India on Sunday approved Oxford COVID-19 vaccine Covishield and Covaxin for restricted emergency use, paving the way for the country to roll out the two vaccines soon. Covishield is manufactured by Serum Institute of India with ASraZeneca in a tieup, while Covaxin is indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Drugs Controller General of India (DCGI) gave the approval for restricted emergency use as recommended by a COVID-19 Subject Expert Committee 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.
Serum Institute of India's CEO Adar Poonawalla also said that Covishield has been approved, safe and effective.
"COVISHIELD, India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks," he tweeted.
Lauding the development, Prime Minister Narendra Modi termed the DCGI approval of Serum Institute of India and Bharat Biotech vaccines, a decisive turning point to strengthen a spirited fight against Corona.
"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," the prime minister tweeted.
In another tweet, the prime minister said the vaccines would make every Indian proud.
"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," he posted.
Modi said the nation would remain eternally grateful to all the Corona warriors.
“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,” the prime minister tweeted.
Meanwhile, Manipur Chief Minister N Biren Singh took to Twitter and congratulated PM Modi on the vaccine development.
"I join the nation in congratulating Hon'ble PM, Shri @narendramodi ji for delivering the promise on Covid-19 vaccine. PM Modi ji's phenomenal leadership in the fight against the pandemic make him the world most popular head of govt. Moment of pride for every Indian," he tweeted.
Biren also said that Modi's leadership will be remembered as one of the most defining moments in the history of Indian politics.
"India's fight against #COVID19 under the leadership of our Hon'ble PM @narendramodi ji will be remembered as one of the. The nation will be always indebted to PM Modi ji for his remarkable roles during the challenging time," Biren tweeted.
COVISHIELD vaccine
Somani said 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 1,00 participants within the country, he said. "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."
"The clinical trial ongoing within the country by the firm will continue," he said, adding permission has been granted to Cadila Healthcare to conduct the Phase III clinical trial of its vaccine candidate in India.
"In terms of safety, Covishield was well tolerated, is safe and can be used effectively for prevention of COVID-19 in the targeted population," the EUA application signed by Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs at Serum Institute of India (SII), had stated.
COVAXIN vaccine
"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," Dr Somani said.
In terms of safety concern, safety and immunogenicity data was generated in various animal species such as mice, rats, rabbits, Syrian hamster. Challenge studies were conducted on non-human primates (Rhesus macaques) and hamsters.
The Phase 1 and Phase 2 clinical trials in India were conducted on nearly 800 subjects. The results showed vaccine is safe and provides a robust immune response, he said.
The Phase 3 efficacy trial was initiated on 25,800 participants and till date, 22,500 of them have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date, Somani said.
"The SEC 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," he said.
