The Indian Regulatory Authority will make the final approval decision Covaxin for minors, after examining the recently obtained “extensive additional data” on side effects after immunization reported in pediatric clinical trials of the vaccine, Indian express learned.
Government sources told The Indian Express that the Comptroller General of Medicines of India (DCGI) has requested additional information on two specific areas of pediatric covaxin trials: number of children and age groups by age; and what side effects after immunization were among these groups. In response, Bharat Biotech “recently” submitted the bulk data to the drug regulator, the sources said.
On October 12, DCGI received a recommendation from a subject review committee to grant emergency use of a vaccine manufactured by Bharat Biotech for the age group 2-18.
“The information is very voluminous. The regulatory body studies and researches it scientifically. Thereafter, the regulator will make the final decision to grant the EUA for Covaxin Bharat Biotech for the 2-18 age group, ”said one source. The National Technical Advisory Group on Immunization (NTAGI) will advise the government on the use of covaxin in minors as part of a national immunization campaign only after the drug regulator makes a final decision, the sources said.
NTAGI is an advisory body for immunization. It provides government vaccination advice through technical reviews of scientific evidence on immunization-related issues. The Emergency Use Permit issued by the Subject Expert Committee is one of the world’s first expert approvals for COVID-19 vaccine for the age group 2-18 years.
However, unlike other Covid-19 vaccine approvals, the regulatory body did not immediately approve Covaxin based on the recommendation. Instead, he is independently conducting detailed studies of pediatric research data on covaxin. “Scientific bodies will not rush the process. The last call should be treated with extreme caution and caution, ”the source said.
Parallel to this, NTAGI’s permanent technical subcommittee, sources said, is in its final stages to recommend “if and when vaccination of children is rolled out, should it be age-based or should it be assessed. on the basis of concomitant diseases “.
NTAGI is in the final stages of its discussions to recommend Zydus Cadila’s three-dose Covid-19 vaccine for minors. Sources said that in addition to discussing childhood vaccinations, the NTAGI subcommittee is also exploring two other issues: the need for a booster dose; and mixing vaccines.