confirmed Covid-19 occurring at least 14 days after the second dose of vaccine, and a reduction in the risk of confirmed severe Covid-19 occurring at least 14 days after the second dose of vaccine.” “Vaccine efficacy appeared to be lower in participants 65 years and older than in younger adults 18 to less than 65 years (86.4 percent vs to 95.6 percent),” they say. Moderna submitted an EUA request to the FDA on November 30 for their investigational coronavirus vaccine (mRNA-1273), which is meant to prevent the sickness. The proposed dosage schedule consists of two 100-gram doses given one month apart. On December 17, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet to discuss the issue. After the first shots of Pfizer-vaccine BioNTech’s were delivered to healthcare personnel on December 14, the latest findings set the Moderna vaccine up for EUA by the FDA, suggesting Americans might have two vaccines by this weekend.
According to a New York Times report citing sources, the FDA intends to approve EUA on December 18. Pfizer, for example, received regulatory approval the next day after receiving approval from the advisory group on December 10.
Because Moderna is seeking approval to use the vaccine in adults 18 and older, one point of contention concerning the Pfizer-BioNTech vaccine — whether it should be permitted for use in 16- and 17-year-olds — will likely be avoided.
There were no major worries about safety. The FDA highlights that the number of participants in the Phase 3 safety population satisfies the requirements outlined in FDA guidance on the development and licensing of coronavirus vaccines. The safety profile of mRNA-1273 was consistent across studies. Brinkwire News in a Nutshell