Over 1,000 volunteers took part in Covaxin phase 3 trials at AMU

Over 1,000 people from different social and religious backgrounds volunteered to take part in phase 3 clinical trials of COVID-19 vaccine ”Covaxin” at the AMU, a professor at the university said on Thursday.

The phase 3 trials had commenced at the Jawaharlal Nehru Medical College (JNMC) of the Aligarh Muslim University (AMU) on November 18 last year and all volunteers have been administered the second and final dose, professor Mohamnad Shameem, principal investigator of the third phase trial told PTI.

They are now undergoing their monitoring protocol. All the volunteers would present themselves before the research team by this weekend for the completion of the first check up after the dose. This process of monthly check ups will continue till November, he said.

“The special feature of the trials is that we have completed the recruitment process in a record time of 11 days while simultaneously maintaining the most stringent standards defined by the Institutional Ethics Committee and Indian Council of Medical Research (ICMR),” Shameem said.

The ongoing trial protocol at the JNMC was commended by Prime Minister Narendra Modi during his address at the AMU centenary celebrations last month and later Vice Chancellor Professor Tariq Mansoor had received a letter of commendation from Bharat Biotech,  the pharma giant which is pioneering the production of Covaxin in India.

The letter which congratulated the AMU scientists for the manner in which the enrolment had been conducted stated “where others failed, your execution will be pivotal. We need leaders like you”.

A senior AMU official told PTI that a similar laudatory message has also been received from the ICMR.

Shameem said keeping in view the sensitivities and possible consequences of such a pioneering trial, a 60 page consent form for all volunteers was prepared and distributed to thousands of potential volunteers before involving them in this major programme.

Each volunteer was given intensive counselling and has been provided a daily diary for “recording any adverse side effects” which is monitored regularly.

“I am happy to announce that till date we have not received any report of adverse reaction,” he said.

The follow up process of all the volunteers will begin from this weekend. This process will take another 10 months and will end in November this year, he said.

When contacted the AMU vice chancellor said, “It is deeply heartening for our young scientists and researchers that their efforts have not gone in vain and are drawing laudatory attention from the scientific community.”

“The AMU has always and will always be at the forefront of any such programme which helps in our national endeavour and brings laurels to the country,” Mansoor told PTI.