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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.