By Raju Vernekar
New Delhi, Dec 10:
An expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday sought additional safety and efficacy data for COVID-19 vaccine candidates of Serum Institute of India (SII) and Bharat Biotech, after deliberating upon their applications seeking emergency use authorisation for the shots.
While considering Pune based SII’s application, the committee, has asked for updated safety data of phase-II and phase-III clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK Medicines and Healthcare products Regulatory Agency (MHRA), sources said.
As for Hyderabad based Bharat Biotech, the SEC recommended that the firm should present the safety and efficacy data from the ongoing phase-III clinical trial in the country for further consideration. The application by the Indian arm of US pharmaceutical firm Pfizer was not taken up for deliberation on Wednesday as the firm sought more time to make presentation before the committee.
Bharat Biotech had applied to the Drugs Controller General of India (DCGI) for emergency use authorisation for its indigenously developed COVID-19 vaccine “Covaxin” on 07 December, while SII sought the nod for the Oxford COVID-19 vaccine, “Covishield”, on 06 December. Pfizer had applied for emergency use authorisation for its vaccine on 04 December.
In related development, 64 envoys visited COVID-19 vaccine facility at Bharat Biotech on Wednesday. Bharat Biotech said in a statement that the envoys appreciated its work of national and global public health significance, through several months to establish a long-lasting efficacious vaccine to combat the extraordinary Covid-19 pandemic.
The delegation was led by the Union Ministry of External Affairs comprising high commissioners and government representatives from Asia, Africa, Europe, North America, South America, and Oceania. The high-level contingent of envoys was divided into two batches and taken to Bharat Biotech Ltd and Biological E Limited in turns.
Bharat Biotech CMD Dr Krishna Yella briefed the delegation about the company’s vaccine development programme, in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).
The world is looking up to India in the fight against the Covid-19 pandemic as the development and clinical evaluation of “Covaxin” marks a significant milestone for novel vaccinology in the country, Joint Managing Director of Bharat Biotech Suchitra Ella, said while addressing a team of 64 ambassadors and high commissioners, who visited the Bharat Biotech facility at Genome Valley, Hyderabad to learn more about their work to establish a safe and efficacious vaccine against COVID-19. “Covaxin” has garnered interest from several countries worldwide for supplies and introduction and it is an honour to have with us the distinguished envoys, she added