Business Standard

No impact of adverse event on Covid-19 vaccine timelines: Bharat Biotech

The firm said subject was now safe. Though it was reported to the drug regulator within 24 hours, the event turned out to be unrelated to the vaccine.

Covaxin, bharat biotech, covid, coronavirus, vaccine, drugs, medicine, pharma
Premium

The firm is now conducting Phase-3 trials and the event will have no impact on timelines

Sohini Das Mumbai
Bharat Biotech has admitted that in August, there was an adverse event during the Phase-1 clinical trials of its Covid-19 vaccine. 

The firm said subject was now safe. Though it was reported to the drug regulator within 24 hours, the event turned out to be unrelated to the vaccine. 

“The adverse event was investigated, and presented to the CDSCO-DCGI, prior to obtaining permission for Phase-2 and Phase-3 trials," it said. 

The firm is now conducting Phase-3 trials and the event will have no impact on timelines.       

What you get on BS Premium?

  • Unlock 30+ premium stories daily hand-picked by our editors, across devices on browser and app.
  • Pick your 5 favourite companies, get a daily email with all news updates on them.
  • Full access to our intuitive epaper - clip, save, share articles from any device; newspaper archives from 2006.
  • Preferential invites to Business Standard events.
  • Curated newsletters on markets, personal finance, policy & politics, start-ups, technology, and more.
VIEW ALL FAQs

Need More Information - write to us at assist@bsmail.in