J&J and Novavax seek approval for vaccines
NEW DELHI: Johnson & Johnson (J&J) has applied for an emergency use authorisation of its single-dose coronavirus disease (Covid-19) vaccine in India, the American pharma major announced on Friday, bringing the country closer to the possibility of another shot becoming available soon.
The company submitted its application for the vaccine, developed by its subsidiary Janssen, to the Central Drug Standard Control Organisation (CDSCO) on August 5.
“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,” said a statement from the company.
J&J has partnered with Hyderabad-based Biological E for clinical trials and production.
The company in May applied for a permission to carry out bridging trials – smaller clinical trials that are meant to assess if the findings are similar to larger trials carried out elsewhere.
But it withdrew the request last week and filed for emergency approval directly, making use of a change in policy in India that allows coronavirus vaccine makers to do so, if they have received approvals by certain regulators around the world. The J&J vaccine is approved by several of these agencies, such as the US FDA, UK’S MHRA and Europe’s EMA.
“The changes in rules were made for Covid-19 vaccines made outside of India that were approved by reputed drugs regulators globally, and the World Health Organization. This was done to facilitate the entry of foreign-made vaccines of quality into India...,” said a senior central government official in the know of things, who requested not to be named.
“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...,” the statement added.
It said J&J looked forward to concluding its discussions with the government of India to accelerate availability of its vaccine.
Union health minister, Mansukh Mandaviya, on Friday met the managing director of Biological E, Mahima Datla. He tweeted that he was briefed on the progress of their Covid-19 vaccine, Corbevax.
“Met Ms Mahima Datla, MD of @Biological_e, who briefed me on the progress of their upcoming #COVID19 vaccine, Corbevax. I assured all the Government support for the vaccine.”