New Delhi: The phase-I human clinical trial of India's first indigenously-developed vaccine against novel coronavirus, Covaxin, began at the AIIMS, Delhi on Friday with the first dose of the injection to a man, who is in his 30s.
Already, over 3,500 volunteers have registered themselves for the trial at AIIMS since last Saturday, of whom the screening of at least 22 people is underway, said Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS and the principal investigator of the study. "The first volunteer, a resident of Delhi, was screened two days ago and all his health parameters were found to be within the normal range. He also does not have any co-morbid conditions.
"The first dose of 0.5 ml intramuscular injection was given to him around 1.30 pm. No immediate side-effects have been observed so far. He was under observation for two hours and will be monitored for the next seven days," Rai said. Few more participants would be given the vaccine on Saturday after screening reports. AIIMS-Delhi is among the 12 sites selected by the Indian Council for Medical Research (ICMR) for conducting phase I and II randomised, double-blind, placebo-controlled clinical trials of Covaxin.
Covishield by first quarter of next year: Adar Poonawalla
In an interview with IANS, Adar Poonawalla, CEO, Serum Institute of India (SII) said as per the arrangement with AstraZeneca, SII will be making one billion doses of Covishield vaccine over the next year for India and other low-and-middle-income countries (GAVI countries).
"We will start producing a few millions of doses at a personal risk. Based on the success of the trials, we are expecting to launch it by the end of this year. I believe by the first quarter of the next year it will start reaching the masses", Poonawalla said.
"Once we get necessary regulatory approvals, we will start manufacturing in large volumes. We will manufacture about 60-70 million doses per month (which might stretch to 100 mn doses later). With this, we are looking to manufacture around 300-400 million doses by the end of this year", Poonawalla said.
“The Phase 3 clinical trials are expected to commence in India in August. For the Phase 3 trials, we plan to look at 4-5,000 patients in India,” he said. On the pricing of the vaccine, he said, "We will keep it under Rs1,000.”
Dept of Biotech provides seed fund for vaccine candidate
The Department of Biotechnology on Friday said it has provided seed funding for the development of Gennova's novel self-amplifying mRNA-based vaccine candidate for Covid-19. In collaboration with HDT Biotech Corporation, US, Gennova has developed an mRNA vaccine candidate (HGCO19), with demonstrated safety, immunogenicity, neutralisation antibody activity in the rodent and non-human primate models. The firm is working aggressively to ensure first injection by year-end, subject to Indian regulatory approvals.
Arrivals through flights
under air bubbles
All international passengers arriving through flights arranged under air bubbles are subjected to 2 layers of health screening besides a mandatory 7-day institutional quarantine at their own cost followed by a 7-day home quarantine, officials said.
Neuberg Diagnostics gets nod for testing in Kerala
Neuberg Diagnostics Private Limited has received approval from the Indian Council of Medical Research (ICMR) for Covid-19 testing in Kerala. Neuberg, India's fourth largest pathology player, had earlier received approvals for Covid testing in Ahmedabad, Bengaluru, Chennai and Pune, it said.
Mass Cremation Of 50 COVID-19 Patients In Hyderabad
In a shocking incident, the bodies of over 50 Covid-19 patients were burnt in mass cremation in Hyderabad due to a lack of transportation and issues with manpower. A viral video on social media showed the mass cremation of Covid-19 patients at the ESI Hospital crematorium, creating a huge outrage. Telangana Director of Medical Education Dr K Ramesh Reddy said over 50 bodies were cremated at a time due to “lack of transportation.” Congress MLA Seethakka tweeted, “The reported Corona deaths are said to be 7 by Govt whereas over 30 bodies were cremated at ESI graveyard only. The govt from the beginning providing us wrong statistics to hide incapability in controlling the virus.”