Tuesday, 19 October 2021

Johnson & Johnson single dose Covid vaccine approved in India

A single-dose covid vaccine of Johnson & Johnson's approved in India

The drug regulator on Saturday permitted the American pharma giant Johnson & Johnson emergency use authorization for the Covid-19 vaccine, lead the way for J&J's Indian subsidiary to inaugurate in India for commercial use for the first single-dose vaccine against infection with a covid virus.

The single-shot vaccine, developed by Johnson & Johnson subsidiary Janssen Pharmaceuticals, is 85 percent effective against severe disease in phase 3 human clinical trials.

Johnson & Johnson is the second Covid-19 vaccine to be granted emergency use authorization through a fast-track approval through the regulator of the Indian drug.

India changes its policy on regulatory approvals for foreign manufacturers to market on April 13 for their Covid-19 vaccine in the country commercially.

They were waiving the pre-condition of phase 2-3 clinical trials for those vaccines that regulators have granted emergency approvals in a nation like the UK, EU, Japan, and the US, listed by the World Health Organisation.

American firm Moderna became the first foreign company to be granted emergency use approval on June 29 for its mRNA vaccine under the liberalized regulatory rule.

After approval, J&J, like Moderna, will not conduct bridging studies in India to establish the vaccine's safety.

India has four other vaccines granted emergency use authorization in India listed below.

  • Covishield AstraZeneca vaccine
  • Bharat Biotech's Covaxin
  • Russia's Sputnik V
  • Moderna's vaccines

Johnson & Johnson said in a statement.

"We are very pleased tell you that on August 7, The India Government issued EUA Emergency Use Authorization for Johnson & Johnson Covid-19 single-dose vaccine in India,"

A single dose covid vaccine of Johnson Johnsons approved in India 1getty image

Read More: Door to Door Vaccination to start from today in Mumbai

While approval paves the way for J&J to bring a 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 giving against the costs of compensation for severe side effects due to vaccination.

Significantly, in August last year, Hyderabad-based Biological E Limited agreed with Janssen Pharmaceutica NV to create and enhance manufacturing capacities for the single-dose Covid-19 vaccine.

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

Follow Us

Popular Post