American multinational company Johnson & Johnson has applied for Emergency Use Authorization (EUA) in India for its single-dose COVID-19 vaccine, the company announced on Friday, August 6. The company said that the application was submitted on August 5. Hyderabad-based Biological E Ltd will be manufacturing and distributing the single-dose COVID-19 vaccine in India, the company has said.
Efficacy and safety data from the Phase 3 trials of the vaccine has shown that the single shot vaccine is 85% effective in preventing severe disease, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination, the company said in a statement.
Compared to other international vaccines yet to be approved in India, the J&J vaccine is easier to handle, lasting three months in the refrigerator compared to the Pfizer and Moderna, which need to be frozen. According to the World Health Organisation, Johnson & Johnson’s vaccine is a single-dose vaccine, estimated to remain stable for two years at -4°F (-20°C), and a maximum of 4.5 months at routine refrigeration temperatures of 36° to 46°F (2° to 8°C).
“This is an important milestone that paves the way to bringing our single-dose COVID-19 vaccine to the people of India, and the rest of the world, through a collaboration with Biological E. Limited,” a spokesperson from Johnson & Johnson said. “We look forward to concluding our discussions with the Government of India to accelerate availability of our COVID-19 vaccine to help end the pandemic.”
Currently, three vaccines are being administered across India — the Oxford/Astrazeneca vaccine Covishield, manufactured by Serum Institute in India; the indigenously developed Covaxin by Bharat Biotech; and Sputnik V, a vaccine developed in Russia and distributed by Dr Reddy's Laboratories. While Covishield and Covaxin have been officially launched, Sputnik V has been soft-launched in India and is available in select private hospitals as of date.
With PTI inputs