Bhubaneswar (Odisha) [India], July 21 (ANI): Ahead of the commencement of the human clinical trial of COVID-19 vaccine, Preventive and Therapeutic Clinical Trial Unit was inaugurated at the Institute of Medical Sciences and SUM Hospital on Monday.
Covaxin is one of the first indigenous vaccine developed against COVID-19 and is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology (NIV), Pune. The Indian Council of Medical Research and Bharat Biotech are jointly working for the preclinical as well as clinical development of this vaccine. It has already received approval for phase-I and phase- II human trials by the Drug Controller General of India (DGCI).
Professor G Sahoo, Dean, IMS and SUM Hospital, Bhubaneswar speaking about the process told ANI that close to 30-40 candidates will be chosen for the first phase of the human trials which will commence from June 22.
“Recruitment and screening of volunteers have already started. After screening, we will select healthy individuals between the age of 18-55 for the first phase of trials. We will start the first phase of human clinical trial of the COVID-19 vaccine from Wednesday, after that volunteer will be in contact with us for two to three months,” Sahoo told ANI here.
“We will monitor those candidates and they will be in constant touch with us. We will also call them here to test the antibody level in their blood after taking the vaccination if it found adequate, then we will go for the second and then for the third phase,” he added.
The Dean also said that till a vaccine is found and is made readily available all the precautions for COVID-19 should be followed strictly by the people taking the rising number of the cases in the country in mind.
Further, Dr E Venkat Rao, principal investigator in the COVID-19 vaccine trials said, “We are committed to the maintenance of quality, ethics, patient safety and confidentiality of the highest level. We conduct clinical trials involving investigational drugs/molecules approved by the DCGI and the Central Drug Standardisation Control Organisation (CDSCO).”
Healthy volunteers who wish to participate in these clinical trials can contact the institution, to register online through their website- http://ptctu.soa.ac.in/ or contact +91 89172 11214 through WhatsApp, Dr Rao said.
Human trials of Covaxin begin at Goa’s Redkar Hospital: Pramod Sawant
Goa Chief Minister Pramod Sawant has said that the human trials of coronavirus vaccine have begun at the state’s Redkar Hospital and congratulated the team behind it.
“Human trials of Covaxin, an indigenously developed vaccine for COVID-19, has begun at Redkar Hospital in Goa. This is a testimony of India’s immense potential in healthcare innovation. My best wishes to the entire team working on Covaxin,” Sawant tweeted on Monday.
The country’s top drug regulator had recently given a green signal for human clinical trials for COVID-19 vaccine candidate Covaxin, which has been developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV). (ANI)
