Research Roundup: Booster shots in the US, antibody treatment recommendation, and an effective COVID-19 vaccine candidate

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On Thursday, US Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky signed off on a recommendation from a CDC advisory panel endorsing Pfizer-BioNTech COVID-19 booster shots for millions of older or otherwise at-risk Americans, following an emergency use authorization from the US Food and Drug Administration the previous day. Dr. Walensky expanded on the advisory panel’s recommendations—which supported the use of boosters in people 65 and older, nursing home residents, and those ages 50 to 64 who have risky underlying conditions—to also include those ages 18 to 64 who are health care workers or live in institutional settings that put them at increased risk for COVID-19 exposure. Boosters will begin rollout among individuals at least six months past their last dose of the Pfizer-BioNTech vaccine.

The World Health Organization (WHO) updated its COVID-19 therapeutics guidelines Friday to include a recommendation for use of Regeneron’s antibody cocktail among non-severe patients at higher risk for hospitalization. The antibody treatment, a combination of casirivimab and imdevimab, is currently recommended in the United States for use in patients with mild-to-moderate COVID-19 cases to prevent a need for hospitalization, but WHO will now work to expand its use to low- and middle-income countries where access has been more difficult due to its high cost and limited availability. WHO and Unitaid are working with manufacturers to ensure equitable distribution around the world, as well as potential donation and distribution of the drug through UNICEF.

A COVID-19 vaccine candidate developed by Clover Biopharmaceuticals showed 67 percent efficacy against illness in a global phase 2/3 clinical trial, the company announced last week. The vaccine demonstrated 84 percent efficacy against moderate-to-severe COVID-19 and 100 percent efficacy against severe COVID-19 and hospitalization. The results also varied among variants of the virus, with efficacy at 79 percent against the delta variant and 59 percent against the mu variant. Clover plans to use the data to seek conditional approval later this year in China and the European Union, as well as emergency use listing from WHO, which would clear the vaccine for use by the COVAX vaccine-sharing facility, to which Clover has agreed to provide up to 414 million doses. The shot is stable under normal refrigeration conditions for at least six months, making it well-suited for global distribution.