Ready to Introduce COVID Vaccine Within 10 Days of Approval: Govt
The Serum Institute of India-manufactured Covishield and Bharat Biotech’s Covaxin were given approval on Sunday.
Addressing a press conference on Tuesday, 5 January, the Union Health Ministry said that they would be able to introduce the COVID-19 vaccine within ten days of emergency use authorisation, based on dry run feedback. However, the final call will be taken by the government.
The Serum Institute of India-manufactured ‘Covishield’ and Bharat Biotech’s ‘Covaxin’ were both given emergency approval on Sunday by the drugs regulator, which means that India should be prepared to roll out the first shots of the COVID-19 vaccine on 13 January.
Covidshield’s clinical trials revealed that it showed an acceptable safety profile among 1,077 participants, and homologous boosting increased antibody responses in Phase 1.
In Phase 2, prime-boost regimen in 560 participants was better tolerated in older adults than in younger adults and had similar immunogenicity across all age groups after a boost dose. Phase 3 revealed that the overall vaccine efficacy was 70.4 percent.
MohFW also informed that while Covaxin’s third phase is still underway, the first two phases of its clinical trials revealed that it had very low adverse events, neutralised antibody responses equivalent to human convalescent serum and showed strong antibody responses to all structural proteins.
At the press conference, Health Secretary Rajesh Bhushan said, speaking about India’s condition, that active cases are below 2.5 lakh after six months.
Meanwhile, the number of daily deaths has been less than 300 for 11 consecutive days, while cumulative positivity rate is 5.87 percent and positivity rate during last week was 1.97 percent.
On the process of rolling out, the health ministry informed that existing logistics management and real-time remote temperature monitoring has been implemented across 29,000 cold chain points as part of the the CO-WIN vaccine delivery management system.
Field tests were conducted in Andhra Pradesh, Assam, Gujarat & Punjab with the objective of assessing planning and preparations of COVID-19 vaccination as per guidelines and end-to-end testing of Co-WIN, and all states and union territories undertook large-scale dry runs, MohFW said.
The dry runs verified all proposed sites for adequacy of space, logistical arrangements, internet connectivity, electricity, safety, etc; vaccinators were identified and trained and all SOPs and protocols related to operationalisation of COVID-19 vaccination followed.
The objective of the run was also to identify possible challenges and address them before implementation, as well as provide confidence to programme managers at various levels.
The Ministry of Health, Commerce, Promotion of Industry and Internal Trade and DG of Foreign Trade also expressed that they have not made any change to the rules, and hence, export of vaccines will still be allowed.
In terms of new UK variant of SARS-CoV-2, the health ministry said that it has “not seen emergence of any untoward clusters in country as of now which is reassuring.”
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