FDA Advisory Panel Gives Big Thumbs Up for Moderna’s COVID-19 Vaccine

The FDA’s vaccines advisory committee voted almost unanimously on Thursday in favor of Emergency Use Authorization (EUA) for Moderna’s COVID-19 vaccine, with all but one abstaining member supporting clearance, and authorization is widely expected to come today.

Asked if they believed the vaccine’s benefits outweigh its risks in patients 18 and older based on the scientific data to date, 20 of the 21 committee members voted yes, signaling their support for EUA. The single abstaining vote came from Michael Kurilla, director of the NIH’s National Center for Advancing Translational Sciences’ Division of Clinical Innovation who expressed concern about the wording of the question before the panel, viewing it as a “blanket statement.”

“[It’s] just too broad. I’m not convinced that for all of those age groups, the benefits do actually outweigh the risks, and I would prefer to see it more targeted toward people at high risk of serious and life-threatening COVID disease,” he said.

An EUA for Moderna’s vaccine would give Americans a highly effective and much needed second option for COVID-19 vaccination, as it will likely be months before other vaccine candidates, such as AstraZeneca’s and Johnson & Johnson’s shots, are assessed for emergency clearance. The FDA, which cleared Pfizer’s vaccine a day after the advisory panel voted 17-4 a week ago Thursday in favor of doing so, is expected to move at the same pace to authorize Moderna’s shot.

Much of the discussion by advisory committee members Thursday focused on the ethical quandary drugmakers face in whether to give their authorized vaccines to trial participants who have received a placebo (see related story).

The initial rollout of Moderna’s vaccine is set to consist of a little under 6 million doses, according to an Operation Warp Speed official (DID, Dec. 16), an amount approximately double that of the initial 2.9 million Pfizer/BioNTech vaccine shots that began being rolled out last weekend.

The federal government signed a $1.5 billion contract with Moderna for 100 million doses and an option for 400 million additional doses (DID, Aug. 13). It has also secured a $1.95 billion contract with Pfizer for 100 million doses and a provision that will allow it to purchase up to half a billion more shots (DID, July 23), and the government claims it is negotiating with the company to obtain additional supplies.

Moderna’s vaccine appears much easier to distribute and manage than Pfizer’s due to its significantly less-intensive temperature requirements, offering an important advantage. Pfizer’s vaccine must be shipped at around -94 F (Fahrenheit) and can be kept for five days in a hospital refrigerator or 30 days in the company’s thermal shippers if they’re refilled with dry ice every five days. By contrast, Moderna’s vaccine is shipped at -4 F, a standard freezer temperature, and can be stored at the same temperature for up to six months. It can also be kept at refrigerator temperatures (36 F to 46 F) for up to 30 days.

Both Pfizer’s and Moderna’s vaccines are based on messenger RNA technology, and while mRNA vaccines have been studied for decades, none have yet been fully approved by the FDA. The vaccines contain pieces of genetic material, mRNA, that must be preserved at cold temperatures to prevent degradation. The drugmakers have not revealed the exact intricacies of their respective vaccines, so it is not known why Pfizer’s vaccine must be kept at such colder temperatures. — James Miessler