Business Standard

Saturday, December 28, 2024 | 11:00 PM ISTEN Hindi

Notification Icon
userprofile IconSearch

Covovax denied trials on children; no nod needed for Sputnik Light

The decision comes as a setback to SII, which had sought permission to start a pediatric clinical trial of Covovax

Novavax vaccine
Premium

Sources in Serum Institute have said that they have not received any official communication from the SEC on the matter so far

Sohini Das Mumbai
The vaccine expert panel denied permission to Serum Institute of India (SII) to conduct clinical trials on children for Novavax, on Thursday. In addition, it felt there was no need to conduct a separate Indian clinical trial of Sputnik Light, as adequate safety and immunogenicity data is already available.

The decision comes as a setback to SII, which had sought permission to start a pediatric clinical trial of Covovax. The Subject Expert Committee’s (SEC) decision means DRL does not require separate safety and immunogenicity trials on Indians for getting approval for Sputnik Light. As for SII, the permission was denied as

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