The American-based biotechnology company Moderna has received the nod from a panel of advisers over at the Food and Drug Administration (FDA), paving the way for an alternative COVID-19 vaccination option.
According to the FDA report, the praise obtained for Moderna’s new COVID-19 vaccine (mRNA-1273) came on the heels of a EUA request submitted as confirmed cases had surged on a mere daily basis in the U.S.
As part of an ongoing Phase 3 randomized, double-blinded trial, so far the new experimental vaccine has demonstrated efficiency at combatting the novel coronavirus, enough for FDA advisers to recommend its approval for immediate use.
“An EUA request for a COVID-19 vaccine should include all safety data accumulated from studies conducted with the vaccine, with data from Phase 1 and 2 focused on serious adverse events, adverse events of special interest, and cases of severe COVID-19 among study participants,” the report reads.
“The Phase 1 and 2 safety data likely will be of a longer duration than the available safety data from the Phase 3 trial at the time of submission of an EUA request and thus, are intended to complement the available data from safety follow-up from ongoing Phase 3 studies,” the report also states.
Thus far, the strongest vaccinational candidates against COVID-19 has centered around Pfizer-BioNTech, along with Sputnik V; however, Moderna’s mRNA-1273 may be similarly effective as both of those vaccines, the Moderna findings claim.
