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Coronavirus Notebook: EMA Data Hack Aimed At 'Undermining Trust' In Vaccines, Russia Plans EU Sputnik V Filing Next Month

 
• By Ian Schofield

France has reported on side-effect reports concerning the Pfizer/BioNTech vaccine, and the World Health Organization has warned that plans to provide global equitable access to coronavirus vaccines are at risk.

Hackers breaking server using multiple computers and infected virus ransomware. Cybercrime, technology, phishing mail concept.
Manipulation of hacked data could undermine trust in COVID-19 vaccines • Source: Shutterstock

“Someone clearly does not want Europeans to get vaccinated.” So says cybersecurity consultant Lukasz Olejnik, after the European Medicines Agency said that the data on COVID-19 vaccines that was unlawfully accessed on its servers was “manipulated” before being leaked on the internet.

The documents included internal and confidential email correspondence dating from November 2020 and relating to the evaluation processes for COVID-19...

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More from Europe

Plans For EU Biotech Act Shift Up A Gear

 
• By Eliza Slawther

Companies have until early November to respond to a public consultation from the European Commission on its planned Biotech Act, which it hopes will help unleash the potential of small and midsize enterprises in the bloc.

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.

Vaccine Developers To Benefit From CEPI’s ‘World First’ Adjuvant ‘Matchmaking’ Service

 
• By Eliza Slawther

Selected vaccine developers will soon be able to use a new adjuvant “matchmaking” initiative that could help create more “effective, potent” vaccines against epidemic and pandemic threats, the Coalition for Epidemic Preparedness Innovations has said.

EMA Tackles Guidance Void As Proposals For External Controls Grow

 
• By Neena Brizmohun

The European Medicines Agency is working on defining when and how external controls can be accepted in clinical research. Among other things, it is looking at the planning, design, conduct, analysis and reporting of studies for which external controls are used.

More from Geography

Japan Gives Global-First Recommendations To Taisho’s Vornorexant, Santen’s Sepetaprost

 
• By Lisa Takagi

Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.

August Brings Fresh Faces And Tough Calls To US FDA User Fee Calendar

 
• By Bridget Silverman

The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.

Court Allows MSN Marketing Of Entresto Generic, But More Legal Issues Pending

 
• By Dean Rudge

Novartis failed to stop MSN from launching a generic Entresto and saw an earlier temporary ban lifted, potentially opening the market to competition before a final decision on a US patent dispute.