FDA Panel Endorses Moderna’s COVID-19 Vaccine for Emergency Use

An FDA advisory panel on Thursday voted 20-0, with one abstention, that the benefits of Moderna’s COVID-19 vaccine mRNA-1273 outweigh its risks in people 18 years and older. The panel backing sets the stage for the FDA to issue an emergency-use authorization (EUA) for the candidate, which if granted, would make it the second coronavirus vaccine to be authorized in the US after Pfizer and BioNTech’s BNT162b2 last week.

In the case of the Pfizer/BioNTech vaccine, which is for individuals ages 16 and older, the EUA came one day after it won 17-4 backing from the same advisory committee, and the national rollout started this week. Gen. Gustave Perna, who oversees logistics for Operation Warp Speed, said the US plans to ship just under 6 million doses of mRNA-1273 next week, pending the agency’s granting of an EUA. “It will be a very similar cadence that was executed this week with Pfizer, where we’re hitting initial sites on Monday, [followed] on Tuesday and Wednesday,” Perna remarked.

Following the latest advisory panel meeting, FDA Commissioner Stephen Hahn issued a statement saying the agency “will rapidly work toward finalization and issuance of an [EUA].” He added that the FDA has also notified the US Centers for Disease Control and Prevention and Operation Warp Speed, “so they can execute their plans for timely vaccine distribution.”

Follows positive review by FDA staff

The vote follows the release of FDA briefing documents in which agency staff confirmed that the efficacy of mRNA-1273 at preventing coronavirus infections was 94.1%, consistent with results obtained from the interim analysis of an ongoing phase 3 study. Moderna’s vaccine requires two doses administered four weeks apart. The interim analysis also suggested that mRNA-1273 is able to prevent severe COVID-19, with all 30 severe cases recorded at the time of the analysis being in the placebo group. However, the FDA revealed that there may have been one severe case that occurred in a vaccine recipient as well.

Further, while there were no additional safety concerns with mRNA-1273, agency staff found a “small imbalance” in the number of participants reporting Bell’s palsy, with three cases occurring among vaccine recipients and one in the placebo group. There were four cases of Bell’s palsy among people who had received the Pfizer/BioNTech vaccine in its trial. The FDA said there was no clear causal link, but acknowledged that the combined data from the two trials raised questions. “It’s something we are looking into and thinking much about,” stated FDA medical officer Rachel Zhang. The agency also said there were 13 deaths in Moderna’s trial reported as of December 3, including six in the vaccine group. It noted that two deaths among those given mRNA-1273 were people over 75 with pre-existing conditions.

Indication too broad?

At Thursday’s advisory panel meeting, committee member Paul Offit said “the question is never when do you know everything, it’s when do you know enough.” He added “we don’t know whether or not [mRNA-1273] going to be effective six months from now or a year from now, but there are systems in place to know that…I think it’s a pretty easy answer.”

The one abstention came from Michael Kurilla, an infectious diseases expert at the US National Institutes of Health who suggested that a blanket authorisation for those 18 and older may be too broad. “I’m not convinced that for all of those age groups the benefits do actually outweigh the risk, and I would prefer to see it more targeted towards people at high risk of serious and life threatening COVID-19 disease,” he said.

Last week, the US government announced that it exercised its option to purchase another 100 million doses of Moderna’s vaccine, on top of an initial order for 100 million doses agreed to in August in a deal worth up to $1.5 billion.

Meanwhile, Moderna said it has expanded the handling guidance for mRNA-1273 to include local transport under controlled conditions in a liquid state at 2°C to 8°C, noting that “in some cases, this may be the only practical means of distribution from clinics and for remote locations. This important update will help facilitate distribution to the final site of administration.” The company previously announced that mRNA-1273 remains stable at standard refrigerator temperatures of 2°C to 8°C for 30 days.