June 1, 2023

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Covid-19: AMU begins Phase 3 trials of Covaxin, V-C registers himself as first volunteer

The phase 3 trials of Covid-19 vaccine candidate Covaxin began at JN Medical College and Hospital (JNMCH) of the AMU in Lucknow. AMU Vice-Chancellor Prof Tariq Mansoor registered to be the first volunteer for the trials in order to motivate and inspire others to come forward, an AMU press release said.
The trial of Bharat Biotech-developed coronavirus vaccine candidate ‘Covaxin’ entered the third phase at Aligarh Muslim University (AMU) on Tuesday and Vice-Chancellor Professor Tariq Mansoor got himself registered to be the first volunteer for the same.
The phase 3 trials of Covaxin developed by Bharat Biotech began at JN Medical College and Hospital (JNMCH) of the AMU in Lucknow.
Prof Tariq Mansoor volunteered himself in order to motivate and inspire others to come forward, an AMU press release said.
Covaxin Phase 3 trial is aimed at evaluating the safety and efficacy of the coronavirus vaccine study led in collaboration with the Indian Council of Medical Research (ICMR) and Bharat Biotech, the release stated.
Seeking active participation from all age groups and socio-economic background in the clinical trials, the AMU VC said, “By volunteering for a trial or study, one gets a chance to participate in ground breaking research and contribute to developing better cure and treatment options,” it further read.

JNMCH principal Prof Shahid Ali Siddiqui said an ethical committee comprising doctors, social workers and lawyers, has already been constituted to manage the clinical trials. He said the required staff for conducting the vaccine trial has been recruited and the registration of volunteers has also been started from Tuesday.
Principal Investigator Prof Mohammad Shameem said ICMR Covaxin Phase 3 trial is going on after the Phase 1 and Phase 2 trials showed encouraging results.
Volunteers who will undergo the Phase 3 trial will receive travel expenses and other benefits as per ICMR guideline, the press release added.
Govt says India in talks with all Covid domestic and foreign vaccine manufacturers
The Health Ministry on Tuesday said the National Expert Group on Vaccine Administration for Covid-19 is in talks with all domestic and foreign vaccine manufacturers.
Health Ministry’s statement comes a day after Pfizer Inc. and BioNTech SE announced more than 90 per cent efficacy of their potential vaccine for the coronavirus.
On whether India is considering a tie-up with Pfizer for its Covid-19 vaccine and if it has the infrastructure for specialised cold chain requirement for this vaccine, Union Health Secretary Rajesh Bhushan said, “The National Expert Group on Vaccine Administration for Covid-19 is in talks with all vaccine manufacturers, including domestic and foreign manufacturers.”
“When we continue this dialogue, we not only look at the status of the development of their vaccines, we also look at the regulatory approvals as to where they have progressed and we also engage in a dialogue about the logistical requirements, if such vaccines have to stored at temperatures that may range from two to eight degrees to minus 50 to minus 90 degrees Celsius as well as the doses that will be required to be administered.
“This is a continuously changing, dynamic situation and if and when the regulatory approval comes, we will share it with you,” news agency PTI quoted Bhushan as saying at a press briefing.
Asked whether the vaccine would only be available in the metro cities initially since the Centre is planning an early 2021 roll-out, Bhushan said the government does not make any discrimination between metro cities and non-metro cities.
“Whenever the regulatory approvals for the vaccines are provided, we have a plan that would ensure that the vaccines would be available to all priority population groups, irrespective of the region where they reside,” he clarified.
Responding to another query on vaccine administration, he said, “We are in a position to not only augment and strengthen, but also to add to our cold chain capabilities.”
Any large-scale immunisation would not only require a substantial increase in the number of cold-chain points, but also a huge rise in the number of cold chain equipment, Bhushan added.
In a major development, Pfizer Inc. and BioNTech SE on Monday said their vaccine candidate was found to be more than 90 per cent effective in preventing Covid-19.
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent Covid-19,” Pfizer chairman and CEO Albert Bourla said.

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