Healthcare company Johnson & Johnson (NYSE:JNJ) said on Wednesday that it has signed an agreement with the US government for the large scale domestic manufacturing and delivery of 100 million doses of its Janssen Pharmaceutical Companies' SARS-CoV-2 investigational vaccine Ad26.COV2.S in the US following approval or Emergency Use Authorization by the US Food and Drug Administration (FDA).
In collaboration with the US Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA) is committing over USD1bn for this agreement. The vaccine will be provided at a global not-for-profit basis for emergency pandemic use. The US government may purchase an additional 200 million doses of Ad26.COV2.S under a subsequent agreement.
Based on Janssen's AdVac technology, the Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, is underway in healthy volunteers in the US and Belgium. It evaluating one- and two-dose regimens in its clinical programme and aims to meet its goal to supply more than 1 billion doses globally through the course of 2021, provided the vaccine is safe and effective.
Sanofi receives FDA complete response letter for tolebrutinib in progressive MS
Aqualung Therapeutics' Phase 2a lung fibrosis study approved by US FDA
AstraZeneca secures US Breakthrough status for Enhertu in early breast cancer
Shield Therapeutics wins FDA approval to expand ACCRUFeR use to adolescents
ECO Animal Health Group secures EU approval for ECOVAXXIN MS
Hansa Biopharma submits imlifidase Biologics License Application to FDA
T-MAXIMUM Pharmaceutical receives IND approval to start Phase II trial of MT027 for rGBM
Alvotech and Teva secure US launch date for Eylea biosimilar AVT06
Egetis initiates rolling US NDA for Emcitate in MCT8 deficiency
Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark
Amphix Bio announces initial closing of USD12.5m seed financing round
BiBBInstruments reports additional US orders during targeted EndoDrill GI launch
Sanofi's efdoralprin alfa receives EU orphan designation for AATD-related emphysema
Black Buffalo partners with Sanova to support regulatory strategy and scientific innovation
Nicox completes key data package for NCX 470 NDA submissions