Good News For India As Oxford Covid-19 Vaccine Likely To Become First To Get Nod For Emergency Use

CDSCO is waiting for the UK drug regulator for giving its nod to the Oxford vaccine, following which the expert committee will hold its meeting.

(Representative Image/ Getty)

New Delhi: As the drug makers are preparing for a possible vaccine rollout by January of 2021, the Indian drug regulator is looking forward to the UK based vaccine for giving the go green signal and according to sources, Oxford’s vaccine candidate which is being manufactured by the Pune-based Serum Institute may get the nod on emergency use authorization by next week. As per sources, the Central Drugs Standard Control Organization (CDSCO) is waiting for the UK drug regulator for giving its nod to the Oxford vaccine, following which the expert committee will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorization for the vaccine in India. Bharat Biotech’s vaccine candidate “Covaxin” may take some time in getting the emergency use approval as the vaccine is still in its third phase of trial and Pfizer is yet to make a presentation on submission for emergency use approval of its mRNA-based vaccine. "Going by this, Oxford vaccine 'Covishield' is likely to be the first to be rolled out in India," source as quoted by news agency PTI. According to the source, SII last week submitted some additional data required to the top drug regulator DCGI. With fears about the mutated virus that were detected in the UK, government officials claimed that there will be no impact on the efficacy of emerging vaccines that are being developed in India and other countries. Three Pharmaceutical Firms Are Seeking Emergency Authorization In India Till now, three vaccine candidates including Bharat Biotech, Serum Institute of India (SII), and Pfizer have applied to DCGI for getting emergency use authorization for their Covid-19 vaccines early this month. Deliberating upon the applications of the vaccine candidate, the subject expert committee (SEC) on Covid-19 of the CDSCO on December 9 had sought additional safety and efficacy data for Covid-19 vaccines of SII and Bharat Biotech. Apart from the applications of Bharat Biotech and SII, Pfizer was the first pharmaceutical firm to apply for emergency use authorization from the Indian government. But the application by the Indian arm of US pharmaceutical firm Pfizer was not taken up for deliberation as the company had sought more time for making a presentation before the committee. The Pfizer vaccine has already been approved by several countries including the UK, the US, and Bahrain. SII Asked To Submit Updated Safety Data The SEC after considering the SII’s application, has asked the firm to submit an updated safety data of phase 2 and 3 clinical trials in India, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK Medicines and Healthcare products Regulatory Agency (MHRA) for grant of EUA. As for Hyderabad-based Bharat Biotech, "after detailed deliberation, the committee recommended that the firm should present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration", the SEC had said. SII which is stationed in Pune is the world's largest vaccine manufacturer which has made a collaborated with the University of Oxford and AstraZeneca to manufacture the vaccine. As per reports, the company under the at-risk manufacturing and stockpiling license from the DCGI has manufactured more than 40 million doses of the vaccine.