1. Scrip
  2. >>COVID-19

Coronavirus Update: EMA To Update Comirnaty And Spikevax Labels On Cardiac Safety

Plus, New REGEN-COV Filing And Novel Vaccine Progress

 
• By Scrip Team

Comirnaty and Spikevax to get EU label update on cardiac safety, Japanese filing for REGEN-COV, plus vaccine progress for ReiThera and Genexine.  

heartgloves
EU regulators add cardiac safety statements for mRNA vaccines • Source: Alamy

The European Medicines Agency is to join the US Food and Drug Administration in adding details of rare cardiac adverse events associated to the product information of two mRNA-based vaccines for COVID-19.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from COVID-19

Arcturus and CSL Take on Pfizer With Longer-Lasting COVID Vaccine

 
• By Kevin Grogan

Kostaive is the first self-amplifying mRNA COVID-19 vaccine to receive approval from the European Commission and could provide serious competition to Pfizer/BioNTech's Comirnaty and Moderna's Spikevax.

Under-Pressure Moderna Banks $590m To Speed Up Bird Flu Vaccine

 
• By Kevin Grogan

A week after a downbeat forecast at J.P. Morgan Healthcare Conference, the US mRNA specialist has pocketed another sizeable sum from the US Department of Health and Human Services to accelerate development of an H5N1 mRNA pandemic influenza vaccine.

Stock Watch: Q3, Bonfire Of The Vaccine Manufacturers

 
• By Andy Smith

Pfizer’s and Moderna’s quarterly pandemic-related product sales could not mask other weaknesses while GSK’s quarter was marred by unimpressive non-pandemic vaccines sales.

Meiji Considers Legal Action Amid Japan Misinformation On Kostaive Vaccine

 
• By Lisa Takagi

Japanese distributor Meiji Seika Pharma is considering possible legal action against what it views as online slander around COVID-19 vaccine Kostaive, which received its global-first approval in Japan last year and has now been launched for regular vaccination in the country.

More from Scrip

Camzyos nHCM Failure Could Open Door To Threat From Cytokinetics’ Aficamten

 
• By Alaric DeArment

BMS’s Phase III ODYSSEY-HCM study did not show statistical significance for either of its two primary endpoints.

Taxes, Not Tariffs, Influence US Manufacturing, J&J CEO Says

 
• By Jessica Merrill

The big pharma forecast a $400m expense this year related to tariffs, but those estimates only reflect medtech tariffs already announced, not potential pharma tariffs.

Disappointing Asthma Phase II Results Take Wind Out Of Sanofi’s Amlitelimab

 
• By Andrew McConaghie

Sanofi’s OX40L candidate missed a Phase II primary endpoint, but the company believes it can still work in a sub-group of ‘heterogeneous inflammatory asthma’ patients.