Bharat Biotech test vaccine approved for children over 12 years of age, Covishield over 18 years of age.
Bharat Biotech’s ‘COVAXIN’ anti-coronavirus vaccine has been authorized to perform its studies on children over 12 years of age, and the ‘Covishield‘ Serum vaccine has been approved for studies of children over 18 years of age. Both vaccines were approved on Sunday for administration.
The Drug Controller General of India approved Bharat Biotech’s anti-coronavirus vaccine “Covaxin,” obtained emergency authorization from the Central drug authority of India on Sunday, to perform their studies on children above the age of twelve years (DCGI).
Oxford-AstraZeneca ‘Covishied’ coronavirus vaccine, manufactured by the Pune-based Serum Institute of India (SII), which also obtained an emergency approval along with Bharat Biotech vaccine, has been authorized for children over the age of 18 years.
The permission for both vaccines, Covaxin Bharat and Covaxin Serum Institute, for limited use in emergency situations, has been given. The DCGi specified in a letter of permission that both vaccines are given in two doses.
India announced formally on Sunday that the anti-coronavirus vaccines Oxford-AstraZeneca and Bharat Biotech would be administered in two dosages each. VG Somani of DCGI said that both companies were given “restricted use” permission in emergencies.
DCGI approval was granted on the basis of a recommendation from the Central Drugs Quality Control Organization’s Topic Coronavirus Expert Committee (SEC) (CDSCO).
Following formal DCGI approval, concerns were asked about allowing Bharat Biotech’s coronavirus vaccine to be used in an emergency without Phase 3 testing. Congress asked the government to clarify why mandatory protocols and data verification were dispensed while warning of “dangerous” approval.
However, the DCGI claimed that it is “safe and gives a robust immune response” while announcing approval of the vaccine of Bharat Biotech. The Drug Regulator also said that no vaccine with even the least risk of safety was approved for use and confirmed that 110% of the vaccines were safe.
Later on Sunday night, the DCGI approved Bharat Biotech to develop Covaxin. The Drug Regulator has also required Bharat Biotech to send its clinical phase I, II, and Ill safety, efficacy, and immunogénicity data before trials are completed.
Bharat Biotech test vaccine approved for children over 12 years of age, Covishield over 18 years of age