On Tuesday, the U.S. Food and Drug Administration (FDA) staff posted a largely positive review of Moderna’s COVID-19 vaccine, prompting that Americans might soon have another vaccine available to prevent COVID-19.
Moderna’s mRNA-1273 coronavirus vaccine is quite similar to Pfizer’s COVID-19 vaccine that received FDA’s emergency approval last week.
On December 11, the FDA granted an Emergency Use Authorization (EUA) for the Pfizer-BioNTech coronavirus vaccine for people aged 16 and above. Both the vaccines are intended to be taken in a two-dose regimen, given four weeks apart.
Massachusetts-based Moderna will now seek FDA’s EUA for its vaccine use in people aged 18 and older.
In the briefing document, the FDA staff noted that Moderna’s vaccine is more than 94% effective. It also noted that the findings suggest that the Moderna vaccine works better in younger people and may protect them from severe COVID-19 illness.
The FDA staff said, “The VE in this analysis, when stratified by age group, was 95.6% (95% CI, 90.6% – 97.9%) for participants 18 to younger than 65 years of age and 86.4% (95% CI, 61.4% – 95.5%) for participants 65 years of age and older.”
“A final secondary efficacy analysis also supported efficacy against protocol-defined severe COVID-19, with 30 cases in the placebo group vs 0 cases in the vaccine group,” the panel added.
However, there have been a few cases of Bell palsy reported in both Pfizer-BioNTech and Moderna vaccine trials. The FDA said there is no evidence of this risk with both vaccines.
The clinician handout says, “Currently available information is insufficient to determine a causal relationship” with the Pfizer-BioNTech vaccine.
“There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuroinflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 vaccine,” it adds.
The FDA has also said that the reaction of Bell’s palsy did not occur immediately after administering the vaccines. In Moderna’s trial, four participants experienced Bell’s palsy, aka facial paralysis, of which three received the vaccine and one received a placebo.
