Moderna Vaccine Trial in Children 12-18
More Good News: This week Moderna released data on their clinical trial in Adolescents - ages 12 to less than 18. There were 3,732 volunteers and 2/3rds of the group received the vaccine (in the same dose as adults) and 1/3rd received placebo. Clinical trials in children are smaller than in adults and the goal is to make sure that it has the same efficacy as seen in the bigger Phase 3 trial in adults. This is called "immunobridging." The vaccine was given the same way as in adults, two doses 4 weeks apart. More than 2 weeks after dose 2 there were 4 cases of Covid-19 in the placebo group and none in the vaccinated group for an efficacy of 100%. The side effects were similar to that in adults with local pain at the injection site and generalized symptoms of headache, fever, chills, and myalgias - most were mild or moderate. See Below
They also calculated the efficacy rate using the CDC definition: the presence of one symptom and a positive nasal swab or saliva test by RT-PCR molecular test. Using this case definition the efficacy was 93%. All volunteers will be followed for a full 12 months after their second dose. Moderna will submit a request for approval of the vaccine in adolescents the beginning of June. All of the data will be reviewed by FDA scientists, and the VRBPAC independent scientific advisory Committee and then presented to the CDC ACIP independent advisory committee for a a one day open discussion and vote. If approved by the outside committee the CDC will have the final decision re: approval.