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India has approved AstraZeneca’s Covid-19 jab for emergency use, despite trials showing it is 62% effective with two full injections. AstraZeneca claims to have discovered a new “winning formula”, but has yet to reveal it.
Indian Information Minister Prakash Javadekar announced on Saturday that the coronavirus vaccine, designed by Anglo-Swedish drugmaker AstraZeneca in collaboration with the University of Oxford, had been approved by regulators a day longer. early for emergency use. The official approval of India’s Comptroller General of Medicines is expected in the coming days.
The news came as India passed its 10 millionth case of Covid-19 and neared 150,000 deaths.
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The vaccine, which will be manufactured locally by the Serum Institute of India, was approved for use in the UK on Tuesday. However, its rollout has been marred by confusing data on the effectiveness of the coronavirus vaccine depending on the dosage used, contained in a peer-reviewed study published in the medical journal The Lancet last month.
The majority of AstraZeneca trial candidates received two full doses of the vaccine, and for those the vaccine was 62% effective – a number significantly lower than those of these rival vaccines. However, a smaller subgroup mistakenly received a half dose, followed by a full dose – and among these patients, a 90 percent efficacy rate was reported. Together, the efficacy of the vaccine was evaluated at 70.4%. Just over 2,700 participants received the lowest dose, and no one in this test group was over 55.
Notably, the Serum Institute had requested a full two-dose regimen, which trials have shown an efficacy of 62%. India’s Central Medicines Standards Control Organization (CDSCO) is expected to announce details in the coming days.
US regulators hesitated over the disparity in results, and AstraZeneca CEO Pascal Soriot has promised another global trial. Last week he told the Sunday Times his company discovered a “Winning formula” that after two doses, “Is up there with everyone.”
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However, Soriot did not reveal any additional details about this formula, claiming only that AstraZeneca would release it. “At one point.”
Unlike Pfizer’s mRNA vaccine, the first of its kind to be licensed, AstraZeneca’s vaccine is based on a genetically engineered cold virus – a version of a chimpanzee adenovirus – making it cheaper to produce and easier to store. under normal refrigeration. This facilitates distribution in less developed countries.
Indian regulators are currently weighing three additional vaccine candidates, including Russian Sputnik V. Like AstraZeneca’s offering, Sputnik V is relatively inexpensive and uses proven technology. Unlike AstraZeneca’s shot, clinical trials have shown Sputnik V to be 91.4% effective against Covid-19, and it is based on a well-studied human adenoviral vector platform. Prior to the approval, the Russian Direct Investment Fund (RDIF) and Indian generic pharmaceutical company Hetero agreed in November to produce more than 100 million doses of Sputnik V per year on Indian soil.
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Russian makers of Sputnik V also announced last month that they would partner with AstraZeneca to study the possibility of using both vaccines in a single vaccination schedule. Its manufacturers say they are currently working on trials to push the efficacy of the AstraZeneca vaccine above 90%.
The Indian regulator recommends approval of the full dosing regimen of the AstraZeneca vaccine with 62.1% efficacy based on phase 3 clinical data. Sputnik V is working on clinical trials with AZ to increase the efficacy of the AZ vaccine to more than 90% .https: //t.co/kt7qRHCsCS
– Sputnik V (@sputnikvaccine) January 2, 2021
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