DETROIT – As doses of the Pfizer-BioNTech COVID-19 vaccine make their way into the arms of the first recipients, the data the Food and Drug Administration will be using to potentially authorize Moderna’s COVID-19 vaccine was made public.
The 83-page document from Moderna and the FDA’s 54-page briefing document are full of details on who received the vaccine and how effective it was. The summary lays out the demographics for the more than 30,000 study participants. Half received the vaccine and the other half received a placebo.
The results of the Moderna trial were similar to the Pfizer results and both came to the same conclusion. That the vaccine is extremely effective.
For the Moderna study, two doses of their mRNA vaccine were administered 28 days apart, that’s different than the 21 days between doses of the Pfizer vaccine.
Twenty-five percent of those enrolled in the Moderna study were older than 65. That’s similar to the 21 percent in the Pfizer vaccine study who were in that age group.
The primary question was how effectively the Moderna vaccine could prevent symptomatic COVID-19 infection 14 days after the second dose of the vaccine. Pfizer looked at 7 days.
At the time the data was initially submitted to the FDA, 90 people who had received the placebo developed COVID-19. That’s compared to only 5 who received the vaccine. That shows an overall efficacy of 94.5 percent. That’s similar to the efficacy of 95 percent for the Pfizer vaccine.
The Moderna data was further broken down by age groups and found between 18 and 65. The vaccine was 95.6 percent effective. It was 86.4 percent effective in people older than 65.
The most common side effect was pain at the injection site. Fever, headache, fatigue, body aches and joint pain were also more common in the vaccine group than the placebo group.