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Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Rules and Regulations 4 Stevens-Johnson syndrome/Toxic epidermal necrolysis SJS/TEN. SJS/
TEN is a spectrum of acute hypersensitivity reactions that affects skin, mucous membranes, and sometimes, internal organs systemic toxicity associated with the use or administration of replicationcompetent smallpox vaccines. For purposes of Table 2, both skin and mucous membrane rash or lesions must be present. Rash or lesion distribution must be widespread. Rash must not have a symmetric acral distribution affecting arms, hands, legs or feet. Two or more mucosal sites must be involved.
Mucosal lesions generally manifest as painful lesions in sites, such as the mouth or eyes. Skin rash or lesions in SJS/TEN usually consist of red or purple raised areas erythematous macules, blisters, and ulcerations.
5 Inadvertent autoinoculation IA.
IA is the spread of vaccinia virus from an existing vaccination site to a second location usually by scratching the vaccination site and subsequently spreading the virus, which produces a new vaccinial lesion on the same person who received the vaccination. IA is the most common adverse event associated with the replication-competent smallpox vaccine.
6 Generalized vaccinia GV. GV is a vaccinial infection that occurs from the spread of vaccinia from an existing vaccination or inoculation site, with the use or administration of a replicationcompetent smallpox vaccine, to otherwise normal skin, resulting in multiple new areas of vaccinial rash or lesions. The vaccinia is believed to be spread through the blood. The rash or lesions, characterized by multiple blisters vesicles or pustules, generally evolve in a similar sequence or manner as the original vaccination site.
7 Eczema vaccinatum EV. EV is the transmission or the spread of vaccinia virus from a vaccination site, after the use or administration of a replicationcompetent smallpox vaccine, to skin that has been affected by, or is currently affected with, eczema or atopic dermatitis. EV is characterized by lesions that include multiple blisters vesicles or pustules, which generally evolve in a similar sequence or manner as the original vaccination site. The lesions may come together to form larger lesions. Lesions may also spread to patches of skin that have never been involved with eczema or atopic dermatitis. The new lesions, if cultured, will be positive for vaccinia virus. A
person with EV may become severely ill with signs and symptoms that involve the whole body systemic illness, such
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as fever, malaise, or enlarged glands lymph nodes.
8 Progressive vaccinia PV. PV is the failure to initiate the healing process in an initial vaccination or inoculation site, after the use or administration of a replication-competent smallpox vaccine, by 21 days after exposure to vaccinia, with progressive ulceration or necrosis at the vaccination site leading to a large destructive ulcer. PV is seen in people who are immunocompromised have an impaired immune system and is characterized by a complete or near complete lack of inflammation or absence of inflammatory cells in the dermis of the skin at the vaccination site. The diagnosis of PV may be made before 21 days after exposure, especially in a known immunocompromised individual who develops a lesion at the vaccination site. PV may spread through the blood to any location in the body.
No one who experiences a significant healing process of the vaccination site within 21 days after receipt of the replication-competent smallpox vaccine or exposure to vaccinia has PV.
9 Post-vaccinial encephalopathy, encephalitis, and encephalomyelitis PVEM. PVEM is a spectrum of overlapping conditions that includes post-vaccinial encephalopathy, encephalitis, and encephalomyelitis, and, for the purposes of Table 2, is treated as one injury. For the purposes of Table 2, PVEM is an autoimmune central nervous system injury that occurs after the use or administration of a replication-competent smallpox vaccine. In rare cases, the vaccinia virus is isolated from the central nervous system. Manifestations usually occur abruptly and may include fever, vomiting, loss of appetite anorexia, headache, general malaise, impaired consciousness, confusion, disorientation, delirium, drowsiness, seizures, language difficulties aphasia, coma, muscular incoordination ataxia, urinary incontinence, urinary retention, and clinical signs consistent with inflammation of the spinal cord myelitis, such as paralysis or meningismus meningeal irritation.
Long-term central nervous system impairments, such as paralysis, seizure disorders, or developmental delays are known to occur as sequelae of the acute PVEM. No clinical criteria, radiographic findings, or laboratory tests are specific for the diagnosis of PVEM. Symptoms that occur before 5 days or more than 14
days after receiving the smallpox vaccine should not be attributed to it. In addition, encephalopathy caused by an infection, a toxin, a metabolic disturbance, a structural lesion, a
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genetic disorder, or trauma would not meet the Table 2 definition.
10 Vaccinial myocarditis, pericarditis, or myopericarditis MP.
For purposes of Table 2, MP is vaccinial myocarditis, pericarditis, or myopericarditis. Vaccinial myocarditis is defined as an inflammation of the heart muscle myocardium because of receiving the replication-competent smallpox vaccine. Vaccinial pericarditis is defined as an inflammation of the covering of the heart pericardium because of receiving the smallpox vaccine. Vaccinial myopericarditis is defined as an inflammation of both the heart muscle and its covering because of receiving the smallpox vaccine. The inflammation associated with MP may range in severity from very mild subclinical to life threatening. In many mild cases, myocarditis is diagnosed solely by transient electrocardiographic EKG abnormalities e.g., ST segment and T wave changes, increased cardiac enzymes, or mild echocardiographic abnormalities. Arrhythmias, abnormal heart sounds, heart failure, and death may occur in more severe cases.
Pericarditis generally manifests with chest pain, abnormal heart sounds pericardial friction rub, EKG
abnormalities e.g., ST segment and T
wave changes, and/or increased fluid accumulation around the heart. A Table 2 injury of MP requires sufficient evidence in the medical records of the occurrence of acute MP.
11 Transfusion-related acute lung injury TRALI. TRALI is defined as the onset of respiratory distress within 6
hours in non-critically ill patients, and 72 hours in critically ill patients, after receipt of blood products containing plasma, in this case, VIGIV. The relative level of illness will be determined on a case-by-case basis after reviewing the medical records and the medical history. The respiratory distress is the result of receiving a plasma containing transfusion VIGIV and subsequently developing pulmonary edema, respiratory distress, and hypoxia. TRALI
occurs as the result of an antibody response in the host to the donor antibodies within the plasma product.
Pulmonary edema is non-cardiac in nature and does not occur more than 72
hours after receiving VIGIV. Pulmonary edema occurring more than 72 hours after receiving a blood product containing plasma VIGIV or associated with cardiac dysfunction is not TRALI
and is excluded as a countermeasurerelated injury. TRALI has been identified as a major cause of mortality in those individual receiving plasmacontaining transfusions. A Table 2
injury for TRALI has occurred in a
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