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Mix and Match COVID Boosters: Time Crunch For Data Review May Mean No Advisory Committee Vote

 
• By Sarah Karlin-Smith

US FDA can’t say whether it will have its vaccine advisors vote on the heterologous uses of booster doses at its 14-15 October meeting of the Vaccines and Related Biological Products Advisory Committee because it is still reviewing the data. The Agency does not appear to need a formal company application or emergency use authorization amendment to allow this type of boosting.

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FDA may not have time to finish reviewing heterologous booster data before the next VRBPAC • Source: Alamy

The US Food and Drug Administration may not be far enough along in its review of key data on whether people can receive a booster COVID-19 vaccines from a different manufacturer than their primary series to have its vaccines advisory committee vote on the topic at a two-day meeting on booster shots next week. That could delay any “mix-and-match” authorizations that has been closely watched for its potential to simplify the booster campaign and increase healthy equity, as well as potentially offering some safety and efficacy benefits.

FDA had said on 1 October that the National Institute of Health’s National Allergy and Infectious Diseases would present data on their study on the heterologous use of booster doses...

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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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US ‘Most Favored Nations’ Drug Pricing Policy Will Jeopardize Innovation In Europe

 
• By Francesca Bruce

The US MFN executive order is the latest in a series of concerning US developments that are contributing to uncertainty for the European pharmaceutical industry, according to France Biotech’s vice president, Alexandre Regniault.

Australia Looks To Modernize Human Tissue Laws, Improving Access For Researchers

 
• By Eliza Slawther

Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.

China NMPA Lays Out Regulatory Priorities At DIA

 
• By Xu Hu

At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.