Breakthroughs Blog: COVID-19

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. Last week, Pfizer and BioNTech released preliminary data from their ongoing phase 3 COVID-19 vaccine trial, indicating up to 90 percent efficacy of their mRNA-based vaccine candidate. The companies hope to have enough data to file for emergency use authorization (EUA) within the next few weeks. If the vaccine candidate does receive approval, Pfizer and BioNTech will launch their extensive distribution plan—which requires the vaccine to be kept at -94°F, a strict cold chain that has led to feasibility concerns from many countries—to fulfil hundreds of millions of doses ordered through advanced purchase commitments. These commitments include a 300-million dose deal with the European Union, a 120-million dose deal with Japan, a 100-million dose deal with the United States, and a 30-million dose deal with the United Kingdom. Pfizer and BioNTech plan to roll out a total of 100 million doses of the vaccine by the end of 2020, followed by an additional 1.3 billion doses in 2021.The US Food and Drug Administration (FDA) last week granted EUA to Eli Lilly’s COVID-19 antibody treatment for use among people age 12 or older with mild or moderate COVID-19 infection. The drug, bamlanivimab, continues to be tested in a clinical trial to establish additional safety and efficacy data, after early results suggested it may help clear COVID-19 infection sooner and cut hospitalization rates in patients with mild or moderate cases. A study of the treatment in hospitalized patients was stopped in late October due to lack of efficacy, upon recommendation from independent monitors of the trial. The US government has signed an agreement with Eli Lilly to purchase 300,000 700-mg vials of the drug, though it is unclear how many doses that will provide, as early results indicated at least 2,800 mg is necessary to provide any effect. Eli Lilly’s therapeutic is the first antibody drug to receive EUA to treat COVID-19.The Senegal-based Pasteur Institute is developing an affordable, handheld COVID-19 diagnostic kit able to provide results in minutes. The rapid test kit contains a simple test strip housed in a plastic unit and requires a small blood sample, collected by finger prick. No electricity or laboratory analysis is required, and the center hopes the kits will cost as little as US$1. Developers plan to start manufacturing and distribution after regulatory checks are complete, making the kits first available to countries in Africa through governments and health organizations like the Africa Centers for Disease Control and Prevention, with a goal of issuing 10 to 15 million kits by February 2021.

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.A World Health Organization (WHO) draft document indicates that the WHO-led Access to COVID-19 Tools (ACT) Accelerator’s drug-supply scheme is prioritizing experimental antibody treatments and steroids while leaning away from remdesivir. The mechanism—one of four ACT Accelerator pillars working to scale COVID-19 health technologies—is co-led by Unitaid and the Wellcome Trust and is dedicated to securing and supplying COVID-19 therapeutics worldwide with an emphasis on equitable distribution. The scheme’s list of priorities outlined in the draft document says efforts will focus on advancing research and manufacturing of monoclonal antibodies and boosting distribution of the steroid dexamethasone, and does not mention remdesivir among priority drugs. The therapeutics pillar is also still working to reach its US$7.2 billion funding goal, $6.1 billion of which is unmet, and aims to distribute hundreds of millions of COVID-19 treatment regimens to lower-income countries by 2022.A recent analysis from researchers at Duke University’s Global Health Innovation Center found that high- and middle-income countries have purchased 3.8 billion COVID-19 vaccine doses, with options for 5 billion more, potentially leaving people in low-income countries without access until 2024. The study suggests that these direct deals between countries and drug manufacturers, known as advance purchase agreements, are exacerbating “vaccine nationalism” and undermining the equitable distribution efforts of mechanisms like the COVID-19 Vaccines Global Access (COVAX) Facility, a sub-mechanism of the ACT Accelerator. More than 150 countries, including many that have also made separate country-specific vaccine deals, have signed on to join the COVAX Facility, which aims to develop and equitably distribute 2 billion vaccine doses by the end of 2021.A nasal spray under development to prevent COVID-19 infection was shown to be effective in blocking absorption of SARS-CoV-2 in ferrets exposed to the virus, according to a research team from Columbia University Medical Center, Erasmus Medical Center, and Cornell University. The spray is designed to intervene in the virus’ process of attaching to airways or lung cells by fusing itself to an amino acid chain on the virus’ spike protein, thereby blocking viral attachment. In the very small animal study, the spray prevented all direct-contact transmission of SARS-CoV-2 during a 24-hour exposure period, indicating potential for the product to protect against COVID-19 infection in humans, although the research is still preprint and pre-peer review. Based on the promising animal results, researchers hope to secure additional funding that would allow them to expand tests of the nasal spray into human trials.

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.