Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration (2024) / Chapter Skim
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HRSA also administers the Countermeasures Injury Compensation Program (CICP) for those harmed by medical countermeasures, which include vaccines, medications, devices, or other preventions, diagnostics, or treatments for a public health emergency or security threat.
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The committee will make conclusions about the causal association between vaccines and specific adverse events. The National Academies convened an ad hoc committee comprising 15 members with expertise in epidemiology, causal inference, cardiology, rheumatology, gynecology, audiology, neurology, infectious disease, pediatrics, internal medicine, hematology, orthopedics, and PREPUBLICATION COPY -- Uncorrected Proofs
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The committee was not tasked with estimating the magnitude or strength of associations between vaccinations and outcomes. To fulfill its narrower goals, the committee did incorporate important attributes of good systematic reviews, such as searching multiple databases, using structured search terms, prespecifying a final date of searching, and using multiple reviewers to screen out irrelevant abstracts identified in the search.
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Although the committee lacked evidence to establish, accept, or reject a causal relationship for many possible harms, it identified sufficient evidence for 20 conclusions. It is not surprising that evidence is insufficient for the majority; many of the conditions had relatively few studies in the literature from which to draw conclusions.
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The conclusion about TTS relied on strong mechanistic evidence of binding of vaccine-generated anti-PF4 antibody to platelets in people who developed TTS who had been given ChAdOx1-S, which is a similar platform to Ad26.CoV2.S. Although the mechanistic findings for ChAdOx1-S were stronger, the similar findings with Ad26.COV2.S combined with pharmacovigilance data led the committee to conclude that the evidence favors acceptance of a causal relationship.
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The committee also concluded that the evidence favors rejection of a causal relationship between vaccine injection and chronic rotator cuff disease. PREPUBLICATION COPY -- Uncorrected Proofs
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Favors rejection Favors rejection Favors acceptance Guillain-Barré of a causal of a causal of a causal I syndrome relationship relationship relationship Chronic inflammatory I I I I demyelinating polyneuropathy Favors rejection Favors rejection Bell's palsy of a causal of a causal I I relationship relationship 3 Transverse myelitis I I I I Chronic headache I I I I Postural orthostatic tachycardia I I I I syndrome Sensorineural I I I I hearing loss 4 Tinnitus I I I I Thrombosis with Favors rejection Favors rejection Favors acceptance thrombocytopenia of a causal of a causal of a causal I syndrome relationship relationship relationship Immune 5 thrombocytopenic I I I I purpura Capillary leak I I I I syndrome PREPUBLICATION COPY -- Uncorrected Proofs
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Favors rejection Favors rejection Myocardial of a causal of a causal I I infarction relationship relationship Favors rejection Ischemic stroke of a causal I I I relationship Hemorrhagic I I I I 6 stroke Deep vein thrombosis, pulmonary I I I I embolism, venous thromboembolism Establishes Establishes Myocarditis I I a causal relationship a causal relationship 7 Pericarditis without I I I I myocarditis 8 Sudden death I I I I Favors rejection Favors rejection 9 Female infertility of a causal of a causal I I relationship relationship * NOTE: "I" indicates that the evidence was inadequate to accept or reject a causal relationship.
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Patterns of non-SARS-CoV-2 infections changed dramatically during the early days of the pandemic due in part to social distancing and other public health interventions. See the discussion on GBS in Chapter 3 as an example.
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Other methodologic limitations across many of the studies include challenges in confirming vaccine receipt and diagnostic validity. Many studies in this report were not initiated to support causal inference reviews.
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2023. Overview of injury compensation programs -- NASEM committee to review relevant literature regarding adverse events associated with vaccines: Division of Injury Compensation Programs.
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12 VACCINE EVIDENCE REVIEW PREPUBLICATION COPY -- Uncorrected Proofs
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