Before an immunization, patients or their guardians are given Vaccine Information Statements. They detail which diseases the vaccine will cover and the risks to people from contracting those diseases. The Vaccine Information Statements also provide a list of potential side effects, because it’s necessary for people to be made aware of what could happen from a vaccination. These Vaccine Information Statements are parts of the materials that doctors are required to disclose under the National Childhood Vaccine Injury Act, according to Regulations.gov. They are a way to make sure that people are able to give informed consent before getting vaccinated or getting their children vaccinated.
“Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa–26), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on the proposed updated vaccine information statements for MMR (measles, mumps, and rubella) and MMRV (measles, mumps, rubella, and varicella) vaccines.”
The Centers for Disease Control has announced that it intends to make some changes to the Vaccine Information Sheets (VISs) that pertain to the MMR vaccine and the MMRV vaccine. The MMR vaccine is intended to provide immunization against measles, mumps, and rubella. The MMRV is intended to provide immunization against measles, mumps, rubella, and varicella (chicken pox).
The CDC is currently taking comments about the proposed changes to the vaccine information materials.
Let’s take a look at some of the proposed language changes that would amend the VISs.
The current MMR vaccine information material states, “Measles, mumps, and rubella are serious diseases. Before vaccines they were very common, especially among children.” The proposed language states, “Measles, mumps, and rubella are diseases that can have serious consequences. Before vaccines they were very common, especially among children.” The simple swap of where the word “serious” is placed is welcomed by many parents who have been saying that the disease itself isn’t normally serious, even if, should things go wrong, there could be serious consequences for some people.
The current MMR vaccine information material states of measles, “It can lead to ear infection, pneumonia, seizures (jerking and staring), brain damage, and death.” The proposed language change removes seizures, but adds in pneumonia, stating, “Measles can lead to ear infections, diarrhea, pneumonia, brain damage, and death.”
The current MMR vaccine information material states of mumps, “It can lead to deafness, meningitis (infection of the brain and spinal cord covering), painful swelling of the testicles or ovaries, and rarely sterility.” The proposed language change adds encephalitis and death, but removes sterility, stating, “Mumps can lead to deafness, encephalitis or meningitis (swelling of the brain and/or spinal cord covering), painful swelling of the testicles or ovaries, and, rarely, death.” Though the CDC admits on its website that death from mumps is exceedingly rare and that there have been “no mumps related deaths reported in the United States during recent mumps outbreaks,” it is still considered a possible complication and will remain on the vaccine information materials.
The current MMR vaccine information material states of rubella, “Rubella virus causes fever, sore throat, rash, headache, eye irritation, and arthritis (mostly in teenage and adult women). If a woman gets rubella while she is pregnant, she could have a miscarriage or her baby could be born with serious birth defects.” The proposed language change calls the fever potential from rubella mild, changes the age of arthritis risk, and removes sore throat, headache, and eye irritation. If approved, it would say, “Rubella virus causes rash, arthritis (mostly in women), and mild fever. If a woman gets rubella while she is pregnant, she could have a miscarriage or her baby could be born with serious birth defects.”
The current MMR vaccine information material says that among people who should not get the vaccine are people who have “ever had a life-threatening allergic reaction to the antibiotic neomycin, or any other component of MMR vaccine” people “who had a life-threatening allergic reaction to a previous dose of MMR or MMRV vaccine,” pregnant women, and “some people who are sick at the time the shot is scheduled.” It also warns that people with HIV, AIDS, or other disease that affects the immune system; people who are being treated with immune-system-altering medications like steroids; people with cancer; people who have ever had a low platelet count; people who have recently had a transfusion or other blood products; or people who have been vaccinated in the last month should talk to their doctors, because they are provided with a great deal more information about the specifics of the vaccines than are provided in the VISs.
If approved, the new vaccine information material will say that some people should not get the vaccine. It will say that anyone who has any severe or life-threatening allergies can ask their healthcare provider for a list of vaccine components. It will still say that pregnant women shouldn’t get the MMR vaccine, but also says that you should avoid getting pregnant for at least a month after getting vaccinated with the MMR. It will still say that people with the immune diseases or certain medical treatments should talk to their doctors. It will suggest that people who have had recent blood transfusions should wait at least three months. It will say that live vaccines shouldn’t be administered too close together and suggest that if you are moderately or severely ill, you should probably wait until you recover, but says that if you are not feeling well, you should ask your doctor for advice.
Under vaccine reactions, the new material, if accepted, will state the following problems as vaccine reactions that could occur: Fever; mild rash; swelling of glands in the cheeks or neck; seizure (jerking or staring) caused by fever; temporary pain and stiffness in the joints; temporary low platelet count, which could cause a bleeding disorder; deafness; long-term seizures; coma; lowered consciousness; and permanent brain damage.
The new language also will state that fainting, shoulder pain, severe allergic reactions, and, as with any medication, serious injury or death could occur, though the CDC states that the chances of these problems arising is “remote.”
While the current VISs have a very short description of the existence of the National Vaccine Injury Compensation Program (VICP), the proposed vaccine information material will provide more information, including the fact that there is a time limit to file a claim for compensation.
The Health Resources and Services Information’s website has a detailed chart of which injuries are covered for which vaccines and the time period in which the symptoms must have occurred within to qualify for compensation. For example, to be eligible for compensation for encephalopathy or encephalitis resulting from the MMR or MMRV vaccine, the condition must arise between five and 15 days after vaccination. To be eligible for compensation for chronic arthritis manifestation, it must arise between seven and 42 days after vaccination. Meanwhile, vaccine-strain measles viral infection that occurs in an immunodeficient recipient must arise within six months of vaccination to be eligible for compensation from the federal government.
Written comments from the public must be received on or before December 19. If you are interested in commenting, you can easily leave a comment using the Federal eRulemaking Portal. Current public comments can also be read online.