An FDA panel voted unanimously this week to support harmonizing an annual primary and booster dose, moving public health strategies to reflect the endemic course of COVID-19.
The COVID-19 pandemic was altered this week—not by a variant or molecule, but a panel of experts.
The US Food and Drug Administration (FDA) Vaccines and Related Biologic Products Advisory Committee (VRBPAC) convened on January 26, ultimately voting after another daylong public meeting to shift national public health priorities from combating the still-rampant virus immediately now and always in the indefinite future, to finding the means to coexist with it.
By voting unanimously 21-0 to support the harmonization of an annual primary and booster vaccine strain, the panel of experts expressed the US’ desire to manage the COVID-19 pandemic more like an endemic they hope it will become.1
“As we’ve turned the corner from a pandemic phase to an endemic phase, today’s vote marks a big, practical win for the American people,” panelist Ofer Levy, MD, PhD, a physician at Boston Children’s Hospital and professor of pediatrics at Harvard Medical School, said. “This is really going to simplify things, benefit public health. There’s more work ahead, as we’ve discussed today, but this will be a big win.”2
Whether it is ideal to create an annual bivalent vaccine dose reflective of the circulating strains of SARS-CoV-2—a strategy somewhat consistent with that of seasonal influenza vaccine doses—should be dictated by epidemiologists and relevant public health experts.
It should be noted, though, that the US 7-day average for new COVID-19 cases has not fallen below 30,000 since April 2022,3 full vaccination rates have stagnated near approximately 70% of the population,4 and the European Medicines Agency (EMA) Emergency Task Force recently made a similar recommendation for a consistent annual primary and booster COVID-19 vaccine.1
COVID-19 remains a major and mostly unchallenged virus among Americans, whether they acknowledge it or not. And most importantly: this decision by the FDA panel realigns the US with global COVID-19 prevention strategies, and it represents what was always the true reality of the pandemic.
During one of my first conversations with a vaccinologist on the prospect of a COVID-19 vaccine in May 2020—at a time when companies were only beginning phase 1 trials—one expert expressed hope for a vaccine that would provide 80% efficacy.5
Two months later—as early-phase randomized, controlled trial data began to circulate—another virologist told me any vaccine that could reduce COVID-19 disease severity, let alone prevent infection, could “change the game.”6 By literal definitions, both experts got what they wanted from the predominant US vaccines.
But on either end of the COVID-19 vaccine rhetoric spectrum are people misled by the total efficacy of available products like Pfizer and Moderna’s mRNA vaccines.
They are neither futile in viral control practices nor comprehensively protective of any individual. They serve as agents in a comprehensive public health strategy; their benefit are dictated by the utility of secondary and tertiary practices like masking, social distancing and frequent testing. How much of that is still being prioritized in January 2023?
Whatever sentiments and hopes were expressed in the early outbreak days of 2020, we were never eradicating the virus; vaccines were never getting that toothpaste back in the tube. Only experts were realistic about this.
Now, the vaccines’ expectations are becoming realistic as well. Our best hope, as it has been since 2020, is that they help keep individuals out of the hospital, and alive. The pandemic continues; vaccines won’t end it, only lessen it.