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BARDA Lays Out Vision For Next Pandemic: Vaccines For The US Within 130 Days

 
• By Bowman Cox

Federal agency seeks dialogue with industry on how to enable surge capacity for pandemic vaccines without cutting back on other production.One key factor: workforce development.

Vaccine vials
getting ready for the next pandemic • Source: Alamy

In preparation for future pandemics, the US government is reaching out to drug and vaccine manufactures and suppliers for advice on how to establish a quick-response industry consortium.

The government’s Biomedical Advanced Research and Development Authority is seeking input on a new approach to pandemic preparedness that

White House To Expand mRNA COVID-19 Vaccine Production Capacity

The White House 17 November announced plans to add 1 billion doses per year of domestic mRNA COVID-19 vaccine production capacity by the second half of 2022 for use globally.

BARDA has issued a request for information for this initiative similar to the one for its next-pandemic response. Additionally, any capacity added under this initiative would be expected to help against future pathogens as well.

“We hope companies step up and act quickly to take us up on this opportunity to expand production of mRNA vaccines for the current pandemic and set us up to react quickly to any future pandemic threats,” Jeff Zients, coordinator of the US COVID-19 response, said at a White House briefing

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Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews

 
• By Sue Sutter and Bridget Silverman

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Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
• By Joseph Haas

During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.

More from Pink Sheet

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.