The Indian vaccine co had an adverse event; experts seek more transparency | India News

MUMBAI: Hyderabad-based Bharat Biotech’s potential Covid-19 vaccine reported a serious adverse event during clinical trials in August, even as the Phase 3 stage of the study has now started. The adverse event occurred in a 35-year-old participant with no comorbidities, who was part of the Phase 1 trials in August, the researchers who monitored the study to TOI confirmed on condition of anonymity. The company also modified its testing protocol for Phase II, with the dosage regimen modified from 14 days to 28 days, and the number of participants was nearly halved from the previous 750 to 380, the sources added.
Bharat Biotech, in collaboration with the lead research body, the Indian Council for Medical Research (ICMR), has developed Covaxin, an inactivated virus vaccine, for which it began phase III clinical trials on November 16, with around 26,000 participants. The adverse event did not cause any life-threatening reactions in the participant and was therefore classified as “ not severe and vaccine-related, ” they added.
The participant, who underwent the trial at a site in western India, was hospitalized with viral pneumonitis a couple of days after receiving the vaccine. He was discharged after a week of hospital stay.

When contacted, a spokesperson for Bharat Biotech said: “ We have reported the adverse event to the DCGI office. ” The company did not respond to the questionnaire despite repeated attempts.
The findings have been reported to the Ethics committee and the Central Drug Control Organization (CDSCO), and were also discussed by the Matter Expert Group, a government panel on Covid-19, the sources said.
Side effects or adverse events are quite routine in large-scale drug trials, and global multinationals, AstraZeneca and Johnson & Johnson, had stopped their vaccine trials due to serious adverse events, only to restart them after a thorough investigation.
Experts say there is a lack of transparency regarding clinical trials of vaccines in India. Against this, globally, Big Pharma, such as Pfizer and Moderna, have announced detailed data. Recently, the US Food and Drug Administration said it is fully committed to transparency regarding emergency approvals around Covid-19 drugs and vaccines, and will publicly release the review of scientific data.

“Transparency is key to building public trust and confidence in Covid-19 vaccines that can receive approval. Given the extensive and continuing role of the government in the development of this vaccine, the agreement between ICMR and Bharat Biotech should be made public. We don’t know if the government is withholding the rights or the terms for commercialization, ”said Malini Aisola, co-convenor of the All India Drug Action Network, a civil society organization working for patients’ rights.
The “indigenous” Covid-19 vaccine has sparked a number of controversies early on, with questions initially being raised about the excessively rapid follow-up of the regulatory process, the role of government, and ICMR’s conflict of interest in its development.