NEW DELHI (BLOOMBERG, REUTERS) - India has followed Britain and granted emergency approval for the coronavirus vaccine developed by AstraZeneca and the University 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 the Serum Institute of India - the world's largest vaccine maker by volume - was approved on Friday (Jan 1).
Experts at India's drugs regulators have also recommended another vaccine backed by a state-run institute.
The locally-produced vaccine, known as Covaxin, has been developed by Bharat Biotech and the government-run Indian Council of Medical Research. Citing sources, Reuters reported on Friday that the shot could be approved, though little is known about the results of its clinical trials.
"Grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains," the government cited the experts' recommendation for Covaxin, referring to the new strain of the virus first detected in Britain.
The government said the final decision on the two vaccines would be made by the chief of the Central Drugs Standards Control Organisation (CDSCO). That process is expected to be a formality given the urgency for a vaccine in the country with the highest number of Covid-19 infections in the world after the United States.
Javadekar told reporters earlier that two other vaccines were waiting to be approved - Zydus Cadila's ZyCoV-D and Russia's Sputnik V that are both on trial in India.
"India is perhaps the only country where four vaccines are getting ready," he said.
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 British regulator gave clearance to the vaccine, which is to roll out to Britain's most vulnerable groups from next Monday.
The approvals mean 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 than 10.2 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 remotest areas of India's hinterlands than one developed by Pfizer and BioNTech that's also being considered.
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 AstraZeneca shot may be less effective than Pfizer's and another similar vaccine from Moderna, which each showed 95 per cent efficacy in trials.
Initial data from AstraZeneca 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 per cent effective when a half-dose was given before a full-dose booster, and that two full doses showed an efficacy of 62 per cent.
While trial results published in The Lancet found the vaccine to be safe and effective, more analysis will be needed to see how well it works in people over 55, who are among those at higher risk from the pandemic.
A United States 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.
Human trials conducted by Serum in India have also been dogged by allegations 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 AstraZeneca vaccine accounts for more than 40 per cent of supplies going to low- and middle-income countries, based on agreements tracked by London-based research firm Airfinity.