Neurological

Moderna COVID-19 Vaccine Safe, Effective in Adolescents

In the TeenCOVE phase 2/3 study, the immune response in adolescents given the Moderna COVID-19 vaccine (mRNA-1273) was not inferior to an adult control group.

The TeenCOVE Study (ClinicalTrials.gov: NCT04649151) enrolled over 3,700 American adolescents aged 12 to under 18 years. Patients were randomly assigned 2: 1 to receive two 100 µg doses of the Moderna COVID-19 vaccine 28 days apart or a placebo. The primary endpoint was non-inferior immunogenicity based on a comparison of the geometric mean of serum neutralizing antibodies in the Phase 3 adult COVE study (ClinicalTrials.gov: NCT04470427).

The results indicated that the study was meeting its primary immunogenicity endpoint. 100% effectiveness of the vaccine was observed 14 days after the second dose; No cases of COVID-19 were reported in the vaccine group compared to 4 cases in the placebo group. Because the incidence of COVID-19 is lower in adolescents, the study also included a secondary case definition that included cases with milder symptoms. Using this definition (1 COVID-19 symptom and one SARS-CoV-2 RT-PCR test positive), vaccine efficacy of 93% has been reported in seronegative participants from 14 days after the first dose.

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The most common side effects seen after the second dose of vaccine were headache, tiredness, muscle pain and chills. According to the company, participants will be monitored for 12 months after their second dose to assess long-term protection and safety; To date, no significant safety concerns have been identified.

“It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We will submit these results to the US FDA and regulatory agencies around the world in early June and apply for approval.”

reference

Moderna announces that the TeenCOVE study of its COVID-19 vaccine in adolescents is meeting the primary endpoint and plans to submit data to regulators in early June. [press release]. Cambridge, MA: Moderna, Inc .; 05/25/2021.

This article originally appeared on MPR

Subjects:

COVID19 COVID19 Vaccine General Infectious Diseases Pediatric Neurology

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