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

J&J Seeks To Conduct Study For COVID-19 Vaccine In India: Reuters
  • Johnson & Johnson (NYSE: 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 (NASDAQ: AZN) and a shot from domestic player Bharat Biotech.
  • In February, Pfizer Inc (NYSE: PFE) - BioNTech SE (NASDAQ: BNTXpulled 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.

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Posted-In: Briefs COVID-19 VaccineBiotech Government News Health Care FDA General

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