Infectious Disease

Evidence doesn’t support boosters for the general public, experts argue

September 13, 2021

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The United States is still planning to offer COVID-19 vaccine booster doses to the general public from September 20, pending FDA approval and CDC recommendations.

However, the question that remains is whether a third dose of the messenger RNA vaccine will be required for most people.

COVID vaccine stock image

Source: Adobe Stock.

In a new position published in The Lancet, Philip R. Krause, MD, MS, Associate Director of the FDA’s Office of Vaccines Research and Review, and experts from six other countries and the WHO argued that “current evidence does not seem to show a need to strengthen the general population while maintaining efficacy against serious diseases “. high.”

The authors suggest that there may be risks associated with giving COVID-19 booster doses “too early or too often”, especially with vaccines, which can have immune-mediated side effects (such as myocarditis, which is more common after the second dose of some ). mRNA vaccines or Guillain-Barré syndrome, which has been linked to adenovirus-vectored COVID-19 vaccines) ”like the shot by Johnson & Johnson.

“If unnecessary refreshment causes significant side effects, it could impact vaccine acceptance beyond COVID-19 vaccines,” the authors wrote. “Therefore, a large-scale increase should only take place if there is clear evidence that it is appropriate.”

According to the authors, a consistent result of all current evidence is that the effectiveness of the available COVID-19 vaccines is “significantly greater” against any infection and “significantly protective” against serious illnesses of all major virus variants, which supports the argument against booster vaccinations.

“Even if humoral immunity appears to be declining, a decrease in neutralizing antibody titer does not necessarily predict a decrease in vaccine effectiveness over time, and a decrease in vaccine effectiveness for mild illnesses does not necessarily predict a decrease in (typically higher) effectiveness against severe illness .” They write.

There was no published study that provided credible evidence that even as the vaccine’s effectiveness against symptomatic diseases deteriorates over time, protection against serious illness deteriorates significantly, ”the authors write.

They argued that now is the time to test variant-specific vaccines “before they become widespread” – a strategy similar to annual flu vaccination.

“All decisions about the need for a booster or the timing of a booster should be based on a careful analysis of adequately controlled clinical or epidemiological data, or both, suggesting a sustained and meaningful reduction in the serious illness, with a risk-benefit assessment that the number of severe cases expected to prevent the booster, along with evidence that a specific booster regimen is likely to be safe and effective against currently circulating variants, ”the authors write.

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Amesh A. Adalja, MD

Amesh A. Adalja

I always hold the position [that] the threshold for booster vaccinations [is] Breakthrough infections severe enough to bring people to the hospital. That doesn’t happen. I agree with the Lancet editorial because it emphasizes the need for this to be a clinically driven decision – not one by the White House, but one by the scientific community after carefully analyzing all the data. Now, if the goal is to prevent mild breakthrough infections in fully vaccinated people, not only will this change the subject of the pandemic in the United States, but there will also be no public health emergency with this endemic respiratory virus that we all eventually get.

Amesh A. Adalja, MD

Senior scholarship holder

Johns Hopkins Center for Health Safety

Disclosure: Adalja does not report any relevant financial information.

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