Bharat Biotech Denies Reports About Phase 3 Trial Data Submission To WHO

Bharat Biotech, the manufacturer of made-in-India Covid-19 vaccine Covaxin, clarified on 17 June that news reports about submitting Phase 3 trial data to the World Health Organization (WHO) are incorrect and lack evidence.

The company took to Twitter and wrote: “The news reports on Bharat Biotech submitting Phase-3 data to WHO is incorrect and lacks any evidence.” This clarification comes after media reports suggested that the vaccine manufacturer had submitted the results of its Phase 3 clinical trial to the Geneva-based global health agency for approval.

According to a WHO document, the company's pre-submission meeting with the global health agency for the approval of its Covid-19 vaccine Covaxin has been scheduled for 23 June. Bharat Biotech has submitted 90 per cent of the documentation required for WHO's Emergency Use Listing (EUL) last month and the remaining documents are expected to be submitted this month. The Hyderabad-based company said in a Tweet: “Application for Emergency Use Listing submitted to WHO-Geneva, regulatory approvals are expected Jul-Sept 2021.”

Bharat Biotech’s Covaxin is among three vaccines approved by Indian authorities. The company earlier said that it will make the Phase 3 trial data public in June but later the Hyderabad-based firm announced that it will do so in July. Last month, it was reported that Covaxin demonstrated a 78 per cent efficacy in preventing symptomatic Covid-19 in the final Phase 3 study, involving 25,800 volunteers across India.

The United States Food and Drug Administration (FDA) denied Bharat Biotech's application for an Emergency Use Authorisation for Covaxin in America, citing "a lack of data on clinical trials". Following the FDA's decision, the Indian company’s American partner, Ocugen, announced that now they would seek full-use approval for the jab.

Bharat Biotech is currently conducting a Phase 3 study on 4,500 volunteers in Brazil and plans to conduct a trial in the United States as part of its decision to pursue the Biologics Licence Application — a request for permission to introduce or deliver a biologic product for introduction into interstate commerce — for that market.

An official at Bharat Biotech told The Times of India: “The good thing is that we already have several WHO prequalified vaccines. It’s not like a new company going for WHO prequalification. All our QC, QA, everything is audited already for our other vaccines… so when they come, they assess everything, almost. They look at the quality management systems, quality control, engineering, warehouse, everything.”

“The Vero cell line that we are using for Covaxin is the same line that we use for the Rotavirus vaccine also. WHO has already seen it and our QC labs, water systems, everything has been audited and approved by WHO (for the other vaccines),” he added.

According to WHO guidelines, EUL is a procedure that streamlines the process by which new or unlicensed products can be used during public health emergencies. An EUL from the WHO would allow the Bharat Biotech’s vaccine into several countries and put to rest concerns about travel restrictions imposed on those who have received vaccines that have not yet been approved by the UN health agency.