India COVID-19 vaccine tracker: SII requests DCGI to alter clinical norms, Epygen Biotech enters vaccine race

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India COVID-19 vaccine tracker: SII requests DCGI to alter clinical norms, Epygen Biotech enters vaccine race
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  • There are about 42 vaccines under clinical evaluation around the world — of which three are from India.
  • Epygen Biotech has joined Bharat Biotech, Serum Institute of India, and Zydus Cadila in the race of developing a vaccine in India.
  • Serum Institute wants India’s drug regulator to change clinical norms for vaccine.
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India’s COVID-19 doubling rate has reduced to 70.4 days from 25.5 days earlier, according to the Ministry of Health and Family Welfare. Moreover, on October 15, India registered the lowest death toll in the last 79 days at 689.

“This indicates a substantial fall in the daily new cases and the consequent increase in time taken to double the total cases,” the ministry said on its official Twitter handle.

Several states in the country have decided to reopen cinema halls and schools in a graded manner. Further, millions of people are hoping to get a vaccine soon.

Scientists in the country are working round the clock to develop a vaccine. There are about 42 vaccines under clinical evaluation around the world — of which three are from India.

According to the World Health Organisation, any healthy person in the world will have to wait until 2022 to get vaccinated.

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Here are the latest developments
Epygen Biotech partners with US-based Dyadic to work on a potential COVID-19 vaccine
Epygen Biotech has joined Bharat Biotech, Serum Institute of India, and Zydus Cadila in the race of developing a vaccine in India. Epygen Biotech has partnered with US biotech Dyadic for a potential COVID-19 vaccine. Epygen and Dyadic plan to offer about 500 million doses of the affordable COVID-19 vaccine soon after the human trials end.

Dyadic has already developed a COVID-19 vaccine antigen which works efficiently in neutralising SARS CoV-2 virus in mice.

Serum Institute wants India’s drug regulator to change clinical norms for vaccine
Serum Institute of India (SII) — which is on track to unveil its COVID-19 vaccine — has proposed Drug Controller General of India to alter some of its clinical norms for developing a vaccine. SII wants to broaden the horizons of trials by including people from different age groups with health conditions.

SII is conducting phase III trials of Oxford-Astrazeneca’s COVID-19 vaccine across 17 sites in India. The Indian government expects SII to have phase III trial results by November-end or early-December.
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Bharat Biotech cut phase II trial size by half
Bharat Biotech, the Indian pharmaceutical developing Covaxin, has decided to cut phase II clinical trials by half. Bharat Biotech said it will be testing 380 volunteers instead of 750. The company will also reduce the number of sites accordingly.

According to CNBC, the move to reduce phase II trial size is aimed at speeding up the process of phase III trials and is likely to reduce the overall clinical trial duration.

The company has tied up with Indian Council of Medical Research to develop a coronavirus vaccine. It might publish results of phase II clinical trials by early November.

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