New Delhi: The World Health Organization (WHO) tends to make decisions including Covaxin Vaccine Covid-19 Bharat Biotech in the Emergency Use List (EUL) within four to six weeks, Soumya Swaminathan, Head of Global Healthy Body scientists have said.
Speaking at a webinar organized by the Center for Science and Environment (CSE) on Friday, Swaminathan said who reviewed Covaxin as his manufacturer Bharat Biotech now uploaded all data on his health portal.
According to WHO guidelines, EUL is a procedure for streamlining processes where new or non-licensed products can be used during public health emergencies.
“There is a process that must be followed for EUL and pre-qualifying vaccines where the company must complete the phase 3 trial and submit all data to the WHO regulatory department examined by the expert advisor group,” Swaminathan said.
“Completeness of data, which includes safety and efficacy and also manufacturing quality, standards are provided.
So, I hope Bharat Biotech has sent data and in four to six weeks there will be a decision about inclusion,” Swaminathan added.
At present, WHO has a vaccine approved by Pfizer / Biontech, Astrazeneca-SK Bio / Serum Institute of India, Astrazeneca EU, Janssen, Moderna and Sinopharm for emergency use.
“We currently have six vaccines agreed with EUL and have recommendations from our strategic advisory group (Sage).
We continue to see Covaxin.
Bharat Biotech has now begun to upload their data on our portal and it is the next vaccine that will be reviewed by the Expert Committee We, “said the head of scientist.
He also mentions the blueprint of the WHO research and development that was prepared in 2016, shortly after the Ebola outbreak, where the research map of the research for disease with the potential of pandemics was arranged.
“I want to mention the research blueprint and development (R & D).
I think we need to think about how we can do better in the future in terms of development not only vaccines but drugs, diagnostics and ensure fair access.
Blueprint It was developed after the Ebola outbreak and basically he put a road map of research for diseases that have a potential pandemic, “he said.
“So, when the road map was developed in 2016, it was mentioned by ‘pathogen x’ in it which showed that we anticipated a pandemic, which is now Covid-19,” he added.
Swaminathan also said roadmaps basically put steps in terms of developing target product profiles – such as standards for vaccines, standard diagnostic regulations, experimental design, and trial simulators.
“This pre-thought helps because who is able to unite scientists, researchers, academics and companies at the beginning of last year to develop a road map of research for Covid,” he said.
At present, there are 105 vaccine candidates in clinical evaluations where 27 are in a three or four phase, he said.
There are 184 other candidate vaccines in preclinical evaluation.
Most vaccines are designed for the schedule of two doses, he added.
The head of WHO scientist also said the Delta variant of Coronavirus was very contagious.
“Two complete doses are needed for protection against the Delta variant but you can still get infection and can transmit it.
This is why masking and other precautions are important to continue,” he said.
Talking about several companies that emphasize the need to develop a booster dose after two doses of vaccine shooting to protect people, said Swaminathan, at this point there is no data to show whether the booster dose is needed.
“Science evolved.
At this point we do not have data to show that everyone will need a booster and will be after one year or two.
But data from the follow-up study of vaccinated people is very encouraging and shows that the immune response survives to 8, 10 or even 12 months, “he said.
“Some studies have seen the administration of booster doses after six months indicate that it can increase the level of antibodies so that they can protect from all variants.
What we know is that you need high-level antibodies, whether it goes through booster or first course.
We need it More studies and see which vaccines will need a booster and when.
It can be possible that the combination of two different vaccines is given in the future but this is all being seen through research and so we have to wait, “he said.
Emergency use decision to use Covaxin is likely in 4-6 weeks: who
