In a statement released on the day, the European regulator said that the Committee for Medicinal Products for Human Use (CHMP) will carry out an accelerated assessment of the data submitted by Moderna in their application.
PUBLISHED ON JUN 08, 2021 10:53 PM IST
The European Medicines Agency (EMA) on Tuesday said that the regulator has started assessment of the application for the usage of the Moderna Covid-19 vaccine on young adults between 12 and 17 years of age. The medical body also said that it would communicate the decision in July 2021, unless more data was required.
In a statement released on the day, the European regulator said that the Committee for Medicinal Products for Human Use (CHMP) will carry out an accelerated assessment of the data submitted by the vaccine maker in their application. “EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted in the application, including results from a large ongoing clinical study involving adolescents from 12 to 17 years of age. This study was carried out in accordance with the paediatric investigation plan (PIP) for COVID-19 Vaccine Moderna, which was agreed by EMA’s Paediatric Committee (PDCO),” it said.
EMA allows accelerated assessment of drugs that are of major interest for public health, especially medicines that are therapeutic innovations. The process would usually involve 150 evaluation days rather than the 210 days which is the norm otherwise.
The European Commission, which is the executive branch of the European Union (EU), will issue the decision to extend the use of the Moderna shot in young beneficiaries across the member states. “The CHMP’s opinion on extending the use of the vaccine, together with any requirements for further studies and additional safety monitoring, will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States,” the EMA further mentioned in its statement.
Moderna’s Covid-19 shot received a conditional marketing authorisation for usage within the EU earlier on January 6 and is currently authorised to be used in the immunisation of people above 18 years of age in the bloc. The vaccine is based on a new technology called the messenger RNA (mRNA) and administered in two doses.