The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an update to the conditional marketing authorization (CMA) to include Moderna’s 50µg booster dose of Covid-19 vaccine, Spikevax, for usage in adolescents aged 12 to 17 years.
According to the recommendation, the booster shot is indicated for use in people of this age group a minimum of three months after they receive the initial vaccine regimen.
The positive opinion from the committee is based on scientific data submitted by the company, including complete safety findings.
Administering the 50µg booster dose a minimum of three months after the primary series is predicted to significantly boost the immune responses against the SARS-CoV-2 virus’ variants of concern, including Omicron, versus pre-boost levels.
Moderna CEO Stéphane Bancel said: “The recommendation to authorise the use of a booster dose of Spikevax in adolescents ages 12-17 is an important step to continue to protect this age group from Covid-19 and the emergence of new variants of concern.
“We are grateful to the CHMP for their comprehensive review of our submission and look forward to an authorisation decision from the European Commission.”
Spikevax received CMA from the European Commission after EMA recommendation and is intended for active immunisation to prevent Covid-19 in people aged six years and above.
In June, the company signed an agreement with the European Commission to amend previously agreed contractual supply schedules for the former’s Covid-19 vaccine booster product or updated booster vaccine candidate.
With this amendment, participating member States can obtain the booster vaccines later this year or earlier next year rather than the previous supply schedule in the second quarter.