Video source: YouTube, Hindustan Times
Johnson & Johnson says it is still in talks with the Indian government regarding its COVID-19 vaccine after the country’s drug regulator announced the pharmaceutical company pulled its application seeking an accelerated approval for local trials.
The development comes two months after India said it was waiving a requirement for post-approval bridging trials for well-established foreign vaccines, a change made to help speed up the national vaccination rollout and fight off additional waves of infections.
On Monday, a J&J spokesperson told The Hindustan Times, “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 spokesperson added that the company looks forward to “ongoing discussions” with the government and “will continue to explore how to accelerate availability” of its one-shot vaccine in India.
Junior health minister Bharati Pravin Pawar said last week the government formed a team to engage with vaccine makers Pfizer-BioNTech, Moderna and J&J “to discuss and address various issues, including the issue of indemnity.”
So far, four vaccines have been granted Emergency Use Authorization in India — AstraZeneca plc’s Covishield, Bharat Biotech's Covaxin, Russian Gamaleya Institute's Sputnik V and Moderna Inc's COVID-19 Vaccine.
Only 7.6% of Indian adults have been fully vaccinated against coronavirus, with 27% having received at least one dose of a vaccine.
The government still proclaims that it aims to vaccinate its entire adult population of 1.08 billion by the end of 2021, but the drive has been hampered by slow pace, dose shortages and vaccine hesitancy.
Source: Equities News