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Friday, March 29 2024
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Will the August 15th Deadline for a vaccine be met? If so how?

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New Delhi: Approval for human clinical trials for two made-in-India COVID-19 vaccine candidates – COVAXIN and ZyCov-D – marks the “beginning of the end” for the novel coronavirus pandemic that has infected over 1.12 crore people worldwide and left more than 5.3 lakh dead, the government said on Sunday. The letter by the Ministry of Science and Technology said there were more than 100 vaccine candidates in the world currently, of which 11 were in human trials. “The nod by Drug Controller General of India, CDSCO (Central Drugs Standard Control Organisation), for the conduct of human trial for vaccines, marks the beginning of the end,” the ministry’s letter added. “Six Indian companies are working on a COVID-19 vaccine. Along with two Indian vaccines, COVAXIN and ZyCov-D, the world over 11 out of 140 vaccine candidates are in human trials,” the ministry said.

The ministry also said manufacturers of two of the leading candidates – AZD1222 (British firm AstraZeneca) and mRNA-1273 (US-based Moderna) – had signed production agreements with Indian companies should their vaccines prove safe and effective. Both have been approved for Phase II, III trials. Normally, the first two phases of drug trials test for safety while the third tests the medicine’s efficacy. Each phase can take months, or even years, to be completed.

COVAXIN, developed by Hyderabad-based Bharat Biotech, and ZyCov-D, developed by Zydus Cadila, were approved for Phase I, II trials this week. Phase I trials for COVAXIN, which was developed in association with the ICMR, are scheduled to be completed in 28 days – which would put the vaccine candidate on track for an August 15 release. But it is not clear how they will bypass Phase II and III which typically could take months.

The government was targeting August 15 for a big announcement about the availability of the vaccine and the letter by the ICMR (Indian Council for Medical Research) setting August 15 – Independence Day – as the target for releasing a coronavirus vaccine kicked up a row in the media, scientific fraternity, and the opposition. According to an article in the NDTV.com an earlier version of the letter included this line: “None of these (the 11 coronavirus vaccines undergoing human trials) are likely to be ready for mass use before 2021”. The line was deleted in an edited version o of the letter released shortly afterward.

ICMR clarified on Saturday that the only objective was to “cut unnecessary red tape, without bypassing any necessary process” in the recruitment of participants for the trial. “ICMR’s process is exactly in accordance with globally accepted norms to fast-track vaccine development…,” the agency said.

Developer Bharat Biotech’s application, accessed by NDTV, lists 15 months as the estimated duration of clinical trials; this is in line with the 2021 estimate by the Ministry of Science that was present in the first version of the letter.

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