DCGI grants ‘restricted use’ permission to two vaccines
India’s wait for the coronavirus vaccines ended on Sunday as the country’s regulator approved two vaccines, Serum Institute’s Covishield and Bharat Biotech’s Covaxin, for “restricted emergency use” in the country.
The green signal from the Drugs Controller General of India (DCGI) was given on the basis of recommendations submitted 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 said at a press conference in New Delhi.
“Serum and Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8 degrees Celsius,” he said.
The decision paves the way for at least two vaccines in the country in the near future.
Prime Minister Narendra Modi, reacting to the move, said that it will “make every Indian proud”, and congratulated the country and its scientists and innovators.
A decisive turning point to strengthen a spirited fight!— Narendra Modi (@narendramodi) January 3, 2021
DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation.
Congratulations to our hardworking scientists and innovators.
“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,” Modi tweeted.
He thanked the frontline workers for their relentless work.
“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 PM said in another tweet.
Serum Institute of India's CEO Adar Poonawalla tweeted, “Happy new year, everyone! All the risks Serum Institute of India 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.”
The SII, the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
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 briefed.
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.
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 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, he said.
All these data have been shared by the firm with CDSCO, he said.
The Phase 1 and Phase 2 clinical trials were conducted on approx 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response, he said.
The Phase 3 efficacy trial was initiated in India on 25,800 volunteers and till date, approximately 22,500 participants 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 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,” he said.
SII had applied to the DCGI for EUA for Oxford COVID-19 vaccine on December 6, while the Hyderabad-based Bharat Biotech had sought the nod for its Covaxin on December 7.
“In terms of safety, Covishield was well tolerated...majority of solicited reactions were mild in severity and resolved without any sequelae. Therefore, Covishield 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.
Pfizer had also applied for regulatory approval for its vaccine on December 4 but not much progress has been made on it after that.