Research Roundup: Moderna seeks vaccine EUA, COVID-19 drug trial launches, and equitable vaccine distribution efforts around the world

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. Pfizer and BioNTech filed on Friday for emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for their COVID-19 vaccine candidate, after data indicated 95 percent efficacy of the vaccine in phase 3 trials. A first look at early phase 3 data had showed the mRNA-based vaccine was more than 90 percent effective at preventing COVID-19 infection; follow-up numbers released after the trial collected sufficient safety data then showed a 95 percent efficacy rate. The vaccine could receive authorization by the end of the year—allowing distribution to begin in 2020—depending on the speed of the review, according to the CEO of BioNTech. The vaccine developers expect to produce up to 50 million doses of the two-shot regimen in 2020 and up to 1.3 billion doses in 2021.New data from AstraZeneca and the University of Oxford’s phase 3 COVID-19 vaccine trial signaled that the candidate has an average efficacy of 70 percent, with a range of 62 to 90 percent in different dosing schemes. Late last week, AstraZeneca and Oxford released results from their phase 2 trial, which showed that the candidate was safe and produced a strong immune response in younger adults and older participants. The developers plan to file for emergency use from regulatory bodies in the United Kingdom and other countries and expect about 3 billion doses to be ready in 2021. The results from Oxford/AstraZeneca’s trial followed announcements by two US-based vaccine efforts—Pfizer/BioNTech and Moderna/National Institute of Allergy and Infectious Diseases—indicating more than 90 percent efficacy of their COVID-19 vaccine candidates in phase 3 trials.FDA has granted EUA to the first rapid COVID-19 diagnostic able to be performed entirely at home. The test, developed by Lucira Health, requires the user to self-conduct a nasal swab, which is then swirled in a vial of laboratory solution that plugs into a portable device. The rapid result—which is delivered within 30 minutes—is then displayed as a light, labeled positive or negative. Initial use of the single-use test kit will require a prescription, but the company has said it expects the test to be widely available by next spring at a cost of US$50. FDA has authorized emergency use of nearly 300 COVID-19 diagnostics to date, but this will be the first conducted entirely at home, which experts hope will allow quicker quarantining and contact-tracing to combat spread of the virus.