Covid-19 Vaccine in India Approved

A trial of vaccine administration 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 Oxford University, the first step in its plan to inoculate the country’s citizens hosting the world’s second outbreak of Covid-19.

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

“India is probably the only country where four vaccine candidates are being trained.” Javdekar said on Saturday in New Delhi, during the briefing of the Bharatiya Janata party. “An emergency vaccine, Serum’s Covishield, was approved yesterday.”

The Comptroller General of Drugs of India has not yet officially announced the approval. Serum has an agreement with AstraZeneca to launch at least one billion doses and has already taken millions of photos. The move came just days after the UK regulator approved the vaccine, which is set to be launched on Monday to the most vulnerable groups in the UK.

Astra-Oxford Covid Shot wins first release with UK Nod

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 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 most global supply, has been identified as a more appropriate blow to reach people in remote areas of the interior of India than one developed by Pfizer Inc. and BioNTech SE are also considered.

Cold storage

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

However, clinical trial data indicate that Astra shot may be less effective than Pfizer and another similar vaccine from Moderna Inc., which have each been shown to be 95% effective in studies.

Initial data from Astra and Oxford in November expressed concern about how much protection the vaccine would offer. The studies produced two different results from two dosing regimens. The partners said that their vaccine was 90% effective when given half a dose before a full dose booster and that two full doses showed 62% efficacy.

The Astra-Oxford vaccine study leaves key questions unanswered

While the results of the process published in The Lancet found that the vaccine is safe and effective, more tests will be needed to see how well it works in people over 55, among those at higher risk of pandemic. A US trial aimed at assessing the shooting at 40,000 people is underway and should clarify some of these questions, with expected results in early 2021.

Local doses

Tests performed by people in Serum in India have also been persevered by allegations of a volunteer who has suffered serious side effects from the vaccine and is seeking compensation. The Pune serum denied the allegations and said the volunteer’s illness had nothing to do with the shooting.

Serum said half of any vaccine it will produce will remain in India, with 100 million doses manufactured in December for local inoculation, executive director Adar Poonawalla said in a November interview.

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

– With the assistance of Abhijit Roy Chowdhury and Santosh Kumar

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