The expert panel of India’s central drug authority on Monday recommended granting restricted Emergency Use Authorisation (EUA) to Biological E’s Covid-19 vaccine, Corbevax, which will be used to vaccinate teenagers aged from 12 to 18 years. The recommendation has been sent to the Drugs Controller General of India (DCGI) for final approval.
“The Subject Expert Committee (SEC) on Covid-19 of the CDSCO which deliberated on the application recommended granting restricted emergency use authorisation to Biological E’s Corbevax for the 12 to less than 18 years age group subject to certain conditions,” a source told PTI.
This approval is likely to significantly ramp up the government’s ongoing drive to vaccinate children between 15 and 18 years of age, and later for those between 12 and 14 years of age. This also comes at a time when schools across the country are opening up as Covid cases are seeing a considerable decline.
Biological E had sought the emergency use authorisation of Corbevax for the 12 to 18 years of age group on Sunday. Corbevax is India’s first indigenously developed RBD protein sub-unit vaccine against Covid-19. The Drugs Controller General of India had approved the vaccine for restricted use in adults on December 28, but it has not been incorporated in the country’s vaccine drive.
The Indian government is yet to take a decision on vaccinating those aged below 15 years. Dr N K Arora, Chairman of India’s Covid-19 Working Group of the National Technical Advisory Group on Immunisation, had recently said that vaccination for children aged between 12-14 years may start in March.
“Adolescents in this age group (15-18 years) have been actively participating in the inoculation process, and going by this pace of vaccination, the rest of the beneficiaries in the 15-18 age group are likely to be covered with the first dose by January-end and subsequently their second dose is expected to be done by February-end,” Arora had said.
NITI Aayog member (Health) V K Paul had also stated recently at a press conference that the additional need for vaccination and inclusion of other age groups for vaccination is being examined constantly.
Corbevax is administered through an intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees Celsius and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial pack. According to the Health Ministry, the company has conducted phase 1/2, 2/3 clinical trials of its vaccine in the country. Further, it has conducted a phase 3 active comparator clinical trial to evaluate superiority against the Covishield vaccine, it said.
Meanwhile, a News18.com report recently suggested that the Central Drugs Laboratory (CDL), India’s apex lab, has cleared stock of 6 crore Corbevax doses. The vaccine is currently being stockpiled by the manufacturing firm as the government is yet to decide its usage plan.
A member of the expert panel told News18.com that the use of the new vaccines is only possible as boosters or among children. “There is no need for boosting population right now as a South African study shows Omicron infection induces much higher antibodies or immune response in the human body apart from giving protection against Delta variant,” the official said.
(With PTI inputs)
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