India approves emergency use of AstraZeneca, Bharat Biotech vaccines

New Delhi, Jan 3 (efe-epa).- India on Sunday approved two coronavirus vaccines for emergency use, one developed by AstraZeneca and Oxford University, and the other by local pharma Bharat Biotech, moving a step closer to one of the world’s largest inoculation campaigns against the Covid-19 pandemic.

The head of India’s drugs regulator, Venugopal G. Somani, said the agency had given final approval to the vaccine candidates “for strict emergency” use after “careful examination” by the Central Drugs Standard Control Organisation.

Somani said the data on the clinical studies have proved that the vaccines were safe.

Covishield, the AstraZeneca-Oxford vaccine, is manufactured by Serum Institute, an Indian drugmaker, which is the world’s largest vaccine manufacturer in terms of volume and sales.

Britain was the first country to give emergency approval for the Oxford-AstraZeneca vaccine, followed by Argentina.

The country’s regulators are still considering giving approvals for the vaccine made by Pfizer and BioNTech, which has already been approved in the United States and Europe.

Indian Prime Minister Narendra Modi said it was a “proud” moment for the people of India.

“It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India. This shows the eagerness of our scientific community to fulfill the dream of an Aatmanirbhar Bharat (self-reliant India), at the root of which is care and compassion,” Modi tweeted.

“We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers and all corona warriors for the outstanding work done, that too in adverse circumstances. We will remain eternally grateful to them for saving many lives.”

India is the second-worst affected by the coronavirus after the United States, with over 10.3 million confirmed cases and 149,435 deaths. The rate of infection in the country has reduced significantly in the last few months from a mid-September peak.

The Indian government initially plans to vaccinate 300 million people by August 2021. These are mostly health care workers, front-line staff including police, and those considered vulnerable due to their age or other diseases.

The country has trained over 20,000 health workers to administer the vaccine, according to the federal health ministry.

The Serum Institute of India (SII) based in the western Indian city of Pune began production of the British vaccine months before gaining approval. The drug makes has accumulated some 100 million doses so far.

“All the risks (the Serum Institute of India) took with stockpiling the vaccine, have finally paid off. Covisheild, India’s first Covid-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks,” Serum president and owner Adar Poonawalla tweeted.

However, the decision to approve Covaxin, developed by Bharat Biotech, has drawn flak from public health watchdog All India Drug Action Network because its clinical trials are underway.

“AIDAN is shocked to learn of the SEC’s recommendation to grant REU approval to Bharat Biotech’s Covaxin in clinical trial mode and specially in the context of infection by mutant strains,” the watchdog said in a statement.

“Disturbingly, it appears that no efficacy data for the vaccine candidate were submitted from the Phase 3 trials that are ongoing and being conducted by Bharat Biotech and ICMR.”

The announcement to approve comes a day after India began a nationwide trial of its vaccination program on Saturday.

The first national trial conducted in 116 districts in the country was carried out by 96,000 vaccinators at 285 centers to test logistics, inventory management, and the effectiveness of the cold chain, which is vital for storing doses, the health ministry said.

The first phase of the plan will 10 million healthcare workers and 20 million frontline officials. EFE-EPA