Conditional Approval for Serum, Bharat Bio COVID-19 Vaccines In India Amid Uproar

Confusion Over Serum's Exports Of AZ Vaccine

India gave a conditional accelerated approval to AstraZeneca partner Serum Institute and separately, to Bharat Biotech for their COVID-19 vaccines. With the latter’s vaccine still in Phase III trials, the unprecedented decision caused a flutter as the regulator had earlier said an EUA would not be granted unless trials are completed.

Close-up Of A Businessperson's Hand Stamping On Approved Contract Form
Conditional Nod For Two COVID-19 Vaccines In India • Source: Shutterstock

In a move indicative of the unusual times that the world finds itself in due to COVID-19, India granted conditional accelerated approvals to two vaccines, one for which Phase III clinical trials recruitment is still not complete and the other which seemingly lacks efficacy data from Indian studies.

Both Serum Institute of India Pvt. Ltd

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from COVID-19

More from Scrip

Finance Watch: Deerfield Closes $600m-Plus VC Fund; Gates Speeds Up Health Investments

 
• By 

Private Company Edition: Deerfield’s third innovations fund will back therapeutics and other opportunities, the Gates Foundation – a sometimes funder of biotech firms – will spend $200bn over the next 20 years, and NewLimit raised a $130m series B round, among other financings.

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pharma Left Hanging After US/UK Trade Pact

 
• By 

An ‘historic economic prosperity deal’ does not include the sector.