Important note: This article is intended for those who understand vaccines as critical to maintaining their health and that of their families. It is NOT intended for those who are anti-vaccine and as such is NOT intended to foster a discussion on the merits of vaccines in this forum. It is also NOT intended to foster a discussion of the lethality of COVID-19 or the need for civic action to limit the spread of the disease.
One day after wide-scale inoculation began in the US with Pfizer’s COVID-19 vaccine, an FDA panel has endorsed Moderna’s vaccine setting the stage for FDA approval in the coming days.
“Messenger RNA” (mRNA) — the active ingredient in Moderna’s vaccine — works on the same principle as that of Pfizer’s by priming the immune system to make antibodies to COVID-19. There is no chance of developing COVID-19 from mRNA.
The panel deemed the vaccine “was highly effective” in preventing symptomatic COVID-19 from occurring “at least 14 days after the receipt of the second dose.”
Like Pfizer’s vaccine, which requires a second dose be administered 21 days after the first, the Moderna vaccine requires a second dose to be administered 28 days after the first.
In the Moderna study comprising 30,000 participants half of which were given a placebo, 185 cases of COVID-19 occurred in those that received the placebo compared to 11 cases given the vaccine. Of the cases reported in the placebo group, 30 developed severe COVID-19 (including one death) while none of the vaccine recipients developed severe illness.
Mild side effects such as aches, pains, and fever expected with most vaccines appeared to be more severe in the Moderna study than those reported for Pfizer’s vaccine, though the side effects from the placebo group in the Moderna study were also higher, so comparisons should be made with caution.
Rates of fever between the studies were similar. In the Moderna study, 65.3% reported fatigue (9.7% severe), muscle pain occurred in 58% of patients (9% severe), and joint pain 42.8% (5.2% severe). The rate and severity of side effects were not concerning to the panel.
Of special importance to the allergic community, the FDA found no serious allergic reactions in the Moderna study. About 1.5% of vaccine recipients and 1.1% who received the placebo reported possible “hypersensitivity” reactions.
Moderna has requested their vaccine be approved for adults 18 years of age and older, while Pfizer’s is approved for individuals 16 years and older.