The World Health Organisation (WHO) is expected to take a decision on putting Bharat Biotech's COVID-19 vaccine Covaxin on its emergency use list (EUL) within four to six weeks, according to Soumya Swaminathan, the global health agency's chief scientist.
WHO is reviewing Covaxin data as Bharat Biotech is now uploading its entire data on the global health agency's portal, Swaminathan said on Friday while speaking at a webinar organised by the Centre for Science and Environment (CSE).
EUL is a process to streamline the way through which new or unlicensed products can be used during public health emergencies, according to WHO guidelines.
"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, as per a PTI report.
The global health agency's chief scientist further added, "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."
COVID-19 vaccine developed by Pfizer-BioNTech, Astrazeneca-SK Bio/Serum Institute of India, AstraZeneca EU, Janssen, Moderna and Sinopharm are the only jabs that have been granted emergency use approval by WHO till now.
"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," Swaminathan said.
She said that at present there are 105 vaccine candidates worldwide that are in clinical evaluation phases. Out of this, 27 are in phase three or four of clinical trials. "There are another 184 candidate vaccines in preclinical evaluation. Most of the vaccines are designed for a two-dose schedule," she added.
Swaminathan also said that the Delta variant of the coronavirus is very transmissible. She explained that two complete doses are required for protection against the Delta variant, but people can still get the infection and transmit it, adding that it is still important to wear masks and take other COVID-19 precautions.
Talking about booster dose, she said that at the moment, there is no data to indicate if a booster dose is needed after receiving two shots of COVID-19 vaccine.
"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.
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