The Central Drugs Standard Control Organisation(CDSCO) expert panel recommended the grant of permission for restricted emergency use of Oxford Covid-19 vaccine Covishield in India. The vaccine was further sent for approval to the regulator Drugs Controller General of India (DCGI). The Oxford-AstraZeneca vaccine, Covishield, has been developed in collaboration with Serum Institue of India (SII).
The decision would pave the way for the vaccine’s rollout in the world’s second-most populous country which, after the United States, has the highest number of Covid-19 infections in the world. Britain and Argentina have already authorised the vaccine for urgent public use. AstraZeneca-Oxford University’s Covid-19 vaccine candidate has a better immune response when a two full-dose regime is used rather than a full-dose followed by a half-dose booster, the university said on Thursday, citing data from early trials.
Earlier this month, the expert committee had sought more data on the safety and efficacy of COVID-19 vaccine candidates after deliberating on the company’s application that sought emergency use authorisation of the sots. Apart from the Serum Institute of India, Bharat Biotech had also approached the CDSCO for emergency use authorisation. While considering the application submitted by Serum Institute of India, the committee had recommended that the firm should provide safety data of phases 2 and 3 clinical trials in the updated applications. The committed had also sought immunogenicity data from the clinical trial in India as well as in the United Kingdom along with the outcome of the assessments made by the MHRA.
The Indian government said Pfizer had sought more time to present data for emergency authorisation of a vaccine it has developed with Germany’s BioNTech. Indian health authorities expect to start a vaccination drive for some 300 million people early next month.
