India Covid-19 update: Govt may approve vaccine with 50% efficacy, Sputnik V trials soon2 min read . Updated: 22 Sep 2020, 07:22 PM IST
- India is hosting clinical trials for all the major vaccine contenders
- Serum Institute of India has started manufacturing Covid-19 vaccine candidate developed by Codagenix Inc, the US biotech said in a statement
Amid the race to develop a potential vaccine against the novel coronavirus, India's drug regulator today said that it plans to approve Covid-19 vaccines for that can provide immunity to at least 50% of the participants in phase clinical trials, according to a Mint report.
The development comes in the backdrop of both World Health Organisation's and US Food and Drug Administration’s benchmarks that says that a coronavirus vaccine must prove to be at least 50% more effective than a placebo in a large-scale trial to be considered for approval.
Here are the major developments on the manufacturing and clinical trials of Covid-19 vaccines in India:
- “To ensure that a widely deployed COVID-19 vaccine is effective, the primary efficacy endpoint estimate for a placebo-controlled efficacy trial should be at least 50%," the Central Drugs Standard Control Organization (CDSCO) said in its draft regulatory guidelines for vaccine development, with special consideration for covid-19 vaccine issued on Monday, reported Mint.
- The Indian regulator has also clarified that people who have been infected with the novel coronavirus, SARS-CoV-2, earlier should be allowed to participate in trials as long as they did not have acute Covid-19 or other acute infectious illnesses.
- Reddy's Laboratories Ltd, which has recently been roped in for Covid-19 vaccine manufacturing, said that it could begin late-stage clinical trials of Russia's potential coronavirus vaccine in the next few weeks, an executive said.
- Indian trials of the Sputnik-V vaccine candidate, being developed by Russia's sovereign wealth fund, will enroll 1,000-2,000 participants and be conducted at multiple government and private hospitals across the country, Deepak Sapra, CEO for API and pharmaceutical services at Dr. Reddy's, told Reuters.
- Moreover, the phase-III or the last stage of clinical trial of the Covid-19 vaccine 'Covishield', being developed by Oxford University, and manufactured by the Serum Institute of India (SII), began on Monday at the state-run Sassoon General Hospital in Pune, Maharashtra on Monday, a senior official said.
- The Covishield vaccine will be administered as a dose to 150 to 200 volunteers, official had said.
- India’s indigenous vaccine developers Bharat Biotech International Ltd. are at the second-phase human trial stage and Zydus Cadila is in the process to receive approvals for conducting third-phase clinical trials.
- Meanwhile, SII has started manufacturing Covid-19 vaccine candidate developed by Codagenix Inc, the US biotech said in a statement.
- Dubbed as CDX-005, the coronavirus vaccine candidate has completed pre-clinical animal studies. The drug maker aims to initiate phase I clinical trial of its COVID-19 vaccine in the United Kingdom by the end of this year.
- A vaccine for the coronavirus will likely be ready by early 2021 but rolling it out safely across India’s 1.3 billion people will be the country’s biggest challenge in fighting its surging epidemic, a leading vaccine scientist told Bloomberg.