Research Roundup: Pfizer shot gets EUA, vaccine inequity threatens global COVID-19 fight, and drug developers pursue COVID-19 therapeutics

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 Friday, the US Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Moderna’s mRNA-based COVID-19 vaccine candidate, making it the second shot to receive a greenlight in the United States after Pfizer and BioNTech’s candidate obtained EUA one week prior. The authorization follows a recommendation from an independent advisory panel to FDA, which met last Thursday to review evidence and subsequently voted to endorse the vaccine for use in people 18 years of age and older. Data released in late November indicated that the Moderna vaccine showed 94 percent efficacy in its phase 3 clinical trial, leading the company to seek regulatory clearances in the United States and Europe. The Moderna vaccine does not require the same ultra-cold temperature storage as the Pfizer/BioNTech vaccine, allowing it to be delivered more widely in upcoming distribution efforts.The US National Institutes of Health (NIH) is sponsoring two phase 3 clinical trials investigating monoclonal antibodies as treatment for hospitalized COVID-19 patients with moderate illness. The trials are sub-studies of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-3 program, an adaptive trial designed to investigate new therapeutics as they become available. One of the treatments, developed by GlaxoSmithKline and Vir Biotechnology, is a fully human anti-SARS-CoV-2 investigational monoclonal antibody with potential to neutralize the virus and kill infected cells. The second treatment, developed by Brii Biosciences, is a combination of two neutralizing monoclonal antibodies. Both trials hope to show treatment efficacy in hospitalized patients, a subset of patients for which monoclonal antibody treatments have so far not shown an impact.The FDA granted EUA last week to the first-of-its-kind rapid COVID-19 test that can be conducted fully at home without need for a prescription. The diagnostic, which was developed by Ellume, detects SARS-CoV-2 virus fragments from a nasal swab sample using an analyzer that connects with a smartphone app, providing results in as little as 20 minutes. While less accurate than typical molecular diagnostics, the test has shown a sensitivity of 96 percent and specificity of 100 percent and, in asymptomatic individuals, a sensitivity of 91 percent and specificity of 96 percent. Ellume intends to produce around 3 million tests by next month and 20 million by the second half of 2021 to be accessible in drug stores for over-the-counter use.

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.