A new FDA assessment of the data behind an emergency use authorization filing for Moderna Inc.'s COVID-19 vaccine candidate, issued in advance of a Dec. 17 meeting of the Vaccines and Related Biological Products Advisory Committee, affirmed efficacy claims for the product and identified "no specific safety concerns that would preclude issuance of an EUA."

Though three reports of facial paralysis in people who received the vaccine drew mention by the agency, data on the events were "insufficient to determine a causal relationship with the vaccine," the regulator said.

If granted, the EUA would make Moderna's mRNA-1273 the second COVID-19 vaccine to receive authorization by the regulator, likely putting it on track for initial deliveries to the U.S. later this month. Company shares (NASDAQ:MRNA) fell 5.1% to $147.22 on Dec. 15.

"On review, we did not note any surprises," Piper Sandler analyst Edward Tenthoff wrote. "Additionally, we did not view any serious safety concerns," he said, suggesting that mRNA-1273 would receive a rapid EUA grant, with the first Americans to be vaccinated by year-end. Millions of vials of the vaccine are already on order by the federal government, which yesterday upped its demand, bringing to 200 million the number of doses it has contracted to receive from Moderna through the first quarter of 2021.

18 and up

Moderna's vaccine candidate is based on the SARS-CoV-2 spike glycoprotein antigen encoded by RNA and formulated in lipid nanoparticles. The Cambridge, Mass.-based company's EUA request proposes the vaccine be used for the prevention of COVID-19 caused by SARS-CoV-2 in people 18 and older, with a two-dose regimen, 100 μg each, administered one month apart. Though the number of doses are the same, the lowest age of potential recipients was two years above one granted for Pfizer Inc. and Biontech SE's BNT-162b2.

Safety and efficacy data from an ongoing phase III randomized, double-blinded and placebo-controlled trial of the candidate in about 30,400 participants were offered in support of the application. Drawing from a final scheduled analysis of data through Nov. 21, the FDA affirmed efficacy of the vaccine. With a median follow-up of greater than two months following the second dose, it demonstrated a vaccine efficacy of 94.1% (95% CI 89.3%, 96.8%), with 11 COVID-19 cases in the vaccine group and 185 COVID-19 cases in the placebo group, the agency said, consistent with results obtained from an earlier interim analysis.

"Subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates across age groups, genders, racial and ethnic groups, and participants with medical co-morbidities associated with high risk of severe COVID-19," the reviewer added. That element held particular weight in light of data showing that, in America, COVID-19 is affecting Black, Indigenous, Latinx, and other people of color the most. Nationwide, Black people with COVID-19 are dying at 1.8 times the rate of white people with the disease according to the COVID Tracking Project.

Furthermore, secondary efficacy analyses of the data to date suggested benefit of the vaccine in preventing severe COVID-19 and in preventing COVID-19 following the first dose, and in preventing COVID-19 in individuals with prior SARS-CoV-2 infection, although available data for some of those outcomes did not allow for firm conclusions, FDA reviewers said.

The most common adverse reactions associated with mRNA-1273 were injection site pain (91.6%), fatigue (68.5%), headache (63.0%), muscle pain (59.6%), joint pain (44.8%) and chills (43.4%). Also, lymphadenopathy, an axillary swelling and tenderness of the vaccination arm, was reported as an unsolicited event in 173 participants (1.1%) in the vaccine group and 95 participants (0.63%) in the placebo group. There was also a numerical imbalance in hypersensitivity adverse events across study groups, with 1.5% of vaccine recipients and 1.1% of placebo recipients reporting those events in the safety population. No anaphylactic or severe hypersensitivity reactions "with close temporal relation to the vaccine" were reported.

The adcom session, for which BioWorld will provide same-day coverage, starts at 9 a.m. ET on Dec. 17.