New Delhi: The World Health Organization (WHO) on Sunday (January 3, 2021) welcomed India’s COVID-19 vaccine approval and said that the decision will help strengthen the fight against coronavirus.
“WHO welcomes the first emergency use authorization given to COVID-19 vaccine in the WHO South-East Asia Region. This decision taken today by India will help intensify and strengthen the fight against COVID-19 pandemic in the Region,” said Dr Poonam Khetrapal Singh, the regional director, WHO South-East Asia Region.
She added, “The use of vaccine in prioritised populations, along with continued implementation of other public health measures and community participation will be important in reducing the impact of COVID-19.”
— WHO South-East Asia (@WHOSEARO) January 3, 2021
Earlier in the day, the Ministry of Health and Family Welfare said that the Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on January 1 and January 2, 2021, and made recommendations in respect of a proposal for Restricted Emergency Approval of COVID-19 virus vaccine of Serum Institute of India and Bharat Biotech.
The Ministry of Health and Family Welfare added that 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 and after detailed deliberations, Subject Expert Committee recommended for the grant of permission for restricted use in an emergency situation subject to certain regulatory conditions.
The clinical trial ongoing within the country by the firm will continue.
On the other hand, Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on Vero cell platform, which has a well-established track record of safety and efficacy in the country & 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. All these data have been shared by the firm with 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.
The Subject Expert Committee (SEC) has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in an emergency situation 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. The clinical trial ongoing within the country by the firm will continue.