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Coronavirus Notebook: Australia To Assess Omicron-Adapted Vaccine Riltozinameran, EU Advises On Boosters For Older & Vulnerable People

 
• By Ian Schofield

The EMA has drawn up a list of groups of critical medicines for use in health emergencies, while the European Parliament’s special COVID-19 committee is to discuss vaccination campaigns and challenges with the chiefs of the ECDC and HERA.

Microscopic view of covid-19 omicron variant or B.1.1.529 and letter of omicron in Greek alphabet on red background
Adapted vaccines are targeting the Omicron variant • Source: Shuterstock

The Australian Therapeutic Goods Administration has given Pfizer Inc. the go-ahead to apply for provisional registration of two adapted versions of the Pfizer/BioNTech COVID-19 vaccine, Cominarty (tozinameran), targeted at the Omicron variant.

The two products are a monovalent vaccine, riltozinameran (Comirnaty Omicron), and a bivalent vaccine combining riltozinameran with tozinameran (Comirnaty Bivalent).

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EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
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EU CHMP Opinions And MAA Updates

 
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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.

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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.

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