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Coronavirus Notebook: EMA Reviews Safety Of All Four Approved Vaccines, EU Buys Big On Comirnaty

 
• By Ian Schofield

Calls grow for a relaxation of IP on COVID-19 vaccines as interest groups pile the pressure on the UK government and the Pope gives his blessing to the proposed waiver.

Side effects sign with wooden letters and a syringe on blue background. COVID-19 vaccination risks concept
The safety profiles of some COVID-19 vaccines are in the spotlight • Source: Alamy

The European Medicines Agency’s drug safety committee has issued recommendations on all four of the EU-approved COVID-19 vaccines: Pfizer/BioNTech’s Comirnaty, AstraZeneca/Oxford University’s Vaxzevria, COVID-19 Vaccine Moderna, and COVID-19 Vaccine Janssen.

A review of unusual blood clots with low platelets (thrombosis with thrombocytopenia syndrome, or TTS) with the Janssen vaccine showed that its benefits outweighed its risks, but the Pharmacovigilance Risk Assessment Committee (PRAC) said the product information should include advice that patients who are diagnosed

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More from Europe

Few Takers For EMA’s OPEN Pathway Prompts Rethink

 
• By Vibha Sharma

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.

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.

Austria To Fine Companies For Violating New Drug Stockpiling Rule

 
• By Neena Brizmohun

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.

More from Geography

Few Takers For EMA’s OPEN Pathway Prompts Rethink

 
• By Vibha Sharma

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.

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.