On Tuesday, Union health secretary Rajesh Bhushan said that two COVID-19 vaccines being developed in India have been given authorization for emergency use and the mass vaccination will start 10 days after this approval.
Rajesh Bhushan said, ‘’the vaccination drive in India will begin 10 days after two vaccines, the one manufacture by SII and Bharat Biotech’s Covaxin, received emergency use authorization”.
Two vaccines Covaxin developed by Hyderabad based Bharat Biotech with Indian Council of Medical Research (ICMR) and the National Institute of Virology. Covishield, a variant of Oxford AstraZeneca’s AZD1222 manufactured under license by Pune based Serum Institute of India, have received emergency use approval from India’s drug regulator.
Approval for a vaccine is mandatory for use it on large scale of population. Approval is only given after the New Drugs and Clinical Trial Rules, 2019 regulator is satisfied with the trial data on two basis, first is safety and second is immunogenicity.
India looks as it become the first country in South Asia to kick-start its mass vaccination drive in the coming days.
Both Bharat Biotech and the Serum Institute are required to submit data continuously for 15 days regarding safety, efficacy and overall immunogenicity from their clinical trials.
The data need to be submitted for next two months.
India reported the first confirmed case came in the state of Kerala on 30 January 2020. The affected person had a travel history from Wuhan, China.
Till date approximately 1,892,123 people have died so far and more than 10 million confirmed cases in 218 countries and it still continues. A new mutation of COVID -19 also found in the United Kingdom few weeks ago, India has suspended all flights to and from UK to prevent from spread of infection from new mutation.