Johnson & Johnson applies for emergency use authorisation of its single-dose Covid-19 vaccine in India


Johnson & Johnson has applied for an Emergency Authorization (EUA) for its Covid-19 single-dose vaccine, according to an official statement from the US pharmaceutical company on Friday.

“On August 5, 2021, Johnson & Johnson Pvt. Ltd. applied for Emergency approval (EUA) of its Covid-19 single dose vaccine to the Government of India“Read the statement.

Johnson & Johnson claimed that its single-use vaccine was 85 percent effective in preventing serious illnesses in clinical trials. The vaccine also shows protection against hospitalizations and deaths related to Covid-19, it said.

“The EEA filing is based on key efficacy and safety data from the overall Phase 3 clinical trial, which showed that our single-use vaccine was 85 percent effective in preventing serious illnesses and protecting against hospitalization-related illnesses in all regions studied Covid-19 showed and death starting 28 days after vaccination, “said Johnson & Johnson.

Johnson & Johnson said Biological E will be an important part of its global supply chain network.

Johnson & Johnson said the latest move is “an important milestone in paving the way for our single-dose vaccine against Covid-19 to be available to the people of India and the rest of the world through a collaboration with Biological E. Limited. “

Biological E will help “deliver our Johnson & Johnson Covid-19 vaccine through the extensive collaborations and partnerships we have with governments, health agencies and organizations such as Gavi and the COVAX Facility,” said Johnson & Johnson in its statement.

“We look forward to finalizing our talks with the Government of India to expedite the availability of our Covid-19 vaccine to end the pandemic,” said Johnson & Johnson.

Beginning of August, Johnson & Johnson had withdrawn its proposal to approve its single-shot Covid-19 Vaccine made in India for no reason as suggested by the sources of the Drugs Controller General of India (DCGI).

Hours after withdrawing his proposal for his Covid-19 vaccine to be approved in India, Johnson & Johnson made a statement on the matter, saying it was “still determined” to bring its single-dose vaccine against Covid-19 to market to the people of India.

It has also been reported that a few thousand doses of Johnson & Johnson’s vaccine could arrive in India by July.

The US FDA approved Johnson & Johnson’s viral vector Covid-19 vaccine for emergency use in February 2021 The vaccine has been associated with a rare but serious bleeding disorder.

According to the World Health Organization (WHO) The effectiveness of the J&J vaccine was 66.3 percent for mild to moderate Covid-19 and 76.3 percent for severe Covid-19 to a critical infection. In addition, it offers 100 percent protection against hospitalization for Covid-19 28 days after vaccination.

Johnson & Johnson said it was Single vaccination showed strong promise against the Delta variant and other emerging strains.

So far, four vaccines have received an Emergency Authorization (EUA) in India – Covishield, Covaxin, Sputnik V and Moderna from AstraZeneca.


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