Govt plans to give free jab to 30 cr by July 2021 with 3 cr health workers, doctors, corona warriors on a priority list
Gearing up to launch one of the world’s largest coronavirus vaccination drive anytime soon, India on Sunday gave final approval for the emergency use of Hyderabad-based Bharat Biotech’s Covaxin and the Serum Institute of India’s Covishield. Both vaccines are being produced in the country.
India’s approval of the UK-developed AstraZeneca/Oxford University jab follows Britain’s recent approval of the vaccine. India plans to inoculate some 30 crore people on a priority list this year by July 2021 with three crore health workers, doctors, and front carona warriors to be given the free jab.
The country’s top drug regulator DCGI in its presser on Sunday said, “Emergency restricted approval has been given for the two vaccine candidates and that it is paying close attention to the increasing cases of the UK’s Covid-19 new strain in the country and was prioritising its threat while conducting clinical trials”.
India’s Drugs Controller General VG Somani said the efficacy of the British-developed AstraZeneca/Oxford vaccine is 70.42 per cent, though he did not give out the efficacy per cent of the jab developed by the Hyderabad-based biotechnology firm, Bharat Biotech.
Somani, however, described the Indian-developed Covaxin vaccine as “safe which provides a robust immune response.” He said the Indian vaccine was approved “in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains”.
Somani also did not take any question from the reporters except saying, “We’ll never approve anything if there is slightest of safety concern. The vaccines are 100 per cent safe. Some side effects like mild fever, pain, and allergy are common for every vaccine. It is absolute rubbish that people may become impotent.”
As per the official release, the Subject Expert Committee (SEC) met on Friday and Saturday had made its recommendations in respect of the accelerated approval process request of the SII, Bharat Biotech International Ltd as well as about phase-III trials of Cadila Healthcare Ltd.
India, which has recorded the second-highest number of infections in the world with more than 10.3 million confirmed cases to date, killing nearly 150,000 held nationwide drills on Saturday to prepare more than 90,000 healthcare workers to administer vaccines across the country.
The DCGI said both manufacturers had submitted data showing their vaccines were safe to use and shared that SII has 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 per cent. Further, 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. After detailed deliberations the SEC 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,” said the DCGI in the statement.
About Bharat Biotech’s Whole Virion Inactivated Corona Virus Vaccine (Covaxin) being developed in collaboration with ICMR and NIV (Pune), the statement said from where they received the virus seed strains has well established track record of safety and efficacy.
“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.
“All these data has been shared by the firm with the CDSCO. Phase I and Phase II clinical trials were conducted in approx.800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response.
“The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, 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,” said the DCGI in the statement.
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, as per the statement.
Serum and Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8° C.
“After adequate examination, the CDSCO has decided to accept the recommendations of the SEC and accordingly, vaccines of Serum and Bharat Biotech are being approved for restricted use in emergency situation and permission,” said the DCGI.
Monday, 04 January 2021 | PNS | New Delhi
