Oxford-AstraZeneca, Bharat Biotech vaccines get restricted emergency use nod

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Home / India News / ‘Ready to roll-out’: Adar Poonawala after Covishield, Covaxin win limited use nod

Two coronavirus disease (Covid-19) vaccines were cleared for restricted emergency use in India on Sunday with Drugs Controller General of India (DCGI) VG Somani announcing that he had approved jabs by both Oxford-AstraZeneca (manufactured here by Serum Institute of India, or SII) and Bharat Biotech.

The drugs controller announced that he accepted recommendations made by the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Friday and Saturday to grant restricted emergency approval to both the vaccines.

Soon after, Prime Minister Narendra Modi put congratulated the country, scientists and innovators on Twitter.

“A decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and Covid-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators,” his first tweet said.

“It would make every India proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion,” he added.

“We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers and all corona warriors for the outstanding work done, that too in adverse circumstances. We will remain eternally grateful to them for saving many lives,” read his third and final tweet.

The World Health Organisation (WHO) also welcomed the first emergency use authorisation given to a Covid-19 vaccine in the WHO-South Asia Region.

For SII Oxford-AstraZeneca vaccine, Somani said, “After detailed deliberations Subject Expert Committee (SEC) has recommended for the grant of permission for restricted use in emergency situation subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue.”

The SEC consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.

Pune based SII, which is manufacturing the Oxford-AstraZeneca Covid-19 vaccine in India, presented a recombinant chimpanzee adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University.

The firm submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged 18 years or older from overseas clinical studies.

“The overall vaccine efficacy was found to be 70.42%. Further, M/s Serum was granted permission to conduct Phase-II/III clinical trial on 1600 participants within the country. The firm also submitted the interim safety and immunogenicity data generated from this trial and the data was found comparable with the data from the overseas clinical studies,” Somani said.

Bharat Biotech has developed a whole virion inactivated corona virus vaccine (Covaxin) in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (Pune), from where they received the virus seed strains. The vaccine is developed on vero cell platform, which has a well-established track record of safety and efficacy in the country and globally.

The firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters.

The company had shared the data with CDSCO, and also put out Phase I and Phase II trial results for publication in December.

Phase I and Phase II clinical trials were conducted in approx.800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase III efficacy trial was initiated in India in 25,800 volunteers; to date, 22,500 participants have been vaccinated across the country; and the vaccine has been found to be safe as per the data available currently, according to the drugs controller

“The Subject Expert Committee has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue,” said Somani.

Minutes after the drugs controller announced grant of approval for the vaccines in India, SII CEO Adar Poonawalla tweeted that the vaccine was ready to be shipped in coming weeks.

“Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. Covishield, India’s first Covid-19 vaccine is approved, safe effective, and ready to roll-out in the coming weeks,” he tweeted.

Meanwhile, Cadila Healthcare’s Covid-19 vaccine, ZyCov-D, received drugs controller’s approval to begin Phase III clinical trials.

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