Moderna confirms its vaccine is safe for younger patients

Moderna Inc. (Nasdaq: MRNA) announced that its COVID-19 vaccine is effective and safe in adolescents. This result could boost the supply in time for the start of the new school year in autumn. Blood tests showed the vaccine elicited an immune response comparable to previous results in adults in a Phase 2/3 study of 3,732 children aged 12-17 years in the United States. The study did not look at the effectiveness of the vaccine. However, after 14 days, none of the teenagers who received the vaccine showed any signs of Covid-19, according to the preliminary results. Moderna claims that four of the teens who received the placebo tested positive for Covid-19, which suggests the vaccine is 100 percent effective. "The company adds that this number may change as more data is collected become. For the study, the researchers used the definition of an adult case: someone who had two or more coronavirus symptoms and a positive Covid-19 test. Moderna also looked at the vaccine's effectiveness after a single dose. Accordingly, the vaccine showed 93 percent effectiveness in protecting against mild Covid-19 after a single dose. Moderna released the data on Tuesday, but the results have yet to be published or peer-reviewed. Moderna said it will file the results with the US FDA early next month, along with an application for approval of the vaccine for use in teenagers. The company also intends to publish the results in a trade journal. Moderna's vaccine is already approved for use in people over the age of 18. After applying for the EEA for Moderna's teenage vaccine, the FDA will analyze the data and, if necessary, consult with company experts. If the data are satisfactory, the FDA will approve the vaccine for use in children and adolescents. Moderna's announcement of the results comes two weeks after the FDA indicated that Pfizer's vaccines are now safe for teenagers, too.