Johnson & Johnson (J&J) has sought approval for its single shot Covid-19 vaccine from the Indian regulator this week. It is not clear whether, like Pfizer and Moderna, it is seeking indemnity against legal action that may arise from any side-effects.
The company did not comment on the matter but a government official indicated that, unlike Pfizer and Moderna, J&J had an Indian partner which would make the indemnity issue less complicated.
This will be the fourth foreign vaccine to enter India after Russia’s Sputnik V, Pfizer-BioNTech and Moderna. Sputnik V is already approved in India and Hyderabad-based firm Dr Reddy’s Laboratories markets it.
Pfizer and Moderna are in discussions with India on legal indemnity but N K Arora, head of the government’s vaccine panel has said that India is unlikely to grant indemnity because the order books of Pfizer and Moderna are full and they can only offer India very small quantities of vaccines.
A J&J India spokesperson confirmed the development: “On August 5 Johnson & Johnson applied for emergency use authorization (EUA) of its single-dose Covid-19 vaccine to the Government of India.” The company said it looks forward to concluding its discussions to accelerate the availability of its vaccine.
Earlier, the company had been talking to India about conducting clinical trials here. In April, the company had indicated that it was discussing a bridging clinical study for the vaccine.
But India has now done away with its earlier provision requiring clinical trials of vaccines that have already been approved by foreign regulators.
“The Emergency Use Authorisation submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which demonstrated our single-shot vaccine was 85 per cent effective in preventing severe disease across all regions studied, and showed protection against Covid-19 related hospitalization and death, beginning 28 days after vaccination,” J&J said.
Terming it an ‘important milestone’, the J&J spokesperson the vaccine would come to India through its collaboration with Indian drug firm Biological E in Hyderabad which will produce it.
“Biological E will be an important part of our global supply chain network, helping to supply our vaccine through the extensive collaborations and partnerships we have with governments, health authorities and organisations such as Gavi and the Covax Facility,” the spokesperson said.
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Earlier, Mahima Datla, MD and CEO of Biological E, had told Business Standard that J&J was looking to produce 500-600 million doses at its plant but did not specify whether this is a per annum figure or the total doses specified in the contract.
While exact details have not been revealed, the J&J vaccine is likely to be made in India under the Quad Vaccine Partnership, an alliance between India, the US, Japan and Australia. Biological E has not revealed its manufacturing or stock-piling plans, nor whether production will be scaled up from the initial quantity.
J&J has said its vaccine can remain stable at 2-8 degrees Celsius for up to three months and the company will ship the vaccine using the same cold chain technologies it uses today to transport treatments for cancer, immunological disorders and other medicines.
The vaccine – Ad26. COV2. S – developed by J&J’s pharmaceutical arm Janssen, received emergency use authorization from the US Food and Drug Regulator in February based on data from the phase 3 Ensemble study. J&J conducted clinical trials on 43,783 participants across countries, including the US.
The US regulator noted that ‘the vaccine was approximately 77 per cent effective in preventing severe/critical Covid-19 occurring at least 14 days after vaccination and 85 per cent effective in preventing severe/critical Covid-19 occurring at least 28 days after vaccination’.
The European Medical Agency authorised the vaccine in March.
The United States Centers for Disease Control and Prevention (CDC), the national public health agency of the US, has said that the vaccine has high efficacy in preventing hospitalization and death.
It also noted that the vaccine was 66.3 per cent effective in clinical trials at preventing laboratory confirmed Covid-19 illness in people who had no evidence of prior infection two weeks after receiving the vaccine.
“Early evidence suggests that the J&J/Janssen vaccine might provide protection against asymptomatic infection, which is when a person is infected by the virus that causes Covid-19 but does not get sick,” the CDC noted.
