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India grants emergency approval to AstraZeneca/Oxford, local vaccine


  3 Janvier      16        Santé (8662),

   

New Delhi, Jan. 3, (dpa/GNA) – India on Sunday authorized the emergency use of two Covid-19 vaccines, including one developed by Oxford University in partnership with AstraZeneca, paving the way for one of the world’s biggest immunization drives against the virus.
« After adequate examination, the Central Drugs Standard Control Organization has decided to accept the recommendations of the expert committee and accordingly, vaccines of Serum Institute of India and Bharat Biotech are being approved for restricted use in emergency situation, » Drugs Controller General of India VG Somani said.
Pune-based Serum Institute is making the Oxford vaccine, known as Covishield locally, for India and other markets.
Covaxin is India’s locally-made vaccine developed by Bharat Biotech with backing from the country’s top medical body, the Indian Council of Medical Research (ICMR).
“It is a matter of pride that the two vaccines that have been given emergency use approval are made in India. This shows the determination of our scientific community to fulfil the dream of Aatmanirbhar Bharat (Self-Reliant India) at the root of which is care and compassion for all,” Premier Narendra Modi said on Twitter.
They are the first vaccines to be approved for use in India, which will likely start one of the world’s largest vaccination drives in January. India is facing one of the worst outbreaks globally and is the second-most infected country after the United States.
Both vaccines will be administered in two doses, Somani said, even as he allayed fears over the vaccines.
While the Oxford vaccine, already approved by Britain and Argentina, is 70.4 per cent effective in preventing infections, no efficacy data is available for Bharat Biotech’s Covaxin which is still in phase 3 clinical trial mode.
« We’ll never approve anything if there is the slightest of safety concerns. The vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine, » Somani said.
India, with a population of 1.3 billion, plans to inoculate 300 million people in the first phase by July and the affordable Oxford vaccine is its biggest hope.
SII, the world’s biggest vaccine maker, has produced some 50 million doses and plans to scale it up to 100 million by March.
Sunday’s decision comes a day after India conducted a trial run of its vaccination drive, across all states, in which authorities tested everything from cold-chain infrastructure and delivery systems to storage platforms.
The expectation of an early roll-out has brought hope in a country where an inadequate health infrastructure has struggled to cope with the pandemic.
“It is an especially important decision, a red-letter day for India. The (roll-out) should happen very soon as the companies have been producing and stockpiling the vaccine,” ICMR head Balram Bhargava told broadcaster NDTV.
Health authorities have said they will focus on vaccinating a “critical mass” of people to break the chain of transmission of the pandemic that has infected more than 10.3 million people in the country and claimed 149,435 lives.
Federal Health Minister Harsh Vardhan has said 10 million healthcare workers and 20 million frontline staff including police will get free vaccine in the initial weeks of the roll-out.
GNA

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