India has approved AstraZeneca’s Covid-19 sample for emergency use, despite trials showing it is 62 per cent with two full shots. AstraZeneca claims to have discovered a new ‘winning formula’, but has not yet announced it.
Indian Information Minister Prakash Javadekar announced on Saturday that the coronavirus vaccine, designed by British-Swedish drugmaker AstraZeneca in collaboration with the University of Oxford, had been approved by regulators a day earlier for emergency use. Formal approval by the Drug Control General of India is expected in the coming days.
The news came as India surpassed its 10 millionth case of Covid-19, approaching 150,000 deaths.
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The vaccine, which will be made locally by the Serum Institute of India, was approved for use in the UK on Tuesday. However, its deployment has been hampered by confusing data on the effectiveness of the coronavirus vaccine, depending on the dose used, contained in a peer-reviewed study published last month in The Lancet medical journal.
A majority of the candidates in the AstraZeneca trial received two full doses of the vaccine, and for those, the jab was 62 percent effective – a number that was significantly lower than what competing vaccines showed. However, a smaller subgroup incorrectly received half a dose, followed by a full dose – and among these patients, an efficacy rate of 90 percent was reported. The efficacy of the vaccine was combined at 70.4 percent. Just over 2700 participants received the lower dose, and no one in this test group was older than 55.
The Serum Institute in particular applied for a two-dose dosing regimen, which according to the trials was 62 percent effective. The Indian Central Drug Standards Control Organization (CDSCO) is expected to announce in the coming days.
U.S. regulators have balanced on the divergent results, and Pascal Soriot, CEO of AstraZeneca, has promised a new global trial. Last week, he told the Sunday Times that his company had a “Winning formula” that, after two doses, “Is up there with everyone else.”
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However, Soriot did not disclose any further details about this formula and only said that AstraZeneca would publish it. “at some point.”
Unlike Pfizer’s mRNA vaccine, the first of its kind ever approved, the AstraZeneca uptake is based on a genetically modified cold virus – a version of a chimpanzee adenovirus – which makes it cheaper to produce and easier to store under normal refrigeration. This makes distribution in less developed countries easier.
Indian regulators currently weigh three additional vaccine candidates, including the Russian Sputnik V. Just like the offering of AstraZeneca, Sputnik V is relatively inexpensive and uses proven technology. In contrast to the AstraZeneca survey, clinical trials found that Sputnik V was 91.4 percent effective against Covid-19, and it is based on a well-studied human adenoviral vector-based platform. Prior to the approval, the Russian Direct Investment Fund (RDIF) and the 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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The Russian manufacturers of Sputnik V also announced last month that they would work with AstraZeneca to investigate the possibility of using both vaccines in a single vaccination regimen. The manufacturers say they are currently experimenting with pushing AstraZeneca vaccine efficiencies above 90 percent.
The Indian regulator recommends that the full dose of AstraZeneca vaccine be approved with an efficacy of 62.1%, based on Phase 3 clinical data. Sputnik V is working on clinical trials with AZ to increase the efficacy of AZ vaccine to more than 90%. Https://t.co/kt7qRHCsCS
– Sputnik V (@sputnikvaccine) 2 January 2021
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