March 4 COVID Quick Takes: More guidance on vaccines for variants; plus EMA begins review of Sputnik V, Novartis-CureVac, Bharat-Ocugen, Novavax and more
The ACCESS consortium, a coalition of regulatory authorities from the U.K., Australia, Canada, Singapore and Switzerland, released guidance on Thursday outlining the data needed to approve variant-specific modifications to authorized COVID-19 vaccines. According to the guidance, immunogenicity and safety data, but not clinical efficacy data, will “usually” be required for adapted vaccines. Data from the initial pivotal trials and real-world evidence may also be used to support regulatory decisions.
EMA starts rolling review of Sputnik V
EMA’s CHMP started a rolling review of Sputnik V, a viral vector COVID-19 vaccine from N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology.
Novartis to manufacture CureVac’s vaccine
Novartis AG (NYSE:NVS; SIX:NOVN) signed an agreement with CureVac N.V. (NASDAQ:CVAC) to manufacture up to 50 million doses of CureVac’s mRNA COVID-19 vaccine, CVnCoV, by year-end and up to 200 million doses in 2022.
Bharat, Ocugen vaccine demonstrates 81% efficacy
Ocugen Inc. (NASDAQ:OCGN) and Bharat Biotech International Ltd. said Wednesday that COVID-19 inactivated viral vaccine Covaxin showed 80.6% efficacy in a Phase III trial based on 43 cases. An additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases.
Novavax vaccine shows efficacy against B.1.351 variant
Novavax Inc. (NASDAQ:NVAX) reported in a medRxiv preprint that its protein-based COVID-19 vaccine, NVX-CoV2373, showed 51% efficacy against the B.1.351 variant in HIV-negative participants based on 33 cases, and 43% efficacy in all participants based on 38 cases.
U.K. launches trial to test vaccines in immunocompromised people
The U.K. is launching the OCTAVE trial to study the immune response to COVID-19 vaccines in immunosuppressed patients. The study will include up to 5,000 participants with cancer, inflammatory arthritis, diseases of the kidney or liver, or who are having a stem cell transplant. The trial is sponsored by the University of Birmingham and funded by the Medical Research Council.
EUA for Quidel’s at-home antigen test
FDA issued an emergency use authorization for the QuickVue At-Home COVID-19 Test from Quidel Corp. (NASDAQ:QDEL). The antigen test is authorized for prescription home use with self-collected nasal swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult.
Cerecor mAb reduces mortality in hospitalized COVID-19 patients
Anti-TNFSF14 mAb CERC-002 from Cerecor Inc. (NASDAQ:CERC) reduced respiratory failure and mortality (p=0.044) in a Phase II trial in patients hospitalized with COVID-19-associated acute respiratory distress syndrome (ARDS). A 50% mortality reduction was observed at the 28-day and the 60-day time points.
MediciNova discontinues COVID-19 vaccine development
MediciNova Inc. (NASDAQ:MNOV; Tokyo:4875) is discontinuing development of its COVID-19 vaccine to dedicate resources to its other programs. The company was developing an intranasal vaccine using BC-PIV, a viral vector platform technology developed by Mie University and BioComo Inc.
Apellis discontinues development of targeted C3 therapy for COVID-19
Apellis Pharmaceuticals Inc. (NASDAQ:APLS) is not pursuing further development of APL-9 to treat severe COVID-19 after Phase I/II results revealed no reduction in overall mortality rate in patients treated with the therapy designed to control the complement cascade.
TNFSF14 (LIGHT; CD258) – Tumor necrosis factor (TNF) ligand superfamily member 14