AMN / NEW DELHI
The Government is fast-tracking the emergency use approvals for foreign vaccines. This will expand the coverage of vaccination drive in the country. Health and Family Welfare Ministry has announced that it is accelerating the approval process for foreign vaccines that have been granted emergency use authorization by several foreign drug regulators like US Food and Drug Administration, European Medicines Agency and others.
National Expert Group on Vaccine Administration for COVID-19, NEGVAC has recommended that Covid vaccines which have been developed, manufactured, granted emergency approval for restricted use by several foreign drug regulators and listed in the World Health Organization’s emergency use listing may be granted emergency use approval in India.
In order to cut short the time-lag for approval of potential vaccine candidates the provision of clinical trials before being recommended by the drug regulator has been relaxed. NEGVAC has however mandated post approval bridging clinical trials in place of conduct of local clinical trial. It has also said that the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before the vaccine is rolled out for further immunization programmes within the country.
Vaccination is one of the important strategies adopted by the Centre to curb the spread of Covid pandemic in the country. This decision will facilitate quicker access to such foreign vaccines by India. It will also provide a fillip to vaccine manufacturing capacity and vaccine availability in the country.