New Delhi:
Health Minister Harsh Vardhan said on Sunday that the government has yet to take action on granting emergency clearance for COVID-19 vaccines in India, as they become available.
The minister also said the locally developed Feluda paper strip test for the diagnosis of SARS-CoV-2 could be rolled out in the coming weeks.
Currently, COVID-19 vaccines are in various stages of phases 1, 2 and 3 of human clinical trials, the results of which are pending, Vardhan said during an interaction with his social media followers on the fifth episode. of the “ Sunday Samvaad ” platform.
“Adequate safety and efficacy data is needed for emergency use authorization, vaccine approval to ensure patient safety. Further action will depend on the data generated,” he said. -He underlines.
The minister had previously said that a COVID-19 vaccine would likely be available by the first quarter of 2021.
Categorically rejecting speculation that the government is prioritizing young people and the working class for the COVID-19 vaccine for economic reasons, Mr Vardhan said: “The prioritization of groups for the COVID-19 vaccine must be based on two key considerations – the occupational hazards and the risks of exposure to infection, and the risk of developing serious illness and increased mortality. “
Asked how the government plans to roll out the COVID-19 vaccine, he said it was expected that vaccine stocks would be available in limited quantities initially.
“In a large country like India, it is essential to prioritize the administration of vaccines based on various factors such as risk of exposure, co-morbidity between various population groups, death rate among cases of COVID-19 and several others, ”said the Minister.
He also added that India is studying the availability of several 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 the planning was the cold chain and other logistical means to avoid any vaccine delivery problem, even at the last mile.
Regarding the need to include other COVID-19 vaccine candidates, Mr Vardhan said given the large population size of India, a vaccine or vaccine manufacturer will not be able to respond to immunization requirements across the country.
“Therefore, we are open to evaluating the feasibility of introducing several COVID-19 vaccines in the country according to their availability for the Indian population,” he said.
Sharing his perspective on public-private partnership during the pandemic, Vardhan said the current situation requires multiple vaccine partners to ensure maximum immunization coverage for the Indian population.
He also said the use of a single vaccine from a certain company shouldn’t be seen through a negative lens.
Mr. Vardhan also highlighted the need for massive advocacy for building community outreach activities to understand the reasons for vaccine reluctance and address them appropriately.
Regarding the deployment of the Feluda test, he said that based on testing more than 2,000 patients during testing at the Institute of Genomics and Integrative Biology (IGIB) and testing in private laboratories, the test showed “A sensitivity of 96 pc and a specificity of 98 pc. “
This compares favorably with the current ICMR acceptance criteria of the RT-PCR kit of at least 95 pc in sensitivity and at least 99 pc in specificity, he said.
He added that the Feluda paper strip test for the diagnosis of SARS-CoV-2 was developed by CSIR-IGIB and has been approved by the Drug Controller General of India for commercial launch.
“The kit has already been validated by the National Center for Biological Sciences of the Department of Atomic Energy in Bangalore.” While I can’t put an exact date on availability, we should expect that test in the next few weeks, ”he said.
Referring to reports of reinfection surfacing in various states, Vardhan said an ICMR scan found that many cases reported as COVID-19 reinfection have been misclassified because RT-PCR tests can detect the dead virus for long periods after healing.
“Actual reinfection would mean that a fully recovered person would be infected with a virus freshly introduced into their body, belonging to the same strain or a different strain. CIMR commissions study to understand the true burden of re-infected cases. The results will be shared in a few weeks, ”he said.
Vardhan explained that the phase 1 trials for vaccines are primarily aimed at establishing the safety of the product, while the phase 2 clinical trial measures immunogenicity as a primary endpoint and safety as a secondary endpoint.
In phase 3 clinical trials, safety and immunogenicity continue to be measured as secondary endpoints, with efficacy being the primary endpoint in this phase of a clinical trial.
Currently, two locally developed candidate vaccines, one by Bharat Biotech in collaboration with ICMR and the other by Zydus Cadila Ltd, are in phase 2 human clinical trials.
The Pune-based Serum Institute of India, which has partnered with AstraZeneca to manufacture the Oxford COVID-19 vaccine candidate, is also conducting phase 2 and 3 human clinical trials on the candidate in India.
During the “Sunday Samvaad” conversation, Mr Vardhan shared that in the first phase, the Indian government released Rs 3,000 crore to states and UTs to combat the COVID-19 pandemic.
Almost all except three states and UT used the full grant they were given: Maharashtra only used 42.5% of the grant, followed by Chandigarh at 47.8% and Delhi at 75.4%, he said.
In view of upcoming festivals, Mr Vardhan urged people to stay away from congregations and diligently follow appropriate COVID behavior, saying “No religion or God says you have to celebrate a festival in such a way. ostentatious”.
(Except for the title, this story was not edited by GalacticGaming staff and is posted from a syndicated feed.)