The Covid-19 vaccine from Moderna is safe and appears to be effective in adolescents, according to the company.
Blood tests in a Phase 2/3 trial of 3,732 children aged 12 to 17 in the United States revealed that the vaccine elicited an immune response comparable to previous findings in adults.
The trial wasn’t intended to look at efficacy specifically. However, after 14 days, none of the children who received the vaccine became ill with Covid-19, according to preliminary findings. Moderna claims that four of the children who received the placebo tested positive for Covid-19, indicating “100% vaccine efficacy.” The company warns that the figure could change as the year progresses.
The company warns that as more data is gathered, the figure may change.
A case was defined in the trial as someone who had two or more coronavirus symptoms, as well as a positive Covid-19 test.
The company also evaluated the vaccine’s effectiveness after only one dose. According to the findings, the vaccine was 93 percent effective after one dose in preventing mild cases of Covid-19, which involved only one coronavirus symptom rather than two or more.
Moderna released the results in a news release on Tuesday, but they have yet to be peer reviewed or published.
The vaccine was “generally well tolerated,” according to the company, and no significant safety concerns were discovered. Following the second dose, side effects included headache, fatigue, muscle pain, and chills. There was also some pain at the injection site.
Moderna says it will submit the findings to the US Food and Drug Administration in early June, along with a request for permission to use the vaccine in teenagers. It also intends to publish the findings in a peer-reviewed journal.
The Moderna vaccine is already approved for people over the age of 18. Following Moderna’s request for emergency use authorization of its vaccine for adolescents, the FDA will review the company’s data and, if necessary, consult its advisers. If the data is strong enough, the FDA will approve the vaccine for use in children and adolescents.
Earlier this month, the FDA expanded the emergency use authorization for Pfizer/Covid-19 BioNTech’s vaccine to include children aged 12 to 15. Previously, the vaccine had only been approved for people aged 16 and up.
Vaccine experts said the process was relatively simple because these vaccines have been used safely in adults. Pfizer made its decision without consulting the FDA’s Vaccines and Related Biological Products Advisory Committee. The Advisory Committee on Immunization Practices of the US Centers for Disease Control and Prevention met a few days later to recommend the use of Pfizer’s vaccines in adolescents.
Pfizer and Moderna are both testing their vaccines in younger children, ranging in age from 6 months to 11 years. The process will most likely take a little longer because those age groups may require different doses.
The director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, recently stated that vaccines for elementary school children will most likely not be available until the end of the year.