The mRNA-based COVID-19 vaccines developed by Pfizer and Moderna under former President Donald Trump’s Operation Warp Speed initiative are associated with an “excess risk of serious adverse events” (SAEs), according to a peer-reviewed study published August 31 in Vaccine, the official journal of the Japanese Society for Vaccinology.
The study, conducted by researchers from Stanford, UCLA, and the University of Maryland, analyzed the vaccines’ randomized clinical trials for serious adverse events, including myocarditis/pericarditis, kidney or liver injury, respiratory distress, hyperglycemia, pancreatitis, and more.
“Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2” respectively, the authors found. “The Pfizer trial exhibited a 36% higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated” while the “Moderna trial exhibited a 6% higher risk of serious adverse events in the vaccine group,” for a combined “16% higher risk of serious adverse events in mRNA vaccine recipients: risk difference.”
The authors caution that their findings should be taken with several limitations in mind. “First, benefits and harms are rarely exact equivalents, and there can be great variability in the degree of severity within both benefit and harm endpoints,” they wrote. “Second, individuals value different endpoints differently. Third, without individual participant data, we could only compare the number of individuals hospitalized for COVID-19 against the number of serious AESI events [adverse events of special interest], not the number of participants experiencing any serious AESI.”
Notably, they added, such limitations cut both ways: “First, Pfizer’s trial did not report SAEs occurring past 1 month after dose 2. This reporting threshold may have led to an undercounting of serious AESIs in the Pfizer trial. Second, for both studies, the limited follow up time prevented an analysis of harm-benefit over a longer period. Third, all SAEs in our analysis met the regulatory definition of a serious adverse event, but many adverse event types which a patient may themselves judge as serious may not meet this regulatory threshold. Fourth, decisions about which SAEs to include or exclude as AESIs requires subjective, clinical judgments in the absence of detailed clinical information about the actual SAEs.”
Still, they argue, the results demonstrate the “need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes.”
“[C]linical studies are needed to see if particular SAEs can be linked to particular vaccine ingredients as opposed to unavoidable consequences of exposure to spike protein, as future vaccines could then be modified accordingly or sensitivities can be tested for in advance,” the study explained. “In parallel, a systematic review and meta-analysis using individual participant data should be undertaken to address questions of harm-benefit in various demographic subgroups, particularly in those at low risk of serious complications from COVID-19. Finally, there is a pressing need for comparison of SAEs and harm-benefit for different vaccine types; some initial work has already begun in this direction.”
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The study, conducted by researchers from Stanford, UCLA, and the University of Maryland, analyzed the vaccines’ randomized clinical trials for serious adverse events, including myocarditis/pericarditis, kidney or liver injury, respiratory distress, hyperglycemia, pancreatitis, and more.
“Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2” respectively, the authors found. “The Pfizer trial exhibited a 36% higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated” while the “Moderna trial exhibited a 6% higher risk of serious adverse events in the vaccine group,” for a combined “16% higher risk of serious adverse events in mRNA vaccine recipients: risk difference.”
The authors caution that their findings should be taken with several limitations in mind. “First, benefits and harms are rarely exact equivalents, and there can be great variability in the degree of severity within both benefit and harm endpoints,” they wrote. “Second, individuals value different endpoints differently. Third, without individual participant data, we could only compare the number of individuals hospitalized for COVID-19 against the number of serious AESI events [adverse events of special interest], not the number of participants experiencing any serious AESI.”
Notably, they added, such limitations cut both ways: “First, Pfizer’s trial did not report SAEs occurring past 1 month after dose 2. This reporting threshold may have led to an undercounting of serious AESIs in the Pfizer trial. Second, for both studies, the limited follow up time prevented an analysis of harm-benefit over a longer period. Third, all SAEs in our analysis met the regulatory definition of a serious adverse event, but many adverse event types which a patient may themselves judge as serious may not meet this regulatory threshold. Fourth, decisions about which SAEs to include or exclude as AESIs requires subjective, clinical judgments in the absence of detailed clinical information about the actual SAEs.”
Still, they argue, the results demonstrate the “need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes.”
“[C]linical studies are needed to see if particular SAEs can be linked to particular vaccine ingredients as opposed to unavoidable consequences of exposure to spike protein, as future vaccines could then be modified accordingly or sensitivities can be tested for in advance,” the study explained. “In parallel, a systematic review and meta-analysis using individual participant data should be undertaken to address questions of harm-benefit in various demographic subgroups, particularly in those at low risk of serious complications from COVID-19. Finally, there is a pressing need for comparison of SAEs and harm-benefit for different vaccine types; some initial work has already begun in this direction.”
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