rotavirus, porcine circovirus, PCV1, PCV2, Rotateq, RotaRix, RotaShield, PMWS, Post weaning multisystemic wasting syndrome, Kawasaki disease

Stomach Flu Vaccines - Should the Risks be Ignored?

Stomach Flu Vaccines - Should the Risks be Ignored?

© 2010 Dale H. Peteson, M.D.

I am quite certain that I am not alone in saying some of the most miserable times in my life were those days I spent fighting stomach flu. I hate to vomit and will do anything within my power to keep from doing so; dealing with explosive diarrhea is only slightly less unpleasant. Being awakened in the middle of the night to clean up the body fluids of one of my children who had been struck by a stomach virus is one of the memories of parenting I would rather forget. Whether personally experiencing waves of nausea, vomiting, stomach cramping, and diarrhea or caring for a family member who is enduring those symptoms, dealing with stomach flu is not something anyone would choose to do if it could be avoided.

The most common cause of stomach flu worldwide is a virus called the rotavirus. It is so named because it has the appearance of a wheel when viewed with an electron microscope. Rotavirus infections are the most common cause of severe diarrhea in children between six and twenty-four months of age. Nearly all children exhibit antibodies to the virus by the age of four.

Rotavirus is extremely contagious as exposure to as few as 200 viral particles can cause an infection. The virus is shed in the feces beginning as early as two days before an individual appears to be ill and viral shedding can persist for up to two weeks. The virus can survive in water for weeks. It remains on hands for approximately four hours during which it can be transferred to hard surfaces where it remains infectious for several days. Day care centers are ideal environments for spread of the virus, and outbreaks proceed quickly once one child becomes infected. The incubation period can range from twelve hours to four days.

Given the challenges of dealing with diarrheal illness it is not surprising that efforts have been made to prevent rotavirus infections through immunization. The first vaccine licensed for use in preventing rotavirus infections was RotaShield, which was released in 1998. RotaShield was taken off the market in 1999 after it was discovered that infants receiving the vaccine were significantly more likely to develop a condition called intussusception, in which the intestine rolls into itself. The term comes from two Latin words: intus, which means “within” and suscipere, which means to receive. The term therefore means “to receive within.” A good example of intussusceptions is a folding telescope in which sections collapse into each other.

Intussusception is a medical emergency that must be addressed as quickly as possible. As the intestine rolls into itself its blood supply can be cut off leading to death of the bowel (gangrene). This can lead to bowel rupture. Bowel ruptures cause severe intra-abdominal infections and are life-threatening. It is therefore important to be aware of the signs and symptoms of intussusception, which include vomiting that often includes yellowish-green bile, the passing of reddish stools that are described as looking like currant jelly, and colicky abdominal pain.

When intussusception is suspected a barium enema is performed. This will not only confirm the presence of the condition, but will, in many cases, correct the problem by pushing the entrapped segment of bowel back into its normal position. If the condition does not correct during the barium enema surgery is required.

The recall of RotaShield was certainly justified because of the risk of intussusceptions. Unfortunately the currently licensed rotavirus vaccines, RotaTeq and RotaRix, may prove to be even more dangerous. Earlier this year pig viruses were discovered in the vaccines. Both contain DNA from a virus called porcine circovirus 1 (PCV 1). RotaTeq also contains DNA from porcine circovirus 2 (PCV 2). The FDA temporarily halted administration of RotaRix in March, but recommended that use of the vaccine be resumed in May. RotaTeq has remained available continuously.

The reasoning followed by the FDA is that no PCV-related disease has been identified in infants who have received the vaccines to date. Unfortunately, the vaccines have been in general use for less than five years. RotaTeq was released in 2006 and RotaRix in 2008. It is far too early to assume that the pig viruses do not pose a threat to infants receiving the vaccines.

I say this because while porcine circovirus antibodies have been detected in blood drawn from Belgian pigs in 1985, post weaning multisystemic wasting syndrome (PMWS), a disease associated with PCV 2, was not described until it appeared in Western Canada in 1991. It has since become widespread in North America and Europe.

The activity of PCV 2 in pigs is unpredictable. PCV 1 and PCV 2 antibodies are commonly found in swine today. Most pigs infected with the viruses appear to do well. Some, however, develop PMWS. PMWS is a slowly progressive disease with a high fatality rate. Affected pigs lose weight and gradually waste away. Their hair becomes rough and their skin appears pale or jaundiced. Coordination is often lost. Lymph nodes become enlarged, diarrhea may occur, and pneumonia may ensue. Sudden death is common.

