A subject expert committee of Drugs Controller General of India (DCGI) on 24th June recommended Emergency Use Authorisation (EUA) for Serum Institute of India’s (SII) Covovax vaccine for children aged between 7-11 years. The expert panel recommendation has been sent to the DCGI for final approval.
DGCI shall give final approval after reviewing the committee’s recommendation. India’s drug regulator had approved Covovax for restricted use in emergency situations in adults on December 28, 2021, and for the 12-17 age group with certain conditions on March 9.
What is Emergency Use Authorisation (EUA)?
Vaccines and medicines require approval from the regulatory authorities before they can be administered. In India, the regulatory authority is the Central Drugs Standard Control Organisation (CDSCO).
Approval is granted after an assessment of their safety and effectiveness, based on data from trials. Actually, approval from the regulator is required at every stage of the trial. This is a long process, designed to ensure that medicine or vaccine is absolutely safe and effective.
Covovax, 9th to receive WHO Emergency Use Listing
The Emergency Use Listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. EUL is crucial for countries that do not have an elaborate regulatory mechanism, in which case they can rely on the WHO endorsement.
On 17th December 2021, WHO had listed the 9th COVID-19 vaccine for emergency use with the aim to increase access to vaccination in lower-income countries. The vaccine, named Covovax produced by the Serum Institute of India under licence from Novavax, made the cut.
So far 11 COVID-19 Vaccines have WHO Emergency Use Listing. Visit theWHO website for a detailed description.
