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Moderna COVID-19 Vaccine Secures FDA Panel's Endorsement

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Moderna COVID-19 Vaccine Secures FDA Panel's Endorsement

Moderna Inc's (NASDAQ: MRNA) COVID-19 vaccine has received the go-ahead from an advisory panel of the U.S. Food and Drug Administration, paving the way for the company to secure an emergency use authorization (EUA).

What Happened: The Vaccines and Related Biological Products Advisory Committee (VRBPAC) gave the nod on Thursday with 20 members in favor and a single abstention. 

The sole dissenter, Michael Kurilla, the director of clinical innovation at the National Center for Advancing Translational Sciences — a part of the NIH — expressed discomfort on the wording of the question, which he said was too broad,  as earlier noted by Stat News.

“A blanket statement for individuals 18 years and older is far too broad,” Kurilla said. The panel member also wanted the vaccine made available under expanded access protocol — a large clinical trial — instead of a EUA.

Oveta Fuller, a University of Michigan microbiologist, said she was impressed by Moderna’s transparency. Fuller voted against the vaccine of Pfizer Inc (NYSE: PFE) and its German partner BioNTech SE (NASDAQ: BNTX) last week.

See Also: Pfizer-BioNTech COVID-19 Vaccine Gets FDA Advisors' Nod

VRBPAC chair and University of Michigan epidemiologist Arnold Monto warned against comparing the two votes.

“To go from having a sequence of a virus in January to having two vaccines available in December is a remarkable achievement,” said James Hildreth, CEO of Meharry Medical College.

Why It Matters: Moderna noted in a statement that the VRBPAC’s recommendations are non-binding but are taken into consideration in making final decisions on approval or authorization.

The company's vaccine received more votes in favor than Pfizer’s which was also examined by the panel earlier. Pfizer’s vaccine had received 17 votes in favor, 4 against, and there was one abstention. 

While Pfizer requested emergency use for people over the age of 16 — despite not having ample data on the vaccine’s benefit for those under 18 — Moderna only applied for a EUA for those over 18 and thus faced no dissent over inoculation of teenagers, as per Stat.

The authorization, expected Friday, will make Moderna’s vaccine the second such to be available in the United States against COVID-19.

Price Action: Moderna shares closed nearly 5.1% higher at $144 on Thursday and fell 2.67% to $140.15 in the after-hours session.

Related Link: Pfizer COVID-19 Vaccine US Supply Could Rise 40% As FDA Clears Use Of Extra Doses In Vials

 

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Posted-In: Covid-19 Covid-19 vaccines Emergency Use AuthorizationBiotech News FDA Top Stories General Best of Benzinga

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