The World Health Organization is likely to take a decision on approving Bharat Biotech's COVID-19 vaccine Covaxin for its emergency use list (EUL) within four to six weeks, Soumya Swaminathan, chief scientist of the UN’s health agency, has said.
Speaking at a webinar organised by the Centre for Science and Environment (CSE) on Friday, Swaminathan said, “Bharat Biotech has now started uploading their data on our portal and that is the next vaccine that will be reviewed by our experts committee."
She explained that the process to be followed for getting an emergency use listing and pre-qualification of vaccines entails that a pharmaceuticals company has to complete phase 3 trials and submit the whole data to the regulatory department of WHO which is then examined by an expert advisory group.
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"The completeness of the data, which includes safety and efficacy and also the manufacturing quality, standard is provided. So, I expect that Bharat Biotech has already submitted data and in four to six weeks there will be a decision on its inclusion," Swaminathan said.
"We currently have six vaccines approved with EUL and have recommendations from our Strategic Advisory Group of Experts (SAGE). We continue to look at Covaxin,” Swaminathan said.
Once Covaxin is approved for WHO’s emergency use listing it will become easier for Indian citizens who have been inoculated with Covaxin to travel to foreign countries without undergoing quarantine on arrival.
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It will also make it easier to export the vaccine, once India is in a position to do so, as there is an acute shortage of doses worldwide to fight the deadly coronavirus pandemic.
Covaxin and Serum Institute of India’s Covishield, which is the Indian brand for AstraZeneca, are the two main vaccines that have been propelling India’s vaccination drive which has now administered 37. 2 crore doses.
Bharat Biotech was producing 10 million doses of Covaxin a month at its Hyderabad plant but now the production is being ramped up as the company has expanded its capacity to two other factories that it owns. Besides, the government has roped in five public sector companies to also start manufacturing the vaccine. The target is to produce 100 million doses of the vaccine in the coming months as India has accelerated its vaccine drive to cover all adults free of cost.
Russia’s Sputnik V is the third vaccine that has been recently approved for emergency use in India and production of the doses has started to pick up with an ultimate target of 750 million shots a year.
At present, the vaccines approved for emergency use by the WHO include Pfizer-BioNTech, Astrazeneca-SK Bio/Serum Institute of India, straZeneca EU, Johnson & Johnson’s single-shot Janssen, Moderna and Sinopharm.
WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply and international procurement. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
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.
