Key FDA report says Moderna's COVID-19 vaccine is safe, effective, keeping it on track for approval

Virus Outbreak Vaccines
Posted at 8:37 AM, Dec 15, 2020

The Food and Drug Administration (FDA) released a key report Tuesday that said a COVID-19 vaccine made by Moderna is safe and effective — the latest in a series of rubber stamp approvals that could allow the vaccine to be distributed by the end of the month.

The FDA report on Tuesday upheld the clinical trials, which have shown the vaccine to be 95% effective with no severe side-effects. The FDA report says that the data is "consistent with the recommendations set forth in FDA’s Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19."

"FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the report reads.

The next step in approval for the Moderna vaccine will come on Thursday when the FDA's Vaccines and Related Biological Products Advisory Committee will meet and vote on whether to approve the Moderna vaccine for Emergency Use Authorization.

The vaccine would then need approval from the FDA as a whole, and then a recommendation from the CDC before health care professionals can begin injections.

The release of the FDA report comes a day after the first Americans received initial doses of a COVID-19 vaccine made by Pfizer.

Should Moderna's vaccine follow the same approval schedule as the Pfizer vaccine, health care professionals should begin injections by Monday.

The U.S. purchased 100 million doses of the Moderna vaccine earlier this year, and Moderna will have millions of doses ready to ship as soon as it receives Emergency Use Authorization.

Late last week, the federal government purchased an additional 100 million doses of the vaccine, meaning it expects to have 200 million doses by spring 2021.

The decision to purchase more doses of Moderna's vaccine came days after the New York Times reported that the U.S. government chose not to purchase more doses of the Pfizer vaccine when it had the chance earlier this year.