After the clinical trials in March showed that its vaccine prevents serious illness – although it wasn’t particularly effective against infection – in children 6 months to under 6 years of age, Moderna submitted on Thursday a request to the Food and Drug Administration (FDA) for emergency use authorization for its COVID-19 vaccine in this age group.
Moderna’s COVID jab for children consists of two 25-microgram doses and has generated a strong immune response in this age group with 43.7% efficacy for children ages 6 months to 2 years and 37.5% in children ages 2 to 6.
The clinical trial data showed that no severe COVID-19 disease was observed in either age group with the majority of cases being mild, and so the drugmaker’s CEO Stéphane Bancel said last month he believes that mRNA-1273 will be able to safely protect these children against SARS-CoV-2.
That has been very important in the continued fight against COVID-19 since young children have been largely unprotected throughout the pandemic because those under 5 are the only group in the US ineligible to receive a Covid vaccine.
While Moderna’s and Johnson & Johnson’s jabs are only available to adults, the Pfizer-BioNTech is available to anyone as young as 5, so Moderna’s request has kicked off the long-awaited federal review process that could greenlight the first immunizations for the youngest Americans.
Moderna is also evaluating booster doses for children, including in this particular age group.
FDA is expected to make its final decision in June after it seeks the advice of the Vaccines and Related Biological Products Advisory Committee, its advisory committee.
Its authorization request for teens has been stalled for months over concerns of vaccine-induced rare heart inflammation side effects.