The emergency use authorization for the Covid-19 vaccine will depend on data from clinical trials: Harsh Vardhan | India News


NEW DELHI: Union Health Minister Harsh Vardhan said Sunday that the government has yet to comment on granting an emergency authorization to Covid-19 vaccines in India, as they become available.
The minister also said that the Feluda paper strip test for the diagnosis of SARS-CoV-2 could be implemented in the coming weeks.
Currently, Covid-19 vaccines are in various stages of phases 1, 2 and 3, the results of which are expected, Vardhan said during an interaction with his social media followers on the ‘Sunday Samvad’ platform.

“Adequate safety and efficacy data are required for authorization of emergency use, approval of the vaccine to ensure patient safety. The further course of action will depend on the data generated,” he stressed.
Categorically denying the speculation that the government is prioritizing the youth and working class for the Covid-19 vaccine for economic reasons, Vardhan said: Group prioritization for the Covid-19 vaccine will be based on two key considerations: occupational hazard. and risk of exposure. to infection and the risk of developing severe disease and increased mortality.
On the question of how the government plans to roll out the Covid-19 vaccine, he said that vaccine supplies are anticipated to be available in limited quantities at first.

In a huge country like India, it is critical to prioritize vaccine delivery based on various factors such as risk of exposure, comorbidity among various population groups, the mortality rate among Covid-19 cases, and several others, “he said the minister.
He also added that India is looking at the availability of several different types of vaccines, some of which may be suitable for a particular age group, while others may not be.
He reiterated that the most important component of planning is the cold chain and other logistics to ensure there are no vaccine delivery failures, even in the last mile.
Vardhan highlighted the need for massive advocacy for building community awareness activities to understand the reasons for vaccine concerns and address them appropriately.

On launching the Feluda test in the near future, he said that, based on tests on more than 2,000 patients during testing at the Institute for Genomics and Integrative Biology (IGIB) and tests in private laboratories, the test showed a sensitivity of 96 pc and 98 pc specificity.
This compares favorably with current ICMR PCR kit acceptance criteria 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 Comptroller General of Drugs of India for a commercial launch.
“The kit has already been validated by the National Center for Biological Sciences of the Department of Atomic Energy in Bangalore. Although I cannot put an exact date on availability, we should expect this test in the coming weeks,” he said.
Referring to reports of reinfection arising in various states, Vardhan said an ICMR analysis has revealed that many cases reported as Covid-19 reinfection have been misclassified because PCR tests can detect the spread of dead viruses over extended periods after recovery.
Actual reinfection would mean that a fully recovered person would be infected by a virus just introduced into their body, belonging to the same or different strain. ICMR is commissioning a study to understand the true burden of reinfected cases. The results will be shared in a couple of weeks, “he said.

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