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