Pace Of Omicron Variants Hindering Work On Adapted COVID-19 Vaccines

The European Medicines Agency says regulators are currently discussing the extent to which clinical data will have to be submitted to support the approval of an adapted vaccine against Omicron variants.

Researcher with blood sample of New Variant of the Covid-19 Omicron
Vaccines are needed to tackle new SARS-CoV-2 variants • Source: Shutterstock

International drug regulators have reached a certain degree of alignment on key principles to support the use of adapted COVID-19 vaccines against Omicron variants of concern, but say that the development of such vaccines is made difficult by the rapid arrival of new variants.

More from Europe

More from Geography

US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

US Pharma Tariff Reprieve May Be Ending

 

Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.