Approval of Covid-19 vaccine in India

A vaccine delivery testing process in Delhi, India, on January 2nd.

Photographer: T. Narayan / Bloomberg

India has followed the UK and granted emergency approval for the coronavirus vaccine developed by AstraZeneca Plc and the Oxford University, the first step in its plan to inoculate citizens in the country hosting the world’s second-largest outbreak of Covid-19.

Information and Dissemination Minister Prakash Javdekar said AstraZeneca’s shooting was being produced locally by the Serum Institute of India Ltd., the world’s largest vaccine maker by volume, was approved on Friday.

“India is possibly the only country where four vaccine candidates are ready.” Javdekar said at the Bharatiya Janata party briefing that was held on Saturday in New Delhi. “An emergency vaccine, Serum’s Covishield, has been approved yesterday.”

India’s general drug controller has not yet formally announced approval. Serum has a deal with AstraZeneca to launch at least a billion doses and has already made millions of shots. The move came just days after the British regulator authorized the vaccine, which will be released on Monday to Britain’s most vulnerable groups.

Astra-Oxford Covid Shot gets first clearance with UK Nod

Approval means India may start vaccinating its population of about 1.3 billion people. This is a daunting task given the vast territory of the country, limited infrastructure and irregular health networks. The South Asian nation already has more 10.2 million confirmed infections and up to 149,000 deaths.

The AstraZeneca vaccine, which has more offers around the world, has been considered as a more suitable feature to reach people in remote areas of inland India than one developed by Pfizer Inc. and BioNTech SE are also being considered.

Refrigerated warehouse

The Pfizer vaccine requires less than zero conditions for transport and storage, while the AstraZeneca vaccine can be stored at refrigerator temperature and is also expected to be cheaper.

However, data from clinical trials indicate that Astra shooting may be less effective than Pfizer and another similar vaccine from Moderna Inc., which each showed 95% efficacy in the trials.

Initial data from Astra and Oxford in November raised concerns about the amount of protection the vaccine would offer. The trials produced two different results from two dosing regimens. Partners said their vaccine was 90% effective when a half dose was given before a full dose booster and that two full doses showed 62% effectiveness.

The study of the Astra-Oxford vaccine leaves key questions unanswered

While the test results published in The Lancet found that the vaccine is safe and effective, more analysis will be needed to see the proper functioning of people over 55, among people at highest risk of pandemic. A US trial aimed at assessing the shooting at 40,000 people is ongoing and should clarify some of these questions, with results expected in early 2021.

Local doses

Serum tests performed on humans in India have also been pursued by complaints from a volunteer who claimed serious side effects from the vaccine and is seeking compensation. Serum, based in Pune, has denied the allegations and said the volunteer’s illness has nothing to do with the shooting.

Serum has said half of the vaccines it produces will be kept in India, with 100 million doses manufactured in December for local inoculation, CEO Adar Poonawalla said in an interview in November.

The Astra vaccine accounts for more than 40% of supplies to low- and middle-income countries, based on agreements followed by research firm Airfinity Ltd. based in London.

– With the assistance of Abhijit Roy Chowdhury and Santosh Kumar

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