Anna Kovacevich

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.

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.Clinical trials for Johnson & Johnson’s (J&J) COVID-19 vaccine candidate and Eli Lilly’s COVID-19 monoclonal antibody treatment were paused last week, while the US arm of AstraZeneca’s COVID-19 vaccine trial remains on hold since a patient’s potential adverse reaction in September. Vaccine experts say these pauses should be reassuring, not frightening, as they indicate the trial process is functioning as it is designed to; a clinical trial with no reports of adverse events would be unusual. J&J announced its trial pause after an “unexplained illness” in a trial participant, and the company will be reviewing the case along with an independent data monitoring board before making a decision on whether to resume the trial. Eli Lilly’s trial pause came after a potential safety concern flagged by an independent review board, and the board will review the data again at a later date to make a decision on its continuation.Pfizer announced last week it has received approval from the US Food and Drug Administration (FDA) to expand its COVID-19 vaccine trial to include children ages 12 and up. This development will look to understand vaccine safety and efficacy among adolescents and will mark the first inclusion of children under 16 in a COVID-19 vaccine trial in the United States. More than half a million children have been infected with COVID-19 this year, and more than two-thirds of the children who died were Black or Latinx, according to Sara Gozer, president of the American Academy of Pediatricians. While vaccine trials began with a focus on older participants due to their higher risk for more serious illness, pediatricians have emphasized the importance of not leaving children behind as trials progress.FDA has approved Inmazeb, an antibody cocktail made by Regeneron, for use as an Ebola therapeutic. This is the first FDA approval for a treatment specific to Ebola, and means there is now an FDA-approved treatment and vaccine for the virus. The treatment, which has been used during the current Ebola outbreak in the Democratic Republic of the Congo (DRC) under compassionate use protocol, was shown to be effective during a clinical trial conducted during the 2018–2020 outbreak in eastern DRC. The Biomedical Advanced Research and Development Authority has purchased an undisclosed number of Inmazeb doses for the US strategic stockpile, and Regeneron has said it will work to ensure low-income countries will also have access to the 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. Moderna announced last week that it would “not enforce” its COVID-19–related patents against other vaccine makers and would be willing to license intellectual property for COVID-19 vaccines for the post-pandemic period. The company, which is currently developing one of the four front-running COVID-19 vaccine candidates, said in a statement that it feels a “special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible.” Some advocates have responded with praise for Moderna being the only company working on a drug or vaccine to pledge open-sharing of its COVID-19 patents, while other advocates question the motivations behind the pledge, given Moderna’s pending intellectual property legal challenges as well as recent consumer and political pressures for access. Moderna plans to submit its vaccine candidate for US Food and Drug Administration (FDA) emergency use authorization by November 25 and later as a candidate for the general population by late January 2021, with the aim of having it available for widespread distribution by spring 2021.BioNTech and Pfizer have begun a rolling submission of their COVID-19 vaccine candidate for review by the European Medicines Agency (EMA), a process that AstraZeneca’s vaccine candidate also began the previous week. The candidate, BNT162b2, was accepted for rolling review based on its strong preclinical and early clinical data, which showed antibody and T-cell responses in people dosed in early-phase trials. BioNTech and Pfizer subsequently launched a phase 3 clinical trial—so far enrolling 37,000 participants across several countries. EMA will start assessing data on the experimental candidate before all necessary evidence is available, allowing it to reduce time spent on a decision once pivotal clinical trial results are available.A monoclonal antibody treatment developed by Eli Lilly appears to be effective in reducing virus levels and preventing hospital use in COVID-19 patients. The treatment, a combination of two monoclonal antibodies, was tested in non-hospitalized patients sick with COVID-19. Eli Lilly is also developing and had previously released results for a similar treatment using a single antibody, for which the company has filed for FDA emergency use authorization. Both antibody regimens have been well-tolerated, with no serious side effects, according to a company statement. Eli Lilly has said it expects to file for emergency use authorization for its combination therapy next month and anticipates having 1 million single-antibody treatment doses and 50,000 combination treatment doses available in the fourth quarter of 2020.

