Bharat Biotech to begin Phase-3 humans trials of COVAXIN candidate from 15 Oct in Punjab
Punjab CM Amarinder Singh gave stern directives about the poor not being pulled into trials without consent and understanding of the potential dangers.
Bharat Biotech is set to begin the third phase of human trials for its COVAXIN vaccine candidate against SARS-CoV-2, the virus that causes coronavirus disease (COVID-19). The trials will be held at three government medical colleges in Punjab, as per an official statement from the state government on Tuesday.
The Phase 3 trials are slated to begin on 15 October, according to a report by Asian News International, as disclosed by a government spokesperson after a virtual COVID-19 review meeting chaired by the Punjab Chief Minister Amarinder Singh. The trial will test the safety and efficacy of the shot, and will reportedly be conducted in about 25,000-30,000 volunteers.
The Punjab Chief Minister has instructed the Medical Education and Research Department to ensure full care and strict adherence to all the required precautions during trials, and that mandatory consent of all participants involved in the trial is taken. As per the ANI report, he followed these instructions up with stern directions to ensure the poor are not pulled into trials without consent, knowledge and understanding of the potential repercussions and dangers.
Bharat Biotech recently shared the results of their COVID-19 vaccine candidate safety trials in animals. The experimental shot, called 'COVAXIN', was found safe in rhesus monkeys that were vaccinated and exposed to the SARS-CoV-2.
The Drugs Controller General of India (DCGI), India's regulatory agency, granted approval for Phase I and II trials of the vaccine in June. Bharat Biotech, in a partnership with the National Institute of Virology, has concluded phase 1 human trials of their COVAXIN candidate at most of the 12 chosen centres as of 14 August. The results from the preliminary trial suggests that the vaccine is safe, principal investigators conducting the trials told the Economic Times. The second phase of human trials for the vaccine are likely to begin in the first week of September, as per the report.
COVAXIN is the first indigenously-developed vaccine against coronavirus. It is an inactivated vaccine candidate, designed to produce unique elements of the SARS-CoV-2 virus, which are used by the immune system to recognize a threat if the whole virus in ever encountered in the real world.
Also read: Bharat Bio's COVAXIN: Ten takeaways from successful animal trials of the experimental COVID-19 vaccine
End of Work from Home? Are TCS employees being forced to come to office?
TCS has begun delivering notes to staff members who don't put in at least 12 days of in-office work each month. The IT company reportedly threatened employees with disciplinary action if they failed to abide by its new policy. The firm is just one of the many that has put an end to work from home
Explained: How the World Health Organisation aims to fight pandemics in the future
Negotiations on new rules for dealing with pandemics are underway at the World Health Organisation. A new pact is a priority for WHO chief who called it a ‘generational commitment that we will not go back to the old cycle of panic and neglect’ at the UN agency's annual assembly
Former UK PM Boris Johnson to face probe again after new 'Partygate' claims
The Metropolitan Police in London announced that it was 'assessing' fresh material received in the previous week regarding 'potential breaches' of coronavirus guidelines in Downing Street between June 2020 and May 2021