According to WHO pointers, EUL is a process to streamline the method by which new or unlicensed merchandise can be utilized throughout public well being 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,” Swaminathan stated.
“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 added.
At current, the WHO has authorised vaccines by Pfizer/BioNTech, Astrazeneca-SK Bio/Serum Institute of India,
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 stated.
She additionally talked about the WHO Research and Development Blueprint ready in 2016, shortly after the Ebola outbreak, in which a analysis roadmap for ailments with pandemic potential was laid out.
“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 stated.
“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.
Swaminathan additionally stated the roadmap primarily laid out the steps in phrases of growing goal product profiles – like requirements for vaccines, diagnostics regulatory requirements, 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 stated.
At current, there are 105 candidate vaccines in scientific analysis out of which 27 are in part three or 4, she stated.
There are one other 184 candidate vaccines in preclinical analysis. Most of the vaccines are designed for a two-dose schedule, she added.
The WHO chief scientist additionally stated the Delta variant of the coronavirus could be 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 stated.
Talking about some corporations stressing on the necessity to develop a booster dose after two vaccine pictures doses to guard individuals, Swaminathan stated, at this level there is no such thing as a knowledge to point 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 stated.
“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 stated.