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US COVID-19 Vaccine Booster Plan Also Boosts Pressure On FDA

 
• By Derrick Gingery

The plan’s White House announcement was described as a transparency move, but meeting its 20 September target start date requires both the FDA and ACIP to act quickly on boosters.    

third vaccine shot
The US government plans to begin administering COVID-19 booster shots in late September. • Source: Alamy

The White House has amped up pressure on the US Food and Drug Administration to quickly complete assessments of COVID-19 vaccine booster shots by unveiling a plan to make them available to everyone in the US in about a month.

Federal officials announced 18 August that data indicates vaccine efficacy against infection declines over time and that preparations should begin for a widespread adult booster shot program. Individuals who received the mRNA vaccines from Pfizer Inc./BioNTech SE and Moderna, Inc. should prepare to get a third shot eight months after their second jab, they said

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FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
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Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
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Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
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Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
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At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.