J&J Seeks To Conduct Study For COVID-19 Vaccine In India: Reuters

Johnson & Johnson JNJ is reportedly in talks with the Indian government to start a clinical trial of its single-dose COVID-19 vaccine in the country.
According to the Indian Express newspaper, J&J had sent a letter to India’s Central Drugs Standard Control Organisation (CDSCO) saying it would “very shortly apply for permission to conduct clinical bridging trials in India.”
JNJ’s vaccine is currently approved for use in the U.S., the European Union, and other nations, including Thailand and South Africa.
The news comes as some parts of India face a shortage of vaccine supplies just as the country battles the second wave of COVID-19 infections. Though the Indian government has said, there is no shortage of shots.
The CDSCO did not immediately respond to Reuter’s request for comment.
“We are in discussions with the government with the objective of starting a bridging clinical study of our Janssen COVID-19 vaccine candidate in India, subject to local regulatory approvals,” a local J&J representative said via email.
India has indicated that any vaccine maker must conduct a local trial for a shot to be considered for its immunization program.
Separately, J&J has a deal with Indian firm Biological E Ltd to contract-manufacture its vaccine.
India currently has two approved vaccines in use, one developed by Oxford University and AstraZeneca plc AZN and a shot from domestic player Bharat Biotech.
In February, Pfizer Inc PFE - BioNTech SE BNTX pulled out its marketing application seeking emergency approval for its COVID-19 shot in India after failing to adhere to the drug regulator’s request for a small local study.
But earlier this month, the companies told the Indian government it wants to produce its COVID-19 vaccine locally if assured of faster regulatory clearance and freedom on pricing and exports.
Price Action: JNJ shares are trading 0.62% lower at $161.99 on the last check Friday.