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FACTBOX-U.S. pours billions into development of coronavirus vaccines, tests

07 Jul 2020 / 23:25 H.

    (Updates with BARDA investment in Novavax vaccine, new grants to Regeneron's and AstraZeneca's therapies, updates development stage for AstraZeneca vaccine and diagnostics table) July 7 (Reuters) - As drugmakers race to develop vaccines, tests and therapies for the novel coronavirus, the United States is rushing to secure access to them by providing funding. The Biomedical Advanced Research and Development Authority (BARDA), a U.S. federal agency that funds disease-fighting technology, awarded Novavax Inc $1.6 billion to cover testing, commercialization and manufacturing of a potential coronavirus vaccine in the United States - the biggest yet grant from "Operation Warp Speed," the White House program aimed at accelerating access to vaccines and treatments for the new coronavirus. BARDA has invested more than $3 billion in vaccines and funded more than 30 projects, including for diagnostics and treatments. The agency has awarded grants to Moderna, the first in the United States to begin human trials of a coronavirus vaccine, Sanofi, the world's largest vaccine maker, and Johnson & Johnson . The following tables list publicly disclosed BARDA funding over $1 mln to date: VACCINES Company BARDA Funding Vaccine type Stage of development AstraZeneca Plc up to $1.2 bln AZD1222 was developed by the Mid-stage trials underway University of Oxford and licensed to AstraZeneca Moderna Plc $486 mln mRNA-1273 - uses synthetic messenger Vaccine produced positive results in 45-subject RNA (mRNA) to inoculate against the safety trial; late-stage trial to start in July coronavirus Johnson & Johnson $456.2 mln Viral Vector Vaccine for COVID-19 - Will begin human testing in September, with an eye uses pharma unit Janssen Research's toward having a vaccine ready under an emergency use established Adenovirus 26 platform authorization in early 2021 Sanofi SA $30.7 mln Recombinant SARS-CoV-2 Protein Vaccine Plans to enroll 1000s of subjects globally for - Based on co's FDA-licensed seasonal early-stage trials for the vaccine it is developing influenza vaccine Flublok with GlaxoSmithKline Plc Merck & Co Inc $38 mln Recombinant COVID-19 vaccine - Based Human trials for vaccine, being developed jointly on same technology used in co's Ebola with research nonprofit IAVI, expected sometime this vaccine ERVEBO year Novavax Inc $1.6 bln Works with an adjuvant - a substance Mid-stage trials to begin in August or September, that boosts immune response to help late-stage in October. Grant covers testing, body build a robust defense against commercialization and manufacturing of vaccine in the virus U.S., with aim of delivering 100 mln doses by January *Sanofi is also working with U.S.-based Translate Bio Inc on another vaccine candidate based on messenger RNA technology (mRNA). This vaccine has not received funding from BARDA. THERAPIES Company BARDA Funding Therapy type Stage of development Grifols Shared Services North $12.5 mln Treatment based on plasma donated by patients who Company collecting plasma samples. Human studies yet America have recovered from COVID-19; plasma contains to begin antibodies that can target the virus Emergent Biosolutions $14.5 mln Treatment based on plasma from recovered COVID-19 Planning clinical trials patients SAb Biotherapeutics $7.2 mln Immunotherapy that uses SAb's technology to produce Human trials have not started. Company says it has COVID-19 antibodies without blood donations from finished preclinical studies recovered people Genentech USA $25.1 mln Repurposing its rheumatoid arthritis therapy, Regulatory nod for late-stage clinical trial to Actemra(tocilizumab), to help control study efficacy along with standard of care in COVID-19-associated inflammation that could cause hospitalized adult patients with severe COVID-19 respiratory failure pneumonia Regeneron Pharmaceuticals $16.3 mln, $82 mln Testing Kevzara, developed with Sanofi and U.S.-based trial stopped as Kevzara did not show approved for rheumatoid arthritis, to see if it can results in patients with severe COVID-19, expects to reduce symptoms of inflammation in hospitalized report results of Kevzara trial outside U.S. in Q3 people with COVID-19 2020 SARS-CoV-2 specific monoclonal antibodies - A Antibody being tested for preventing and treating $450 mln therapeutic antibody cocktail using Regeneron's COVID-19, late-stage prevention trial run jointly discovery platform VelocImmune with National Institutes of Health $450 mln contract to cover manufacture and supply of a fixed number of bulk lots of the antibody cocktail, to be completed in fall of 2020 Johnson & Johnson $152 mln Janssen Research & Development and Rega Institute of No development details available Medical Research to screen libraries to identify therapeutic compounds with antiviral activity against COVID-19. AstraZeneca $23.6 mln Novel monoclonal antibody combination that recognizes Grant supports company's efforts to develop the and neutralizes SARS-CoV-2 treatment, including early clinical trial and manufacturing of investigational product for testing DIAGNOSTICS Company BARDA funding Type of test Stage of development Hologic Inc $13 mln Aptima SARS-CoV-2 assay and Panther Emergency Use Authorization issued Fusion SARS-CoV-2 assay - use respiratory specimens to detect SARS-CoV-2; both can process 1,000 tests in 24 hours and deliver test results in 3 hours Cue Inc $13.6 mln A portable test that can detect Emergency Use Authorization issued SARS-CoV-2 in less than 25 minutes using a simple nasal swab Cepheid, a unit of Danaher $3.7 mln; A rapid, point-of-care test that detects Emergency Use Authorization issued Corp Additional funding virus in nasal swab samples within 45 planned as the minutes and is designed for use in program progresses clinical and hospital laboratories There are 24 other diagnostics-makers, including GenMark Diagnostics and Luminex Corporation, who have received grants under $1 million from BARDA. Source: BARDA website (https://bit.ly/2z9CMDr), U.S. FDA as well as company press releases (Reporting By Vishwadha Chander and Mrinalika Roy in Bengaluru; Editing by Ankur Banerjee, Sriraj Kalluvila and Aditya Soni)

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