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. At a high-level event last week, global leaders pledged about US$1 billion to the Access to COVID-19 Tools (ACT) Accelerator, a global collaboration launched in April to accelerate development, production, and equitable access to COVID-19 tools. Despite the recent financial commitments from the United Kingdom, Canada, Germany, and Sweden, the ACT Accelerator is still facing a large funding gap of about $35 billion overall, with an urgent gap of $1.3 billion for the COVAX advance market commitment mechanism, which focuses on ensuring access to vaccines in low- and middle-income countries. During the same event, the Bill & Melinda Gates Foundation announced a new joint agreement with 16 pharmaceutical companies to scale up manufacturing of COVID-19 vaccines and other products and ensure broad distribution, a commitment that could help reduce the ACT Accelerator financial needs.The World Health Organization (WHO) has announced a plan to distribute 120 million rapid COVID-19 diagnostic tests to low- and middle-income countries at $5 per test. The program, which is supported by several WHO partner organizations and requires an initial $600 million in funding, will utilize antigen-based rapid diagnostics provided by SD Biosensor and Abbott, for which WHO recently issued emergency use listings. Several leaders of organizations involved in the plan have emphasized the need to close the testing gap in low- and middle-income countries to help health care workers understand and contain the virus’ circulation. Leaders have said the program will begin as early as next month in 20 African countries.Early results published by Regeneron last week indicate that the company’s COVID-19 antibody cocktail treatment lowered virus levels and relieved symptoms more quickly than a placebo did in non-hospitalized COVID-19 patients. The data comes from the first 275 patients in Regeneron’s adaptive phase 1/2/3 study in which participants received either a high treatment dose, low treatment dose, or placebo. The treatment—a combination of two antibodies that target different areas of the receptor-binding domain on the SARS-CoV-2 spike protein—appeared to be more effective among participants who tested negative for antibodies pre-study, indicating they had not yet produced their own effective immune response. Regeneron has enrolled a second group of patients to continue testing and will also expand its study to examine efficacy in hospitalized patients and as a preventive treatment for those who have been exposed to COVID-19 patients.

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. Johnson & Johnson (J&J) has moved into phase 3 trials for its COVID-19 vaccine candidate, making the company the fourth vaccine maker to enter late-stage trials in the United States and the first to do so with a single-dose vaccine candidate. In addition to being single-dose, J&J’s vaccine candidate can be stored at refrigerator temperatures for three months, making it more accessible to countries with less health care infrastructure than vaccines that require freezing. The phase 3 trial will be run at sites in the United States, Brazil, Mexico, South Africa, and other countries, and will include significant representation of people over the age of 60 and minorities at disproportionate risk of infection, according to J&J. The company is enrolling up to 60,000 volunteers and has said the trial could yield results by the end of the year, allowing it to seek emergency use authorization in early 2021.The US Food and Drug Administration (FDA) recently authorized for emergency use the first COVID-19 antibody test designed for use at point of care, instead of requiring samples to be shipped and tested at a laboratory. The fingerstick blood test—manufactured by Assure Tech, represented by Azure Biotech in the United States—provides results for two types of coronavirus antibodies within 15 minutes, using a lined strip similar to a pregnancy test. During an independent evaluation run in June, the test was found to have no false-negative results and a 1.2 percent false-positive rate. FDA Commissioner Stephen Hahn emphasized in a statement that point-of-care tests are more convenient, require less resources, and will decrease the time spent running antibody tests, in comparison with tests requiring lab processing.Achieving equitable distribution of a COVID-19 vaccine, once available, will require overcoming substantial financing and misinformation hurdles, according to global health and development leaders who spoke at the United Nations General Assembly. While optimistic that a vaccine will be developed and can end the COVID-19 pandemic, leaders noted the importance of ensuring delivery to all in need, including communities at highest risk. One global mechanism working to ensure such equitable distribution is the COVID-19 Vaccine Global Access (COVAX) Facility, which intends to help ensure a vaccine reaches vulnerable populations by guaranteeing all participating low- and middle-income countries receive enough vaccines to cover 20 percent of their population. The COVAX Facility also includes 64 high-income countries and is working to raise US$2 billion to help produce 1 billion vaccine doses by the end of 2021.