DCGI Has Not Yet Approved Covaxin for Children
A drug expert panel of CDSCO has recommended that the vaccine be approved, but the DCGI is yet to decide
The Subject Expert Committee (SEC) of India's drug regulatory body Central Drugs Standard Control Organisation (CDSCO) has, on October 12, 2021, recommended that the Drugs Controller General of India (DCGI) can grant emergency use authorisation (EUA) to Hyderabad-based Bharat Biotech's Covaxin for children and adolescents in the age group of 2-18 years.
Several politicians and news publications have been quick to claim that the vaccine has received the final approval, which is misleading.
Bharatiya Janata Party's (BJP's) National General Secretary BL Santosh tweeted, "COVAXIN vaccine approved for children aged 2-18. Another milestone in handling COVID-19. Well done scientists."
Union Minister for Tribal Affairs and former chief minister of Jharkhand Arjun Munda credited Prime Minister Narendra Modi and said, "For children aged 2-18 COVAXIN Vaccine Approved. Another milestone in tackling the scientists and Hon'ble Prime Minister Mr. Narendra Modi Thank you sir."
Shortly after these claims, Union Minister of State for Health and Family Welfare Dr Bharati Pravin Pawar told ANI that it's a confusion and DCGI hasn't approved Covaxin for children yet. "The evaluation is still going on. There is some confusion & the talks are underway with the experts' committee. Till now Drugs Controller General of India (DCGI) hasn't approved it," she said.
The SEC deliberated on Bharat Biotech's application on October 11, 2021 and PTI reported that the panel noted that interim safety data of the phase 2/3 clinical trial was reviewed in a meeting on August 26. After detailed deliberation, it recommended that market authorisation be granted to the vaccine for the age group of 2-18 years "for restricted use in emergency situations subject to certain conditions".
The SEC has reportedly recommended that Bharat Biotech should continue studying the vaccine according to the approved clinical trial protocol, provide updated prescribing information/package insert and submit safety data as per the New Drugs and Clinical Trial Rules 2019.
In January 2015, the DCGI approved the formation of 25 SECs to aid the office of the CDSCO in decision making. This means that the decision is yet to be made.
To put it in context, the SEC on January 2, 2021 had similarly recommended the restricted emergency use of COVID-19 vaccine of Serum Institute of India (SII) and Bharat Biotech and the Phase 3 clinical trial of Cadila Healthcare Ltd to the DCGI. The DCGI, after a thorough examination, had approved the request only the next day.
"After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to M/s Cadila Healthcare for conduct of the Phase III clinical trial," DCGI's press statement on January 3, 2021 read.
FactChecker tried contacting BL Santosh for clarification via calls and text but had not received a response by the time this article was published.
Once approved, Covaxin will be the second COVID-19 vaccine to be approved for children in India. The regulatory body had, in August 2021, approved ZyCoV-D for children aged 12 and above. However, the rollout is yet to begin.