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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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More from Europe

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 
• By Francesca Bruce

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 
• By Francesca Bruce

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

More from Geography

UroGen’s Bladder Cancer Drug Draws Split Decision From US FDA Panel

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee voted 5-4 that the overall benefit-risk of UGN-102 is not favorable in patients with recurrent low grade, intermediate-risk, non-muscle invasive bladder cancer and also divided on whether randomized trials should be required for future development programs.

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

 
• By Cathy Kelly

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.