The panel that advises the Food and Drug Administration on vaccines rejected the use of a booster dose of the Pfizer COVID-19 vaccine in people younger than 65 on Friday.
Pfizer had petitioned the FDA to approve a third dose of the two-shot vaccine for use in those ages 16 to 65 in the United States about six months after receiving the second dose of the vaccine, but the FDA’s Vaccines and Related Biological Products Advisory Committee voted 16-2 to deny the petition, citing a lack of evidence to show the clear benefit of administering the booster shots to patients with fully functional immune systems. The committee did end up approving third doses of the Pfizer vaccine for people ages 65 and older, the group deemed most susceptible to serious complications and even death due to the disease.
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There were two key controversies that informed the decision. The first was whether the effectiveness of the COVID-19 vaccine waned over time against cases of severe COVID-19 and hospitalizations.
There was ample evidence that the vaccine’s efficacy at preventing severe illness dropped over time. Data from the Centers for Disease Control and Prevention show that prior to the delta surge, the vaccine provided between 72% and 97% protection against infection. That fell to 39% to 84% during the surge. Pfizer reported that protection against infection was about 88% shortly after the second dose of the two-shot vaccine was administered. But that fell to 47% after five months.
But neither the CDC nor Pfizer found that protection against hospitalization dropped following about six months after the second dose.
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Dr. Michael Kurilla, director of the Division of Clinical Innovation at the National Institutes of Health, seemed to speak for many on the panel in saying that most of the focus had been on the waning of antibodies, which prevent infection, and not enough on B and T cells, which prevent hospitalization and severe disease.
“So, it’s unclear that everyone needs to be boosted other than a subset of the population that’s clearly at high risk for severe disease,” Kurilla said.
Another controversy concerned the safety of the third dose. Pfizer data showed that in the trials of the third dose of its vaccine, the side effects were no worse than those after a second dose, but that was based on only 300 patients.
“That’s a small number of people,” said Dr. Paul Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia.
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Dr. Doran Fink, deputy director of the Division of Vaccines and Related Products Applications at the FDA, worried that the data was insufficient to determine whether younger people would suffer higher rates of heart inflammation known as myocarditis and pericarditis. The CDC had previously found a link between the Pfizer and Moderna vaccines and heart inflammation in people under age 30.
The FDA has only authorized extra doses for people with weakened immune systems due to underlying medical conditions such as end-stage renal disease and those being treated for cancer. Over 76% of U.S. adults have received at least one dose of a vaccine, totaling more than 211 million people. However, roughly 80 million people have declined to get the shots, putting them at increased risk of becoming seriously ill due to COVID-19.
