The Indian drug regulator will most likely approve Oxford/AstraZeneca's coronavirus vaccine as soon as next week. This is contrary to earlier speculations that India will give go-ahead once the UK authorities approve the vaccine candidate for mass use.
The current development pertains to the fact that AstraZeneca-Oxford's partner Serum Institute of India has submitted additional data sought by the Drugs Controller General of India (DCGI).
Oxford-AstraZeneca's Covid-19 vaccine may get emergency use approval by next week, reported Reuters. If the DCGI gives a green signal to SII, India will be the first nation to approve the Oxford vaccine under emergency use authorisation.
Notably, the British health regulator Medicines and Healthcare products Regulatory Agency (MHRA) is still evaluating the data presented by Oxford-AstraZeneca for their vaccine candidate.
Pfizer India and Bharat Biotech have also applied for an emergency approval from the DCGI, and could also receive clearance as India plans the mass inoculation drive from January.
The Subject Expert Committee (SEC), a government panel tasked with vetting coronavirus vaccines, had earlier asked Bharat Biotech and SII to submit updated country-specific trial data of their vaccine candidates Covaxin and Covishield.
Serum Institute conducted clinical trials on two full doses of the Oxford vaccine, named Covishield. The company is presently conducting phase-3 trials of its experimental vaccine on 1,600 participants in India.
After the clearance, SII may sign a supply contract with the Centre, under which the price of the COVID-19 vaccine may be fixed at Rs 250 per dose, suggest reports.
Although there is not much clarity on the number of doses that would be secured from the Serum Institute, reports say around 60 million could be made available soon. The company is likely to have around 100 million doses for the government by January-February (2021) if the Centre chooses to procure them from it.
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