An investigator said, if the process continued smoothly, the vaccine would be available in the first half of 2021.
Covaxin, the COVID-19 vaccine developed by Bharat Biotech and the ICMR, is safe, according to preliminary results of the Phase 1 clinical trials, according to a report by The Economic Times.
Hyderabad-based Bharat Biotech is developing the vaccine candidate in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
"The vaccine is safe. We have not observed any adverse events in any of the volunteers at our site,” said Savita Verma, the principal investigator who is leading the trial at PGI, Rohtak, told the publication.
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.
Investigators are collecting blood samples to test the immunogenicity of the vaccine, and expect to complete the Phase 1 trials by the end of August, the report said.
Moneycontrol could not independently verify the story.
The Economic Times reported that 375 volunteers at 12 sites across India have enrolled for the clinical trial, with two doses being administered to each individual.
"We are in the process of giving a second dose to the healthy volunteers and so far, we have not seen anything unusual event in patients. It is safe," Sanjay Rai, the principal investigator at All India Institute of Medical Sciences, Delhi told the publication..
Another investigator told the paper, if the process continued smoothly, the vaccine would be available in the first half of 2021.
The pandemic has created a race to develop a vaccine for the novel coronavirus. Apart from Bharat Biotech, Zydus Cadila is the other Indian company that has begun human clinical trials of its vaccine candidate.
"There is a tremendous pressure on us to develop the vaccine. But for us, safety and quality are paramount. We don't want to kill more people with the wrong vaccine," Krishna Ella, Chairman of Bharat Biotech International, recently said as quoted Business Standard.Serum Institute of India is also expected to soon begin human trials and manufacturing of the experimental vaccine developed by Oxford University and Swedish-British drugmaker AstraZeneca.