Pfizer and BioNTech initiate a study as part of broad development plan to evaluate COVID-19 booster and new vaccine variants
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they have begun an evaluation of the safety and immunogenicity of a third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the circulating and potential newly emerging SARS-CoV-2 variants.
Sanofi and GlaxoSmithKline (GSK) announced the initiation of a new Phase 2 study with 720 volunteers aged 18 and over to select the most appropriate antigen dosage for Phase 3 evaluation of their adjuvanted recombinant protein COVID-19 vaccine candidate.
Sanofi has entered into an agreement with Janssen Pharmaceutical NV and Janssen Pharmaceuticals, Inc., two of the Janssen Pharmaceutical Companies of Johnson & Johnson, under which Sanofi will support manufacturing of Janssen's COVID-19 vaccine in order to address the COVID-19 pandemic and supply needs. Janssen has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization for its single-dose Janssen COVID-19 vaccine candidate and an application for conditional marketing authorisation to the European Medicines Agency.
Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen-Cilag International N.V. has submitted for Emergency Use Listing (EUL) to the World Health Organization (WHO) for the investigational single-dose Janssen COVID-19 vaccine candidate. The data package delivered includes interim efficacy and safety results from the Phase 3 ENSEMBLE clinical trial.
AstraZeneca's COVID-19 vaccine has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for active immunisation to prevent COVID-19 in individuals 18 years of age and older, including those over 65.