Oxford's, Bharat Biotech's Covid vaccines approved for restricted emergency use
New Delhi: India's drugs regulator on Sunday approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.
The Drugs Controller General of India (DCGI) granted the approval on the basis of recommendations by a COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
"After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and, accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situations," DCGI Dr V G Somani told the media here.
This clears the way for the roll out of at least two vaccines in India in the coming days.
"Serum and Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8 C," Somani said.
The Serum Institute of India, the world's largest vaccine manufacturer, has tied up 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 termed the approval a "decisive turning point" in India's fight against Coronavirus.
"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," he tweeted.
"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 Atma Nirbhar Bharat, at the root of which is care and compassion," he said in another tweet.
He also saluted the frontline workers who have been leading the country's fight against the virus.
Health Minister Harsh Vardhan termed it a "watershed moment in India's battle against Covid-19".
The World Health Organisation also welcomed the move, saying it will "help intensify and strengthen the fight against the pandemic in the region".
"The use of vaccines in prioritised populations, along with continued implementations of other public health measures and community participation will be important in reducing the impact of COVID-19," said Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region.
Serum Institute of India's CEO Adar Poonawalla tweeted: "COVISHIELD, India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks."
In his media statement, Somani also said Cadila Healthcare has been granted the permission to conduct the Phase III clinical trial of its vaccine candidate in India.
Pune-based SII's shot is 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 per cent," Somani said.
Further, Serum was granted permission to conduct Phase-2/3 clinical trials on 1,600 participants within the country, he said.
On Covaxin, Somani said: "Bharat Biotech has developed a Whole 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 Vero cell platform, which has a well established track record of safety and efficacy in the country & globally."
Meanwhile, Mexican authorities said they are studying the case of a 32-year-old female doctor who was hospitalised after receiving the Pfizer-BioNTech Covid-19 vaccine.
The doctor, whose name has not been released, was admitted to the intensive care unit of a public hospital in the northern state of Nuevo Leon after she experienced seizures, difficulty breathing and a skin rash.