India Grants Emergency Approval to Astra-Oxford Covid-19 Vaccine

India has followed the U.K. and granted emergency approval for the coronavirus vaccine developed byAstraZeneca Plc and theUniversity of Oxford, the first step in its plan to inoculate citizens in the country that’s home to the world’s second-largest Covid-19 outbreak.

Information and Broadcasting Minister Prakash Javdekar said the AstraZeneca shot being produced locally by theSerum Institute of India Ltd. — the world’s largest vaccine maker by volume — was approved Friday.

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

The Drugs Controller General of India has yet to formally announce the approval. Serum has an agreement with AstraZeneca to roll out at least one billion doses and has already made millions of shots. The move came just days after the U.K. regulator gave clearance to the vaccine, which is to roll out to Britain’s most vulnerable groups from Monday.

The approval means India can begin to vaccinate its population of about 1.3 billion. That’s a daunting task given the country’s vast territory, limited infrastructure and patchy health networks. The South Asian nation already has more than10.2 million confirmed infections and as many as 149,000 deaths.

AstraZeneca’s vaccine, which has the most supply deals globally, has been pegged as a more suitable shot for reaching people in the remotes areas of India’s hinterlands than one developed byPfizer Inc. and BioNTech SE that’s also being considered.

Cold Storage

Pfizer’s vaccine requires subzero conditions for transportation and storage, while AstraZeneca’s can be stored at refrigerator temperatures and is also expected to be cheaper.

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

Initial data from Astra and Oxford in November raised concern over 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 a half-dose was given before a full-dose booster, and that two full doses showed an efficacy of 62%.

While trial resultspublished in The Lancet found the vaccine is safe and effective, more analysis will be needed to see how well it works in people over 55, among those at higher risk from the pandemic. A U.S. trial that aims to evaluate the shot in 40,000 people is ongoing and should clarify some of these questions, with results expected early in 2021.

Local Doses

Human trials conducted by Serum in India have also been dogged byallegations from a volunteer who claimed serious side effects from the vaccine and is seeking compensation. Pune-based Serum has denied the claims and said the volunteer’s illness had nothing to do with the shot.

Serum has said half of any vaccine it produces will stay in India, with 100 million doses manufactured in December for the local inoculation drive, Chief Executive Officer Adar Poonawalla 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 tracked by London-based research firm Airfinity Ltd.

— With assistance by Abhijit Roy Chowdhury, and Santosh Kumar

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