The union health ministry last week conducted a nationwide mock drill of the vaccination program at 285 session sites to test the end-to-end planned operations and the mechanism set up to ensure smooth vaccination for the highly infectious disease
India’s covid-19 vaccination programme, what Prime Minister Narendra Modi said is going be the largest in the world, will be rolled out by January 13, centre said on Tuesday.
Indicating the government’s plan for a speedy start of the program, Rajesh Bhushan, Secretary, Ministry of Health & Family Welfare on Tuesday said that the covid-19 vaccine will be rolled out within 10 days of receiving the emergency use authorization. He was speaking at the press conference on status of covid-19 pandemic in the country and government preparations to deal with the ongoing health crisis.
“We are prepared to roll out Covid-19 vaccines within 10 days of granting emergency use authorization date, based on dry run feedback. But the government will only decide the exact date of the roll out of the vaccination program," said Bhushan.
The union health ministry last week conducted a nationwide mock drill of the vaccination program at 285 session sites to test the end-to-end planned operations and the mechanism set up to ensure smooth vaccination for the highly infectious disease. The government has said that it will use the digital platform, Co-WIN for providing real time information of vaccine stocks, their storage temperature and individualized tracking of beneficiaries of the covid-19 vaccine.
Bhushan elaborated about the existing logistics management involved and to be adopted in the vaccination chain. The vaccine is transported under refrigerated condition and digitally tracked during transit i.e. manufacturer to primary vaccine store to State vaccine store to District Vaccine store to Primary Health Centre. "Manufacturers first transport the vaccines to the four Primary Vaccine Stores, at Karnal, Mumbai, Kolkata and Chennai; from there it is transported in bulk to the 37 State Vaccine Stores for further dissemination. There are temperature trackers inside all Primary Vaccine Stores, State Vaccine Stores and District Vaccine Stores and information is uploaded on a real-time basis about temperature inside the facility on to a central server," Bhushan added.
Once the vaccine reaches the Sub centre Session Site, there is a requirement for beneficiary registration, on the basis of which District Magistrate can allocate the session based on the requirements, Bhushan said. "There is no need for beneficiary registration of healthcare and frontline workers as their data will be taken from a bulk database that has been populated onto the CO-WIN Vaccine Delivery Management System," the health secretary said.
“At Session Allocation, details of vaccination to the beneficiary, information about the next dose will be captured and communicated digitally. "CO - WIN will also give permission to create a Unique Health ID. After both doses a QR code certificate will also be generated which can be stored on Government's DigiLocker app", he added.
He also said that in case of any Adverse Effect Following Immunisation, there is a provision for real time reporting. Other features include SMS in 12 languages, 24X7 helpline, Chat Bot assistance etc. As of now more than 90,000 users have been trained in more than 700 districts. “No major issues were observed in operational aspects of the program. Minor issues noted in Co-WIN for further enhancement which have been addressed. All States expressed confidence in the operational guidelines and IT platform for large scale programme implementation. We have also done multiple dry run for the software," said Bhushan.
The government on January 3 announced that the Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) has granted permission for restricted emergency use of Pune based Serum Institute of India’s vaccine (Covishield), subject to multiple regulatory conditionalities and permission of restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strain, to Bharat Biotech International Ltd., Hyderabad for its vaccine Covaxin.
Amidst the controversy over lack of efficacy data on Covaxin, Dr Balram Bhargava, director general at the Indian Council of Medical Research (ICMR) clarified that the emergency use authorisation of the two vaccines by the drug regulator and said that safety, efficacy and immunogenicity data are required for approval or a vaccine in a non- emergency situation. “The existing pandemic situation with high mortality available science, and a lack of definite and treatments are considered by SEC for accelerated approval. It is in our legal provision in a pandemic situation, restricted use is considered based on safety and immunogenicity data while phase three is still ongoing immunogenicity data generated through phase two clinical trial serves as a surrogate for efficacy," said Bhargav.
“The clinical trial rule, 2019, the Clinical Trial Registry (CTR) provides for considering phase two results to guide approval. This subject expert committee guides the drug controller general of India in the process of decision making for restricted use under emergency situation," he said. While Pune-based Serum Institute of India (SII) is manufacturing Covishield which is developed by Oxford University and pharma giant AstraZeneca, Covaxin-- is developed by Bharat Biotech in association with the country’s apex biomedical research body ICMR.
Bhargava said that covidshield is safe and immunogenic and its data shows that it is non inferior to UK product. For Covaxin, the ICMR chief said that the Phase 1 and 2 clinical trial showed very low adverse events, T cell memory response and in the Phase 3 clinical trial with 25,800 participants there were no safety concerns. “There will be a restricted use in clinical trial mode with consent of the vaccine taker with follow ups," said Bhargava.
Covid-19 vaccination is expected to reduce the disease burden in India which is currently at the second spot in the world after the USA in terms of the covid-19 cases. The total tally of covid-19 cases on Tuesday climbed to 1,03, 58,056 and the toll has increased to 1,51,057. India reported 16,375 new cases of covid-19 in last 24 hours. Also, the total number of cases infected with the new strain of the novel Coronavirus first reported in the UK now stands at 71.
Of all the covid-19 cases, 10 States/UTs have contributed 80.05% of the new cases, the union health ministry said. Maharashtra reported 4,875 cases in the last 24 hours. Kerala recorded 3,021 new cases while Chhattisgarh reported 1,147 daily cases yesterday. Also, 70.15% of the total 201case fatalities that have been reported in the past 24 hours are from Ten States/UTs. At least 14.42% of new fatalities reported are from Maharashtra which reported 29 deaths. West Bengal and Punjab also saw a fatality count of 25 and 24 contributing another 12.44% and 11.94% of the fatalities, the health ministry said.
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