WHO expects a decision on Covaxin’s emergency use listing within the next 4-6 weeks.

New Delhi: According to Soumya Swaminathan, the World Health Organization’s chief scientist, the World Health Organization (WHO) is likely to make a decision on including Bharat Biotech’s COVID-19 vaccine Covaxin on the emergency use list (EUL) within four to six weeks.

Swaminathan stated at a webinar hosted by the Centre for Science and Environment (CSE) on Friday that the WHO is reviewing Covaxin and that its manufacturer, Bharat Biotech, is now uploading its entire data set to the health body’s portal.

According to WHO guidelines, EUL is a procedure that streamlines the process of using new or unlicensed products during public health emergencies.

“There is a process to be followed for EUL and pre-qualification of vaccines,” Swaminathan explained. “A company must complete phase 3 trials and submit the entire data to the WHO regulatory department, which is then reviewed by an expert advisory group.”

“The data completeness standard, which includes safety and efficacy as well as manufacturing quality, is provided. So, I anticipate that Bharat Biotech has already submitted data, and that a decision on its inclusion will be made within four to six weeks “Swaminathan went on to say.

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

“We currently have six vaccines that have received EUL approval, as well as recommendations from our Strategic Advisory Group of Experts (SAGE). We’re still looking into Covaxin. Bharat Biotech has now begun uploading their data to our portal, and this will be the next vaccine reviewed by our expert committee “According to the chief scientist.

She also referred to the WHO Research and Development Blueprint, which was published in 2016, shortly after the Ebola outbreak, and outlined a research roadmap for diseases with pandemic potential.

“I’d like to draw your attention to the Research and Development (R&D) Blueprint. I believe we must consider how we can improve in the future in terms of developing not only vaccines, but also drugs, diagnostics, and ensuring equitable access. This blueprint was created in the aftermath of the Ebola outbreak, and it essentially outlined a research roadmap for diseases with pandemic potential “she stated

“So, when the roadmap was developed in 2016, it mentioned ‘Pathogen X,’ indicating that we were anticipating a pandemic, which is now COVID-19,” she explained.

Swaminathan also stated that the roadmap essentially laid out the steps for developing target product profiles, such as vaccine standards, diagnostic regulatory standards, trial designs, and trial simulators.

“This forethought was beneficial because WHO was able to bring together scientists, researchers, academics, and companies at the beginning of last year to develop a COVID research roadmap,” she explained.

She stated that there are currently 105 candidate vaccines in clinical trials, with 27 of them in phase three or four.

Another 184 candidate vaccines are being tested in preclinical trials. She went on to say that the majority of the vaccines are designed for a two-dose regimen.

The WHO chief scientist also stated that the Delta variant of the coronavirus is extremely contagious.

“Two full doses are required for protection against the Delta variant, but you can still become infected and spread it. This is why masking and other precautions must be maintained “She stated.

Concerning some companies’ emphasis on the need to develop a booster dose after two vaccine shot doses to protect people, Swaminathan stated that there is currently no data to indicate whether a booster dose is required.

“Science is advancing. At this time, we don’t have enough data to say whether everyone will need a booster and whether it will be after a year or two. Data from follow-up studies of vaccinated people, on the other hand, are very encouraging, indicating that immune responses can last up to 8, 10, or even 12 months “She stated.

“A few studies that looked at giving a booster dose after six months found that it could raise antibody levels so high that it could protect against all variants. What we do know is that you require a high level of antibodies, whether from a booster or the first course. More research is needed to determine which vaccines will require boosters and when. It is possible that a combination of two different vaccines will be administered in the future, but this is still being researched, so we must wait “She stated.

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