The phase-3 clinical trials of India’s own COVID-19 vaccine candidate – Covaxin - will begin at Sir JJ Hospital in Mumbai. The medical facility is reportedly the second one in Maharashtra’s capital to start human trials of the vaccine candidate against the novel coronavirus after BMC-run Sion hospital.
Covaxin is being developed by the Hyderabad-based firm Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The ICMR completed paperwork with the hospital on November 25 and enrolment of suitable volunteers, following the norms, will start from November 27 onwards, reported Mumbai Mirror citing sources.
The hospital will also enroll frontline workers in the human clinical trial of Covaxin, said the report.
According to the dean of Sir JJ Hospital, Dr Ranjit Mankeshwar, it is expected to enroll at least 1,000 people for the trial of the coronavirus vaccine candidate.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
Each and every volunteer will be followed for 28 days for the trail, Dr TP Lahane, director of the Directorate of Medical Education and Research told the publication.
A special team of doctors, which includes ethics committee doctors, have been appointed to look into the trial, Dr Mankeshwar was quoted as saying. “All the paperwork has been done. We are set to start enrolling the volunteers soon,” said the dean.
At present, four COVID-19 vaccine trials are going on in Maharashtra, including the two Covaxin trials, said the report citing Dr Sashank Joshi, member of the state task force on COVID-19.
“The Serum Institute of India (SII) is leading the race in terms of completing the trials and, hopefully, if they get permission, the vaccine can be given from December onwards,” Dr Joshi said.
Besides Maharashtra, the phase-3 clinical trials of Covaxin will begin at Sola civil hospital in Ahmedabad, Gujarat deputy Chief Minister Nitin Patel said on November 25. Talking to reporters, he said that the hospital received 500 doses of the vaccine candidate for the trial.
Patel, who also holds the Health portfolio, said doctors at the hospital would be trained for administering the shots by experts from Union Health Ministry.
(With inputs from PTI)Follow our full coverage on COVID-19 here.