The World Health Organisation (WHO) is likely to take a decision on including Bharat Biotech’s Covaxin in its list of vaccines approved for Emergency Use, within four to six weeks, Chief Scientist Soumya Swaminathan of the WHO said at a webinar organised by the Centre for Science and Environment (CSE).
A WHO prequalification, or EUL, is necessary for a vaccine company to supply vaccines to global facilities such as COVAX or other international procurement procedures. Eight vaccines have so far got EULs from the WHO.
“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, comprising 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 about the decision-making process.
In late May, Bharat Biotech had said it had submitted “90% of the data” required for the pre-qualification process. On 4 July, 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 an analysis involving 25,800 volunteers.
The two-dose vaccine was 93.4% effective also 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.
Bharat Biotech did not respond to a query on Dr Swaminathan’s statement.
At Friday’s seminar, Dr Swaminathan said that it was “frustrating” that countries were contemplating and testing booster doses for themselves when large parts of the world, especially Africa, had not yet got vaccinated.
The target was to have at least 10% of the world fully vaccinated by September and 40% by December. She said that it was unlikely that the world would be sufficiently protected at least until the next year and a half and ‘herd immunity’, or when a 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.