The Drugs Control General of India on Monday recommended restricted emergency use authorization (EUA) to Corbevax, Biological E's Covid vaccine. The recommendation has been made for the age group 12 to 18 subject to certain conditions.
Corbevax is India's first indigenously developed RBD protein subunit vaccine. However, the government has still not taken a decision on vaccinating those aged below 15 years.
Corbevax has not been included in the country's vaccination drive. NITI Aayog member (Health) V K Paul at a press conference recently said that the additional need for vaccination and inclusion of population for vaccination is examined constantly.
The Drugs Controller General Of India (DCGI) has already approved Corbevax, which is India's first indigenously developed RBD protein sub-unit vaccine against COVID-19, for restricted use in an emergency situation in adults on December 28.
"The Subject Expert Committee (SEC) on COVID-19 of the CDSCO which deliberated on the application recommended granting restricted emergency use authorization to Biological E's Corbevax for the 12 to less than 18 years age group subject to certain conditions," a source said.
The recommendation has been sent to the DCGI for final approval.
"Based on the no-objection certificate, Biological E has initiated the clinical study in October 2021 and has evaluated the available safety and immunogenicity results of the ongoing phase 2/3 study which indicated that the vaccine is safe and immunogenic.
The Corbevax vaccine 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 COVID-19 vaccine in the country.
(With PTI Inputs)
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