NEW DELHI (BLOOMBERG, REUTERS) – The head of  India’s drugs regulator said on Sunday (Jan 3) he had given final approval for the emergency-use of two coronavirus vaccines, one developed by AstraZeneca and Oxford University and the other by local company Bharat Biotech.

The overall efficacy of the AstraZeneca-Oxford vaccine was 70.42 per cent, while Bharat Biotech’s Covaxin was “safe and provides a robust immune response”, Drugs Controller General of India V.G.  Somani said. 

The British-developed AstraZeneca-Oxford shot is being made locally by the Serum Institute of India, while Bharat Biotech has teamed up with the government-run Indian Council of Medical Research. 

“Vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situations,” Somani read out from a written statement at a press conference. 

Somani did not take questions.  

Prime Minister Narendra Modi welcomed the approvals.  “It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India!” he said on Twitter, calling it a sign of a “self-reliant” country.

Covaxin, which has yet to complete vital phase three trials, had been granted permission “for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains,” Somani 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 Monday (Jan 4).

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 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 remotes areas of India’s hinterlands than one developed by Pfizer and BioNTech, which is 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 Astra 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 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 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 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 US 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.

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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 Astra 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.

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