J&J Applies for Emergency Use Approval of Its COVID Vaccine in India
Johnson & Johnson had developed a single-dose COVID-19 vaccine, which is already in use in the US and Europe.
advertisement
American pharmaceutical major Johnson & Johnson (J&J) has applied for Emergency Use Authorisation (EUA) of its single-dose COVID-19 vaccine in India, the company said on Friday, 6 August, news agency PTI reported.
"This is an important milestone that paves the way for bringing the company's single-dose COVID-19 vaccine to the people of India, and the rest of the world, through a collaboration with Biological E Limited," a company statement said, PTI reported.
Last week, J&J had said that it was still in talks with the Indian government over its vaccine after India's drug regulator Central Drugs Standard Control Organisation (CDSCO) announced that it had withdrawn its proposal seeking accelerated approval for local trials, Reuters reported.
In May, India had scrapped local trials for 'well-established' foreign coronavirus vaccines in order to hasten vaccination rollouts to fight the second wave of infections.
More About Johnson and Johnson Vaccine
In an announcement made in January, Johnson & Johnson had said that its single-dose vaccine was 66 percent effective in preventing COVID-19.
The vaccine was proven to be 72 percent effective against moderate and severe disease in the United States, the company said. The vaccine, however, was found to be 85 percent effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults.
In the trial of nearly 44,000 volunteers, the vaccine was tested against multiple variants, and public health officials have recommended the use of it considering the vast spread of the pandemic.
India's Biological E will produce the Johnson & Johnson COVID-19 vaccine in India, the company had announced on 18 May.
(With inputs from PTI and Reuters)
(At The Quint, we question everything. Play an active role in shaping our journalism by becoming a member today.)