Covaxin trials: Phase 1 findings show robust response, no serious adverse events, says Bharat Biotech
The study said the vaccine candidate “induced” neutralising antibody responses, and that vaccine-induced responses were “comparable to those observed in the convalescent serum collected from patients who had recovered from COVID-19”.
As inexplicable is Modi’s neglect of the two areas in which decades of rule by the Dynasty produced dismal results: education and healthcare. (File)
Advertisement
BHARAT BIOTECH’S indigenous Covid vaccine candidate Covaxin, which is currently in late-stage clinical trials, has been found to be well-tolerated, with no vaccine-related serious adverse events, and triggered a robust immune response in its early Phase 1 clinical trial, according to a research paper published by the Hyderabad-based firm, which is yet to be peer-reviewed.
This comes even as the subject expert panel, which is examining Bharat Biotech’s application for emergency use authorisation of its vaccine candidate, has asked it to present the safety and efficacy data from the ongoing Phase 3 clinical trial for further consideration. The firm has only submitted interim safety and immunogenicity data of its Phase 1 and 2 trials in the country, while seeking emergency use authorisation of its vaccine.
You have exhausted your monthly limit of free stories.
Read more stories for free with an Express account.
Phase 1 of human clinical trials, in which the vaccine candidate is tested on a small group of healthy adults, reveals interim data on two important aspects. First, reactogenicity, which is the ability to produce anticipated adverse reactions like muscle pain, fever as well serious or rare adverse reaction. Second, immunogenicity or the ability to trigger an immune response.
In the Phase 1 study, which is being jointed conducted by the ICMR, the researchers have said the reactogenicity “was absent in the majority of participants, with mild events”. And on immune response, the researchers concluded that both “robust humoral and cell-mediated responses were observed”.
“…this study has several strengths. To ensure generalizability, this study was conducted with participants from diverse geographic locations and socioeconomic conditions, enrolling 375 participants across 11 hospitals. Despite the fact that enrollment occurred during a national lockdown, which led to several operational challenges, the overall participant retention rate was 97%. The sample size was intentionally large to enable the inference of meaningful conclusions regarding immunogenicity and safety,” the researchers concluded.
On the adverse events, the researchers said that the “overall incidence rate of local and systemic adverse events” was 10%-20% in all vaccine treated arms. “The majority of adverse events were mild and were resolved,” the study said. Also, one serious adverse event was reported – “which was found to be unrelated to vaccination” — the researchers said.
On safety, the researchers concluded, “After the first vaccination, local and systemic adverse events were predominantly mild or moderate in severity and resolved rapidly, without any prescribed medication. A similar trend was observed after the second vaccination.”
Story continues below this ad
The study further said that pain at the injection site was the most common local adverse event. “The distribution of local and systemic AE (adverse events) was equal among the vaccine treatment groups when compared to the control arm… Biochemical, hematological, and urine parameters outside of the normal ranges had no corroborating clinical manifestations,” it said.
The study said the vaccine candidate “induced” neutralising antibody responses, and that vaccine-induced responses were “comparable to those observed in the convalescent serum collected from patients who had recovered from COVID-19”. “All three vaccine formulations resulted in robust immune responses comparable to a panel of convalescent serum,” the study said.
Kaunain Sheriff M is an award-winning investigative journalist and the National Health Editor at The Indian Express. He is the author of Johnson & Johnson Files: The Indian Secrets of a Global Giant, an investigation into one of the world’s most powerful pharmaceutical companies.
With over a decade of experience, Kaunain brings deep expertise in three areas of investigative journalism: law, health, and data. He currently leads The Indian Express newsroom’s in-depth coverage of health.
His work has earned some of the most prestigious honours in journalism, including the Ramnath Goenka Award for Excellence in Journalism, the Society of Publishers in Asia (SOPA) Award, and the Mumbai Press Club’s Red Ink Award.
Kaunain has also collaborated on major global investigations. He was part of the Implant Files project with the International Consortium of Investigative Journalists (ICIJ), which exposed malpractices in the medical device industry across the world. He also contributed to an international investigation that uncovered how a Chinese big-data firm was monitoring thousands of prominent Indian individuals and institutions in real time.
Over the years, he has reported on several high-profile criminal trials, including the Hashimpura massacre, the 2G spectrum scam, and the coal block allocation case. Within The Indian Express, he has been honoured three times with the Indian Express Excellence Award for his investigations—on the anti-Sikh riots, the Vyapam exam scam, and the abuse of the National Security Act in Uttar Pradesh. ... Read More
