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Coronavirus Notebook: Pfizer/BioNTech On Plans For EU Vaccine Rollout, COVAX Strikes New Deals

 
• By Ian Schofield

The latest round-up from the Pink Sheet of developments relating to COVID-19.

European Union health care and Europe or EU pandemic as coronavirus or covid-19 in France Germany Italy and England as a 3D render. L
The EU has its first COVID-19 vaccine • Source: Shutterstock

Approvals are coming thick and fast for Pfizer/BioNTech’s COVID-19 vaccine, Comirnaty. The COVAX program is working to ensure countries have equitable access to vaccines. And ministers from EU member states have laid out a set of proposals for strengthening the bloc’s response and resilience to ongoing and future health threats. In the meantime, a new global consortium, GTEC, is looking at how the T cell response can help in diagnosing COVID-19 and assessing immunity as new vaccines come onstream.

Following its approval by the European Commission yesterday, Pfizer/BioNTech’s COVID-19 vaccine, Comirnaty (also known as BNT162b2), now has a conditional marketing authorization or an emergency/temporary use authorization in more than...

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More from Europe

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

More from Geography

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.