With the coronavirus caseloads in India surging past the 11.5 lakhs mark, the efforts to arrive at a COVID-19 vaccine have accelerated in the country. The indigenously developed vaccine–COVAXIN has entered the critical human trails phase.
12 centres across the country selected for human trials of COVAXIN
About 12 centres across the country have been selected by India’s Premier Medical Research Body, ICMR, where the phase 1 and 2 of the human trials of the vaccine would be conducted. After Haryana’s PGI, human trials of the COVAXIN are all set to start in another Bhubaneswar-based institute.
A special laboratory is set up at the Institute of Medical Sciences and SUM(IMS and SUM) Hospital, pursuant to the protocols laid down by the Drugs Controller General of India (DCGI). The human trials of BBV152 COVID Vaccine will begin on Wednesday at the said facility.
The first Human trials of the Bharat Biotech created vaccine had started in AIIMS Patna last week on July 15. 10 volunteers were chose to administer the vaccine. After two weeks, if the vaccine is found safe and efficacious, it will be given to more people.
On Friday last week, the Haryana Health Minister Anil Vij took to Twitter to inform that PGI Rohtak has also started the human trials of the COVAXIN. He claimed that 3 volunteers were given the vaccine and they have responded well to the antidote. He also added that no adverse side effects had been reported on the subjects so far.
In addition, human trials of the vaccine have also begun in Goa at the state’s Redkar Hospital. Goa CM Pramod Sawant informed about the same and congratulated the team for entering a crucial phase in developing the vaccine.
The director of AIIMS, Dr Randeep Guleria, said on Monday that human trials of India’s first indigenously developed coronavirus vaccine has also begun at the All India Institute Of Medical Sciences.
Volunteers to be monitored for the antibody levels in their blood
According to the guidelines set for carrying out human trials, the subjects who are administered the vaccine have to stay in the trial centre for around 2 hours for observation to rule out any possibility of adverse effect or other serious complications.
The volunteers will be given two doses within a gap of 14 days. They will be monitored and kept in touch with the trial centres. If the antibody level in their blood is found to be adequate, they can go for second and third phase of the trials.
COVAXIN expected to be released by August 15
It is pertinent to note that this is the same coronavirus vaccine that the Indian Council of Medical Research (ICMR), the apex body for the medical research in the country, had announced earlier of being released for the public use by August 15. However, it is not yet clear whether the vaccines will be ready by then.
Hyderabad-based Bharat Biotech successfully developed COVAXIN™ in collaboration with the ICMR and National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech for the effort.
Besides Bharat Biotech’s COVAXIN, the Drugs Controller General of India (DCGI) had permitted another vaccine prepared by ZydusCadila Healthcare Ltd to go in for the first and second phase of human clinical trials.