After long deliberations, the Central Drugs Standard Control Organisation (CDSCO) recommended granting emergency use authorisation for the Oxford COVID-19 vaccine Covishield, being manufactured by Serum Institute of India (SII).
The vaccine was earlier approved by the United Kingdom, and their immunogenicity data was a major point of consideration for the CDSCO which convened a meet on January 1.
The Centre had two primary candidates in mind—the Pune-based Serum Institute of India (SII) for the Oxford COVID-19 vaccine, and Bharat Biotech's 'Covaxin'. The process of granting emergency use approval for Bharat Biotech's COVID-19 vaccine 'Covaxin' may take time as its phase 3 trials are still underway, while Pfizer is yet to make a presentation.
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Pfizer India was first pharmaceutical firm to apply for vaccine clearance in India, after its parent company secured such clearance in the UK and Bahrain. The firm, in its application submitted to the drug regulator, has sought permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019. Pfizer claims to offer up to 95 per cent protection against COVID-19.
SII had applied to the Drugs Controller General of India (DCGI) for EUA for Oxford COVID-19 vaccine on December 6, while the Hyderabad-based Bharat Biotech had sought the nod for its indigenously developed Covaxin on December 7. Pfizer had applied for regulatory approval for its vaccine on December 4.
The Oxford vaccine was found to have had an average efficacy of 70.4 per cent—with a double-dose regime generating efficacy of just 62 per cent while those who received a half-dose regime had a 90 per cent efficacy.
The CEO of AstraZeneca, the British-Swedish firm co-developing a coronavirus vaccine with Oxford University, had claimed the Covishield vaccine will protect 95 per cent of patients and that it is as effective as the Pfizer and Moderna alternatives. CEO Pascal Soriot made the claim to the Sunday Times, saying scientists had figured out a “winning formula to get efficacy up there with everybody else”.
While the Oxford vaccine was long considered a front-runner among COVID-19 vaccines, it was the vaccines by Pfizer/BioNTech and Moderna that were approved and deployed first, with Pfizer’s vaccine already in circulation in the US and Europe.
However, the Oxford vaccine requires less refrigeration and is less expensive, making it a target candidate for developing countries, with three billion doses expected to be made ready by next year.
