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Pfizer, Moderna Discussing When To Drop Controls In COVID Vaccine Trials With US Government

 
• By Cathy Kelly

Crossover could happen along with the EUAs, Operation Warp Speed's Slaoui says, or when enough high-priority groups are inoculated, or maybe when the vaccines receive full BLA approval. Whatever officials and sponsors decide, it will create challenges for vaccine candidates still in development.

COVID-19 vaccine
Pfizer, Moderna Vaccines Moving Toward Release

Pfizer Inc. and Moderna, Inc. are working with the US Food and Drug Administration and the Trump Administration’s Operation Warp Speed on when they should allow placebo recipients in their COVID-19 vaccine trials to cross over to the active vaccine, Operation Warp Speed chief science officer Moncef Slaoui said during a press briefing on 18 November.

Pfizer announced completed results from its late stage vaccine trial the same day, and Slaoui noted that Moderna may make...

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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.

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To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
• By Kate Rawson

Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.

House Gives US FDA More Non-User Fee Funds Than Requested

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.