‘Ready for Deployment’: Adar Poonawala After Covishield, Covaxin Wins Limited Use Clearance
Two coronavirus disease (Covid-19) vaccines have been approved for emergency restricted use in India, and the Controller General of Drugs of India (DCGI), VG Somani announced on Sunday that it had approved both the Serum Institute of India ( SII) Oxford -AstraZeneca and Bharat Biotech vaccines.
The drug controller announced that it had accepted the recommendations made by the subject matter expert committee (SEC) of the Central Drug Standards Control Organization (CDSCO) on Friday and Saturday, to grant restricted emergency approval to both vaccinations
Shortly after the approval was announced, Prime Minister Narendra Modi posted three tweets congratulating the country and its scientists and innovators.
“A decisive turning point to strengthen an energetic fight! DCGI grants approval to the vaccines of @SerumInstIndia and @BharatBiotech accelerates the path to a healthier and Covid-free nation. Congratulations India. Congratulations to our hard working scientists and innovators, ”read their first tweet.
“All Indians would be proud that the two vaccines that have received emergency use approval are made in India! This shows the enthusiasm of our scientific community to fulfill the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion, ”the second tweet read.
“We reiterate our gratitude to the doctors, medical personnel, scientists, police personnel, sanitation workers and all the warriors of the crown for the excellent work done, also in adverse circumstances. We will be eternally grateful to them for saving many lives ”, reads his last tweet.
The World Health Organization (WHO) also welcomed the first emergency use authorization granted to the Covid-19 vaccine in the WHO South Asia Region.
The CDSCO subject matter expert committee is made up of experts in domain knowledge from the fields of pulmonology, immunology, microbiology, pharmacology, pediatrics, internal medicine, etc.
For the Oxford-AstraZeneca IBS vaccine, Somani said: “After detailed discussions, the Expert Committee on the matter recommended the granting of permission for restricted use in emergency situations subject to certain regulatory conditions. The clinical trial underway in the country by the firm will continue ”.
Also Read: WHO Welcomes India’s Decision To Approve Emergency Use Of Covid-19 Vaccines
Pune-based SII, which makes the Oxford-AstraZeneca Covid-19 vaccine and the trial in India, introduced a recombinant chimpanzee adenovirus (Covishield) vector vaccine that encodes the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca / Oxford University.
The firm presented safety, immunogenicity and efficacy data generated on 23,745 participants aged 18 years and over from clinical studies abroad.
“The overall efficacy of the vaccine was found to be 70.42%. Additionally, M / s Serum was granted permission to conduct a phase II / III clinical trial in 1600 participants in the country. The company also presented interim safety and immunogenicity data generated from this trial and the data was found to be comparable with data from overseas clinical studies, ”said Somani.
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Bharat Biotech has developed a full virion inactivated coronavirus vaccine (Covaxin) in collaboration with the Indian Council for Medical Research (ICMR) and the National Institute of Virology (Pune), from where they received the seed strains of the virus. The vaccine is developed on a vero cell platform, which has a well-established record of safety and efficacy in the country and worldwide.
The firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamsters, and has also performed challenge studies in non-human primates (Rhesus macaques) and hamsters.
The company had shared the data with CDSCO and also released the test results of phases 1 and 2 for publication in December.
Phase I and Phase II clinical trials were conducted in approximately 800 subjects, and the results have shown that the vaccine is safe and provides a robust immune response. Phase III efficacy trial started in India on 25,800 volunteers, and 22,500 participants have been vaccinated nationwide to date and the vaccine has been found to be safe based on currently available data, according to the drug controller .
“The committee of experts in the field has reviewed the data on safety and immunogenicity of the vaccine and recommended granting permission for restricted use in emergency situations of public interest as an abundant precaution, in clinical trial mode, to have more vaccination options , especially in case of infection by mutant strains. The clinical trial that the firm is carrying out in the country will continue, ”said Somani.
Minutes after the drug controller announced the granting of approval for the vaccines in India, SII Executive Director Adar Poonawalla tweeted that the vaccine was ready to ship in the next few weeks.
“Happy New Year everyone! All the risks that @SerumInstIndia took by storing the vaccine have finally paid off. Covishield, India’s first Covid-19 vaccine is approved, safe, effective and ready to roll out in next weeks, ”he tweeted.
Meanwhile, Cadila Healthcare’s Covid-19 vaccine, ZyCov-D, received drug controller approval to begin phase 3 clinical trials.