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Coronavirus Notebook: EMA Starts Review Of Sanofi/GSK Vaccine, UK Boosts mRNA Lipid Production

 
• By Ian Schofield

Sanofi/GSK's vaccine is under review in the EU and the UK government has awarded a grant to a company to allow it to increase its production of a key component of mRNA vaccines. Also, EU member states have proposed ways of improving the supply and donation of COVID-19 vaccines, including for those fleeing the conflict in Ukraine. Germany’s InflaRx has reported “encouraging” results with its anti-inflammatory drug vilobelimab in seriously ill patients.

Six vials of coronavirus vaccine. Glass bottles with red and blue caps. Two-stage injection against COVID-19 virus. 3D rendering - Image ID: 2H5DPKG
Vidprevtyn would be the EU's sixth COVID-19 vaccine • Source: Alamy

The European Medicines Agency has begun assessing a conditional marketing authorization application (MAA) filed by Sanofi and GlaxoSmithKline plc for their COVID-19 vaccine, Vidprevtyn.

The vaccine is an adjuvanted recombinant protein-based product that includes an S-protein antigen from Sanofi and an adjuvant platform from GSK

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More from Vaccines

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews

 
• By Sue Sutter and Bridget Silverman

The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
• By Joseph Haas

During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.

More from Pink Sheet

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.

EMA Explores Using AI Language Models To Refine Oncology Guidance

 
• By Vibha Sharma

The European Medicines Agency has for the first time explicitly stated it is considering the use of large language models as a tool to improve the readability of a scientific guideline.

Industry On Making England’s HTA Innovation Lab A Success

 
• By Eliza Slawther

England’s health technology assessment institute, NICE, must ensure that there is clarity for manufacturers on how its methods and processes might change following testing in its sandbox environment, the Association of the British Pharmaceutical Industry said.