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 deficiencies.”
GMP stands for good manufacturing practice.
“The intent for WHO EUL (emergency use listing) is to supply to UN agencies such as Unicef… but we have not received any orders till date from any of the UN agencies so we have not made any supplies so far. We have only supplied to the government of India and some other countries based on emergency use authorisation that we received from those countries,” added the Bharat Biotech official on Monday, describing WHO’s Saturday note as “a global advisory of sorts and countries get to do decide what they need to do”.
“A lot of the facilities we use to manufacture Covaxin are not designed facilities for Covid vaccines, so these are repurposed facilities; some were meant for rabies vaccine or Japanese encephalitis and other different facilities. When you are in an environment like that the facility design is not 100% perfect for Covid vaccine manufacturing. We have given our committee to WHO that whichever are those facilities in the future where we are going to make Covid vaccines, it will be perfect for manufacturing Covid vaccines,” said the official.
“Once we do all of these upgrades and maintenance activities then we will apply for full licence to WHO. I don’t have the timelines yet ,” he added.
The cost of upgradation could run into tens of crores.
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 are doing a clinical trial right now as we have got all the approvals for a clinical trials. We are going to do clinical trials in adults, and then in children in the US. We are not looking at a short term, quick, EUA in the US to sell some product. We want Covaxin to get licensed in the US.”
Responding to a question on whether the company has submitted the report on the action the company is going to take now, the official added, “not yet; it will take time. They will give us an official report then we will respond officially.”
Bharat Biotech’s nasal Covid vaccine is also taking shape, the official said.
“The phase 3 trial is currently on; my guess is that in next four months we will have all the data readouts even though it is a very complex trial with multiple trial designs. We will make a go, no go decision on this vaccine candidate after four months — whether we need to do additional trials or we need to apply for licence.”
