Hyderabad: After successful completion of Phase 1&2 clinical trials of COVAXIN, Bharat Biotech initiates Phase 3 trials in more than 25000 participants in over 25 centres across India.
An expert panel at the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission for conducting phase 3 clinical trials of its indigenously developed COVID-19 vaccine with certain conditions.
The recommendation was given after assessing the safety and immunogenicity data of phase 1 and 2 clinical trials and have been sent to the Drugs Controller General of India (DCGI) for final approval, official sources said.
The vaccine -- 'Covaxin' -- is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Hyderabad-based vaccine maker had on October 2 sought the DCGI's permission to conduct phase 3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine.
Meanwhile, India on Thursday reported 55,839 fresh new infections and 702 deaths. The total active coronavirus case load stands at 6,95,509 and 69,48,497 patients have been cured and discharged till date. The death toll is pegged at 1,17,306.
The US Food and Drug Administration has approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization.
Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval.
Bihar
Bihar on Friday reported 1,093 new cases of COVID-19, taking the state's tally to 2,10,388, as per a bulletin issued by the Health Department. The state also recorded eight more COVID-19 deaths, following which the toll rose to 1,034, it said.
Two of the latest deaths were reported from Patna, while one each from Muzaffarpur, Nalanda, Jehanabad, Begusarai, Purnea and Saran, it said. The Patna district, which has reported 34,055 cases so far with 2,532 patients undergoing treatment at present, has registered the highest number of COVID-19 deaths in the state
at 256.
Delhi
Delhi Chief Minister Arvind Kejriwal Friday laid the foundation stone for construction of a 1500-bed block at Lok Nayak Jai Prakash (LNJP) Hospital.
The Delhi government-run hospital has 2,000 beds at present, all of which have been dedicated for coronavirus patients.
Kejriwal hailed the "corona warriors" of the LNJP, who have either lost their lives or continue to serve in the frontline.
The cost of RT-PCR test for Covid-19 is likely to be reduced by Delhi government to encourage more people to get themselves tested.
Odisha
Even as coronavirus cases in Odhisha continued to show a declining trend, the state's death toll surpassed the 1,200-mark when 18 more patients succumbed to the deadly virus in the last 24 hours, a health official said on Friday.
The total cases climbed up to 2,77,887 as 1,793 more cases were reported in the last 24 hours, said the official. The death toll is 1,214 in Odisha.
Odhisha's active cases now total 19,579, whereas 2,57,041 patients have recovered so far.
Khordha, Angul and Gajapati districts reported three deaths each while two each died in Jajpur and Mayurbhanj districts. One COVID-19 patient each succumbed in Bhadrak, Dhenkanal, Malkangiri, Nabarangpur, and Puri districts.
Karnataka
Karnataka has reported 5,356 new cases of COVID-19 and 51 more deaths, taking the total number of infections to 7,93,907 and the toll to 10,821, the health department said on Friday. The day also saw 8,749 patients getting discharged after recovery. A total of over 71,68,545 samples have been tested so far, out of which 1,08,356 were tested on Friday alone, and 21,615 among them were rapid antigen tests. Out of 5,356 fresh cases reported today, 2,688 cases were from Bengaluru urban alone.
Goa
Health authorities in Goa have achieved a 70 per cent success rate with the combination of antiviral Remdesivir, plasma and steroid treatment for Covid-19 patients, Health Minister Vishwajit Rane said on Friday and added that the state government would continue the successful treatment protocol.
Rane also said that the state would beef up its testing apparatus to conduct between 2,000 to 2,500 tests a day, to get a comprehensive picture of the pandemic status, which has claimed 564 lives in the coastal state so far.
"Remdesivir has been approved by the FDA (US Food and Drug Administration), as one of the drugs for Covid-19. In Goa, we have also found that plasma in a combination with Remdesivir and maybe in a certain proportion with steroids, has given us excellent results. So, we are going ahead with this protocol as far as Goa is concerned," Rane told a press conference in Panaji.
The Health Minister said that Remdesivir should be administered to patients immediately after admission for best results.
Rajasthan
Fourteen more people died from coronavirus in Rajasthan on Friday and as 1,815 fresh cases took the state's infection count to 1,82,570. So far, 1,814 people have died from the infection in Rajasthan, according to an official report.
Two fatalities were reported from Jaipur and Jodhpur while Ajmer, Alwar, Bharatpur, Bikaner, Ganganagar, Jalore, Kota, Nagaur, Sikar and Udaipur reported one death each. Of the 1,815 fresh cases, 339 were reported from Jaipur followed by 296 in Jodhpur, the report said.
Telangana
Telangana reported 1,421 new COVID-19 cases taking the tally to 2,29,001 while six more deaths pushed the toll to 1298, the state government said on Friday. In a milestone, the state has conducted over 40 lakh COVID-19 tests so far.
Greater Hyderabad Municipal Corporation (GHMC) accounted for the most number of cases with 249, followed by Medchal Malkajgiri (111) and Rangareddy (97) districts, it said in a bulletin, providing data as of 8 PM on October 22. As many as 20,377 are under treatment and 38,484 samples were tested on October 22.
Cumulatively, 40, 17,353 samples have been tested.
Jammu and Kashmir
As many as 586 more persons tested coronavirus positive in Jammu and Kashmir on Friday, taking its total tally to 90,752 and active cases to 7,842.
The Information and Public Relations Department said that 206 new cases were reported from Jammu division and 380 from Kashmir division. In all, 684 more patients were cured and discharged from hospitals, taking the total recoveries to 81,486 in the Union Territory.
With 12 more COVID-19 fatalities, the death toll due to the disease increased to 1,424. Of the active cases, 2,581 patients are in Jammu division and 5,261 in Kashmir division.
READ: Bharat Biotech gets final nod to conduct Phase 3 trails of COVAXIN
