SII, Bharat Biotech vaccines: Centre calls reports of rejection of emergency approval of Covaxin as 'fake'
A team of 70 foreign envoys from several nations visited the Bharat Biotech facility at Genome Valley on Wednesday and were apprised of India's work.
The Centre on Wednesday denied media reports about the government rejecting emergency use authorisation for Serum Institute and Bharat Biotech vaccines. "The media report about the rejection of Serum Institute and Bharat Biotech's emergency use authorisation of vaccine is fake," said the Ministry of Health and Family Welfare in a statement.
Earlier it was reported in the media that Serum institute and Bharat Biotech's proposals for emergency vaccine use were not cleared over inadequate safety and efficacy data. However, the two firms have been asked to provide more data on the vaccines.
A day after this news made the rounds, the media report has been completely denied by the Ministry of Health and Family Welfare, according to news agency ANI.
Meanwhile, a team of 70 foreign envoys from several nations visited the Bharat Biotech facility at Genome Valley, in Hyderabad on Wednesday and were apprised of India's work to establish a safe and efficacious vaccine against COVID-19.
The delegation led by the Ministry of External Affairs (MEA) comprised of high commissioners and government representatives of 70 countries across the world from Asia, Africa, Europe, North America, South America, and Oceania.
They were briefed about Bharat Biotech’s vaccine development program by Dr Krishna Ella, Chairman and Managing Director, spearheading the Covaxin research, development, clinical trials and production teams. The delegates were presented Bharat Biotech’s research process, manufacturing capabilities, expertise, given virtual and physical tours of the facilities.
The envoys voiced their appreciation of Bharat Biotech work of national and global public health significance, working very hard for several months to establish a long-lasting efficacious vaccine to combat the extraordinary COVID 19, pandemic.
Covaxin, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility.
The Phase III human clinical trials of the vaccine began in November, involving 26,000 volunteers across India. This is India’s first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India.