In response to the proposed amendments to 12 VAC 5-90, the National Vaccine Information Center (NVIC) submits the following public comment opposing the fast tracking of this legislation, which violates the privacy of Virginia citizens and raises health care costs when there is no public health emergency or legal justification for doing so. 

By way of background, NVIC is a Virginia-based non-profit charitable 501c3 organization founded in 1982 to prevent vaccine injuries and deaths through public education. NVIC is the oldest and largest consumer led organization in America advocating for the institution of vaccine safety and informed consent protections in U.S. vaccine policies and laws. 

NVIC opposes the proposed amendments to 12 VAC 5-90 which would, in part, require that doctors and laboratory directors report “at a minimum, that person's name, address, age, date of birth, race, sex, and pregnancy status for females; name of disease diagnosed or suspected; the date of onset of illness; available laboratory tests and results; and the name, address, and telephone number of the physician and medical facility where the examination was made” to the state government for every person who is suspected of or has a lab confirmed case of influenza. 

The proposed amendments, which require the reporting of detailed personal information to state officials, constitute unnecessary and unwarranted government overreach in violation of the Virginia Constitution, which guarantees all Virginia citizens the right to privacy. This amendment would allow the creation an electronic database of individuals who have tested positive for, or who are suspected of having, influenza, which potentially could be accessed by federal government officials, researchers and law enforcement officers without the individual’s informed consent.

The amendment proposes to change the current reporting requirement for influenza from “number of cases only (and type if available)” to one that applies the same detailed reporting requirements currently in place for infectious diseases such as anthrax, cholera, diphtheria, leprosy, malaria, and typhoid fever. It is a transparent attempt to elevate a common viral infection, which is often asymptomatic and rarely involves complications, to the same far more serious infectious disease status as the plaque, smallpox, rabies, tuberculosis and yellow fever. 

The public has legitimate justification for viewing this amendment, which involves the electronic tagging and tracking of individuals who are suspected of being infected with or have tested positive for influenza, as a first step to mandating influenza vaccinations for all residents of the Commonwealth of Virginia. It raises the question of whether individuals included in the electronic database will be required to receive influenza vaccinations, even if they have had previous vaccine reactions, are already vaccine injured or they hold sincere religious beliefs opposing vaccination. 

There is no scientific or legal justification provided for these proposed amendments that would allow state officials to electronically gather personal data and share it with federal officials and other entities, in violation of the constitutional right to privacy just because a Virginia citizen contacts a doctor with common influenza-like-illness (ILI) symptoms that may or may not be type A or B influenza. In this regard, the proposed amendments are especially invasive for Virginian citizens who test negative for influenza. The Centers for Disease Control acknowledges that about 80 percent of suspected influenza cases test negative for type A or B influenza when they are lab tested during the flu season because most influenza-like-illness (ILI) is caused by other types of viruses and bacteria that cause respiratory symptoms.  

The proposed amendment would require doctors to report, “suspected or confirmed cases” of influenza to the local health department and there could well be under-reporting of patients with ILI symptoms who have received a flu shot and over-reporting of patients with ILI symptoms who have no record of receiving a flu shot. Over the past 15 flu seasons, the CDC has reported that influenza vaccines have been less than 50 percent effective. Vaccinated and unvaccinated persons can be asymptomatically infected with influenza or show only mild symptoms and annual estimates of prevalence and associated influenza mortality are far from precise. 

Rapid lab tests for influenza, which are suppoed to confirm the presence of influenza A or B in about 15 minutes, can be unreliable with both false positives and false negatives. The Annuals of Internal Medicine analyzed data from 124 studies to determine the accuracy of different types of rapid flu tests and found that rapid flu tests were between 54% to 95% accurate, depending on the type of test.

In addition, not all doctor’s offices have access to rapid lab tests for influenza and instead must send a culture to be tested by an outside laboratory. It is unlikely that the results will be received back from the laboratory within the required three-day reporting period. This not only places an administrative burden on doctors to report every single case of ILI that might be influenza and drives up health care costs, but it also invades the privacy of and penalizes the vast majority of patients who will have their personal information entered into an electronic database for no other reason than they had ILI symptoms, but whose tests are more likely than not to come back negative for influenza.

The amendment to Subsection B which requires laboratory directors to report, “any laboratory examinations of any clinical specimen that yields evidence of a disease” on the specified list of diseases, removes the requirement that “evidence” be, “by the laboratory method(s) indicated or any other confirmatory test”. The effect is that laboratory directors may have to report examinations of any and all specimens which yield evidence of the listed diseases including the influenza virus (confirmed), whether or not the laboratory testing confirms the diagnosis through testing. This amendment has the potential to grossly inflate the number of cases of influenza reported each year. 

These amendments have been slated for fast-tracking. Va. Code § 2.2-4012.1 Fast-track rulemaking process allows for "rules that are expected to be noncontroversial” to be rushed through the rule making process. The proposed amendments are indeed controversial in nature and application.  Any perceived or alleged lack of public controversy is more likely solely due to the fact that Virginia citizens were not made aware of these proposed amendments until very recently. 

The proposed amendments to 12 VAC 5-90 threaten the privacy of all Virginians and should not be quietly fast tracked into law. There is no public health emergency that necessitates the fast tracking of this proposal, a legislative change that should be given full public hearings and discussion.