WHO’S suspension of Covaxin supply won’t affect Bharat Biotech’s business, says official
NEW DELHI: The World Health Organisation’s (WHO) suspension of supply of Bharat Biotech’s Covaxin through UN channels will not affect the company’s business in any way as the suspension is only for UN procurement and there has been no procurement requests from UN agencies so far, a company official claimed on Monday in a detailed briefing. The official asked not to be named.
The official added that the technical deficiencies pointed out by the UN health body have no impact on the safety and efficacy of their anti-covid vaccine and it will rectify deficiencies and apply for full market authorisation to WHO.
“They (WHO) have already made a statement that there is no safety and quality impact, and they are not recommending anything else… this applies to only supplies to UN agencies. There have been zero orders from them,” this person said.
This is Bharat Biotech’s first response after WHO’S Saturday’s suspension of supply, although the company put out a statement late on Friday in anticipation of the move in which it announced “temporary slowing down of production” with the company focusing on “pending facility maintenance, process and facility optimization activities.”
The statement did not refer to the suspension by WHO and only referred to the inspection carried out by the agency. “Bharat Biotech agreed with the WHO team on the scope of the planned improvement activities and indicated they will be executed as soon as practical,” the company added in that statement. It also cited WHO to say there was no indication of a “change in risk-benefit ratio (for Covaxin)...” .
WHO’S Saturday suspension note mentioned that its inspection highlighted “the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.”
The official also denied that WHO’S suspension will have an impact on Covaxin market in the US. “Our strategy in the US is not based on an emergency use listing or immediate supplies... we have got all the approvals for a clinical trials. We are not looking at a short term, emergency use authoritsation in the US to sell some product. We want Covaxin to get licensed in the US.”