66002More than 80 flights of AI express cancelled
In April the company had said indicated that it was in discussion with the government about starting a clinical study for the vaccine.
Under the primary end-point, the SEC has asked the company to monitor adverse events closely, including Multisystem Inflammatory Syndrome in Children (MIS-C), post the first and the second vaccine dose for 42 days to three months.
Johnson & Johnson has been given approval for the emergency use of its single dose vaccine in India, Union Health Minister Mansukh Mandaviya tweeted on August 7. This means that India now has five EUA vaccines which will increase the collective strength of the nation to fight against Covid-19. “We are pleased to announce that on August 7 2021, the Government of India issued Emergency Use Authorization (EUA) for the Johnson & Johnson Covid-19 single dose vaccine in India, to prevent Covid in individuals 18 years of age or older” said a spokesperson of Johnson & Johnson.
Earlier this week, the US pharma major had applied for an EUA for its single dose Covid-19 vaccine to the Government of India. a spokesperson of the company said in a statement.
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
— Mansukh Mandaviya (@mansukhmandviya) August 7, 2021
Partnership with Biological E
In April, the company had said indicated that it was in discussion with the government about starting a clinical study for the vaccine.
The government had then asked the vaccine maker to directly apply for the approval, as it had done away with the provision of trial for Covid-19 vaccines that are approved by foreign regulators like the USFDA or UK-MHRA.
Earlier, the J&J spokesperson had said that the vaccine would come to India through its collaboration with the Indian drug firm Biological E in Hyderabad, which will produce it.
The spokesperson also added that the Indian drug firm would be a key part of their global supply chain network, helping to supply our vaccine through extensive partnership and collaborations that the company has with governments, health authorities and organisations such as Gavi and Covax facility.
Biological E had not revealed its manufacturing or stock piling plans nor whether production would be scaled up from the initial quantity.
The vaccine from J&J is likely to be developed in India under the Quad Vaccine Partnership between India, US, Japan and Australia. Though the exact details have not been revealed.