Moderna, Inc. (MRNA), Pfizer, Inc. (NYSE: PFE) – Moderna analysts discuss Adcom verdict, distribution and commercialization of coronavirus vaccine

Moderna Inc. (NASDAQ: MRNA) The coronavirus vaccine candidate, mRNA-1273, has received FDA panel support, as expected, and is expected to receive emergency use clearance at all times.

A decision without surprise: 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 vaccine’s high overall efficacy of 94 , 5% and protection in all subgroups, SVB Leerink analyst Mani Foroohar said in a note.

Needham analyst Alan Carr noted that the member who abstained expressed reservations about the vaccine being given to the general population before more data became available. Instead, he preferred administration to high-risk individuals for the time being.

No significant concerns were raised regarding the safety profile.

Discussion points: The vaccine committee discussed at length the unblinding and crossing over of placebo recipients in the Phase 3 study, the safety and durability of the vaccines, said Foroohar.

Carr noted that the FDA supports keeping the blind in order to generate additional placebo-controlled safety data as a way to provide valuable long-term information on the vaccine’s safety profile.

With both Pfizer Inc. (NYSE: PFE) and Moderna arguing for giving the subject the option of being released from the blind and receiving the vaccine, the committee gradually began to lean in to offer subjects a chance to stand up, the committee said. analyst.

EUA imminent, focus on distribution, commercial aspects: Carr said he expects the FDA to grant an EUA very soon.

The CDC’s ACIP meetings are scheduled for Saturday and Sunday to discuss mRNA-1273 as well as the 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, without any dilution, he added.

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

Needham estimates that mRNA-1273 will likely bring Moderna in revenue of $ 7.28 billion in 2021, assuming 500 million doses shipped worldwide.

“We recognize the huge accomplishment in developing a vaccine for COVID-19 in a very short period of time, but believe the stock is valued enough and is holding HOLD,” the company said.

In pre-market trading, Moderna shares edged down 0.52% to $ 143.25. The stock is up about 636% year-to-date.