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India Approves Oxford and Bharat Biotech Covid-19 Vaccines for Restricted Emergency Use | India News

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NEW DELHI: India’s drug regulator on Sunday approved the Oxford Covid-19 Covishield vaccine, made by the Serum Institute, and locally developed Bharat Biotech’s Covaxin for emergency restricted use in the country, paving the way for a campaign of massive inoculation.
The Comptroller General of Drugs of India (DCGI) granted approval based on the recommendations of a COVID-19 Subject Matter Experts Committee (SEC) of the Central Medicines Standards Control Organization (CDSCO).
“After proper review, the CDSCO has decided to accept the Expert Committee’s recommendations and consequently the M / s Serum and M / s Bharat Biotech vaccines are being approved for restricted use in emergency situations,” said the Dr. VG Somani from DCGI to the media here. .
This paves the way for the deployment of at least two vaccines in India in the coming days.
“The serum and Bharat Biotech vaccines should be given in two doses. All three vaccines should be stored at 2-8 ° C,” he said.
The Serum Institute of India, the world’s largest vaccine manufacturer, has partnered with AstraZeneca to manufacture Covishield, while Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Prime Minister Narendra Modi called the approval a decisive turning point in India’s fight against the coronavirus.
“DCGI grants approval to vaccines from @SerumInstIndia and @BharatBiotech accelerates the path to a healthier and COVID-free nation. Congratulations India. Congratulations to our hard-working scientists and innovators,” he tweeted.
“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, rooted in care and compassion, “he said in another tweet.
He also greeted frontline workers who have led the country’s fight against the virus.
Serum Institute of India Executive Director Adar Poonawalla tweeted: “Covishield, India’s first Covid-19 vaccine is approved, safe, effective and ready to roll out in the next few weeks.”
In his statement, Somani also said that Cadila Healthcare received permission to conduct the phase III clinical trial of its candidate vaccine in India.
The Pune-based IBS injection is a recombinant chimpanzee adenovirus (Covishield) vector vaccine, encoding the SARS-CoV-2 Spike (S) glycoprotein with transfer of technology from AstraZeneca / Oxford University.
“The firm presented safety, immunogenicity and efficacy data generated on 23,745 participants aged 18 years or older from overseas clinical studies. The overall efficacy of the vaccine was found to be 70.42 percent,” Somani said.
Additionally, Serum was granted permission to conduct phase 2/3 clinical trials on 1.00 participants within the country, he said. “The company also submitted interim safety and immunogenicity data generated from this trial and the data was found to be comparable with data from overseas clinical studies.”
“The clinical trial under way in the country by the firm will continue,” he said.
About Covaxin, Somani said: “Bharat Biotech has developed a full virion inactivated coronavirus vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on the platform of Vero cells have a well-established record of safety and efficacy in the country and around the world. ”
The firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamsters, and also conducted challenge studies in non-human primates (Rhesus macaques) and hamsters, he said.
All of this data has been shared by the firm with CDSCO, he said.
Phase 1 and Phase 2 clinical trials were conducted in about 800 subjects and the results have shown that the vaccine is safe and provides a robust immune response, he said.
The phase 3 efficacy trial started in India with 25,800 volunteers, and to date, approximately 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe based on data available to date, Somani said. .
“The SEC has reviewed the data on the 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 underway in the country by the firm will continue, “he said.
SII had applied to DCGI USA for the Oxford Covid-19 vaccine on December 6, while Hyderabad-based Bharat Biotech had applied for the go-ahead for its Covaxin on December 7.
“In terms of safety, Covishield was well tolerated … most of the requested reactions were mild in severity and resolved without sequelae. Covishield is therefore safe and can be used effectively for the prevention of COVID-19 in the target population, “said the US application signed by Prakash Kumar Singh, Additional Director of Governance and Regulatory Affairs at the Serum Institute of India (SII), had stated.
Pfizer had also applied for regulatory approval for its vaccine on December 4, but little progress has been made after that.

Times of India

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