Research Roundup: Promising Pfizer vaccine data, first COVID-19 antibody drug EUA, and a cheap diagnostic kit
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Last week, Pfizer and BioNTech released preliminary data from their ongoing phase 3 COVID-19 vaccine trial, indicating up to 90 percent efficacy of their mRNA-based vaccine candidate. The companies hope to have enough data to file for emergency use authorization (EUA) within the next few weeks. If the vaccine candidate does receive approval, Pfizer and BioNTech will launch their extensive distribution plan—which requires the vaccine to be kept at -94°F, a strict cold chain that has led to feasibility concerns from many countries—to fulfil hundreds of millions of doses ordered through advanced purchase commitments. These commitments include a 300-million dose deal with the European Union, a 120-million dose deal with Japan, a 100-million dose deal with the United States, and a 30-million dose deal with the United Kingdom. Pfizer and BioNTech plan to roll out a total of 100 million doses of the vaccine by the end of 2020, followed by an additional 1.3 billion doses in 2021.
The US Food and Drug Administration (FDA) last week granted EUA to Eli Lilly’s COVID-19 antibody treatment for use among people age 12 or older with mild or moderate COVID-19 infection. The drug, bamlanivimab, continues to be tested in a clinical trial to establish additional safety and efficacy data, after early results suggested it may help clear COVID-19 infection sooner and cut hospitalization rates in patients with mild or moderate cases. A study of the treatment in hospitalized patients was stopped in late October due to lack of efficacy, upon recommendation from independent monitors of the trial. The US government has signed an agreement with Eli Lilly to purchase 300,000 700-mg vials of the drug, though it is unclear how many doses that will provide, as early results indicated at least 2,800 mg is necessary to provide any effect. Eli Lilly’s therapeutic is the first antibody drug to receive EUA to treat COVID-19.
The Senegal-based Pasteur Institute is developing an affordable, handheld COVID-19 diagnostic kit able to provide results in minutes. The rapid test kit contains a simple test strip housed in a plastic unit and requires a small blood sample, collected by finger prick. No electricity or laboratory analysis is required, and the center hopes the kits will cost as little as US$1. Developers plan to start manufacturing and distribution after regulatory checks are complete, making the kits first available to countries in Africa through governments and health organizations like the Africa Centers for Disease Control and Prevention, with a goal of issuing 10 to 15 million kits by February 2021.