Thursday, January 16, 2025
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‘Emergency authorisation for vaccine to depend on clinical data’

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New Delhi: Union Health Minister Harsh Vardhan on Sunday said the government has not yet taken a view on granting emergency authorisation to COVID-19 vaccines in India, as and when they become available.
The minister also said that the indigenously developed Feluda paper strip test for SARS-CoV-2 diagnosis could be rolled out in the next few weeks.
Presently 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 during an interaction with his social media followers on the fifth episode ‘Sunday Samvaad’ platform.
“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,” he underlined.
The minister had earlier said that a COVID-19 vaccine is likely to be available by the first quarter of 2021.
Categorically rejecting speculation that the government is prioritizing young and working-class for the COVID-19 vaccine for economic reasons, Vardhan said, 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.
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.
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.
He reiterated that the most important component of the planning is the cold chain and other logistics to ensure no glitches occur in vaccine delivery even at the last mile.
On the need to include other candidates of COVID-19 vaccine, Vardhan said considering the large population size of India, one vaccine or vaccine manufacturer will not be able to fulfil the requirements of vaccinating the whole country.
Sharing his views on public-private partnership during the pandemic, Vardhan said that the present situation demands multiple vaccine partners to ensure maximum vaccination coverage to the Indian population.
He also said that the use of a single vaccine from a certain company should not be seen through a negative lens.
Vardhan also highlighted the need for massive advocacy for building community sensitization activities to understand the reasons for vaccine hesitancy and address them appropriately.
On the rollout of the Feluda test, he 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. (PTI)

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