Global healthcare major Johnson & Johnson on Monday said it remains committed to bringing 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,” the company said.
“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.
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“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.
India registered 40,134 fresh COVID-19 infections on Monday, pushing its virus tally to 3,16,95,958, while the number of active cases registered an increase for the sixth consecutive day, according to the Union Health Ministry data updated on Monday.
The death toll from the pandemic climbed to 4,24,773 with 422 daily fatalities.
In another development, Bharat Biotech’s COVID-19 vaccine Covaxin (BBV152) is effective against Delta Plus (AY.1) variant of the coronavirus, according to a study published in bioRxiv by the Indian Council of Medical and Research (ICMR).
“Here, we have evaluated the IgG antibody titer and neutralising potential of sera of COVID-19 naive individuals full doses of BBV152 vaccine, COVID-19 recovered cases with full dose vaccines and breakthrough cases post-immunisation BBV152 vaccines against Delta, Delta AY.1 and B.1.617.3.,” the study said.
(Disclaimer: Additional background information has been added to this PTI copy for context)