News & Insights

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.The United Kingdom’s Medicines Healthcare products Regulatory Authority on Wednesday authorized Pfizer and BioNTech’s COVID-19 vaccine for emergency use across the country. The United Kingdom has a supply deal for 40 million doses of the vaccine, enough for 20 million people, which it will begin to distribute in the upcoming days to priority groups including care home residents, health and care staff, the elderly, and populations that are clinically extremely vulnerable. The mRNA-based vaccine, which was shown to have 95 percent efficacy in phase 3 trials, requires a strict cold chain and will be delivered through a network of 50 hospitals, as well as specialist vaccination centers, and any general practitioners and pharmacists that have cold storage capacity. The US Food and Drug Administration (FDA) and the European Medicines Agency are expected to finalize their reviews of the vaccine candidate within the next few weeks.A major federal advisory committee in the United States voted Tuesday that health care personnel and people who live in long-term care facilities should receive priority in COVID-19 vaccine distribution. However, the Advisory Committee on Immunization Practices (ACIP) also acknowledged that pregnant health care workers, who make up about 330,000 members of the workforce, are at heightened risk of COVID-19 mortality and that none of the initial vaccine products have been specifically tested in pregnant people, leaving their inclusion in early vaccine rollout an open question. The unclear implications of the guidance likely means that if the ACIP recommendation is accepted by the Centers for Disease Control and Prevention, the decision will fall to individual states and health care systems to determine whether to offer pregnant health care workers the vaccine alongside their non-pregnant colleagues. FDA emergency use authorization applications for Pfizer’s and Moderna’s COVID-19 vaccine candidates are currently pending, which could lead to approval and rollout later this month.Biotech company Roche received FDA emergency use authorization for its COVID-19 antibody blood test capable of measuring the levels of specific antibodies that target the virus’ cell-unlocking spike protein. The quantitative antibody test provides a result in about 18 minutes and was shown to be very accurate in the 15 days after screening and diagnosis of an active infection with a molecular test. Studies also showed that patients’ antibody concentrations did not fall below a detectable range for at least 100 days following infection. The company has said tests of this kind will play a critical role in measuring vaccine-induced immune responses, and hopes it will help track the success of vaccines as well as identify people who have recovered from an infection and could serve as convalescent plasma donors or assist in the development of new therapies.

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.