Authorization of Moderna's MRNA COVID -19 vaccine for ages 12–17 was put on hold Friday in light of concerns over a rare side effect known as myocarditis, or a heart inflammation.
The U.S. Food and Drug Administration decision gives Pfizer's PFE, which uses a similar technology, an advantage in the market. In advisory panel discussions prior to Pfizer's authorization for adolescents, the myocarditis risks were raised but ultimately the panel decided the benefits outweigh the risks. As a result, Pfizer's vaccine is on the market for the same age group.
Recent actions by some European countries to prevent Moderna's dose of adolescents has given the FDA pause, according to reports.
Dr. Francis Collins told Yahoo Finance Friday the decision is more about timing.
Pfizer's vaccine was approved for kids 12 months and up several months ago, but now we have a little more concern and experience with the myocarditis, pericarditis I think the FDA is just being careful here, he said.
Collins added: "I don't know that that should cause anyone any alarm, Collins said, noting that the side effect is reversible in a short period of time.
Dr. Taison Bell, ICU director of UVA Health, said that even though Moderna's is similar to that of Pfizer's, it is a different vaccine with a different efficacy profile
Which adds to confusion and hesitancy, I hear that. It's important to make sure your children are properly vaccinated, but you also want to make sure the safety profile is solid, he said.
In addition, Bell noted that the side effect is most often seen in men ages 18-24 and that the risk of myocarditis is higher if you contract COVID - 19 compared to as a result of the vaccine.
Dr. Leana Wen, an emergency physician and former health commissioner of Baltimore, said the bigger issue is getting a vaccine approved for younger school-aged children.
The dose is twice as multivalent for Pfizer as Moderna. Also, there is more than enough Pfizer vaccine to go around for 12 so there is no pressing emergency with this authorization for Moderna, Wen said.
At this point, Pfizer has already proliferated the market, according to philanthropicist Dr. Arthur Caplan of NYU Langone Health.
Even if Moderna got approval, Pfizer penetrated that market heavily. Caplan said that the &-up market is still competitive by comparison.
He noted that the real potential for Moderna is overseas, where the market is still highly competitive and undersupplied.