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FDA Briefing Document On Moderna's Coronavirus Vaccine Positive On Efficacy, Safety

FDA Briefing Document On Moderna's Coronavirus Vaccine Positive On Efficacy, Safety

Moderna Inc's (NASDAQ: MRNA) application requesting emergency use authorization for its coronavirus vaccine candidate will discussed by FDA's Vaccines and Related Biological Products Advisory Committee Thursday.

The briefing document prepared by FDA staff to aid discussions at the Adcom meeting shows a favorable disposition toward the vaccine candidate

What Happened: The final scheduled efficacy analysis on the primary endpoint showed a vaccine efficacy point estimate of 94.1% for Moderna's mRNA-1273, the briefing documents released Tuesday showed.

This aligns with the data obtained from the interim analysis, except for a lower efficacy observed in participants ages 65 years and older relative to younger adults from 18-65, FDA staffers said.

Moderna filed for emergency use authorization Nov. 30, with the dataset used as the basis of the application having a cut-off date of Nov. 11.

Since then, Moderna provided additional data collected through Nov. 25, which included data from at least two months after the second dose of vaccine.

Related Link: The Week Ahead In Biotech: 2 IPOs Plus FDA Decisions On Moderna's COVID Vaccine And Drugs From Amgen, MacroGenics

On safety, FDA staffers said the information provided by Moderna was adequate for review and to make conclusions about the safety of the mRNA-1273 vaccine in the context of the proposed indication and population for intended use under emergency authorization. 

The safety analysis from the Nov. 25 cut-off date aligned with the interim analysis in terms of overall rates and types of solicited and unsolicited adverse events, the agency said.

Adverse events were reported in a higher proportion of vaccine recipients than placebo recipients, and this imbalance was driven by reactogenicity reported in the seven days following each dose of vaccine.

"No specific safety concerns were identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection," FDA staffers said.

Why It's Important: With the FDA giving its nod for emergency use of Pfizer Inc. (NYSE: PFE) and BioNTech SE's – ADR (NASDAQ: BNTX) BNT162b2, expectations are running high that Moderna's could also be cleared.

The expectation is cemented by the briefing document, which underlined the favorable disposition of the regulatory agency toward Moderna's vaccine candidate.

Both BNT162b2 and mRNA-1273 belong to the same class of vaccines, which trick the body into producing some of the viral proteins, triggering an immune response.

The Adcom meeting is a full-day affair scheduled between 9 a.m. and 6 p.m. Thursday.

MRNA Price Action: At last check, Moderna shares were slipping 3.42% to $149.77. 

Related Link: The Daily Biotech Pulse: Mesoblast Releases Mixed Data, MediWound Jumps On Distribution Deal, Kezar Life Sciences Rallies On Index Inclusion, Opiant Gets BARA Funding


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