With news of Dr. Reddy's applying for accelerated approval of 'Sputnik V' vaccine, here is a quick summary of the potential candidate:
✅ Vaccine platform: Viral vector technology using Adenovirus as the vector. Covishield uses the same platform, but there is a difference.
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✅ Sputnik V uses 2 different variants of the human adenovirus for the 1st and 2nd dose, unlike Covishield where both doses use the same variant of a chimpanzee adenovirus.
✅ Who is developing this vaccine? Gamaleya Research Institute, Russia.
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✅ Has the vaccine got approval in other countries? Russia stirred critical discussions when use of Sputnik V was authorized in Russia before completion of trials. Subsequently Phase 3 interim results have been published.
20+ countries have given emergency approval.
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✅ What is the efficacy of the vaccine? Interim results of Phase 3 trials published in The Lancet, puts the efficacy at 91.6%.
More importantly, 100% efficacy noted for severe cases.
Important fineprint regarding the efficacy data:
➡️ Asymptomatic cases not considered.
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➡️ Efficacy analysis done 21 days after 1st dose. In effect, the 91.6% efficacy is for a single dose and 21 days after the 1st dose.
➡️ High efficacy of 91.8% noted in those above 60.
➡️ Efficacy of 73% noted for cases reported ANY TIME after 1st dose.
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➡️ The graph compares reported cases across vaccine and placebo groups over time. Cases were similar between the 2 groups till about 16 days from 1st dose. But post that, cases drastically dropped in the vaccine arm group. Pointing to an effective response under 20 days.
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✅ Other properties: Stored between 2 to 8C.
Administration route: Intramuscular.
Number of doses: 2 doses administered 21 days apart.
✅ Is any trial conducted in India? Bridging trial with 1500 participants is in advanced stage in India. Overseen by Dr. Reddy's in India.
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✅ Will the vaccine be manufactured in India?
Russian Direct Investment Fund (RDIF) talked about deals with 3 to 4 Indian players for manufacturing Sputnik V. Names floated include Hetero Biopharma and Virchow Biotech.
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✅ Interesting tidbit: AstraZeneca did announce trials to combine Oxford vaccine and Sputnik V, with the aim to boost the efficacy of the Oxford vaccine. Trial started in Azerbaijan.
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