Play: TRICK or TREATment?

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. Regeneron will need to place on hold enrollment of patients requiring high-flow oxygen or mechanical ventilation in its COVID-19 antibody cocktail clinical trial, based on recommendations from an independent data monitoring committee. The trial can continue to enroll hospitalized patients who need either no or low-flow oxygen, and the treatment’s outpatient trial will continue unaffected. Early data on the antibody cocktail, REGN-COV2, indicated it reduced COVID-19–related medical visits by 57 percent. The cocktail is currently under evaluation by the US Food and Drug Administration for emergency use authorization, specifically in mild to moderate outpatients at high risk for poor outcomes.Singapore-based startup firm Breathonix has developed a breathalyzer test able to diagnose COVID-19 infection in under a minute. The device, designed to avoid cross-contamination, uses disposable mouthpieces and assesses the chemical compounds of the breath to determine infection. Results are then generated by a computer within 60 seconds. The test achieved more than 90 percent accuracy in a pilot clinical trial of 180 people, according to Breathonix, and could act as a first-level screening device with a more sensitive polymerase chain reaction nasal swab test used to confirm the diagnosis. The company will be expanding its trial in Singapore with the intention of improving accuracy and receiving a green light for commercial use in the first quarter of next year.Sanofi and GlaxoSmithKline (GSK) announced an agreement to supply 200 million doses of their COVID-19 vaccine candidate, if approved by regulators, to the COVID-19 Vaccine Global Access (COVAX) Facility. The vaccine candidate began a phase 1/2 clinical trial in early September, and first results are anticipated in December 2020 to support a phase 3 trial before the end of the year. Sanofi and GSK, in statements on the COVAX partnership, emphasized a commitment to ensuring affordable and accessible COVID-19 vaccines around the world. The COVAX Facility—a global collaboration of governments, global health organizations, businesses, and philanthropic organizations focused on accelerating development and production of COVID-19 products—is designed to ensure people in all parts of the world get access to COVID-19 vaccines once available. More than 180 countries and economies are currently a part of the mechanism.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email.On Thursday, independent advisors to the US Food and Drug Administration (FDA) met in their first full-day meeting to begin laying the groundwork for upcoming COVID-19 vaccine approval guidelines. While there are no guarantees for which, and when, vaccine candidates will be shown to be safe and effective, several vaccine candidates are currently in late-stage trials, and early data on Pfizer’s and Moderna’s candidates may be available this month or next as both companies predict having sufficient safety data by the end of November. Johnson & Johnson’s vaccine trial and the US arm of AstraZeneca’s vaccine trial have been cleared to restart after pauses for safety investigations. Novavax recently began a late-stage trial in Britain and will soon start one in the United States as well, as will Sanofi and GlaxoSmithKline. Once evidence of safety and efficacy is available from vaccine makers, regulatory review will take a few weeks and will require the vaccine be at least 50 percent effective, among other criteria.LabCorp has launched a COVID-19 antibody test designed to evaluate the strength of a person’s immune response to the virus and assist in determining the effectiveness of vaccine candidates. The Cov2Quant test provides a quantitative measurement of the concentration of IgG antibodies in a person’s blood and is currently available for use in research only, including Centers for Disease Control and Prevention (CDC) epidemiological studies working to better understand how antibodies are produced by the body after exposure and infection. So far, only two quantitative antibody diagnostics have been authorized by the FDA for wider use, both from Siemens Healtineers in early August. It remains unknown exactly how many antibodies a person needs to be considered immune to COVID-19, and quantitative measurement tools will be an essential tool in better understanding COVID-19 immunity.Pfizer—currently in phase 3 trials for its COVID-19 vaccine candidate and expecting early indications about efficacy this month—is preparing a supply chain and distribution system aimed at delivering hundreds of millions of doses globally. Distribution sites in Kalamazoo, Michigan, and Puurs, Belgium, are at the center of the effort, at which the company will load reusable, temperature-controlled containers on two dozen trucks per day and ship 7.6 million doses daily to nearby airports. Pfizer’s mRNA-based vaccine candidate requires storage at -94 degrees Fahrenheit, which the company is hoping to accomplish with suitcase-sized shipping containers designed to keep doses at ultracold temperatures for up to ten days. Pfizer’s delivery plan utilizes cargo space on 20 planes per day, followed by trucking from airports to vaccination sites, all carried out by FedEx, UPS, and DHL International. Pfizer expects deliveries to take three days and aims to deliver 100 million vaccine doses in 2020 and 1.3 billion in 2021, as part of supply deals with the United States, Europe, Japan, the United Kingdom, and more.