'Covaxin approval to be finalised in 4-6 weeks', says WHO chief scientist Dr. Swaminathan

In a boost for India's indigenous COVID vaccine Covaxin, WHO Chief Scientist Dr. Soumya Swaminathan anticipated that a decision on WHO's approval for the vaccine will be done in the next 4-6 weeks. Addressing a webinar on vaccine access across the world on Friday, Dr. Swaminathan, said that the vaccine's phase-3 trial data was encouraging and looked good. Covaxin clocks an overall efficacy 77.8% as per the phase-3 trial data released by Bharat Biotech (BBL).

WHO to decide on Covaxin's approval in 4-6 weeks

"Bharat Biotech has already started submitting the data and the dossier is being assessed. It is the next vaccine to be reviewed by our committee. There will be a decision on inclusion in the next four to six weeks,” said Dr Swaminathan. BBL has already applied for WHO's Emergency approval for Covaxin 

"I think the Phase-3 trial data is good and encouraging. The overall efficacy is high while efficacy against the Delta variant is comparatively low, but it's still very good. So all indications are that the efficacy and safety profile are meeting the WHO benchmarks," she added.

Covaxin clocks 77.8% efficacy

On 2 July, BBL finally published Covaxin's phase-3 trial putting an end to all speculations.  Clocking an overall efficacy of 77.8%, Covaxin is 93.4% efficacious against severe symptomatic cases, 78% effective against mild and moderate cases and 63% effective on asymptomatic cases. The vaccine has also shown 65.2% efficacy against the Delta variant of COVID-19 with the vaccine being well tolerated with no clinically or statistically significant differences in serious adverse events. Covaxin has been tested on 25,800 volunteers across 25 trial sites on subjects ages 18-98 years - India's largest efficacy trial.

The COVAXIN journey

In March, Bharat Biotech said that its COVID-19 vaccine - Covaxin - a Whole Virion Inactivated Corona Virus Vaccine - has shown an interim clinical efficacy of 81% in its Phase 3 trials. The phase 3 trials involved 25,800 subjects and is the largest ever trial conducted in India. COVAXIN has been granted permission for restricted use in an emergency situation by the DGCI in January 3. Union Health Minister Dr. Harsh Vardhan explained that COVAXIN is more likely to work against newer variants like N501Y Variant (UK variant) and the recent double mutation (Indian variant). Amid heavy politicisation, Centre roped in several PSUs to produce Covaxin and approved an advance payment of Rs 1500 crores to BBL to ramp up COVID-19 vaccine production.

BBL has informed that Covaxin will even undergo phase-4 trials to check the real-world effectiveness of the vaccines to meet every rigorous scientific standard for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. Centre has capped vaccine prices at Covishield Rs 780 per dose, Covaxin Rs 1,410 and Sputnik V Rs 1,145, while vaccines are provided free of cost at govt centres from June 21 as Covaxin is supplied to Centre at Rs 150. India has ordered an additional 19 crore Covaxin doses till September 2021, while Covaxin awaits WHO's approval.