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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.

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More from Vaccines

Kennedy’s Comments On Novavax Delay Scientifically, Legally Inaccurate, Experts Say

 
• By Sarah Karlin-Smith

The HHS Secretary publicly acknowledged the unusual delay of Novavax's COVID-19 vaccine licensure, but his justification was neither scientifically accurate nor legally justifiable, experts said.

‘Highly Problematic’: Acting FDA Commissioner Paused Planned OK Of Novavax Shot

 
• By Sarah Karlin-Smith

Former Acting FDA Commissioner Sara Brenner is said to have asked Tracy Beth Høeg, new special assistant to the commissioner, to help reexamine the application. Høeg’s position at the agency is raising concerns about the FDA's ongoing approach to vaccine regulation.

Updated: US FDA Commissioner Makary Was Sworn In, Knew Of Plan to Push Out Marks, Sources Say

 
• By Sarah Karlin-Smith

FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.

Peter Marks Resigns From US FDA, Warns Kennedy Does Not Want Truth On Vaccines

 
• By Sarah Karlin-Smith

In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."

More from Pink Sheet

Japan Looks To Build Domestic Capacity In New Modalities

 
• By Lisa Takagi

Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.

GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

 
• By Cathy Kelly

Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.

US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.