NEW DELHI, July 9: A decision on incorporating India’s “Covaxin” in the list of vaccines approved for Emergency Use is likely to take another four to six weeks for the World Health Organisation, the WHO chief scientist Soumya Swaminathan said on Friday.
Speaking at a webinar organized by the Centre for Science and Environment (CSE), Swaminathan said the organization was sized with the matter and might take a decision within four to six weeks.
A WHO prequalification, or EUL, is necessary for a vaccine company to supply vaccines to global facilities such as COVAX or international procurement. So far eight vaccines have got an EUL from the WHO but Bharat Biotech’s Covaxin is still in the pipeline.
“It is mandatory to supply a complete dossier listing safety, efficacy and manufacturing conditions of the vaccine to the WHO. I understand that Bharat Biotech is in this process and I think a decision on their case is likely in the next four to six weeks,” said Swaminathan.
The EUL assesses the quality, safety and efficacy of COVID-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements. The assessment is performed by the product evaluation group, composed by regulatory experts from around the world and a Technical Advisory Group (TAG), in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under which conditions, the WHO says.
In late May, Bharat Biotech said it has submitted “90% of the data” required for the pre-qualification process. Last Saturday, the firm publicised its long-awaited phase-3 trial efficacy data, via a non-peer-reviewed pre-print publication, reporting an overall 77.8% efficacy against symptomatic COVID-19 based on analysis involving 25,800 volunteers.
The two-dose vaccine was also 93.4% effective against severe disease and 63% protective against asymptomatic COVID. Moreover, it was 65% protective against the Delta variant of the coronavirus, the most widespread in India and linked to a rising number of cases in Europe as well as the United States.
At Friday’s seminar, Swaminathan said it was “frustrating” that countries were contemplating and testing booster doses for themselves when large parts of the world, especially Africa, hadn’t yet got vaccinated.
The target was to have at least 10% of the world fully vaccinated by September and 40% by December. She said it was unlikely that the world would be sufficiently protected at least until the next year and a half and ‘herd immunity’ or when substantial fraction of people was protected by antibodies, was only likely when 80% had been vaccinated.
So far only 5% of Indians have been fully vaccinated and only 21.8% have got at least one dose of the vaccine.
(Manas Dasgupta)
