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Covaxin | WHO Approval

Decision on Covaxin's emergency use listing in 4-6 weeks: WHO

| @indiablooms | Jul 11, 2021, at 02:11 am

New Delhi/IBNS: The World Health Organisation (WHO) will take a decision on emergency use approval for Bharat Biotech's Covaxin in the next four to six weeks, Soumya Swaminathan, the UN health body's chief scientist has said.

Swaminathan said this at a webinar by Centre for Science and Environment (CSE) on Friday, adding that WHO is reviewing the Covaxin as Bharat Biotech has started to upload all the required data on the health body's portal.

Emergency Use Listing (EUL) is a way to streamline the process by which new or unlicensed products can be used during public health emergencies.

"There is a process to be followed for EUL and pre-qualification of vaccines under which a company has to complete phase 3 trials and submit the whole data to the regulatory department of WHO which is examined by an expert advisory group," Ms Swaminathan said, NDTV quoted.

"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," Ms Swaminathan added.

So Far, WHO has approved Pfizer/BioNTech, Astrazeneca-SK Bio/Serum Institute of India, AstraZeneca EU, Janssen, Moderna and Sinopharm  for emergency use.

"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. 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," the chief scientist said, NDTV quoted further.

She spoke about the WHO Research and Development Blueprint, prepared in 2016, that lays out a research roadmap for diseases with pandemic potential, soon after the Ebola outbreak.

"I want to mention the Research and Development (R&D) Blueprint. I think we need to think about how we can do better in the future in terms of development of not just vaccines but drugs, diagnostics and ensuring equitable access. This blueprint was developed after the Ebola outbreak and essentially it laid out a research roadmap for diseases which have pandemic potential," she said.

"So, when the roadmap was developed in 2016, it mentioned "Pathogen X" in it which showed that we were anticipating a pandemic, which is now COVID-19," she added.

Currently, 105 candidate vaccines are in clinical evaluation out of which 27 are in phase three or four, she said.

Another 184 candidate vaccines are in preclinical evaluation, she said, adding that most of the vaccines are designed for a two-dose schedule.

The WHO chief scientist also said the Delta variant of the coronavirus is very transmissible.

"Two complete doses are required for protection against the Delta variant but you can still get the infection and can transmit it. This is why masking and other precautions are important to continue," she said.

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