Vacid-19 approved in India

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

Photographer: T. Narayan / Bloomberg

India 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 that is home to the second largest Covid-19 outbreak in the world.

The Minister of Information and Transmission, Prakash Javdekar, said that the footage of AstraZeneca being produced locally by The Serum Institute of India Ltd. – the world’s largest manufacturer of vaccines by volume – was approved on Friday.

“India is possibly the only country where four vaccine candidates are ready.” Javdekar said at the ruling Bharatiya Janata meeting on Saturday in New Delhi. “Yesterday, a vaccine was approved for emergency use, Covishield by Serum.”

The General Drug Controller of India has not yet formally announced approval. Serum has an agreement with AstraZeneca to launch at least one billion doses and has already made millions of injections. The move came just days after the UK regulator released the vaccine, which is expected to be distributed to Britain’s most vulnerable groups as of Monday.

Astra-Oxford Covid Shot wins first release with UK Nod

The approval means that India may start vaccinating its population of around 1.3 billion. This is a difficult task due to the country’s vast territory, limited infrastructure and uneven health networks. The South Asian nation already has more than 10.2 million confirmed infections and up to 149,000 deaths.

The AstraZeneca vaccine, which has the largest number of supply offers worldwide, has been identified as a vaccine more suitable for reaching people in remote areas of inland India than one developed by Pfizer Inc. and BioNTech SE are also being considered.

Cold warehouse

The Pfizer vaccine requires sub-zero conditions for transport and storage, while AstraZeneca can be stored in refrigerator temperatures and should also be cheaper.

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

Initial data from Astra and Oxford in November raised concerns about how much protection the vaccine would offer. The trials produced two different results from two dosing regimens. The partners said their vaccine was 90% effective when half a dose was administered before a full dose boost, and that two full doses showed 62% effectiveness.

Astra-Oxford vaccine study 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 how well it works in people over 55, among those most at risk of a pandemic. A trial in the United States that aims to evaluate the injection in 40,000 people is underway and should clarify some of these issues, with results expected in early 2021.

Local Doses

Human tests conducted by Serum in India have also been pursued by allegations of a volunteer who claimed serious side effects of the vaccine and is seeking compensation. Serum in Pune denied the allegations and said the volunteer’s illness had nothing to do with the injection.

Serum said half of any vaccine it produces will be in India, with 100 million doses made in December for the local inoculation campaign, CEO Adar Poonawalla said in an interview in November.

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

– With the help of Abhijit Roy Chowdhury and Santosh Kumar

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