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The apex All India Institute of Medical Sciences (AIIMS) will begin Phase 3 clinical trials on Bharat Biotech’s intranasal booster dose BBV154 from Friday, Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS, New Delhi told BusinessLine.
The process of recruitment of at least 100 adults for the clinical trial will start tomorrow, he said. An intra-nasal vaccine is simple to administer and does away with the need for needles and syringes, among other things.
“The participants must be adults and fully vaccinated with either Covishield or Covaxin. There should be a minimum gap of five months between both the doses and maximum seven months,” added Rai.
“Registration for the participants who are adults will commence from March 10 through email --HYPERLINK “mailto:ctaiims. covid19@gmail. com”ctaiims. covid19@gmail.com --- and whatsapp (7428847499) for those who received both the doses of either Covaxin or Covishield for more than 5 months but less than 7 months ago,” Dr Rai stated.
The Drugs Controller General of India (DCGI) in January had given its nod to Hyderabad-based Bharat Biotech to organize phase-3 multi-centric study to evaluate the immunogenicity and safety of its booster dose in those who are fully vaccinated with Covishield or Covaxin.
Need for new vaccines
Though Covid-19 cases have receded significantly, the quest for new vaccines is still on as the current vaccines do not prevent the infection. Also, according to the experts, the virus keeps mutating, so there is always a fear that a new variant may crop up which can be more virulent like the Delta variant. According to Rai, the current vaccines including Covishield and Covaxin which are available for Covid 19 are not able to prevent the infection. All the Covid vaccines which are being used worldwide, only decrease the severity of diseases and hospitalization,he added.
“We need to have a vaccine which can prevent the infection, so the research should continue to find an effective vaccine which can provide overall protection from a scientific point of view. Current vaccines are not able to prevent the infection. They only reduce the severity of infection,” said Rai when asked about the need for new vaccines when the cases have receded significantly. Rai added, there was no plan to conduct trials on children as of now.
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