This week India overtook the US in daily addition of new COVID-19 cases. It is worrying. The World Health Organization says that the infection is now spreading in rural areas and among the young. However, there is hope.
The Serum Institute, which is exclusively controlled by a small and fabulously rich Indian family and started out years ago as a horse farm, is doing what a few other companies in the race for a vaccine are doing: mass-producing hundreds of millions of doses of a vaccine candidate that is still in trials and might not even work.
Earlier this week, a committee of experts had deferred a decision on the request of SII to start trials and asked the company to amend its protocol for the clinical study. The subject expert committee (SEC) had recommended eight amendments to be made to the firm's proposal to conduct Phase-II and -III trials.
SII's Oxford vaccine is one of the front runners in the fight against Covid-19. On July 20, researchers at the University of Oxford published their data from Phase 1 and 2 trials of the vaccine candidate. The researchers said the trials involving 1,077 healthy adults found that the vaccine induced strong antibody and T-cell immune responses up to day 56.
Regulators that normally work within their own countries or regions will likely harmonize efforts on potential COVID-19 vaccines to speed up their approvals once they become available, WHO chief scientist Soumya Swaminathan said on Friday. Swaminathan, answering questions on social media platforms, also said testing vaccines for safety and efficacy - usually a years-long process - could be accelerated to just six months in the midst of the pandemic, if data satisfied regulators that they have enough information to issue approvals.Still, she said,
As the Oxford-AstraZeneca's COVID-19 vaccine gains momentum after showing positive results in the initial trials, Serum Institute of India, headed by Adar Poonawalla is all set to conduct trials for the vaccine in India, and begin production of the doses as well. In an exclusive conversation with TIMES NOW's Swati Joshi, Adar Poonawalla talked about Oxford COVID-19 vaccine, its effectiveness and availability, Bharat Biotech-ICMR controversy and more. Listen-in!!!
The licensing agreement, signed between Biocon Biologics’ subsidiary Biocon Sdn. Bhd., Malaysia and Voluntis, would make Biocon Biologics one of the first insulin companies to offer a US Food and Drug Administration-cleared and CE-marked, digital therapeutic product - Insulia - to Type 2 diabetes patients, said Biocon in a press release.
AIIMS Delhi has received an overwhelming response for COVID Human Trials Phase 1 participation. Over 1000 volunteers have sent a request for being part of trials. 100 volunteers to be given the vaccine in the first phase.
“Human trial with Corona vaccine (COVAXIN) of Bharat Biotech started at PGI Rohtak today,” Vij, who is also the Home and Science & Technology minister said. “Three subjects were enrolled today. All have tolerated the vaccine very well. There were no adverse effects,” Vij further said in his tweet.
Zydus Cadila's move to begin human trials of its indigenously developed vaccine candidate for COVID-19 is an important milestone for an 'Atmanirbhar Bharat', Department of Biotechnology Secretary Renu Swarup said.
The company said in the preclinical stage the vaccine was found to be safe, immunogenic and well-tolerated. It was also able to produce neutralising antibodies in animal studies, a key requirement for a vaccine. In the phase-I and II trials, the company will assess the safety, tolerability and immunogenicity of the vaccine.
Biotechnology major Biocon says it will launch biologic drug Itolizumab for the treatment of moderate to severe coronavirus patients at a price of around 8,000 per vial. The company has received approval from the Drugs Controller General of India (DCGI) to market Itolizumab injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome in moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. Biocon says Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with such complications. ET's Divya Rajagopal brings you all the details. (Text: PTI)
The World Health Organisation has come up with a detailed response to the letter written by 239 experts asking the Geneva-based health body to declare transmission of the coronavirus as airborne. WHO maintains the primary mode of transmission is through droplets from symptomatic people but adds that in certain settings short-range airborne transmission can not be ruled out. ET's Divya Rajagopal has more.
In an open letter to the World Health Organisation published Monday, a group of experts have outlined evidence that they say shows floating coronavirus particles can infect people who breathe them in. Because those smaller exhaled particles can linger in the air, the researchers are urging WHO to update its guidance. The Geneva-based health body says it is open to study this 'emerging evidence' and understand the implications. ET's Divya Rajagopal has more. (Text: Reuters)
Earlier in March, Mylab had received commercial approval from the Central Drugs Standard Control Organisation (CDSCO) for its COVID-19 test kit, which it said was the first 'Made in India' kit to receive such an approval from the regulator.
The ethics committee of the All India Institute of Medical Sciences in New Delhi has found discrepancies in the protocol submitted for trials, raising questions on how other sites enrolled for the trials have got approvals from their ethics committees.