PMWS is a multifactorial disease, meaning that while it appears that PCV 2 must be present for the disease to occur, PCV 2 itself is not capable of triggering the process. Other viral infections apparently interact with PCV 2 or weaken the immune system causing the disease to develop. There are at least two reasons to be concerned about the administration of vaccines containing porcine circoviruses to human infants. The fact that PCV 2 associated disease was not recognized until at least six years after the virus first appeared in swine calls into question the safety of vaccines that were released two and four years ago. Just because circovirus associated disease has not been seen to date does not mean that it will not be seen in the future. The lack of understanding of what factors trigger PMWS in piglets means that we have no idea what conditions might give rise to PCV associated disease in humans.

I find it unconscionable that infants are knowingly being infected with a virus known to predispose pigs to a devastating and often fatal disease. Advocates of the currently available rotavirus vaccines point to a reduction in physician office visits and hospitalizations for diarrheal illness since RotaTeq was introduced in 2006. Hospitalizations in 2008 were one-half to two-thirds less at the peak of the flu season compared with hospitalizations in the 2000 – 2006 time period.

Interestingly, there was nearly a 25 percent reduction in hospitalizations for infants less than two months of age, the age at which rotavirus vaccination is started. Vaccine proponents attribute this drop to the vaccine suggesting that vaccination of older infants has decreased the likelihood of newborns being exposed to rotavirus. While this may be true, other factors may be at work. If this is the case, the decrease in hospitalizations for diarrhea may be due in a significant degree to factors unrelated to the rotavirus vaccination program.

Rotavirus vaccines are currently recommended for infants at 2, 4, and 6 months of age. The first dose is not to be given before 6 weeks of age nor after 14 weeks 6 days of age. The reason that the series is not to be started in older infants and children is because there is a risk that the vaccines will trigger a high fever in those who have reached that age before starting the vaccine series. No dose is to be given after 8 months of age because the vaccines have not been shown to be safe when given to older infants.

It appears that the rotavirus vaccines are tolerated by infants because their immune systems have not matured to the point that they react violently to the challenge. This makes the injection of pig viral particles of even greater concern. It may be argued that people are exposed to PCV1 and PCV2 simply by eating pork. This is true, viral exposure in the digestive tract of someone with a mature immune system cannot be equated with the injection of the virus into a muscle of an infant with an immature immune system.

As I was writing this article I received an invitation to participate in an online continuing medical education activity, “Changing Perspectives on Rotavirus: Understanding the Vaccines' Efficacy, Safety, and the Impact on Public Health.” Predictably, the program was underwritten by a grant from Merck, the manufacturer of RotaTeq. Although the presentation was released on June 3, 2010 no mention was made of the presence of pig virus in the vaccine. The message was that the vaccine was extremely safe and effective in preventing rotavirus infections, and that its use should be universal.

In spite of the reassurances given at vaccine-manufacturer sponsored continuing medical education programs, grave concerns about the safety of the vaccines exist, and a basic tenet of medical ethics is being ignored. The primum non nocere principle has been taught in medical ethics courses for at least 150 years. A literal English translation is “First do no harm.” It means that in some instances it may be better to do nothing that to do something that carries the risk of causing more harm than the condition that is present. It is intended to encourage physicians to carefully consider their actions in a spirit of humility, admitting that good intentions may have unintended, but disastrous consequences. Following the primum non nocere requires two questions to be asked about the use of rotavirus vaccines. First and foremost one must ask whether administering the vaccine to infants poses a risk to those infants. Secondly, one must ask whether any risk present is clearly outweighed by the benefit obtained from the vaccine.

In the opinion of the FDA the benefits of administration of rotavirus vaccines clearly outweigh what their experts believe to be theoretical rather than real risks of adverse consequences from the pig viral particles. I sincerely hope that their assumptions prove to be correct. Unfortunately, it is not possible to know conclusively at this early stage of vaccine use that injecting portions of pig viruses into human infants is a safe practice. Merck, the manufacturer of RotaTeq, released the following statement on June 24, 2010: “Although these data suggest that there is no infectious PCV in ROTATEQ, additional studies are ongoing to confirm these results.” (Italics mine.)

The presence of PCV1 and PCV2 fragments in the vaccines is not the only reason for concern. Kawasaki disease is a serious condition that can affect the heart and be life-threatening. Symptoms include fever, rash, red eyes, red mouth, swollen glands, and swollen hands and feet. The cause of Kawasaki disease is unknown, but it appears to be an abnormal response of the body’s immune system to an infectious agent such as a virus.

During phase III trials five cases of Kawasaki disease occurred in infants receiving RotaTeq compared to only one case in the control group not receiving the vaccine. Eighteen cases of Kawasaki disease have been reported in recipients of RotaRix compared to nine cases in those receiving a placebo. Despite the 5:1 ratio of the disease between the RotaTeq group and the control group and a 2:1 ratio of the disease between RotaRix and controls, the FDA does not consider the vaccines to be a risk factor for development of Kawasaki disease, stating that the evidence is not strong enough to prove that the vaccine plays a role in triggering the disease.

