Research Roundup: Pfizer vaccine effective in adolescents, at-home OTC tests authorized, and NIH tests variant-specific Moderna vaccine
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The Pfizer/BioNTech COVID-19 vaccine prevented symptomatic disease and was well-tolerated in a phase 3 trial of adolescents aged 12 to 15, the companies said Wednesday. The trial enrolled 2,260 adolescents, and efficacy was primarily measured through antibody levels in comparison to levels seen in older adolescents and adults. The vaccine prevented symptomatic COVID-19 infection, with no cases of COVID-19 among those who received the vaccine, and was well-tolerated, with participants experiencing symptoms similar to those aged 16 to 25. Pfizer and BioNTech plan to submit the data to the US Food and Drug Administration (FDA) to expand the vaccine’s emergency use authorization, which currently extends to those ages 16 and up. They hope to begin vaccinating adolescents aged 12 to 15 by the beginning of the next school year, according to the press release.
Last week, the FDA issued emergency use authorizations to three COVID-19 rapid antigen diagnostic tests, including two tests that will be available over the counter for at-home use. The over-the-counter tests include Quidel’s QuickVue test and multiple versions of Abbott’s BinaxNOW test, which can be used at home and are designed to check an individual twice over two to three days. The FDA also reauthorized a BD hand-held antigen test for point-of-care use without a prescription. The National Institutes of Health (NIH) and Centers for Disease Control and Prevention plan to use the Quidel diagnostic in a community self-testing program, for which they will provide up to 160,000 residents of two counties in North Carolina and Tennessee access to the diagnostic for free in an effort to understand how best to use at-home tests to reduce viral transmission in communities.
NIH has begun a clinical trial evaluating a version of Moderna’s COVID-19 vaccine modified to target the B.1.351 variant, first identified in South Africa. The trial will test the modified vaccine, mRNA-1273.351, in 210 adults and is expected to be fully enrolled by the end of April. The modified vaccine will be evaluated in both unvaccinated adults and adults who already received Moderna’s original mRNA-1273 vaccine as part of a clinical trial last year. The vaccinated group will be randomly assigned to receive either a single vaccination of 50 µg of mRNA-1273.351 or a single vaccination containing one 25 µg dose of mRNA-1273 and one 25 µg dose of mRNA-1273.351. A separate clinical trial will assess a booster shot of the original vaccine in the remaining vaccinated participants of the 2020 trial.