India's indigenously developed Covaxin is likely to get the approval of the World Health Organisation (WHO) in the next four-six weeks, said the agency's Chief Scientist, Dr Soumya Swaminathan on Friday, 9 July.
"Bharat Biotech has already started submitting the data and the dossier is being assessed. It is the next vaccine to be reviewed by our committee. There will be a decision on inclusion in the next four to six weeks,” Dr Swaminathan was quoted as saying by Hindustan Times, during a webinar.
Bharat Biotech's Covaxin, which has so far received emergency approval in 16 countries, released it's Phase-3 clinical trial data via a non-peer reviewed pre-print publication earlier this month, which showed the vaccine to be 77.8 percent effective against symptomatic infections.
If approved and included in the Emergency Use Listing (EUL), the move will come as a relief and ease international travel for Indian citizens who have been vaccinated with Covaxin.
As per WHO guidelines, EUL is a procedure that streamlines the process by which new or unlicensed products can get authorisation for use during public health emergencies. Under this process, companies are required to submit complete data – including safety, efficacy and manufacturing standards – on the WHO's health portal, which is then examined by an expert advisory group, Swaminathan said.
The authorisation will also allow Bharat Biotech to export its vaccine and also supply it to the global COVAX facility.
At present, the WHO has approved vaccines by Pfizer/BioNTech, Astrazeneca-SK Bio/Serum Institute of India, AstraZeneca EU, Janssen, Moderna, and Sinopharm for emergency use. The EUL has currently approved six vaccines and have recommendations from the Strategic Advisory Group of Experts (SAGE).
Swaminathan proceeded to mention the WHO Research and Development Blueprint prepared in 2016, shortly after the Ebola outbreak, in which a research roadmap for diseases with pandemic potential was mapped out.
The roadmap was developed for 'Pathogen X', which showed that the WHO was anticipating a pandemic, which is now COVID-19. The plan laid out steps in terms of developing target product profiles like standards for vaccines, diagnostics regulatory standards, trial designs, and simulators, she said.
Speaking at the webinar, Dr Swaminathan also spoke about the global immunisation drive and said that it was 'frustrating' that countries are testing booster doses for themselves when parts of the world, like Africa, hadn't got vaccinated, reported The Hindu.
Referring to the global targets and the vaccination rate, she said that it is unlikely that the world would be protected sufficiently until the next year and a half.
There are 105 candidate vaccines in clinical evaluation, of which 27 are in Phases three or four. Another 184 candidate vaccines are in preclinical evaluation and most of them are designed for a two-dose schedule.
(With inputs from The Hindu and Hindustan Times)
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