Covid-19 vaccine approved in India

A test process for vaccine delivery in Delhi, India, on 2 January.

Photographer: T. Narayan / Bloomberg

India has followed the UK and approved the coronavirus vaccine developed by AstraZeneca Plc and the University of Oxford, the first step in its plan to vaccinate citizens in the country where the second largest Covid-19 outbreak in the world exists.

Information and Broadcasting Minister Prakash Javdekar said the AstraZeneca shot was manufactured locally by the Serum Institute of India Ltd. – the largest vaccine producer in the world by volume – was approved on Friday.

“India is possibly the only country where four vaccine candidates are ready.” Javdekar said during the briefing Bharatiya Janata Party in New Delhi on Saturday. “Yesterday, one vaccine was approved for emergency use, Serum’s Covishield.”

The Drug Control General of India has yet to formally announce the approval. Serum has an agreement with AstraZeneca to deliver at least one billion doses and has already made millions of shots. The move came days after the British regulator approved the vaccine, which will launch to Britain’s most vulnerable groups from Monday.

Astra-Oxford Covid Shot gets first clearance with British note

The approval means that India can start vaccinating its population of about 1.3 billion. This is a daunting task, given the country’s vast territory, limited infrastructure and clumsy health networks. The South Asian nation has more than 10.2 million confirmed infections and as many as 149,000 deaths.

AstraZeneca’s vaccine, which has the most offer offerings worldwide, has been tied as a more suitable shot to reach people in the remote areas of India’s interior than one developed by Pfizer Inc. and BioNTech SE which are also being considered.

Coldroom

Pfizer’s vaccine requires conditions for transport and storage, while AstraZeneca’s can be stored at refrigerator temperatures and will also be cheaper.

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

The initial data from Astra and Oxford in November expressed concern about how much protection the vaccine offers. The trials yielded two different results from two dosing regimens. The partners said their vaccine was 90% effective when half a dose was increased before a full dose, and that two full doses had an effectiveness of 62%.

Astra-Oxford vaccine study leaves key questions unanswered

While trial results published in The Lancet found that the vaccine is safe and effective, and more analysis will be needed to see how well it works in people over 55, among those at higher risk due to the pandemic. A US trial aimed at evaluating the shot at 40,000 people is underway and it should clear up some of these questions, with the outcome in early 2021.

Local doses

Human trials conducted by Serum in India have also been plagued by allegations from a volunteer who claimed serious side effects of the vaccine and is seeking compensation. Serum, based in Pune, denied the claims, saying the volunteer’s illness had nothing to do with the shot.

Serum said half of the vaccine it produces will remain in India, with 100 million doses produced for local vaccination in December, CEO Adar Poonawalla said in an interview in November.

The Astra vaccine accounts for more than 40% of the stock that goes to low- and middle-income countries, based on agreements reached by London-based research firm Airfinity Ltd.

– With the help of Abhijit Roy Chowdhury and Santosh Kumar

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