New Delhi: The World Health Organization (WHO) on Sunday (January 3, 2021) welcomed the approval of India’s COVID-19 vaccine and said the decision will help strengthen the fight against coronavirus.
“WHO welcomes the first emergency use authorization granted to the COVID-19 vaccine in the WHO South-East Asia Region. This decision taken today by India will help intensify and strengthen the fight against the COVID-19 pandemic. 19 in the Region, “said Dr Poonam Khetrapal Singh, Regional Director of the WHO South-East Asia Region.
He added: “The use of the vaccine in prioritized populations, along with the continued implementation of other public health measures and community participation will be important in reducing the impact of COVID-19.”
WHO welcomes India’s decision to authorize emergency use for # COVID-19-19 #vaccines –
Dr. Poonam Khetrapal Singh, Regional Director,
WHO South-East Asia Region pic.twitter.com/jyQGI6Gymp– WHO Southeast Asia (@WHOSEARO) January 3, 2021
Hours earlier, the Ministry of Health and Family Welfare said that the Committee of Experts on Matters of the Central Organization for the Control of Drug Standards (CDSCO) met on January 1 and January 2, 2021 and made recommendations regarding a proposal for a Restricted Emergency Approval of a COVID-19 Vaccine from the Serum Institute of India and Bharat Biotech.
The Ministry of Health and Family Welfare added that the company also submitted interim safety and immunogenicity data generated from this trial and the data was found to be comparable with data from overseas clinical studies and, after detailed deliberations , the Committee of Experts on the matter recommended the granting of permission for restricted use in an emergency situation subject to certain regulatory conditions.
The clinical trial underway in the country by the firm will continue.
On the other hand, Bharat Biotech has developed a Full Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from which they received the virus seed strains. This vaccine is developed on the Vero cell platform, which has a well-established history of safety and efficacy in the country and worldwide.
The firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamsters, and has also performed challenge studies in non-human primates (Rhesus macaques) and hamsters. All this data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in approximately 800 subjects, and the results have shown that the vaccine is safe and provides a robust immune response. The Phase III efficacy trial was started in India on 25,800 volunteers and to date ~ 22,500 participants have been vaccinated nationwide and the vaccine has been found to be safe based on the data available to date.
The Subject Matter Experts Committee (SEC) has reviewed the vaccine safety and immunogenicity data and recommended the granting of the restricted use permit in an emergency public interest situation as an abundant precaution, in clinical trial mode, to have more options for vaccines, especially in case of infection by mutant strains. The clinical trial underway in the country by the firm will continue.
.
