Breakthroughs Blog: Access

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. The US Food and Drug Administration (FDA) on Friday granted emergency use authorization (EUA) to Pfizer and BioNTech’s COVID-19 vaccine candidate, following a vote by the agency’s independent advisory panel last Thursday recommending authorization. Results from the vaccine’s phase 3 clinical trial released in late November showed 95 percent efficacy of the two-dose regimen, leading the companies to submit the candidate to regulatory bodies around the world. The candidate, the first mRNA-based vaccine ever to receive regulatory authorization, is the first COVID-19 vaccine to receive a green light in the United States and has also been authorized in the United Kingdom, Canada, and several other countries. The EUA allows the United States to begin vaccinating people 16 years of age and older in a massive distribution effort prioritizing health care personnel and residents and staff of long-term care facilities.As COVID-19 vaccine approval and rollout becomes a reality, a group of global health organizations is warning that low-income countries will face extreme challenges with vaccine access due to high-income countries securing a vast majority of the global vaccine supply through advance purchase deals with vaccine developers. Data on these agreements and the current vaccine pipeline indicates that nearly 70 low- and middle-income countries will be only able to vaccinate 10 percent of their populations against COVID-19 in the next year. A recent study also outlines the confirmed purchases of at least 6.8 billion doses by primarily high-income countries, creating a risk that lower-income countries will be forced to wait for doses, deepening existing inequities and furthering economic damages. Low-income countries will likely be reliant on doses provided through the COVAX Facility, a global mechanism to speed up development, manufacturing, and equitable distribution of COVID-19 vaccines—an initiative researchers say is being undermined by these unequal vaccine deals.Efforts to develop COVID-19 treatments are moving forward as companies look to add to the arsenal of therapeutics helping to minimize the effects of COVID-19 illness. Since the onset of the pandemic, FDA has authorized a few treatment options, including remdesivir, convalescent plasma, and monoclonal antibodies. Other therapeutics remain under development, including an apelin agonist peptide treatment developed by CohBar, which recently demonstrated efficacy in preclinical models to treat acute respiratory distress, and Sorrento Therapeutics’ intravenous STI-2020, which recently received FDA clearance to begin phase 1 trials as a potential early treatment for COVID-19 outpatients with mild symptoms. Both developers plan to accumulate further safety and efficacy data of the therapeutics in the upcoming months.

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.This morning, Moderna announced 94 percent efficacy of its mRNA-based COVID-19 vaccine candidate in the main analysis of its late-stage trial, and the company is now seeking emergency use regulatory clearances in the United States and Europe. The updated results from Moderna’s 30,000-volunteer phase 3 study show a total of 196 symptomatic cases of COVID-19, of which 185 received a placebo injection and 11 received the vaccine. The news follows similarly strong results from Pfizer and BioNTech’s vaccine candidate, which the companies submitted for US Food and Drug Administration (FDA) emergency use authorization on November 20. The FDA committee will convene December 10 to review Pfizer’s vaccine candidate and December 17 to review Moderna’s candidate.Thirteen African countries and an international network of research institutions are launching a multi-country clinical trial of COVID-19 treatments in patients with mild to moderate illness. Led by the Drugs for Neglected Diseases initiative, the ANTICOV trial aims to identify drugs that can be used for early treatment of COVID-19. The ANTICOV consortium will carry out the trial at 19 sites across 13 countries and will begin by examining repurposed drugs that have previously been used for HIV, malaria, and other infectious diseases before expanding to additional treatments and adapting over time. The trial is part of the Access to COVID-19 Tools (ACT) Accelerator therapeutics pillar, launched in April to ensure equitable global access to COVID-19 innovations.As several COVID-19 vaccine candidates await regulatory clearance by health authorities around the world, the question of global distribution efforts is becoming more relevant. While the United States and European countries have signed direct agreements with vaccine developers to secure enough doses to cover their populations if the vaccine candidates are approved, many low- and middle-income countries (LMICs) will be reliant on the ACT Accelerator’s vaccines pillar, a mechanism aiming to accelerate development and equitable distribution of COVID-19 vaccines. The effort plans to distribute 1 billion vaccine doses to LMICs based on a “fair allocation program” by the end of 2021, which will cover about 20 percent of their populations, but it will likely face distribution and storage challenges due to funding gaps, manufacturing facility locations, and cold-storage requirements.  

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.