The European Medicines Agency on Friday approved the coronavirus vaccine developed by pharmaceutical company Moderna for children aged 12 to 17 years. The vaccine is already authorised for use in the European Union among beneficiaries aged 18 and above.
The medicine regulator said that a study conducted among 3,732 children in the 12-17 age group showed that Moderna’s Spikevax jab produced a similar antibody response as seen in young adults aged 18 to 25 years.
The most common side effects of the Spikevax vaccine in children were similar to those in adults, the European Medicines Agency said. The side effects include pain and swelling at the injection site, headache, nausea, vomiting and fever.
The Moderna vaccine now awaits formal approval from the European Commission, following which it would be allowed to roll out the shots for teenagers in European Union countries. The European Commission typically follows recommendations from the medicine regulator.
In May, Moderna had said that its vaccine was found to be safe and effective on children in the 12-17 age group. During the trial on the children, the researchers found out that the vaccine was 100% effective 14 days after receiving the second of the two-dose regimen.
In June, the Moderna vaccine received approval for restricted emergency use in India too. However, the vaccine will only be administered to adults in the country.
India’s drug regulator has not yet cleared any vaccine for children.
In an affidavit to the Delhi High Court earlier this month, the Centre said that clinical trials of coronavirus vaccines for children were almost complete. Additional Solicitor General Chetan Sharma submitted that pharmaceutical company Zydus Cadila has finished its vaccine trials for those aged between 12-18. The vaccine will be available for use among children in the near future once the statutory provisions are met, Sharma said.