However, for specific populations at high risk of occupational exposure to orthopoxviruses, the Advisory Committee on Immunization Practices ACIP recommends routine vaccination against the disease. The U. The vaccine does not contain variola virus and cannot cause smallpox. It contains vaccinia virus, which belongs to the poxvirus family, genus Orthopoxvirus.
The vaccinia virus may cause rash, fever, and head and body aches. In certain groups of people, particularly those who are immunocompromised, complications from the vaccinia virus can be severe. In evaluating both the inflammatory i. As CDC has acknowledged, evaluation of the cardiac adverse events reported following smallpox vaccination is very important to safely continue the smallpox vaccination program.
Both CDC and the working group described considering the utility of animal studies that would investigate the basic pathophysiology of cardiac disease in relation to smallpox vaccination. As stated earlier, the committee endorses carrying out such studies, and any other studies that could help elucidate possible biological mechanisms for the cardiac adverse events seen following smallpox vaccination. The committee also endorses the working group's proposal that a prospective protocol-driven case-control study be conducted to assess the association between cardiac adverse events and smallpox vaccination ACIP SVS WG, a.
To supplement the studies being planned by CDC, the committee suggests that CDC consider collecting data on which states are using screening criteria for cardiac events that are more stringent than those recommended by ACIP on April 4, CDC, d. Subsequently, CDC may want to consider using these data to determine if states that are using more stringent cardiac screening criteria are experiencing lower rates of cardiac adverse events in people vaccinated after April 4, than states adhering to ACIP's recommendations.
For example, Rhode Island is requiring proof of a recent in past 45 days negative HIV test before someone can be vaccinated A. Knowing now that at least one state is using different screening criteria than what was recommended by CDC, the committee suggests that CDC collect data on the screening practices of other states, and use these data to supplement the overall evaluation of the implementation of the civilian smallpox vaccination program.
After review of the month data, DoD will determine whether additional follow-up is warranted J. When the follow-up procedures and guidelines have been finalized, the committee looks forward to receiving this information. The committee has some additional general comments on CDC's approaches and planned efforts for evaluation and safety studies related to smallpox vaccination. These issues may need to be addressed in order to have reliable findings from all the evaluation and research efforts.
By listing these guiding principles, the committee is not saying that CDC is not already implementing such measures, but rather, that these principles should be considered for every evaluation or safety study undertaken by CDC to assess the smallpox vaccination program:. The committee also suggests that CDC and the ACIP consider holding periodic invitational workshops on the science of smallpox vaccine safety and efficacy to update and disseminate new findings in these areas. The results of these workshops could be actively disseminated to CDC's state and local partners in the smallpox vaccination program to update them on the latest research.
The committee encourages CDC to think long-term about the research agenda for the smallpox vaccination program. CDC has stated that the pre-event smallpox vaccination program will be an ongoing program CDC, i; CDC, m , specifically in terms of vaccinating new people for maintenance of response teams, and broadly in terms of planning for a smallpox response.
There will be many policy and implementation questions that will have to be answered along the way. The committee recommends that CDC begin developing a structured, prioritized research agenda that can aid decision-making as the smallpox preparedness program moves forward.
The committee offers its assistance in refining this research agenda as the program evolves. CDC has asked for the committee's assistance in prioritizing research and evaluation efforts specific to the smallpox vaccination program, given the limited resources available for these activities B.
The committee recommends that in the short-term, studies of the serious adverse events should receive the highest priority. For safety-related questions, in the longer-term, studies examining long-term outcomes for those who experienced both serious and mild adverse events and studies of how mild adverse events contributed to lost work or social function should be a high priority.
For system-related questions, in the longer-term, studies of cost and opportunity costs should be a high priority. Although still important, the committee believes that studies on the reasons why people declined vaccination, tracking rarer adverse events, improving adverse event classification, and tracking persons with missing data should be considered next-tier priorities.
However, at the time of the writing of this report, the compensation language in the Smallpox Vaccine Information Statement VIS CDC, f had not yet been updated to reflect the newly enacted legislation. To ensure that potential vaccinees are aware of the compensation available to them for any adverse events that are determined to be connected to the smallpox vaccine, the committee encourages CDC to update the VIS as soon as possible, and publicize the existence of the fact sheet.
When the interim final rule implementing SEPPA is published, this fact sheet should be expanded with further information on what types of compensation are available, how to apply for compensation, the statute of limitations and statute of repose, and any other relevant information.
The issue of compensation for live born children who were exposed to the vaccine in utero should be clarified as well. To help publicize the existence of these materials, the committee suggests that CDC notify states when these updated materials are available. The committee also encourages CDC to send a post-vaccination fact sheet or letter explaining the compensation available under SEPPA to every person who has been identified as experiencing an adverse event.
CDC could also consider whether such information should also be sent to everyone who has already been vaccinated. Research in non-smallpox vaccine settings suggests that some people who experience myocarditis may develop long-term sequelae such as left ventricular dysfunction Hiroe et al, and cardiomyopathy Hayakawa et al, ; Das et al, ; Drucker and Newburger, As of June 20, , two cases of dilated cardiomyopathy were diagnosed in civilian smallpox vaccinees three months after vaccination CDC, n.
In one study, one fourth of patients reporting to a major medical center with symptomatic dilated cardiomyopathy died within a year, and half died within five years Dec and Fuster, The possibility of long-term sequelae from the smallpox vaccine must be acknowledged.
Whereas the acute smallpox vaccine injuries are relatively well understood, less is known about smallpox vaccine injuries that occur on a longer-term basis. Congress, Congress, ] to file an initial request. For individuals who received the smallpox vaccine, it currently is unclear to the committee how, if at all, any injuries that manifest themselves more than one year after vaccination will be addressed. It also is unclear how longer-term sequelae that result from an acute smallpox vaccine injury e.
The committee encourages CDC to work with those who are developing the interim final rule for the smallpox vaccine injury table to clarify the conditions under which longer-term sequelae from the smallpox vaccine will be considered to be a direct result of smallpox vaccination. Turn recording back on. National Center for Biotechnology Information , U.
Search term. Subjects: US service members and DoD civilian workers eligible for smallpox vaccination. Main outcome measures: Numbers of vaccinations and rates of vaccination exemptions, symptoms, and adverse events.
Data were collected via reports to headquarters and rigorous surveillance for sentinel events. Results: In 5. J Infect Dis ; ]. The appearance of hyperlinks does not constitute endorsement by the Defense Health Agency of non-U.
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Q2: What if somebody has already been vaccinated years ago A: Research indicates that the first dose of smallpox vaccine offers an increased level of protection from smallpox for 3 years.
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