FDA Advisory Panel To Consider Moderna COVID-19 Vaccine Next
PITTSBURGH (KDKA) - The Moderna COVID-19 vaccine is next to come before the FDA for emergency use authorization.
"They want to make sure this new vaccine will be safe and also that it will be very effective," says Dr. Marc Itskowitz, a primary care internist at the Allegheny Health Network. "As each of these vaccines come on line, it gives us additional tools to be able to decrease severe COVID-19 disease and get out of this pandemic."
Like the Pfizer vaccine, this one uses messenger RNA, or mRNA, also. In studies, it was 94% effective. As of Dec. 3, 13 deaths have occurred in the study, six in the vaccine group.
"The most important study data that I'm looking at is severe COVID-19 disease," says Dr. Itskowitz. "Really, what we have to do initially is stop severe disease, which would stop hospitalizations. There were almost no cases of severe disease in patients who received the vaccine."
Unlike the Pfizer vaccine, which received emergency use authorization for those 16 and up, Moderna's will be for adults only.
"Adults, especially older patients, are the ones who are suffering the most from severe COVID-19 in terms of hospitalizations and deaths. So really the priority would be to vaccinate the high-risk population first," Dr. Itskowitz says.
Also, the Moderna vaccine can be stored at -4 degrees Fahrenheit for six months, and in the refrigerator for 30 days.
"That's going to be helpful and a little bit easier in terms of the storage and distribution," he adds.
The most common reactions have been pain, fatigue, headache, muscle aches and chills.
One condition not clearly related to the vaccine will be monitored -- a facial droop called Bell's Palsy. Three people in the vaccine group developed this, compared to one in the placebo group. This could simply be the background rate.
The vaccine advisory panel meets on Thursday to discuss and vote on the Moderna vaccine. The FDA usually goes along with the recommendations of the panel.