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As Delta Plus Variant Identified, Changes To India’s Trials Policy Could Help

Serum/AZ COVID-19 Vaccine Interval Could Be Revised

 
• By Vibha Ravi

As a new Delta plus variant is identified, India’s exemption of bridging trials for imported COVID-19 vaccines could help speed up immunization efforts. The urgency to fully immunize individuals could also prompt a reduction in the interval between Serum/AstraZeneca’s COVID-19 vaccine doses

New Coronavirus variant outbreak and covid-19 virus cell mutation
Policy Flexibility Is The Need Of The Hour As Coronavirus Changes It Colors

As if the Delta variant wasn’t enough, a Delta plus variant of SARS-CoV-2 has been recently identified and while it’s only causing the scientific community to take note as of now, it could soon cause governments across the world to hasten their immunization efforts.

On 13 June, clinician and scientist at Delhi's CSIR-Institute of Genomics and Integrative Biology (IGIB), Vinod Scaria tweeted "One of...

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More from Vaccines

EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 
• By Eliza Slawther

The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

Pink Sheet Podcast: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine Advice

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.

US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

More from Pink Sheet

Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.