India could roll out the world’s largest vaccination drive against the coronavirus disease (Covid-19) in about 10 days after the national drug controller approved two vaccines for restricted emergency use in India on Sunday, officials with knowledge of the development said.
Drugs Controller General of India (DCGI) VG Somani on Sunday announced that he had approved both the Oxford University-AstraZeneca Plc. vaccine being manufactured in India by the Serum Institute of India (SII), and Bharat Biotech International Limited’s locally developed vaccine candidate.
He said that he had accepted recommendations made by the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Friday and Saturday to grant restricted emergency approval to both the vaccines.
A top official with knowledge of the matter said the vaccination drive could begin as early as in 10 days. “It will take about a minimum of 10 days from now for the vaccine to be rolled out,” the official said on condition of anonymity.
Soon after the approval was announced, Prime Minister Narendra Modi put out three tweets congratulating the country, scientists and innovators.
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“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,” his first tweet said.
The Subject Expert Committee consists of domain experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine and so on .
On SII’s Oxford-AstraZeneca vaccine, Somani said: “After detailed deliberations Subject Expert Committee has recommended for the grant of permission for restricted use in emergency situation subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue.”
Pune-based SII, which is manufacturing the Oxford-AstraZeneca Covid-19 vaccine and testing it in India, presented 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%. Further, M/s Serum was granted permission to conduct Phase-II/III clinical trial on 1,600 participants within the country. 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,” Somani said.
Bharat Biotech has developed a whole virion inactivated coronavirus vaccine (Covaxin) in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (Pune), from where it received the virus seed strains. The vaccine is developed on a 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.
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The company had shared the data with CDSCO, and also put out phase 1 and 2 trial results for publication in December.
Phase 1 and Phase 2 clinical trials were conducted in approximately 800 subjects, and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase 3 efficacy trial was initiated in India in 25,800 volunteers and to date, 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available currently, according to the drugs controller.
“The Subject Expert Committee 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,” said Somani.
Both the vaccines have to be intramuscularly administered in two doses.
On the sidelines of a media briefing, Somani said that people of India must rest assured that all safety concerns have been met before the vaccines were approved.
“Even if there is smallest of doubt regarding safety of the vaccine, it won’t be approved. Of course, the ones approved are safe; I would say 110%. There are some side-effects but those are minor ones that are commonly seen in vaccines such as pain at the injection site, slight temperature, minor allergies, etc. Don’t believe in rumours as all scientific processes have been strictly adhered to,” he added.
Clinical trial mode condition means that the company will closely monitor and take full responsibility for any side-effects to any participants.
While there has been criticism from a large section of experts about the way approvals were given without adequate efficacy data, some experts say there is a provision for such approvals in the Indian regulatory system during emergency situations such as a pandemic.
“There is a provision in the Drugs and Cosmetics Act for grant of approval even without the efficacy data but the terminology used is somewhat different from emergency use authorisation. The approval can be granted on the basis of phase 1 and 2 clinical trials’ safety and immunogenicity data. The data gradually has to be updated. I don’t see the fuss created around it by people, many of whom aren’t even domain experts,” said a senior public health expert, who requested anonymity.