Emergency use authorization for COVID-19 vaccine to depend on clinical trial data; roll-out of FELUDA test expected in next few weeks: Vardhan

Union Health Minister Harsh Vardhan on Sunday said  government has t yet taken a view on granting emergency authorisation to COVID-19 vaccines in India, as and when y become available. minister also said that Feluda paper strip test for SARS-CoV-2 diagsis could be rolled out in next few weeks.Presently COVID-19 vaccines are in various sts of phases 1, 2 and 3, results of which are awaited, Vardhan said during an interaction with his social media followers on 'Sunday Samv' platform.

"equate safety and efficacy data is required for emergency use authorisation, vaccine approval for ensuring patient safety. Furr course of action will depend on data generated," he underlined.

Categorically denying speculation that government is prioritizing young and working-class for COVID-19 vaccine for ecomic reasons, Vardhan said, “ prioritisation of groups for COVID-19 vaccine shall be based on two key considerations -- occupational hazard and risk of exposure to infection, and risk of developing severe disease and increased mortality.”

On issue of how government plans to roll out COVID-19 vaccine, he said that it is anticipated that supplies of vaccines would be available in limited quantities in beginning.In a huge country like India, it is critical to prioritise vaccine delivery based on various factors such as risk of exposure, comorbidity among various population groups, mortality rate among COVID-19 cases, and several ors,  minister said.He also ded that India is looking at availability of several different s of vaccines, of which some may be suitable for a particular group while ors may t be.

He reiterated that most important component of planning is cold chain and or logistics to ensure glitches occur in vaccine delivery even at last mile.Vardhan highlighted need for massive vocacy for building community sensitization activities to understand reasons for vaccine hesitancy and dress m appropriately.

On rollout of Feluda test in near future, he said that based on tests in over 2,000 patients during trials at Institute of Gemics and Integrative Biology (IGIB) and testing in private labs, test showed 96 pc sensitivity and 98 pc specificity.This compares favourably to ICMR's current acceptation criteria of RT-PCR Kit of at least 95 pc sensitivity and at least 99 pc specificity, he stated.

He ded that Feluda paper strip test for SARS-CoV-2 diagsis has been developed by CSIR-IGIB and has been approved by Drug Controller General of India for a commercial launch.

" kit has alrey been validated by Department of Atomic Energy's National Centre for Biological Sciences, Bangalore.While I cant put an exact date on availability, we should expect this test within next few weeks,"  he said.

Referring to reports of reinfection surfacing in various states, Vardhan said an analysis by ICMR has revealed that many cases reported as COVID-19 reinfection have been misclassified because RT-PCR tests can detect de-virus shed for prolonged periods after recovery.

“Actual reinfection would mean a fully recovered person getting infected by a freshly introduced virus in his/her body, belonging to same or different strain. ICMR is commissioning a study to understand true burden of re-infected cases. Results will be shared in a couple of weeks,"  he said. 

(IM CREDITS:PTI)