EU Approval Of COVID-19 Vaccines Possible In Weeks

The European Medicines Agency will continue working over the Christmas period so that it can complete its assessment of the newly filed marketing applications for BioNTech/Pfizer’s and Moderna’s COVID-19 vaccines as soon possible.

EU Coronavirus vaccine, Europe. Covid-19 vaccination, flu prevention, immunization concept. Vial dose and medical syringe, European Union flag background. 3d illustration
COVID-19 vaccines are nearing the market in Europe • Source: Shutterstock

The European Medicines Agency could decide within weeks whether the COVID-19 vaccines being developed by BioNTech/Pfizer and Moderna respectively should be granted pan-EU marketing approval.

More from Vaccines

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

 
• By 

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.

How States And Courts Could Insulate America From An Anti-Vaccine Executive Branch

 

The mood at the World Vaccines Congress in Washington, D.C. was bleak given Robert F. Kennedy Jr.’s rise to lead the Trump Administration’s Health and Human Services Department, but vaccine lawyers offered an optimistic outlook and ideas for countering his vaccine agenda.

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review

 

In an unusual move, Tracy Beth Høeg, a special assistant to FDA Commissioner Martin Makary, is leading the continued negotiations on Novavax’s delayed COVID-19 vaccine approval.

More from Pink Sheet

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.