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Single-dose J&J vaccine cleared, will be India’s fifth Covid shot

The single-shot vaccine, developed by J&J subsidiary Janssen Pharmaceuticals, has been shown to be 85 per cent effective in preventing severe disease in phase 3 human clinical trials.

Written by Kaunain Sheriff M | New Delhi |
August 8, 2021 2:59:24 am
This is the second Covid-19 vaccine to be granted emergency use authorisation through the fast-track approval route by the Indian drug regulator.

The drug regulator on Saturday granted the American pharma giant Johnson & Johnson emergency use authorisation for its Covid-19 vaccine, paving the way for J&J’s Indian subsidiary to introduce in India for commercial use the first single-dose vaccine against infection with the novel coronavirus.

The single-shot vaccine, developed by J&J subsidiary Janssen Pharmaceuticals, has been shown to be 85 per cent effective in preventing severe disease in phase 3 human clinical trials.

This is the second Covid-19 vaccine to be granted emergency use authorisation through the fast-track approval route by the Indian drug regulator.

On April 13, India changed its policy on regulatory approvals for foreign manufacturers to commercially market their Covid-19 vaccine in the country — waiving the pre-condition of phase 2-3 clinical trials for those vaccines that have been granted emergency approvals by regulators in the US, EU, UK, and Japan, and those listed by the WHO.

On June 29, the American biotechnology firm Moderna became the first foreign company to be granted emergency use approval for its mRNA vaccine under the liberalised regulatory regime.

After Saturday’s approval, J&J, like Moderna, will not be required to conduct bridging studies in India to establish the safety of the vaccine.

“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 5 EUA vaccines. This will further boost our nation’s collective fight against #COVID19,” Union Minister of Health & Family Welfare Mansukh Mandaviya said in a tweet.

The four other vaccines that have been granted emergency use authorisation in India are Serum Institute’s Covishield, which is the Indian version of the Oxford-AstraZeneca vaccine, Bharat Biotech’s Covaxin, Russia’s Sputnik V, and Moderna’s mRNA vaccine.

“We are pleased to let you know that on 7th August 2021, the Government of India issued Emergency Use Authorization (EUA) for the Johnson & Johnson Covid-19 single-dose vaccine in India,” Johnson & Johnson said in a statement.

While Saturday’s approval paves the way for J&J to bring its vaccine to India, talks with the Indian government continue on the contentious issue of indemnity. Multiple rounds of discussions have taken place with Pfizer, Moderna, and J&J, and the negotiations are now in their final stage. On July 27, the Centre informed Parliament that a team of officials is in “continuous dialogue” with Pfizer, Moderna, and J&J to discuss and address “various issued including the issue of indemnity”.

Globally, pharmaceutical companies have supplied their Covid-19 vaccines only after indemnities have been given against the costs of compensation for severe side effects due to vaccination.

Significantly, in August last year, Hyderabad-based Biological E Limited had entered into an agreement with Janssen Pharmaceutica NV for the creation and enhancement of manufacturing capacities for the single-dose Covid-19 vaccine.

J&J is using its flagship AdVac vaccine platform, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen, and construct its Zika, RSV, and HIV investigational vaccine candidates.

Janssen’s AdVac vectors are based on a specific type of adenovirus, which is genetically modified so that it cannot replicate in humans and cause disease.

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