Moderna Analysts Discuss Adcom Verdict, Distribution And Commercialization Of Coronavirus Vaccine

Moderna Inc's MRNA coronavirus vaccine candidate, mRNA-1273, got FDA panel backing, in line with expectations, and is likely to be accorded emergency use authorization any time now.

An Unsurprising Decision: The 20-0 vote, with one abstention, in favor of issuing an EUA for mRNA-1273 in patients 18 years and older, is not surprising, given the high overall vaccine efficacy of 94.5% and protection across all subgroups, SVB Leerink analyst Mani Foroohar said in a note.

Needham analyst Alan Carr noted the member who abstained expressed reservations about the vaccine being administered to the broader population before additional data is available. Instead, he preferred administration to high-risk individuals for the time being.

No substantial concerns were raised regarding the safety profile.

Discussion Points: The vaccine committee discussed at length on unblinding and crossover of placebo recipients in the Phase 3 study, safety and vaccine durability, Foroohar said.

Carr noted FDA is in favor of maintaining the blind in order to generate additional placebo-controlled safety data as a means of providing valuable long-term insight into the safety profile of the vaccine.

With both Pfizer Inc. PFE and Moderna arguing for giving the subject's option to be unblinded and receive vaccine, the committee gradually began to lean towards providing subjects an option to unblind, the analyst said.

EUA Imminent, Focus Shifts to Distribution, Commercial Aspects: Carr said he expects the FDA to grant a EUA very soon.

CDC's ACIP meetings are scheduled for Saturday and Sunday to discuss mRNA-1273 as well as allocation of COVID-19 vaccines in Phases 1b and 1c, the analyst said.

Moderna's mRNA-1273 is shipped at -20 degrees Celsius as a single carton containing 100 doses, and each vial contains 10 doses, with no dilution required, he added.

The vaccine remains stable at 4 degrees Celsius for 30 days and at room temperature for 12 hours, Carr said.

Needham estimates mRNA-1273 is likely to fetch Moderna revenues of $7.28 billion in 2021, assuming shipment of 500 million doses globally.

"We acknowledge the enormous accomplishment in the development of a vaccine for COVID-19 in a very short period of time, but believe the stock is fairly valued and maintain HOLD," the firm said.

In premarket trading, Moderna shares were edging down 0.52% to $143.25. The stock is up about 636% in the year-to-date period.