More lives could have been saved by authorizing COVID-19 booster sooner

The initial two-dose series of mRNA vaccines were highly effective initially, but their effectiveness waned over time, against both COVID-19 infection and severe disease. Israel was one of the first countries to vaccinate its population in early 2021, and was, therefore, also first to see the effects of waning. In mid-2021, Israel faced an exponential rise in infections, hospitalizations and deaths, many among the already vaccinated. In response, Israel authorized a booster dose of the Pfizer-BioNTech vaccine in late July 2021, with strong public health messaging on the importance of the booster dose.

“The booster campaign reversed the Israeli infection wave,” Black said. “Israel became a laboratory for the rest of the world on vaccine waning and the value of a booster dose in reducing hospitalization and mortality rates for persons aged 60+. Israeli evidence showed that boosters were both effective and highly safe.”

The U.S. moved more slowly to authorize boosters. It authorized boosters almost two months later — with boosters largely restricted to those age 65 and older or with major health complications. Senior U.S. policymakers wanted to move more quickly, but the U.S. regulatory system requires FDA approval before vaccinations and boosters can be readily available. The FDA, however, resisted acting quickly, with substantial internal opposition to approving boosters at all.

“The FDA is a science agency,” Black said. “They are accustomed to moving slowly and carefully vetting new drugs and vaccines and approving them only if benefit and safety are firmly established.”

The study illustrates the risks of regulatory caution in the middle of a pandemic. “Israel had highly credible data, which it shared with U.S. regulators, but the FDA wanted to see more U.S. data and not rely primarily on Israel,” Black said. “That U.S. data did not yet exist, because the U.S. vaccinated its population more slowly than Israel, and lacked Israel’s ability to collect real-time data.”

The study is titled “COVID-19 Boosters: If the U.S. Had Matched Israel’s Speed And Take-Up, An Estimated 29,000 U.S. Lives Would Have Been Saved.”

Black is the Nicholas D. Chabraja Professor at Northwestern, with positions in the Pritzker School of Law, the Kellogg School of Management and the Institute for Policy Research. In addition to Black, co-authors of the study include Israeli coauthors Aharona Glatman-Freedman, Lital Keinan-Boker, Amnon Reichman, and U.S. coauthors Vladimir Atanasov, Lorenzo Franchi, John Meurer, Qian Luo, David B. Thaw and Ali Moghtaderi.