Drug controller hints vaccine approval will make it a 'happy new year'

V G Somani's statement comes even as subject expert committee is set to meet on Jan 1 to consider three emergency-use authorisation applications

India could start the new year with an approved Covid vaccine, the country's drug regulator indicated on Thursday even as the subject expert committee would meet on January 1 to consider three emergency-use authorisation applications including Serum Institute of India, Bharat Biotech and Pfizer-BioNtech. 

“Probably we will have a happy new year with something in hand, that’s what I can hint at,” said V G Somani, Drug Controller General of India speaking at a webinar on the science of vaccine development. 

Somani assured that processes were fast tracked by allowing parallel and seamless phase one and two trials and there had been no compromise on the safety or efficacy of the data and. “It has been possible to compress timelines...The only thing is that the regulator has accepted partial data for emergency use authorisation.” he added. 

The regulator has decided to have at least 50 per cent efficacy for a vaccine which is approved, on the basis of international guidance. 

 

He also said that it had been a challenge to handle vaccines on different platforms and have correct chemistry, manufacturing and control data and  validated assay methods. 

“Industry and research organisations have stood the test of time...Along with the department of biotechnology we made a commitment that there will be a rapid response,” Somani said.

Serum Institute of India (SII) has stockpiled 75 million doses of AstraZeneca-Oxford University Covid-19 vaccine, and will be increasing it to 100 million doses by the first week of January, Umesh Shaligram, Director- Research and Development, SII said. “Everyone is looking at us to supply this product...If experts approve we will have the emergency authorisation in the coming few days so we can supply,” Shaligram said.

SII will also soon announce the safety data of Novavax, another indigenously developed vaccine for covid by the company.

India plans to inoculate 300 million people in the first tranche of vaccinations including healthcare workers, frontline workers and those above either 50 years of age or with comorbidities. 

 

“We hope that the ecosystem that we have created and the cultural change that has come in, along with the proactive planning, we are confident that we will be able to take it forward and deliver to the world,” Renu Swarup, secretary, department of biotechnology said while addressing the webinar. 

Swarup said that it is for the first time that a vaccine has been developed in less than 12 months.  till now science and technology was responding to societal needs but now it is delivering due to unique innovation ecosystem and national & international collaborations.

The Subject Expert Committee in the Central Drugs Standard Control Organisation (CDSCO) on Wednesday decided to meet again on January 1 for further analysis of the additional information supplied by Serum Institute and Bharat Biotech. The UK drug regulator approved the Oxford-AstraZeneca vaccine on Wednesday.