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Last month, U.S. News & World Report gave readers the encouraging news that vaccine failures, in the form of so-called breakthrough infections, were actually a reason (for those who survived them) to celebrate added protection from subsequent infection.
This week, CNN — reporting on a study published last week in the Journal of the American Medical Association (JAMA) Network Open — reassured us that the worse you feel after receiving a COVID-19 mRNA injection, the better your protection.
As outlined below, the authors of the study make unfounded claims and raise more questions than answers.
What the study found
The authors examined blood samples and self-reported post-vaccination symptoms in 928 study participants to determine if there was an association between symptoms and antibody response.
- There was no statistically significant difference in antibody reactivity between those who had no reported side effects and those with systemic side effects (fever, chills, muscle pain, nausea, vomiting, headache and/or moderate to severe fatigue).
- Females, those who received the Moderna product and those who had a previous COVID-19 infection, had a statistically significant higher risk of having systemic side effects.
- Systemic side effects were associated with higher, statistically significant antibody levels.
In other words, virtually the same percentage of people developed SARS-CoV-2 antibodies whether they suffered systemic side effects or not — but those who did suffer systemic side effects had a higher level of antibodies than those who didn’t.
Based on these results the authors of the study claimed their “findings support reframing postvaccination symptoms as signals of vaccine effectiveness and reinforce guidelines for vaccine boosters in older adults.”
There are two problems with the authors’ conclusions.
First, their findings have no bearing on vaccine boosters for older adults as no boosted individuals were included in the study.
Second, attributing vaccine effectiveness — the risk reduction in contracting COVID-19 — to a greater antibody response is also an unfounded assumption that contradicts the U.S. Food and Drug Administration’s (FDA) own public safety communication to healthcare providers to “not interpret the results of qualitative, semi-quantitative, or quantitative SARS-CoV-2 antibody tests as an indication of a specific level of immunity or protection from SARS-CoV-2 infection after the person has received a COVID-19 vaccination.”
The FDA’s position was reiterated by its advisory committee, in April 2022, whose members agreed that antibody levels are not a valid measure of immunity.
Why didn’t they answer the billion-dollar question?
The question of whether antibody levels are a correlate of protection is an important one that still remains unanswered. Interestingly, the authors of this study had an excellent opportunity to put this question to rest — but they chose not to.
The U.S. government also purchased 170 million bivalent boosters at a presumed cost of several billion dollars.
The authorization of the COVID-19 vaccine primary series in children of this age range was not based on COVID-19 outcomes, only on an immune response.
And in the case of the bivalent booster, the authorization was based on an immune response in a handful of mice.
The authors of the JAMA study noted that prior COVID-19 infection was an independent factor that was associated with vaccine-induced symptoms. Prior infection was established through self-reporting only.
The average time between vaccination and antibody testing was approximately four months.
Is there a reason why the participants were not asked if they had contracted COVID-19 during this period as well? With reactogenic (side effects) and immunogenic (antibody levels) data obtained for nearly 1,000 participants, it is puzzling that the study design was not extended to resolve the debate about whether or not immunogenicity is associated with vaccine efficacy.
Why did these National Institutes of Health-funded researchers choose not to answer this question definitively and instead make the unfounded claim that their “findings support reframing of postvaccination symptoms as signals of vaccine effectiveness?”
I will answer my own rhetorical question.
If higher antibody levels resulted in a lower incidence of COVID-19, this could mean that systemic side effects are associated with better protection. This would lead to more questions, such as, are males and Pfizer recipients less protected?
If there were no difference in COVID-19 incidence, this would prove that antibody levels are not a surrogate for protection — which would destroy the justification of authorizing the pediatric vaccine and the bivalent booster.
The authors’ conclusion that symptoms are signals of vaccine effectiveness is not only unfounded and reckless, but it also puts them in a difficult position.
If females had systemic reactions more frequently, aren’t they admitting that males are less protected?
If systemic symptoms occurred more with Moderna than with Pfizer, doesn’t that mean that Pfizer’s formulation isn’t as effective?
What about those who had no symptoms after the jab? Should they be worried that they aren’t as protected?
Dr. William Schaffner, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center and medical director of the National Foundation for Infectious Diseases, told CNN:
“I don’t want a patient to tell me that, ‘Golly, I didn’t get any reaction, my arm wasn’t sore, I didn’t have fever. The vaccine didn’t work.’ I don’t want that conclusion to be out there. …
“This is more to reassure people who have had a reaction that that’s their immune system responding, actually in a rather good way, to the vaccine, even though it has caused them some discomfort.”
In other words, there is apparently no downside to getting the COVID-19 vaccine. If you didn’t suffer any symptoms, good! If you did, that’s good, too.
Schaffner’s sanguine framing of the “discomfort” that occurs after inoculation may be acceptable to some. I wonder how it sits with the 1 in 4 vaccine recipients who either were unable to participate in daily activities or missed work or school, or the nearly 8 in 100 who sought medical attention after vaccination?