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EU OKs Bivalent COVID-19 Vaccines From Pfizer/BioNTech & Moderna

 
• By Ian Schofield

The European Commission will shortly issue marketing authorizations for bivalent versions of Comirnaty and Spikevax targeting the Omicron BA.1 subvariant, after the European Medicines Agency recommended their approval for EU-wide use. Bivalent Spikevax has also been provisionally approved in Australia.

spikevax and comirnaty
Bivalent versions of the two mRNA COVID-19 vaccines will soon be available in Europe • Source: Shutterstock

Two bivalent COVID-19 booster vaccines from Pfizer/BioNTech and Moderna have been recommended for EU-wide approval by the European Medicines Agency, which says they can trigger “strong immune responses” against the Omicron BA.1 subvariant and the original SARS-CoV-2 strain.

The recommendations by the EMA’s human drugs committee, the CHMP, were announced on 1 September and will now be sent to the European Commission, which issues

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More from Europe

UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
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Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

Few Takers For EMA’s OPEN Pathway Prompts Rethink

 
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EU Council Could Adopt Pharma Reform Package Next Week, But Disputes Risk A Year’s Delay

 
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EU HTA Regulation: How Rare Disease Drug Makers Can Meet Worrisome JCAs Data Requirements

 
• By Francesca Bruce

In an interview with the Pink Sheet, Fonadazione Telethon’s Stefano Benvenuti discusses how companies developing and marketing rare disease treatments can overcome the challenges presented by EU-joint clinical assessment evidence requirements.

More from Geography

Most Favored Nation Policy ‘Lazy, Misguided,’ But US Price Reforms Politically ‘Inevitable’

 
• By Cathy Kelly

Policy experts and pharma executives react to President Trump’s executive order on “equalizing” drug prices between the US and comparable nations at the ISPOR 2025 conference.

Few Takers For EMA’s OPEN Pathway Prompts Rethink

 
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While drug companies say they support the European Medicines Agency’s expanded OPEN framework for the collaborative assessment of marketing applications with non-EU authorities, they are reluctant to participate in the initiative for a number of reasons.

EU Council Could Adopt Pharma Reform Package Next Week, But Disputes Risk A Year’s Delay

 
• By Eliza Slawther

The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.