USFDA panel recommends emergency use of Moderna COVID-19 vaccine

The panel of independent experts that advise the USFDA has recommended the emergency use of Moderna's COVID-19 vaccine. The panel's recommendation on December 17 in favour of the Moderna vaccine will set a stage for the rollout of the second COVID-19 vaccine in the US. Last week, the USFDA approved the emergency use of the vaccine by Pfizer and its German partner BioNTech.

The panel called the Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on December 17, following a day-long discussion and presentations, decided to back the vaccine by a vote of 20 in favour and one abstention.

USFDA advisory committees provide non-binding recommendations. The USFDA will take the VRBPAC’s recommendation into consideration in making a final decision on approval.

“We have been working with the U.S. 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 U.S. to help address this ongoing public health emergency,” said Stéphane Bancel, Chief Executive Officer - Moderna.

The VRBPAC based its recommendation on the totality of scientific evidence shared by the company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30, Moderna said.

Please read here more about the safety, efficacy and storage of Moderna vaccine.

The primary efficacy analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1 percent. The most common solicited adverse reactions (ARs) after the two-dose series included injection site pain (88.2 percent), erythema (8.6 percent), swelling (12.2 percent), and ipsilateral lymphadenopathy (14.2 percent).

While the majority of these ARs were grade 1 (mild) or grade 2 (moderate), there was a higher occurrence of grade 3 (severe) reactions in the mRNA-1273 group and after the second injection.

Moderna said the majority of local solicited ARs occurred within the first one to two days after injection and generally persisted for a median of one to two days.
It added that safety data continue to accrue, and the study continues to be monitored by an independent Data Safety Monitoring Board (DSMB) appointed by the National Institutes of Health (NIH).

"All participants in the COVE study (Phase 3) will be monitored for two years after their second dose to assess long-term protection and safety," the company said.

The Phase 3 study enrolled more than 30,000 participants in the US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services.