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Filling COVID-19 Vaccine Data Gaps Will Take Time

 
• By Sarah Karlin-Smith

Timeline for getting data on COVID-19 vaccines ability to prevent transmission is likely pushed due to the decision not to proceed with a NIH study on the topic. CDC warns that it will take more time than people expect to get other key data points filled in and vaccine regimen plans shouldn’t change without such data.

The US government’s decision against funding a clinical trial to test whether currently available COVID-19 vaccines prevent transmission of SARS-CoV-2 and asymptomatic infections is emblematic of the challenges of filling in missing data gaps on COVID-19 vaccines post-emergency use authorization.

Plugging a variety of data holes could make stopping the pandemic and restoring the economy easier by permitting vaccination of...

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More from Vaccines

Pink Sheet Podcast: CBER Director’s Political Spin On COVID-19 Vaccines And US FDA RIFs Finalized

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

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad using an unproven theory to help explain his COVID-19 vaccine decisions and the impact of the recently finalized reduction-in-force at the FDA.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 
• By Sarah Karlin-Smith

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.

Valneva Expects UK And France to Lift Ixchiq Age Restriction Following EMA Decision

 
• By Anabel Costa-Ferreira

Other authorities are expected to mirror the European Medicines Agency’s decision to lift the temporary restriction it placed on using Valneva’s chikungunya vaccine in people aged 65 years and older.

Senate Panel Approves US CDC Director Candidate Monarez With Measles Outbreak Growing

 
• By Cathy Kelly

The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.

More from Pink Sheet

A Record Year For US FDA Approvals? Commissioner Says It’s Possible

 
• By Michael McCaughan

FDA Commissioner Martin Makary suggested 60 new molecular entities could be approved in 2025, which appears possible, but can the strained staff deliver?

PharmaMar Withdraws EU Aplidin Filing After Regulatory Rollercoaster

 
• By Eliza Slawther

PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.

Italy To Reward Locally Conducted R&D In Innovative Medicines Fund Revamp

 
• By Francesca Bruce

Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.