BackWHO approval for Covaxin soon? Chief scientist says data 'meets benchmark'
Sharing the final phase-3 pre-print data on medRxiv on 3 July, the company claimed that its vaccine demonstrates overall efficacy of 77.8% against symptomatic infection
PremiumAmid concern over the absence of international recognition for locally-manufactured Covaxin, a statement by Soumya Swaminathan, the chief scientist of the World Health Organisation has come as a potential sigh of relief for students, officials and others who meant to travel abroad.
In a statement given to CNBC-TV18, Swaminathan has said that the final phase trial data for Covaxin “looks good" and the safety profile of the vaccine "meets the WHO benchmarks". She added that while the efficacy against the dominant Delta variant is low, the overall efficacy is high and "quite good".
Swaminathan also said that the data packet is currently being assembled after Bharat Biotech's pre-submission meeting with the WHO officials on 23 June. She said that the agency is awaiting more data for a final say on the matter.
Bharat Biotech officials had on 19 April submitted an expression of interest for emergency use listing by WHO, but the agency had sought additional details from the company.
This comes in the backdrop of people who were given the Covaxin jab facing restrictions when travelling abroad as many countries are considering such individuals "unvaccinated" in the absence of a WHO approval.
Countries such as Saudi Arabia, the UK and the US are asking travellers vaccinated with Covaxin to undergo lengthy quarantine procedures until they get a WHO-approved vaccine shot.
As countries worldwide open up non-essential travel, lifting travel bans, many of them are only allowing fully vaccinated individuals to enter their country.
Phase-3 data
The WHO was said to be delaying its approval as the Hyderabad-based Bharat Biotech had not published its data from the final analysis of Covaxin until last week.
Sharing the final phase-3 pre-print data on medRxiv on 3 July, the company claimed that its vaccine demonstrates overall efficacy of 77.8% against symptomatic infection.
Additionally, Bharat Biotech said that Covaxin provides 65.2% protection against the B.1.617.2 (Delta) variant, which is currently dominant in India.
In what it called "India's largest efficacy trial", over 25,798 participants between 18 and 98 years of age were recruited from 16 November year to 7 January 2021.
The company said 130 cases of symptomatic Covid-19 infections were reported in 16,973 (0.77%) participants at least two weeks after the second dose -- 24 occurred in the vaccine group and 106 in placebo recipients giving an overall vaccine efficacy of 77.8%.
In addition to this, 16 cases, one vaccinee and 15 placebo recipients met the severe symptomatic Covid-19 case definition giving a vaccine efficacy of 93.4%.
After the pre-print submission, National Technical Advisory Group on Immunisation (NTAGI) Chief Dr NK Arora said that these results will help the vaccine get recognition from the WHO.
"It is good that these results have finally been published and this will help to get Covaxin the WHO emergency use listing. People who have been administered Covaxin in India will be able to travel without restrictions," Arora was quoted as saying by ANI.
Covaxin has received emergency use authorizations in 16 countries including, Brazil, the Philippines, Iran and Mexico.
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