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FDA is expected to issue Emergency Use Authorization for Moderna’s vaccine, enabling immediate distribution.
Moderna’s messenger RNA-based (mRNA) vaccine for COVID-19 received a positive recommendation from a panel of FDA advisors following a virtual day-long hearing on Dec. 17, 2020, setting the stage for the issuance of an FDA Emergency Use Authorization (EUA) and delivery to patients in days.
By a vote of 20–0 with one abstention, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that FDA grant an EUA for the vaccine candidate, mRNA-1273, for people ages 18 years and older. FDA will review the recommendations and issue the EUA if it determines the benefits of the vaccine outweigh the risks.
The vaccine is based on the SARS-CoV-2 spike glycoprotein (S) antigen encoded by RNA and formulated in lipid nanoparticles. Primary efficacy analysis of data from a Phase III clinical study of more than 30,000 participants indicated a vaccine efficacy rate of 94.1%, the company reported in a press statement. Adverse reactions following the second of two doses were classified as mild or moderate, occurred within two days after injection, and persisted for one or two days.
The vaccine reduced the risk of someone developing confirmed COVID-19 or severe confirmed COVID-19 at least 14 days after the second dose of vaccine compared with placebo, FDA reported. In the interim analysis, efficacy was consistent across subgroups including racial and ethnic minorities, people age 65 years and older, and those with conditions that make them susceptible to severe COVID-19.
On December 11, 2020, FDA issued an EUA for an mRNA COVID-19 vaccine developed by Pfizer-BioNTech. The first person was vaccinated on December 14.
Moderna’s candidate does not have the extreme cold chain requirements of the Pfizer-BioNTech vaccine product. At the December 17 meeting, Moderna said it has expanded the handling guidance for mRNA-1273 to include local transport under controlled conditions in a liquid state at 2–8 °C (36–46 °F).
“We were grateful for the opportunity to present the clinical data package for our mRNA vaccine against COVID-19 to the FDA’s advisory committee today. We thank the committee for their review and for their positive recommendation in support of Emergency Use Authorization,” said Stéphane Bancel, chief executive officer of Moderna in a press statement. “We have been working with the US Centers for Disease Control and Prevention and Operation Warp Speed to prepare for the distribution of mRNA-1273, if the FDA chooses to grant an Emergency Use Authorization. We look forward to getting our vaccine to people in the US to help address this ongoing public health emergency.”