Johnson & Johnson yesterday said it remains committed to bring its single-dose COVID-19 vaccine to India and looks forward to ongoing discussions with the Indian government.
The statement comes after the company withdrew its application to conduct bridging clinical studies of its vaccine in India after the government waived the requirement of such trials for foreign-approved vaccines.
“Johnson & Johnson remains committed to bringing its single-dose COVID-19 vaccine to the people of India.
“Since the Drugs Controller General of India (DCGI) recently directed that there is no longer a requirement to conduct bridging clinical studies of COVID-19 vaccines in India, Johnson & Johnson withdrew its application to conduct these studies,” the company said in an emailed statement.
According to the latest recommendations of the Subject Expert Committee (SEC) meeting to examine COVID-19 related proposals under the accelerated approval process, Johnson & Johnson had informed that it was withdrawing its proposal.
“We look forward to ongoing discussions with the Government of India and will continue to explore how to accelerate availability of the Johnson & Johnson COVID-19 vaccine in India,” the company said.