Moderna Inc (NASDAQ: MRNA) demonstrated the safety of its COVID-19 vaccine in adolescents.
The company conducted a phase 2/3 clinical trial of its COVID-19 vaccine in children aged between 12 and 17 years old in the US. According to the blood test results, the vaccine demonstrated an immune response on par with previous findings in adults.
Children are safe after the second dose
The initial observations showed that none of the adolescents administered with Moderna’s COVID-19 vaccine fell sick beginning 14 days after the second dose. According to the findings, four children administered a placebo tested positive for the coronavirus.
It also reviewed the working of the vaccine in kids after the first dose. The results showed Moderna’s COVID-19 vaccine is 93% effective in eliminating the mild cases of coronavirus involving just one symptom rather than two or more symptoms.
Children well tolerate Moderna COVID-19 vaccine
The results announced by Moderna on May 25, 2021, are yet to be peer-reviewed. According to a communiqué from Moderna, children administered its COVID-19 vaccine showed no safety issues. However, children experienced mild side effects like chills, muscle pain, fatigue, and headache after the second dose. They also experienced pain at the injection site.
Prepares to submit results to the US FDA in June
Moderna is preparing to submit its findings to the US FDA in June 2021 and request permission for use in adolescents. It will also seek peer review by submitting the data.
Moderna COVID-19 vaccine has already received approval for use in people aged 18 and above. The US FDA will review the data after receiving it from Moderna to consider for EUA (Emergency Use Authorization) in children. If the FDA feels that data is strong enough, it could grant permission for administration in children.
FDA granted EUA for Pfizer/BioNTech’s coronavirus vaccine for administering in children aged between 12 and 15 years in early May 2021. The agency already apprived this vaccine for use in adolescents aged 16 and above.
Moderna and Pfizer tested vaccines in children aged between 6 months and 11 years. They need to administer varying doses of the vaccine in these age groups and could take a little longer duration to read out the results.