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Buying The Coronavirus Vaccine: What Would A ‘Fair And Reasonable’ Price Be?

 
• By Derrick Gingery

The US government has a routine approach for negotiating single-seller/single-buyer contracts, but drug pricing politics and public fears of coronavirus will likely complicate any purchasing talks with a sponsor, should an effective vaccine or therapeutic emerge.

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An affordable price for a coronavirus vaccine may be determined with a formula used when the government is the only buyer for a product. • Source: Shutterstock

The 'fair and reasonable' price mandated for new coronavirus vaccines and therapeutics under new US legislation may wind up a largely subjective decision for the government officials that would be tasked with any procurement.

With little data and no competitors as a benchmark, the sponsor’s accounting of costs plus a mark-up for profit may be

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Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
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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.

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

 
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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.

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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

 
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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.