Moderna Inc. (NASDAQ: MRNA) has said that its COVID-19 vaccine is effective and safe in adolescents. This outcome could boost supply time for the commencement of the new school year in the autumn.
Study shows Moderna’s COVID-19 vaccines is safe for adults
Blood testing revealed that the vaccine induced an immune response comparable to prior findings in adults in a Phase 2/3 study of 3,732 children between the ages 12 and 17 in the United States. The study wasn’t evaluating the efficacy of the vaccine. However, after 14 days, none of the adolescents who took the vaccine showed signs of Covid-19, according to preliminary results. Moderna claims that four of the adolescents who received the placebo were found to be positive for Covid-19, indicating 100% vaccine efficacy.” The company adds that when more data is gathered, the number could change.
For the study, the researcher used the definition of a case as they had in adults: someone who had two or more coronavirus symptoms and a positive Covid-19 test. Moderna also evaluated the vaccine’s effectiveness after a single dose. According to the findings, the vaccine showed 93% efficacy after a single dose in protecting against mild Covid-19. Moderna released the data on Tuesday, but the results have yet to be published or peer-reviewed.
Moderna to submit study findings to the FDA in June
Moderna said it will submit the findings to the US FDA at the beginning of next month, together with an application for approval for the vaccine use in teenagers. Also, it intends to publish the findings in a peer-reviewed journal.
Already Moderna’s vaccine has approval for use in persons over the age of 18. Following Moderna’s application for EUA of its vaccine for teenagers, the FDA will analyze the data and, if necessary, engage company experts. If the data are satisfactory, the FDA will authorize the vaccine for use in children and teenagers.
Moderna’s announcement of the results comes two weeks after the FDA indicated that the Pfizer vaccines are now safe for teenagers.