The US Food and Drug Administration (USFDA) has placed the Phase 2, 3 immuno-bridging and broadening study of Bharat Biotech’s Covid vaccine, Covaxin, on clinical hold.
“This is a result of the company’s decision to voluntarily implement a temporary pause in dosing participants of OCU-002 (Covaxin) while it evaluates statements made by the World Health Organization following their inspection of Bharat Biotech International Limited’s (BBIL) manufacturing facility,’‘ said Ocugen, partner of Bharat Biotech in the US, in a release.
“We will work with the FDA to address any questions,’‘ it added. The World Health Organization (WHO) recently suspended the supply of Covaxin through its agencies on some GMP-related issues. Hyderabad-based Bharat Biotech recently said it had temporarily slowed down production of its Covid vaccine across its manufacturing facilities. Certain highly sophisticated equipment required to enhance the process stringency were unavailable during the Covid pandemic, it had said