Bharat Biotech underplays adverse event in Covaxin Phase 1 trial as start date for Phase 3 nears

Bharat Biotech, during its phase 1 trials, experienced an adverse event in a volunteer that it did not promptly admit to the public. As per a statement from the vaccine maker, the event was reported in a timely manner to all the necessary committees and the regulatory body within 24 hours of the incident. Bharat Biotech, along with six other Indian biotech and pharma companies (and collaborators), are working towards an Indian COVID-19 vaccine along with the Indian Council of Medical Research (ICMR). Currently, there is no vaccine approved by national health authorities or the WHO, against COVID-19. The adverse event in the COVAXIN trial led by Bharat Biotech, took place in August 2020 during Phase 1 human trials. The volunteer, with no comorbidities, developed viral pneumonitis. This occurred after he was given a dose of the COVAXIN shot. “The adverse event during phase I clinical trials during August 2020 was reported to the CDSCO-DCGI within 24 hours of its occurrence and confirmation. The adverse event was investigated thoroughly and determined as not vaccine-related," the company said in a statement. Viral pneumonia develops as a result of a viral infection in the lungs, and a wide range of viruses including influenza and coronaviruses like SARS-CoV-2, can cause it. While the pneumonitis is often mild, it can be life-threatening in some cases. The volunteer was a 35-year-old male who had taken part in the COVAXIN study in Nagpur. Bharat Biotech said that the cost of the treatment “was fully paid for by the sponsor.” The company also said that the subject is safe and the pneumonia was not caused due to the vaccine. However, the issue only came to light after it was reported by The Times of India and  Economic Times. Neither Bharat Biotech nor regulators – the Central Drugs Standard Control Organisation under the Drug Controller General of India V G Somani – released any information to the public. According to the  ET report, the company said that it “submitted all documentation within timelines, and as mandated by the ethics committees and CDSCO, including a complete causality report.” **Phase 1 of the trials** included 375 healthy volunteers while Phase 2 was supposed to have double that number. However, after the event, the Phase 2 trials was only conducted with 380 participants (only five more than the first trials), where the original plan was for double that figure. This was reported by The Times of India after speaking to investigators that were monitoring the study. Bharat Biotech recently received approval to begin Phase 3  human trials for COVAXIN in 26,000 volunteers across 22 centres. Without publicly releasing findings of the Phase 1/2 trial, Bharat Biotech hasn’t been stopped from proceeding with the trial. When Oxford-AstraZeneca and Johnson & Johnson reported adverse events during their trials, the trials were halted till it was determined the vaccine was safe to go further. The companies also made an official announcement regarding the event, and did not wait till it was reported by news media. Bharat Biotech said that the World Health Organisation (WHO), United States Food and Drug Administration (USFDA), and India’s Central Drugs Standard Control Organisation (CDSCO) approves respiratory disease vaccine if it was at least 50 percent effective. Now, the company is aiming only a little higher, announcing that the trial data shows the vaccine is at least 60 percent effective. “Chances of the vaccine being less than 50% effective are remote, as suggested by our trial results so far," the company said, as per a News18 report. However, other vaccine candidates like Pfizer showed that it is 95 percent effective while Moderna says its vaccine is 94.5 percent effective. The Russian vaccine Spuntik V, as per experts, is 92 percent effective.