WHO’s Emergency Use Listing is a prerequisite for COVAX facility vaccine supply for other countries

The World Health Organization (WHO) is likely to take a decision on including Bharat Biotech’s COVID-19 vaccine Covaxin in the Emergency Use List (EUL) within four to six weeks, the global health body’s chief scientist Soumya Swaminathan has said.

Speaking at a webinar organised by the Centre for Science and Environment (CSE) on Friday, Swaminathan said the WHO is reviewing Covaxin as its manufacturer Bharat Biotech is now uploading its entire data on the health body’s portal.

WHO’s Emergency Use Listing is a prerequisite for COVAX facility vaccine supply for other countries. 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.

“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,” Swaminathan said.

“The completeness of the data, which includes safety and efficacy and also the manufacturing quality and 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 added.

Bharat Biotech International Limited’s (BBIL) which manufactures India’s homegrown covid-19 Covaxin vaccine has submitted almost complete documentation needed for the apex global health agency’ Emergency Use Listing.

When granted the EUL, it will open the doors for the Indian developed Covaxin to be accepted and used by other countries. At present, Covishield has been accepted by at least 15 European Union countries.

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.

“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.

Swaminathan also said the roadmap essentially laid out the steps in terms of developing target product profiles like standards for vaccines, diagnostics regulatory standards, trial designs, and trial simulators.

“This pre-thinking helped because WHO was able to bring together scientists, researchers, academics and companies at the beginning of last year to develop a research roadmap for COVID,” she said.

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

There are another 184 candidate vaccines in preclinical evaluation. Most of the vaccines are designed for a two-dose schedule, she added.

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.

Talking about some companies stressing on the need to develop a booster dose after two vaccine shots doses to protect people, Swaminathan said, at this point there is no data to indicate if a booster dose is required.

“Science is evolving. At this point we don’t have data to indicate that everyone will need a booster and is it going to be after one year or two years. But data from follow up studies of vaccinated people are very encouraging and is showing that immune responses are lasting up to 8, 10 or even 12 months,” she said.

“A few studies that have looked at giving booster dose after six months have shown that it can increase the antibody levels so high that they can protect against all variants. What we know is you need a high level of antibodies, whether it’s through a booster or the first course. We need more studies and see which vaccines will require a booster and when. It could be possible that a combination of two different vaccines is administered in future but these are all being looked into through research and so we have to wait,” she said.