No impact of WHO action on Covaxin, have not supplied to any UN agency: Bharat Biotech

So far, sources said, the firm has supplied vaccines to the Indian government and around nine countries under the Centre’s Vaccine Maitri programme, and has made direct commercial supply under emergency use authorisation.

Covaxin has received emergency use approvals from over 25 countries.

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“After we got an emergency licence in India, we applied for EUL with the WHO and we also got that. The intent for EUL was to supply vaccines to UN agencies like UNICEF, PAHO and GAVI Covax facility.

“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 vaccines to government of India and to quite a few other countries but all these supplies were based on EUA received from those countries,” a company source said.

Gavi Covax, the international vaccine alliance, has also not placed any orders for Covaxin, the source reiterated.

“Our vaccine certificates remain valid and there will be no interruption in supplies in India,” a source said, stressing that the “WHO itself has already said that there is no impact on quality and safety”.

Citing good manufacturing practices (GMP) deficiencies, the World Health Organization (WHO) on April 2 confirmed the suspension of supply of Covaxin through UN procurement agencies and recommended countries that received the vaccine to take actions as appropriate.

In a statement, WHO had said this suspension is in response to the outcome of WHO post Emergency Use Listing (EUL) inspection and the need to conduct process and facility upgrade to address recently identified GMP deficiencies.

On facility upgrade, company sources said on Monday that a lot of these facilities where Covaxin is being made were not designed specifically for manufacturing the COVID-19 vaccine.

These are repurposed facilities that were already existing for manufacturing other vaccines. “The facility designs are not 100 per cent perfect for manufacturing COVID vaccines.

“We have given a commitment to WHO that whichever are those facilities where we will manufacture Covaxin in future will be perfectly designed for manufacturing Covaxin. These are facility upgrades that we are coming up,” the source said. In some places it will be facility upgradation while in some places it will be procurement of equipments.

“Our vaccine certificates remain valid and there will be no interruption in supplies in India. They (WHO) have given just a global advisory, countries get to decide what they need to do,” the source pointed out.

The WHO officials carried out an inspection of the BB facility during March 14-22.

It was not a surprise visit, the sources said, adding there was no inspection before the EUL was granted and the WHO audit focused on Covaxin.

In response to a question, the source said once all facility upgrades are done “we will apply to WHO for full licensure for Covaxin” in due course of time.

Responding to a question, sources said that in the pharma world or in the vaccine space, any kind of regulatory audits and approvals are part of the process.

“We have got some feedback. We will do the facility modifications and the maintenance and upgrades that are required and move forward. These are small issues and we don’t see them as a final or penal issue,” the source said.

“Also the feedback or observations that we have received is not anything that is detrimental to future products. WHO itself has already said that there is no impact on quality and safety,” the source said

Asked about possible cost escalation, the source said it will be in tens of crores of rupees.

On Bharat Biotech issuing a statement on April 1 announcing temporary slowing down of production of Covaxin across its manufacturing facilities, the source said the facilities did not have a break for 15 months due to production pressure.

“We had decided we will be turning down sometime in the month of January or February based on what orders we have received.

“If we keep producing at the same rate what we are producing at high rate of 80 million, then we will end up having so much stock and product available that then nobody else is going to pick it up from us,” the source said.

“Also, once we convert it into a vial, the shelf life starts. We had started shutting down or turning down those facilities already.”

The sources said the firm has enough drug substances (bulk available) and has also build up an antigen bank.

“If the country needs it, we can convert it within 30-45 days timeline and we can supply the product.”

“We had two facilities in Ankleshwar and we have slowly closed them down. We had been manufacturing at Indian Immunologicals and that has also been closed down. Here at campus, there is only one facility right now that is actually making Coxavin. The rest have been closed down.”

“Because of all the production pressure, we were not able to conduct these activities in the frequency that we would like to do it and now it is the time, there is reduction in procurement. We can take those breaks right now,” the source said.

In response to a question on the nasal vaccine, the company source said the phase-3 trial is going on and in four months it will have the data as this is a very complex trial.

“After analysing the data we will decide if we should go for additional trials or apply for licensure,” the source said.

The WHO had said that Bharat Biotech has committed to comply by addressing the GMP deficiencies and is developing a corrective and preventive action plan, for submission to the Drugs Controller General of India DCGI and WHO.

In the interim and as a precautionary measure, Bharat has indicated its commitment to suspend its production of Covaxin for export, the WHO had said.

The WHO said risk assessment to date does not indicate change in the risk-benefit ratio. The data, available to WHO, indicate the vaccine is effective and no safety concern exists.

Bharat Biotech also said the WHO announcement will not impact the Ocugen trials. Ocugen had entered into a deal with Bharat Biotech to develop, supply, and commercialise Covaxin for the US market.

“We have just got the approval for a clinical trial. So we are going to do clinical trials in adults and then in chidren in the US. It’s a long drawn out process.

“We are not looking at a short time quick EUA in the US and to sell some product. That’s not our strategy. Our strategy is long term. We want to get Covaxin approved as a licenced vaccine in the US not the EUL,” the source said.

The FDA has cleared application for Phase 2-3 adult clinical trials of Covaxin.

Bharat Biotech last month touched its annualised maximum capacity of 1 billion  for Covaxin.