Johnson and Johnson¡¯s single-dose vaccine has become the fifth COVID-19 vaccine to be approved for emergency use in India.
On Saturday, Union Health minister Mansukh Mandaviya said that the vaccine has been approved for use, adding that it will further boost the country's collective fight against the novel coronavirus infection.
"India expands its vaccine basket! Johnson and Johnson's single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has five EUA vaccines. This will further boost our nation's collective fight against #COVID19," the minister tweeted.
¡°The US-based pharmaceutical company had applied for Emergency Use Authorisation for its jab on Friday and was granted the approval the same day by the Drugs Controller General of India (DCGI),¡± a senior official said.
The company had earlier sought approval to conduct phase-3 clinical trial of its vaccine on approximately 600 participants in two age groups---those aged 18 and below 60 years and those aged 60 years and above---to evaluate the safety, reactogenicity and immunogenicity of the jab in healthy Indian adults.
However, on July 29, the firm withdrew its proposal.
Earlier, in a bid to fast-track emergency approvals for all foreign produced coronavirus jabs, the central government had announced that COVID-19 vaccines which were approved for restricted use by regulators in the US, UK, Europe and Japan, or which were on the World Health Organisation's Emergency Use Listing, would not have to conduct bridging clinical trials in India.
With the EUA, the number of COVID-19 vaccines available in India has risen to five - Serum Institute's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V, and Moderna.
Approvals for at least three more COVID-19 vaccines, including two by homegrown pharma companies and one by Novavax are in the pipeline.
Zydus Cadila's Covid vaccine, which can even be administered to children is likely to be cleared in the coming days.
Hyderabad-based Biological-E's Covid-19 vaccine, Corbevax could also be granted approval soon.
In June, the Union Health Ministry had finalised arrangements with Hyderabad-based vaccine manufacturer Biological-E to reserve 30 crore of Covid-19 vaccine doses.?
The Serum Institute which is already manufacturing Covishield and Sputnik V in India has sought EUA for Novavax's COVID vaccine which will be made in India as Covovax.