Johnson & Johnson have asked for an approval to supply single dose COVID-19 vaccine in India

As an American Pharma Comnglomerate, Johnson & Johnson have a history over 134 years. Now, they have been seeking approval from Central Directorate Drug Standard Control Organization in India for an emergency use of their single dose COVID vaccine within the country. Previously, the company has requested permission for a trial. However, provision of trial does not exist in India anymore prior to emergency use of coronavirus vaccine. Therefore, Johnson & Johnson have requested for an emergency use.

Through a statement, the company has said couple of days ago “This is an important milestone that paves the way to bringing our single-dose COVID-19 vaccine to the people of India, and the rest of the world, through a collaboration with Biological E. Limited. Biological E will be an important part of our global supply chain network, helping to supply our Johnson & Johnson Covid-19 vaccine through the extensive collaborations and partnerships we have with governments, health authorities and organisations such as Gavi and the COVAX facility”
In case vaccine from J&J manages to get an approval for an emergency use within India, then it is going to be the second vaccine to achieve such a feat. Previously, Moderna has been given approval by the Indian Government.
Janssen Pharmaceutical Companies of J&J has developed the coronavirus vaccine. Reports have suggested that through one dose of vaccine, you can achieve 85.4% efficacy as far as severity of disease is concerned. In case of hospitalization, efficacy is around 93.1%.

By USA FDA, Johnson & Johnson COVID-19 vaccine has been approved in the month of February. Till now, it has been approved by several countries in the world.
In spite of approval to Moderna by the Indian Government, it has not delivered vaccine to India yet. Here an issue of legal indemnity has been noticed for both Pfizer and Moderna. Both the company has been looking for a legal cover from the government. Delivery of Moderna vaccine is stuck due to this indemnity issue. If J&J manages to secure an approval then it is going to be the first foreign vaccine in India. Issues of legal indemnity may not be seen as they have been partnering with a local company called Biological E in India.

Johnson & Johnson has also said “The EUA 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”

This entry was posted in Vaccine. Bookmark the permalink.