FDA raises no concerns about safety, efficacy of Moderna COVID-19 vaccine

simon2579/iStockBy STEPHANIE EBBS, ABC News

(NEW YORK) — The Food and Drug Administration appears to be on track to authorize Moderna’s COVID-19 vaccine this week in the same process used to evaluate and issue emergency authorization for Pfizer’s COVID-19 vaccine.

FDA scientists and experts did not identify any safety concerns about Moderna’s COVID-19 vaccine, which uses similar technology to the one authorized from Pfizer, and confirmed the Moderna vaccine was 94.5% effective at preventing COVID-19 cases at least 14 days after vaccination.

If the Moderna vaccine is authorized, about six million doses could start being distributed as soon as next week, in addition to additional shipments of the Pfizer vaccine. Both vaccines will be prioritized for health care workers and residents and staff in nursing homes and long-term care facilities.

One significant difference is that the Moderna vaccine has not been studied in children so it will only be authorized for people 18 and older at this time.

A group of independent experts that advises the FDA on vaccines will meet Thursday and vote on whether the benefits of authorizing the Moderna vaccine outweigh any risks, essentially recommending it for emergency authorization.

FDA Commissioner Stephen Hahn will then decide whether to sign off on emergency authorization. Advisors for the Centers for Disease Control and Prevention will then meet to finalize recommendations on who should receive the Moderna vaccine, which would need to be approved by CDC Director Robert Redfield.

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