Research Roundup: Phase 3 vaccine trials, a rapid saliva-based COVID-19 test, and diversity in clinical trials
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Moderna and Pfizer announced last week the launch of phase 3 clinical trials for their COVID-19 vaccine candidates, the first late-stage studies supported by Operation Warp Speed in the United States. Both vaccine candidates are mRNA-based, meant to induce an immune response by mimicking the virus. The 30,000-subject phase 3 trials—to be conducted in locations across the United States—will evaluate the safety and efficacy of the vaccines. Moderna, in partnership with the National Institute for Allergy and Infectious Diseases (NIAID), and Pfizer, in partnership with BioNTech, have said they hope to seek regulatory approval and start supplying vaccines by the end of the year.
Sorrento Therapeutics has licensed a saliva-based rapid COVID-19 diagnostic test developed by a fertility lab at Columbia University. The test, COVI-TRACE, is single-step and contained within a small tube, requiring no laboratory equipment. It works by applying heat to saliva in the tube, inducing a reaction from enzymes and reagents to provide a result within 30 minutes. If positive, the enzymes and reagents will react to the presence of the virus’ RNA and turn the liquid from red to yellow. A preliminary, preprinted study produced a sensitivity level of 97 percent and a specificity level of 100 percent, indicating low rates of false negatives and false positives. Sorrento intends to pursue emergency use authorization from the US Food and Drug Administration (FDA) and scale up production of the test.
As COVID-19 vaccine trials increasingly scale up, some advocate groups and individuals are pushing to ensure diverse representation in clinical research. Clinical diversity—the inclusion of diverse populations including racial and ethnic minorities, elderly people, and those with underlying medical conditions in clinical trials—helps ensure that research covers the different ways individuals might respond to drugs and therapies. When it comes to COVID-19, populations that have historically been underrepresented in clinical research are among the highest risk for infection and death. Data has shown that Black and Latino populations are three times more likely to be infected with COVID-19 than white people and twice as likely to die. Chronic kidney disease has been identified as one of the top risk factors for serious infection. Eight out of ten COVID-19 deaths reported in the United States have been of people ages 65 and older. Several vaccine developers have acknowledged the importance of representing high-risk communities in clinical trials, and recent FDA guidance “strongly encourages” the inclusion of diverse populations in clinical trials but does not mandate representation.