Covaxin Volunteer Showed Adverse Effect During Phase 1 Trials, Says Report

During the Phase 1 trials of Bharat Biotech’s COVID-19 vaccine- Covaxin, a 35-year-old healthy male volunteer who was given a shot of the vaccine on July 15 had developed viral pneumonitis and was hospitalised for a week in Nagpur. The company has however claimed that it was unrelated to vaccine and the incident was reported to the regulatory authorities.

November 21, 2020

National

2 min

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New Delhi, November 21:  During the Phase 1  trials of Bharat Biotech’s COVID-19 vaccine- Covaxin,  a 35-year-old healthy male volunteer who was given a shot of the vaccine on July 15 had developed viral pneumonitis  and was hospitalised for a week in Nagpur, according to a report by CNN-News 18.  But there was not any halt in the  trials even briefly after the incident. Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech  has confirmed about the incident and said that it was reported to the CDSCO. “We can’t give every adverse reaction to the press,” he said at an online event, on being questioned about the same. Covaxin: Bharat Biotech’s COVID-19 Vaccine into Phase-3 Trials.

Covaxin Volunteer Showed Adverse Effect During Phase 1 Trials, Says Report; Bharat Biotech Claims Illness ‘Unrelated’ to Vaccine

The company however claims that viral pneumonitis was not caused because of vaccine and it was reported to the regulatory authorities within 24 hours of confirmation about it. Bharat Biotech, in a statement,  said “the adverse event was not related to the vaccine and as required by the clinical trial guidelines, there was due reporting to the regulatory authorities. 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,” CNN-News 18 reported. COVID-19 Vaccine Update: Bharat Biotech & Washington University Developing Nasal Vaccine for Coronavirus, Says Harsh Vardhan.

Bharat Biotech developed India’s first indigenous COVID-19 vaccine – Covaxin, in collaboration with the Indian Council of Medical Research (ICMR). The vaccine is currently in the third phase of clinical trials. It’s phase 3 trials begun on November 16 with around 26,000 volunteers from all over the country.

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