An additional concern is that immunocompromised infants develop severe diarrhea and prolonged shedding of the virus following vaccination. Physicians are warned not to administer a rotavirus vaccine to infants with a condition called Severe Combined Immune Deficiency (SCID). Unfortunately, in most instances SCID is not discovered until after an infant has had a severe reaction to the RotaTeq vaccine.

It may be proven over time that injecting pig viruses into infants is perfectly safe. Kawasaki disease is an uncommon event, and SCID is a rare condition. It is important to recognize, however, that the knowledge that a condition is rare is of no comfort to a parent whose child has become severely ill or died from that condition.

Perhaps the FDA is correct. Perhaps the currently available rotavirus vaccines do not pose a risk of triggering serious illness or death in those infants receiving them. A parent, however, must at least consider the possibility that the FDA’s position will ultimately prove to have been incorrect. The parent must ask the second question: Are the consequences of rotavirus infections so serious that I should ignore the potential risks of the rotavirus vaccine?

Stomach flu is unpleasant, but it need not be devastating or life-threatening. Appropriately managed, rotavirus infections should not result in dehydration requiring hospitalization and the administration of intravenous fluids. Parents should be instructed in the steps to take when an infant or child presents with the stomach flu.

The first and most important step in managing stomach flu is to put the gastrointestinal tract to rest. No attempt should be made to give anything by mouth until vomiting has been brought under control. If this rule is observed, vomiting will ease in a short amount of time. A remedy for nausea and vomiting should be part of every family’s emergency chest. Homeopathic remedies are preferred as they can be administered under the tongue and have no adverse effects. In the case of an infant or young child a homeopathic tablet may be dissolved in an ounce of water and a spoon or eyedropper used to place a small amount under the tongue repeatedly until vomiting is controlled. Anti-nausea medications can be administered as creams or suppositories if the homeopathic remedy appears to be unsuccessful in settling the stomach.

Once nausea and vomiting subside small amounts of clear liquids should be given. Start with an ounce of pure water at ten to fifteen minute intervals. An ounce of pure water at ten to fifteen minute intervals should be the first liquid offered. If no vomiting has occurred over the course of an hour it should be safe to begin offering larger quantities of water and other clear liquids. (A clear liquid is defined as something that one can see through. Examples are water, broth, gelatin, and apple juice. Since ginger is helpful in calming nausea, ginger ale is often well-tolerated.)

When vomiting and diarrhea occur, body salts (electrolytes) are lost along with water. The main body electrolytes are sodium, potassium, chloride, and bicarbonate. I have seen great success in avoiding serious dehydration and electrolyte abnormalities when an electrolyte rich rehydrating solution is used. The recipe includes salt, which provides sodium and chloride, baking soda, which provides sodium and bicarbonate, and orange juice, which is rich in potassium.

Diarrhea should be allowed to run its course, as this is the most efficient means the body has of ridding itself of the virus causing the condition. Anti-diarrheal medications can prolong the illness and create a greater risk of dehydration or other complications. Once clear liquids are being tolerated without difficulty it is safe to use substances such as psyllium husk to help reduce the wateriness of the stools.

As the diarrhea subsides, bland foods such as rice, potatoes, bananas, cooked vegetables, and fruit sauces may be added. Expand the diet if bland solids have been tolerated for a day or two. Milk and other dairy products should be avoided for at least two weeks because the ability to digest milk sugar, lactose, is temporarily lost when a diarrheal illness occurs. The exception is processed cheese, such as cheddar, Swiss or Colby, since the processing predigests the lactose.

During the flu season supplementing probiotics (desirable bacteria) and colostrum can support intestinal health and the body’s immune system. Using them will decrease the likelihood of contracting a viral illness and significantly decrease the severity of an infection if one does occur. Both are available in capsules that can be sprinkled into food or liquid and given to infants and young children. One-half capsule of a probiotic and one-half capsule of colostrum may be given to infants twice daily, while toddlers can be given a whole capsule of each twice daily. Older children and adults should take two capsules twice daily.

My personal experience is that breastfed infants and older children who are being fed a diet limited in refined sugars, who do not have their immune systems compromised by excessive antibiotic use, who have been receiving probiotics and colostrum for immune support, and who are placed on clear liquids at the onset of an episode of stomach flu do extremely well and rarely, if ever, become dehydrated to the point that hospitalization is required.

Rotavirus immunization is an overly simplistic approach to the challenge of stomach flu and a poor substitute for making good dietary choices, providing nutritional support, and proactively managing episodes of vomiting and diarrhea. Caring parents need not risk their children’s future by allowing the use of questionable vaccines, and caring physicians should not be giving vaccinations laced with pig viruses in place of instructing parents in proper dietary choices and nutritional support.