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Coronavirus Notebook: EMA Issues Guidance On Development Of Variant Vaccines, EU Leaders Urge Production Ramp-Up

 
• By Ian Schofield

A batch of AstraZeneca/Oxford University coronavirus vaccines has arrived in Ghana, the first country in the world to receive vaccines via the COVAX Facility.   

World Global Ecology International Meeting Unity Learning Concept
Global efforts are under way to boost COVID-19 vaccinations • Source: Shutterstock

The European Medicines Agency has issued guidance outlining the regulatory requirements companies will need to meet if they plan to modify their coronavirus vaccines to address new SARS-CoV-2 variants.

The guidance was published on the same day that EU heads of state and government pledged to support efforts...

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More from Europe

EU Countries Rally Behind Novel Pathway For Combined Drug/IVD Trials

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

New EU Approvals

 
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Swissmedic Appoints Trivigno As New Agency Head From 2026

 
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New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 
• By Eliza Slawther

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

More from Geography

PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

 
• By Derrick Gingery

Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.

Swissmedic Appoints Trivigno As New Agency Head From 2026

 
• By Anabel Costa-Ferreira

Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.

New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 
• By Eliza Slawther

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.