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On the eve of the World Health Organization’s technical advisory group meeting to consider an emergency approval for Bharat Biotech’s Covaxin, the Health Ministry and research organisations here said that data related to clinical trials and manufacturing have been submitted and that there was no issue with the manufacturing of the Covid vaccine.
“BBIL is responding to different questions posed by WHO around manufacturing processes and other issues. That’s the way scientific evaluation advances. We should not assume that as the questions are being asked there must be something wrong with the vaccine – this will mean jumping to an inference without evidence.
“Evidences are being provided by Bharat Biotech and are being examined by WHO so far the approval process is concerned. It is also important to appreciate that Bharat Biotech has an impressive track record in vaccine development against various infectious diseases,” Samiran Panda, a senior scientist at the Indian Council of Medical Research’s (ICMR) epidemiology and communicable diseases division, told Business Line . Bharat Biotech’s Covaxin is in collaboration with the ICMR.
“France is also making its Covid vaccine on the same technology as used in the Covaxin manufacturing. This technology is effective against Covid,” said Health Ministry sources. An industry representative echoed similar thoughts, adding that Bharat Biotech had submitted clinical trial and manufacturing-related data to the UN health agency. In the Phase 3 clinical trials, Bharat Biotech had involved 25,800 volunteers.
The WHO will take a call on granting an emergency use listing (EUL) tag for the Indian vaccine, based on the outcome of the Technical Advisory Group’s deliberations. Bharat Biotech had begun the regulatory process for an EUL from the WHO in June 2021.
Though a EUL is not required for countries to source vaccines from the company, it helps when people travel abroad. International travel requires people to get a vaccine that’s on the WHO’s approved list.
“It is a vaccine developed using the time-tested method – using an inactivated virus. The method has been proven safe several times over. It should have been allowed by now,” said a source in the vaccine industry, who wished to be anonymous.
Data crunching
Bharat Biotech has submitted efficacy studies that it conducted on over 26,000 volunteers. Earlier this month, the WHO admitted that the company had been submitting data to the organisation “on a rolling basis and submitted additional that we sought on September 27”.
It said its experts were going through the information. “If it addresses all questions raised, our assessment will be finalised next week,” it said. While confirming the technical group’s meeting on October 26, WHO’s Chief Scientist Soumya Swaminathan said that the organisation was working with Bharat Biotech to complete the dossier. “The goal is to have a broad portfolio of vaccines approved for emergency use and to expand access to populations everywhere,” she had said.
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