UK nod to Oxford-AstraZeneca COVID-19 vaccine strengthens case for India approval

The UK government on December 30 approved the use of Oxford University-AstraZeneca COVID-19 vaccine after a "thorough analysis of the data by experts at the MHRA, which has concluded that the vaccine has met its strict standards of safety, quality and effectiveness".

The UK nod will strengthen the case for quick approval of the Serum Institute of India's emergency use authorisation application. SII is a partner of the Oxford University-AstraZeneca and is manufacturing the vaccine in India.

The subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), India's drug regulator, is likely to meet later on December 30 to take a possible decision on SII's application.

AstraZeneca said it would continue to work with regulatory authorities around the world to support their rolling reviews for emergency supply or conditional marketing authorisation. AstraZeneca is also seeking emergency-use listing from the World Health Organization (WHO) for a quick vaccine availability in low- and middle-income countries.

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Along with data from local clinical trials, drug regulators of emerging world like India generally take cues from their counterparts in the US, the UK, Europe and Japan before deciding on approvals.

Government officials and ministers have hinted at the possibility of the vaccine rollout in India as early as January first week.

Earlier this week, SII CEO Adar Poonawalla said the company had been adding 40-50 million doses every month and will be reaching a production capacity of about 300 million doses by July 2021.

Poonawalla said 50 percent of the vaccine supplies will go to India, and the rest will go to COVAX, the WHO's programmed to deliver COVID-19 vaccine to poorer countries. However, during the initial months, India would prioritise supplies.

Also read: Expect India to approve Oxford-AstraZeneca vaccine in next few days, says SII's Cyrus Poonawalla

The government is planning to vaccinate 300 million, or 23 percent of the population, in the first wave of vaccination. The first phase will target 10 million frontline health workers by February. In the second phase, 20 million frontline and essential workers would be administered the jab by March and in the third phase, 270 million people aged over 50 and with co-morbidities would be vaccinated by August.

VK Paul, NITI Aayog member and the head of the national expert group on vaccine administration for COVID-19, told media that the government had formed a committee to come out with guidelines on ascertaining the high-risk groups that need to be vaccinated. The government has also been conducting dry runs in four states.