A Food and Drug Administration advisory committee recently voted to recommend updating the COVID-19 vaccine. But important questions remain: When will it be updated, for whom, and who will pay? Based on past experience, there is little guarantee that the government will have the right answers.
The panel suggested a new vaccine targeted at the currently predominant omicron subvariant. This would replace the bivalent boosters first authorized in August 2022 that target the original virus plus the omicron strains that were once prevalent but are no longer circulating.
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Changing the vaccine makes good scientific sense. The virus that causes COVID-19, SARS-CoV-2, has been evolving since 2020. The original variant used in the first vaccines authorized in December 2020 is long gone. There is no point in vaccinating against it, and including it in the bivalent booster may have made the shot less effective due to an immunological phenomenon called imprinting, where repeated exposure to the original viral strain makes the vaccine recipient react more strongly to the original strain than to the more current second strain in the vaccine.
Furthermore, it may be time to boost vaccine immunity, at least for some people. The vaccines remain effective against severe disease for at least six months but with some temporal diminution in effectiveness against COVID-associated emergency department visits and hospitalizations, particularly in the 65 and older age group.
These data suggest an updated, monovalent COVID-19 vaccine to match currently circulating omicron sublineages more closely is warranted. The new mRNA technology used to manufacture the COVID-19 vaccines makes rapidly updating the vaccine possible.
But when should this be done, and for whom should the updated vaccine be recommended?
There is no guarantee the variants selected now will still be predominant in the fall when the vaccine is ready. Nor is there any guarantee that COVID-19 will follow the same seasonal pattern as influenza where disease ticks up in the fall and winter. It might make more sense, particularly in light of the flexibility the mRNA technology affords, to wait for signs of an uptick in infections or a new, more virulent strain to change the vaccine composition.
COVID-19 hospitalizations and deaths have been relatively low since April 2022. Only the groups most vulnerable throughout the pandemic — the elderly and people with multiple underlying chronic conditions — have experienced an appreciable burden of illness. The median age for COVID-associated hospitalizations has been 75, and the median number of underlying medical conditions has been three. Also, nearly all Americans have some protection against severe disease via vaccine immunity, natural immunity from prior infection, or both. Barring a major uptick in infections and severe illness, updated vaccines would likely only be needed for the vulnerable, elderly, and sick.
If the FDA and Centers for Disease Control and Prevention recommend an updated vaccine, will anyone use it?
Just 17% of the U.S. population has taken the bivalent booster. This is not surprising considering the low level of COVID-19 disease this past year. People respond to risk. With low levels of COVID-associated hospitalizations and deaths, widespread vaccine and natural immunity, and increased reports of vaccine side effects, the benefit-cost balance for most people tilted against additional vaccination. Unless current conditions radically change, there is little reason demand for a new vaccine will be any higher.
Will anyone make it? Even if government agencies recommend a new monovalent vaccine for the fall, there is no guarantee that it will be made. Until recently, the government purchased and provided COVID-19 vaccines free of charge. Manufacturers had contracts ensuring government purchase. The result of relying on government fiat instead of the market to match supply and demand has been that government bought millions of doses no one wanted. Between December 2020 and mid-May 2022, the U.S. wasted 82.1 million doses of the original vaccine. And the Biden administration purchased 170 million doses of the bivalent vaccine; only 56.5 million were used.
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Now that guaranteed government purchase is over, manufacturers will be loath to commit resources to manufacture large amounts of vaccines that will go unsold. While Pfizer, Moderna, and Novavax reportedly told the FDA they would make an updated vaccine, their willingness may be contingent on government committing to purchase large quantities. Considering the government’s wasteful record and the uncertain need and demand for updated vaccines, having the government once again supplant the market is a bad idea.
Dr. Joel M. Zinberg is a senior fellow at the Competitive Enterprise Institute and the director of the Paragon Health Institute’s Public Health and American Well-Being Initiative. He served as senior economist at the White House Council of Economic Advisers from 2017–19.