This post is a continuation of a series that will be providing information on each disease and vaccine that is currently on the CDC’s recommended national immunization schedule. I hope this information is able to help those attempting to decide on an alternative vaccine schedule (whether that is a delay, select or decline one). Please leave a comment if you have any questions.
The information below is gathered from sources included PubMed, the CDC, the Mayo Clinic, and package inserts published from the vaccine manufacturer. (See below for a full list) Be sure to check out the other posts on this series (Hepatitis B).
The Disease
According to the CDC, rotavirus is the most common cause of diarrhea in children and infants across the globe. The majority of children will experience at least one rotavirus infection by 2 or 3 years of age.
There are many different strains of the rotavirus however five strains account for nearly 90 percent of human infections in the US and other developed countries (there is more diversity seen in developing countries).
Once a child has been infected with a rotavirus strain, antibodies are produced and a child is either immune for life or has a milder case after re-infection. The majority of healthy children who are infected with rotavirus strains within the first years of life will develop lifelong natural immunity to infection.
According to the CDC, 20 to 60 deaths occur annually in the US due to rotavirus infection.
Transmission
Several days prior to symptoms occur and up to 10 days after symptoms recede, the rotavirus is easily spread via hand-to-mouth contact through infected individuals stools -another reason that it is imperative to your health (and your children) to learn an excellent hand washing routine. The virus lives on hands for hours and even longer on hard surfaces.
Risk of infection is most common between 4 months – 24 months. Children who are in group care settings also have an elevated risk.
In non-tropical climates, such as the US, rotavirus infection seems to be highest in winter and spring months.
Symptoms
In healthy adults, a rotavirus infection may only cause mild symptoms or none at all. In children, the infection will start with an onset fever, followed by watery diarrhea and in some cases vomiting. This can last anywhere from 3 days to a week.
After a child has been infected once, they can be infected again due to the several strains circulating, however subsequent infections are not as serious as the first.
The principal concern of rotavirus is dehydration, especially in young children. This concern is particularly important in developing countries.
Treatment
In children, rotavirus can be unpleasant and treatment focuses on providing extra fluids to prevent dehydration.
Breast milk is ideal in treatment and prevention since it has shown in many studies to specifically protect babies from rotavirus infection. If you are not breastfeeding you can offer electrolyte solutions along side formula feedings. For older children, you can eliminate/limit/avoid sugary drinks, dairy products and juice which can make diarrhea worse.
Remember, antibiotics have no effect on rotavirus.
The Vaccine
The rotavirus vaccine is not mandated or required for school entry in any US state.
There are two live oral rotavirus vaccines approved for use in the US. Each one differs slightly in their manufacturing process and the doses prescribed. The CDC recommends administering the rotavirus vaccines at the same time as other vaccines at that age group.
Please note, according to the ACIP and CDC, vaccination should NOT be started on infants 12 weeks or older because of lacking safety data of first dose in older infants. In this case, if you delay this vaccine until 12 weeks, then your child should not receive it at all.
RotaTeq
RotaTeq is manufacturer by Merck (invented by H. Fred Clark and Paul Offit) and was approved for use in the US by the FDA in 2006. It is given by mouth in three doses (2 months, 4 months and 6 months). The vaccine is manufactured by genetically engineering a vaccine made of five live attenuated human-bovine (cow) hybridized reassorted rotaviruses. It contains polysorbate 80 and trace amounts of fetal bovine (cow) serum.
This vaccine does not contain preservatives.
On March 22, 2010, the FDA announced that Rotateq was found to be contaminated with foreign DNA from two porcine (swine/pig) circoviruses: PCV1 and PCV2. The PCV2 is a fatal pig virus which causes immune suppression in baby pigs (damaging lungs, brain, kidney, and the reproductive system). The FDA suggested a temporary postponement of Rotateq. However, a little over a month later on May 7, 2010, the FDA lifted the recommendation. No adjustment was made to the vaccine; instead the FDA stated that they are working with Merck to update the labeling on vaccines to include information about the presence of PCV1 and PCV2 in the vaccine.
Intussusception (a rare but life-threatening form of intestinal blockage) has been reported after vaccination with Rotateq. Another rotavirus vaccine called RotaShied was revoked from the US market in 1999 because of the association with increased cases of intussusception. However, the CDC and FDA state that the number of cases reported following Rotateq is similar to the cases found in unvaccinated children.
If your child experiences stomach pain, diarrhea or vomiting after vaccination you should contact your doctor immediately.
The estimated effectiveness against rotavirus cases after completely the 3 doses of Rotateq is about 74 percent and about 98 percent of severe cases. According to the manufacturer’s package insert, the vaccine may not protect all vaccine recipients.
Some of the more common side effects after administering Rotateq is diarrhea, irritability, vomiting and otitis media (ear infection).
Additions to package insert and public health notifications: In 2007, the FDA issued a Public Health Notification on Rotateq when reports where confirmed of intussusception after vaccination. Approximately half of the cases occurred 1 to 21 days after vaccination.
One month later the CDC reversed the statement by the FDA and issued a new statement stating that postmarketing surveillance data does not suggest that Rotateq is associated with intussusception. The number reported did not exceed the expected background cases.
In June 2007, a label change was approved by the FDA for Rotateq to include Kawaski syndrome which is an inflammation of blood vessels occurring in five cases before licensure and three following licensure.
Rotarix
Rotarix is manufactured by GlaxoSmithKline and was licensed by the FDA in 2008. It is administered in two doses (2 months and 4 months of age). The Rotarix vaccine is genetically engineered out of live attenuated human rotaviruses.
On March 22, 2010, the FDA temporarily suspended use of the Rotarix vaccine in the US because an extraneous virus (PCV1) was found to be contaminating the solution. (Compared to Rotateq – which was only suggested to postpone use NOT completely suspended). The suspension was revoked on May 7th of that year and GlaxoSmithKline pledged to reformulate the Rotarix vaccine and remove PCV1 DNA.
No date was given for when the Rotarix vaccine will be free of contamination.
The estimated effectiveness of the Rotarix vaccine (according to the New England Journal of Medicine) is 85 percent and reached 100 percent against severe rotavirus gastroenteritis.
More common reactions that are reported are temporary diarrhea, fussiness, fever, loss of appetite, vomiting and cough/runny nose.
Included in the manufacturers insert for Rotarix, reports of infants with intussusception following vaccinated has been received by VAERS.
Live Vaccines
Since RotaTeq and Rotarix are live vaccines, the manufacturers acknowledge it is possible to transmit the vaccine strain virus to others who come in contact with a recently vaccinated child.
RotaTeq: “RotaTeq is a solution of live reassortant rotaviruses and can potentially be transmitted to persons who have contact with the vaccine. The potential risk of transmission of vaccine virus should be weighed against the risk of acquiring and transmitting natural rotavirus.”
Rotarix: “There is a possibility that the live vaccine virus can be transmitted to non-vaccinated contacts. The potential for transmission of vaccine virus following vaccination should be weighed against the possibility of acquiring and transmitting natural rotavirus.”
Whenever you make a health care decision for yourself or your child, especially one that involves a pharmaceutical product such as a vaccine, you should consider obtaining information from many different sources as well as consulting your health care professional.
Becoming an informed health care consumer is important and will empower you to ask doctors important questions and ultimately help you to take control of your health choices.
If your doctor is not supportive of your informed health choices, consider consulting another doctor who will work with you as a partner helping you make important health care decisions for yourself or your child(ren).
Information presented on this post can be reviewed in depth from the following sources:
