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AstraZeneca Vaccine’s ‘Big Gap’: DSMB Questions Results Released By Firm In Latest Controversy

 
• By Brenda Sandburg

‘Harsh note’ from Data Safety and Monitoring Board follows AstraZeneca press release that contained incomplete information about the Phase III US trial for its COVID vaccine. It remains to be seen how the company will fix this ‘unforced error’ and weather the latest threat to public trust.

AZ vaccine
AstraZeneca criticized for incomplete COVID-19 vaccine trial data • Source: Shutterstock

If there’s no such thing as bad publicity, AstraZeneca PLC’s COVID-19 vaccine is doing great, having generated a series of embarrassing events surrounding the rollout in Europe and development in the US.

Now, in an extraordinary move, the Data and Safety Monitoring Board overseeing the US clinical trial has voiced concerns about...

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Senate Panel Approves US CDC Director Candidate Monarez With Measles Outbreak Growing

 
• By Cathy Kelly

The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.

US FDA Advisory Committee Supports Vaccine Safety, Scrutinizes AE Reporting Quality

 
• By Sue Sutter

The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.

US FDA Pediatric Adcomm To Examine HPV, Flu, Dengue Vaccines: No News Is Good News?

 
• By Sue Sutter

Pediatric Advisory Committee will weigh the FDA's recommendation that routine safety monitoring continue for Merck & Co's Gardasil and Sanofi's Fluzone and Dengvaxia despite a political climate that has been unkind to vaccines.

England’s NHS Plan Eyes Cancer Vaccine Boost, Single Formulary & ‘Pay For Impact’ Drug Deal

 
• By Eliza Slawther

The creation of a single national formulary for medicines prescribing that could impact industry is among the action points in the UK government’s new 10-year health plan for the National Health Service in England.

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Opuni Appointed Acting CEO Of Ghana’s FDA As Darko Leaves To Lead African Medicines Agency

 
• By Anabel Costa-Ferreira

Kwabena Frimpong-Manso Opuni has been appointed as the new acting CEO of the Ghana Food and Drugs Authority, succeeding Delese Darko, who is now head of the Africa’s pan-continental medicines agency.

UK HRA Working On ‘Trusted’ Path Forward To Support Simplified Informed Consent

 
• By Vibha Sharma

The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.

EU Ups Ante On Stockpiling For Crises

 
• By Francesca Bruce

The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.