The phase-3 clinical trials of Bharat Biotech's COVID-19 vaccine began at Sola civil hospital Bharat Biotech's COVID-19 vaccine began at Sola civil hospital in Gujarat's Ahmedabad city on Thursday, officials of the state-run hospital said.
On the first day, five healthy volunteers, including a woman, were given the first dose of the vaccine at hospital. Its second dose will be given after 28 days, said Principal Investigator, Sola Civil, Dr Parul Bhatt.
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"In the first phase, we have planned to cover 1,000 healthy volunteers. They must be in the age group of 18 to 60 healthy volunteers and with no history of coronavirus infection. Anyone who fulfils the criteria can approach us and enrol as a volunteer," she added. Covaxin is being developed by the Hyderabad-based firm Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
She said that doctors at the hospital engaged in the clinical trial exercise will remain in touch with the volunteers over phone to monitor their health condition after the vaccine is administered.
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.
Volunteers will be called at the hospital at regular intervals for follow-up procedures and tests, including blood test and oxygen level, Bhatt said. "This whole exercise will continue for 12 months. We will also give a contact number to the volunteers in case they need any urgent intervention. The hospital will provide necessary treatment in case of any complication," she added.