EMA’s CHMP recommends authorization of Moderna's Covid-19 vaccine Spikevax for SARS-CoV-2 Variant LP.8.1

Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision

Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’

Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease

FDA grants EUA to Aptitude’s Covid/flu multiplex test for OTC use

Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19

Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization

Pfizer and BioNTech receive FDA authorization for Omicron KP.2-adapted Covid-19 Vaccine

The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older

Pfizer and BioNTech update on mRNA-based combination vaccine program against Influenza and Covid-19

In a Phase 3 trial, Pfizer and BioNTech’s combination vaccine candidate against influenza and COVID-19 met one of its two primary immunogenicity objectives

Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention

Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID?19 in an immunocompromised patient population

Pfizer and BioNTech receive Positive CHMP opinion for Omicron JN.1-adapted COVID-19 vaccine in EU

Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission

Moderna announces positive Phase 3 efficacy data for next generation COVID-19 vaccine

Higher efficacy was observed in mRNA-1283 compared to Spikevax in adults 18 years of age and older

Supernova Phase III trial of sipavibart long-acting antibody met primary endpoints in preventing COVID-19

SUPERNOVA is a large Phase III global trial providing the only efficacy data in immunocompromised patients