Two vaccines against the coronavirus disease (Covid-19) have been approved for restricted emergency use in India, with the Drugs Controller General of India (DCGI), VG Somani announcing on Sunday that he had approved both Serum Institute of India (SII) Oxford-AstraZeneca and Bharat Biotech vaccines.
The drugs controller announced that he had accepted recommendations made by the subject expert committee (SEC) of Central Drugs Standard Control Organisation (CDSCO) on Friday and Saturday, to grant restricted emergency approval to both the vaccines.
Soon after the approval was announced, Prime Minister Narendra Modi put out three tweets congratulating the country and its scientists and innovators.
“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 Indian 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,” read the second tweet.
“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 final tweet.
The World Health Organisation (WHO) also welcomed the first emergency use authorisation given to Covid-19 vaccine in the WHO-South Asia Region.
The CDSCO subject expert committee consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.
For SII Oxford-AstraZeneca vaccine, Somani said, “After detailed deliberations, Subject Expert Committee 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.”
Pune based SII, which is manufacturing the Oxford-AstraZeneca Covid-19 vaccine and testing it 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 coronavirus vaccine (Covaxin) in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (Pune), from where they received the virus seed strains. The vaccine is developed on a vero cell platform, which has 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 1 and 2 trial results for publication in December.
Phase-I and Phase-II clinical trials were conducted on approximately 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 and 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 situations 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 the 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 the drugs controller’s approval to begin phase 3 clinical trials.
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