The FDA's expert committee has recorded seven serious adverse events in trials of Moderna's vaccine.
The US Food and Drug Administration (FDA) has warned of rare side effects from the administration of Moderna's vaccine. However, these symptoms are not necessarily severe, but they are unpleasant.
The main side effects generated by the Moderna vaccine have been fatigue, headache, or muscle pain. These ailments are expected after the injection of practically any vaccine. However, Moderna's vaccine has produced intractable nausea or vomiting and facial swelling in his trials.
The FDA has accounted for seven cases of severe mishaps during vaccine trials, although none of them were triggered by death. The researchers themselves and the US company even recognized four of them.
Three volunteers suffered from swollen cheeks or lips, a side effect that had not yet been noticed with the use of either vaccine. There have also been cases of rheumatoid arthritis, that is, the wear of the cartilage that covers the joints. The Bell's palsy, which temporarily blocks a portion of the face, is another symptom that appeared in four of the 30,000 volunteers.
Recommendation for its use
Despite the side effects they have found, an independent committee of FDA experts has recommended the emergency use of Moderna's vaccine in the United States. Twenty favorable votes and one abstention have adopted the final decision.
The committee has been meeting for almost eight hours, in which it has analyzed the data provided by the company and the procedures for distributing the vaccine throughout the country. Finally, because "the safety profile is favorable" and that the detected side effects "do not represent a specific safety problem that prevents its emergency use," immunologists, epidemiologists and experts in infectious diseases have recommended the use of the antidote.
The efficacy of Moderna's vaccine is 94.5%. But its 100% effectiveness in people over 65 is especially noteworthy. Of the 3,527 volunteers belonging to this age group, none were infected after administering the drug, while only 5 of the 10,407 volunteers aged between 18 and 65 have suffered from the disease.
The recommendation for the emergency use of Moderna's vaccine comes on the day that the United States has exceeded 17 million infections and has been exceeding 3,000 victims of the disease day after day.