India’s homegrown COVID-19 vaccine Covaxin is to face scrutiny from the World Health Organization (WHO) on June 23rd when a pre-submission hearing will be held.
Manufacturer Bharat Biotech received the WHO’s nod for its expression of interest for emergency use listing of Covaxin, in a step commentators regard as moving the vaccine closer to securing global approval. Sources say that Bharat Biotech submitted phase-III clinical trial data to the WHO on Wednesday, in the hopes it will join the roster of vaccines approved by the agency for inoculation against COVID-19. The other vaccine candidates include AstraZeneca’s Covishield (also known as Vaxzevria) – which the Serum Institute of India manufactures in India – in addition to the Johnson & Johnson, Moderna, Pfizer, Siniopharm, and Sinovac vaccines. Covaxin, alongside Covishield and Sputnik-V, are the three vaccines approved for use in India. Covaxin is further expected to enter phase-IV trials.
“When we get our phase-III efficacy study data, then our dossier will be completed and we will submit it to WHO…they will start reviewing it,” a Bharat Biotech official informed The Times of India. “We’ve been in discussions with the WHO prequalification team and they know exactly what we are doing and what status we are in.”
India recently adjusted its implementation of its mass inoculation campaign. Prime Minister Narendra Modi announced a more federalised approach, wherein the “the Government of India itself will buy 75 percent of the total vaccine production from vaccine manufacturers and give it for free to the state governments.” As we noted “vaccines…have been in short supply, in part due to a strategy of vaccine diplomacy embraced by the Centre which saw India export vaccine doses in their millions. To be more precise, on April 26th, Quartz reported that the country had exported 66 million vaccine doses. Since the onset of the second wave and the resultant chaos, a moratorium has been imposed on vaccine exports which has left a gaping hole in the global vaccination campaign…
“…Modi’s announcement on national television came after weeks of criticism of a bungled vaccine rollout that has covered fewer than five percent of India’s estimated adult population of 950 million,” Reuters summarised. “Health experts have warned that vaccination is the only way to protect lives from a third wave of infections after a surge in April-May overwhelmed hospitals in the big cities and in the vast hinterland.” The Government announced that almost 120 million vaccine doses will be available for domestic use this month versus the 79.4 million available in May.” The reorientation in policy has been welcomed by experts.
In the case of Bharat Biotech, the company is optimistic. “The good thing about us is that we already have several WHO prequalified vaccines,” the official quoted by The Times of India said. “It’s not something brand new. It’s not like a new company going for WHO prequalification. It’s an existing company. All our QC, QA, everything is audited already for our other vaccines…so when they come, they make an assessment of everything, almost. They look at the quality management systems, they look at quality control, engineering, warehouse, everything,” he said. “The Vero Cell line that we are using for Covaxin is the same Vero Cell line that we use for the Rotavirus vaccine also. So WHO has already seen it and our QC labs, our water systems, everything, has been audited and approved by WHO.”
Approval is expected in the July-September period.