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‘Don’t Make Promises Until You Have The Data’: FDA Gamble On Speeding Up COVID Vax In Kids Flops

 
• By Sarah Karlin-Smith and Sue Sutter

FDA praised for pulling back on plans to host 15 February advisory committee review of Pfizer’s COVID-19 vaccine in children but faulted, along with other parts of US government, for raising expectations this month that the vaccine might be available for this population imminently.

roulette wheel, gambling scene
FDA’s failed bet on Pfizer’s two-dose data for COVID-19 vaccines in children under five raises public confusion • Source: Alamy

The US Food and Drug Administration did a rapid about face on 11 February, canceling Pfizer Inc. and BioNTech SE’s 15 February advisory panel review of the sponsors' COVID-19 vaccine in children 6 months through 4 years of age saying the agency needed to review data on the impact of a third dose of the vaccine before making an authorization decision.

The sudden shift raised questions about why FDA so publicly hyped up the possibility of a faster-than-anticipated authorization in this...

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• By Sue Sutter

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BIO CEO On Industry And US FDA, Trump’s Vaccine Views And MFN Counter Proposals

 
• By Sarah Karlin-Smith

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Engage With HTA Body NICE Before Submitting MAA, UK Govt Tells Companies

 
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EU Pharma Reform: Council Wants Strengthened Member State Powers On Drug Supply

 
• By Eliza Slawther

The Council of the EU’s vision for the pharma reform package includes a stronger role for member states regarding the supply of medicines and the prevention of indication-stacking for orphan drugs.