COVID-19 Quick Takes: secondary consequences of COVID-19 in children; plus BioNTech receives funding and expands trial, Regeneron enters RECOVERY, Valneva and Novavax
Icahn researchers identify autoantibodies in COVID-19-recovered children
Icahn School of Medicine at Mount Sinai researchers published in Cell the immune profiles of nine COVID-19-recovered children with a median age of 12 years and multisystem inflammatory syndrome in children (MIS-C), and found elevated levels of inflammatory cytokines and autoantibodies. Symptoms presented weeks after the peak of viral load, suggesting MIS-C is a secondary consequence of SARS-CoV-2 infection. Autoantibody analysis revealed hundreds of autoantigens expressed in several organ systems, including ones associated with Sjögren syndrome and idiopathic inflammatory myopathies. The scientists also identified signatures of myeloid cell activation and chemotaxis, mucosal immune dysregulation and immune exhaustion.
BioNTech, Pfizer expanding Phase III enrollment in vaccine trial
BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) submitted an amended protocol to FDA to increase enrollment in the Phase III trial of their COVID-19 vaccine BNT162b2 from 30,000 to 44,000 participants in order to enroll new populations including teenagers and participants with HIV, HBV or HCV. The companies reiterated an expected efficacy readout by the end of October (see “Pfizer, BioNTech Unveil Data”).
BioNTech receives funding from German Federal Ministry of Education and Research
BioNTech announced Tuesday it will receive €375 million ($444.9 million) from the German Federal Ministry of Education and Research (BMBF). The BNT162 vaccine program is one of three programs supported by the BMBF initiative, which will provide a total of up to €750 million ($889.7 million) to its recipients. The funding is dependent on the achievement of eight milestones — five of which BioNTech has completed. The funding will support its BNT162 vaccine program, scale up of its manufacturing capabilities in Germany and its clinical trial expansion.
Regeneron’s antibody cocktail added to RECOVERY trial
The University of Oxford-run RECOVERY trial has added a study arm that will evaluate the impact of REGN-COV2 from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) in combination with standard of care on 28-day mortality in an estimated 2,000 hospitalized patients. REGN-COV2 is the first novel COVID-19 antibody to be tested in the master protocol study, which is also evaluating three other potential COVID-19 treatments — azithromycin, tocilizumab and convalescent plasma.
Data from RECOVERY have guided authorizations and treatment decisions such as the EUA for dexamethasone in the U.K., the discontinuation of lopinavir/ritonavir in clinical trials, and the withdrawal of the EUA for hydroxychloroquine in the U.S. (see “Master Protocols”).
U.K. secures 60 million vaccine doses from Valneva
Valneva SE (Euronext:VLA; VSE:VLA) will provide the U.K. government with 60 million doses of its inactivated COVID-19 vaccine, VLA2001, in 2H21 for €470 million ($557.6 million). The government has an option for an additional 40 million doses in 2022 and 30 to 90 million doses between 2023 and 2025. The two-dose vaccine, adjuvanted with CpG 1018 from Dynavax Technologies Corp. (NASDAQ:DVAX), is slated to enter the clinic in December. Dynavax will supply CpG 1018 for up to 100 million doses of vaccine in 2021. Valneva has the option to purchase up to an additional 90 million doses of adjuvant through 2025.
Novavax doubles vaccine manufacturing capability
Novavax Inc. (NASDAQ:NVAX) amended its existing agreement with the Serum Institute of India to increase its manufacturing capacity for NVX-CoV2373 to over two billion doses annually by mid-2021. The agreement includes a global supply chain, enabling vaccine production on three continents: North America, Europe and Asia.