New Delhi: Union Health Minister Harsh Vardhan said Sunday the government has not yet taken a view on granting emergency authorisation to COVID-19 vaccines in India, as and when they become available. Harsh Vardhan also said that the indigenously developed ‘Feluda’ paper strip test for SARS-CoV-2 diagnosis could be rolled out in the next few weeks. COVID-19 vaccines are in various stages of phases 1, 2 and 3 of human clinical trials, the results of which are awaited, Vardhan said. He was interacting with his social media followers.
“Adequate safety and efficacy data is required for emergency use authorisation, vaccine approval for ensuring patient safety. Further course of action will depend on the data generated,” Vardhan said. The minister had earlier said that a COVID-19 vaccine is likely to be available by the first quarter of 2021.
Vardhan categorically rejected speculation that the government is prioritising young and working-class for the COVID-19 vaccine. “The prioritisation of groups for COVID-19 vaccine shall be based on two key considerations – occupational hazard and risk of exposure to infection, and the risk of developing severe disease and increased mortality,” Vardhan asserted.
The minister was asked how the government plans to roll out the COVID-19 vaccine. He said that it is anticipated that supplies of vaccines would be available in limited quantities in the beginning.
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“In a huge country like India, it is critical to prioritise vaccine delivery based on various factors such as the risk of exposure, comorbidity among various population groups, the mortality rate among COVID-19 cases, and several others,” the minister said. He also added that India is looking at the availability of several different types of vaccines, of which some may be suitable for a particular age group while others may not be so.
“Therefore, we are open to assessing the feasibility of introducing several COVID-19 vaccines in India as per their availability for the population,” informed Vardhan.
On the rollout of the ‘Feluda’ test, Vardhan said that based on tests in over 2,000 patients during the trials at the Institute of Genomics and Integrative Biology (IGIB) and testing in private labs, the 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 added that the ‘Feluda’ paper strip test for SARS-CoV-2 diagnosis has been developed by CSIR-IGIB and has been approved by the Drug Controller General of India (DGCI) for a commercial launch.
“The kit has already been validated by the Department of Atomic Energy’s National Centre for Biological Sciences, Bangalore. While I cannot put an exact date on the availability, we should expect this test within the next few weeks,” informed Vardhan.