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Coronavirus Notebook: EMA OKs Updated Cominarty Vaccine, UK Brings Forward Vaccination Campaign Amid Spread Of BA.2.86 Strain

 
• By Ian Schofield

The World Health Organization’s C-TAP has signed new COVID-19 vaccine licensing deals with Medigen Vaccine Biologics of Taiwan and a Spanish research body, while the WHO and UNICEF say overall immunization rates are rebounding after the pandemic backslide, but not in all countries equally.

Mutated coronavirus SARS-CoV-2 flu disease pandemic
The new virus variant BA.2.86 is causing concern • Source: Shutterstock

The European Medicines Agency has recommended EU-wide approval of an updated version of Pfizer’s COVID-19 vaccine, Comirnaty, that is targeted to the Omicron XBB.1.5 sublineage of the SARS-CoV-2 virus.

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More from Europe

CSL Makes Landmark National-Level Pay-For-Performance Deal In Germany For Hemgenix

 
• By Francesca Bruce

A blanket pricing agreement CSL has formed with German health insurers for the gene therapy, Hemgenix, makes the cost of treatment budget-neutral compared to traditional treatment.

New Carbon Monitoring Initiative Could Help Future Proof Clinical Research

 
• By Francesca Bruce

A new European initiative will help trial sponsors better understand whether digitization and decentralized clinical trials of drugs generate less carbon than traditional methods.

Major Analysis To Help MHRA Fill Gaps In UK Clinical Trials Landscape

 
• By Vibha Sharma

A first-of-its-kind review of clinical trial applications submitted to the UK medicines regulator, the MHRA, shows there is a concentration of research in certain disease areas and identifies opportunities to enhance the representation of specific patient groups.

New Medicines Pricing Proposals Would Mean More Uncertainty For Spanish Supply Chains

 
• By Francesca Bruce

Proposals to reform Spain’s reference pricing system are out of whack with the national pharmaceutical strategy published in December, six industry associations have warned.

More from Geography

GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

 
• By Cathy Kelly

Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.

US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

Kennedy’s Comments On Novavax Delay Scientifically, Legally Inaccurate, Experts Say

 
• By Sarah Karlin-Smith

The HHS Secretary publicly acknowledged the unusual delay of Novavax's COVID-19 vaccine licensure, but his justification was neither scientifically accurate nor legally justifiable, experts said.