Toxic Exposures
India’s Rotavirus Vaccine Increases Risk of Serious Bowel Condition in Infants — Are U.S. Vaccines Any Safer?
A rotavirus vaccine used in India increases infants’ risk of intussusception, a serious bowel condition that if left untreated could cause death, according to a new peer-reviewed study by Dr. Jacob Puliyel and Children’s Health Defense’s Brian Hooker, Ph.D. U.S. rotavirus vaccines may pose similar risks.
Rotavac, the rotavirus vaccine used in India, increases the risk of intussusception in infants, according to a peer-reviewed study published Tuesday in the International Journal of Risk & Safety in Medicine.
Intussusception is a serious condition that occurs when the intestine slides or telescopes into itself, obstructing the bowel and potentially leading to gangrene or death if left untreated.
The study, co-authored by Dr. Jacob Puliyel of the Indian Institute of Health Management Research and Children’s Health Defense Chief Scientific Officer Brian Hooker, Ph.D., calls into question the safety of the vaccine and the statistical methods used in previous analyses of the product.
Puliyel told The Defender that although the rotavirus vaccines used in the U.S. — Merck’s RotaTeq and GSK’s Rotarix — are safer than the Rotavac brand used in India, a review of information sheets for the U.S. vaccines indicates concerns are still warranted.
Intussusception can be life-threatening
Puliyel and Hooker emphasized the need for parents and caregivers to be aware of the potential risk of intussusception associated with the Rotavac vaccine and to recognize the symptoms of this serious condition.
The sliding or telescoping of the intestine can block food or fluid from passing through and also can cut off the blood supply to the affected portion.
The most common symptoms in infants and young children include abdominal pain, vomiting, blood and mucus in stool, abdominal mass, and lethargy and irritability.
In a press release Wednesday, Hooker noted that “the first symptom of intussusception is typically the passage of blood and mucus in the stools,” sometimes referred to as “currant jelly” stool, which “parents can easily mistake … for infectious dysentery,” a more common condition.
As the condition worsens, infants may become increasingly lethargic, irritable and difficult to console. If left untreated, intussusception can lead to bowel necrosis, perforation and potentially life-threatening complications such as sepsis.
Intussusception often requires a fairly minor surgical intervention to prevent death, making it crucial for parents to be informed and vigilant.
This is especially important when the vaccine is administered in remote rural areas to the infants of poor, illiterate parents as part of a national immunization program such as India’s.
Study highlights Rotavac vaccine risks
Bharat Biotech’s Rotavac vaccine used in India is an oral monovalent, live, attenuated 116E strain formulation prepared in Vero (monkey kidney) cells. The three-dose administration takes place at 6, 10 and 14 weeks of age.
In 2013, Bharat Biotech and a consortium of organizations including the Bill & Melinda Gates Foundation completed the Rotavac clinical trial, which included a two-year follow-up. The vaccine was licensed in India in 2014.
The study by Puliyel and Hooker found a 1.6-fold increase in the risk of intussusception in vaccinated infants. An earlier analysis, published in 2020 in the New England Journal of Medicine (NEJM) did not find the increase. The NEJM study used the self-controlled case series (SCCS) method.
According to the new study, the increased risk rose to nearly 2.5 times within 21 days after the third dose. The study also revealed that the mean age of developing intussusception was lower in vaccinated babies — 205 days versus 223 days in the unvaccinated.
The SCCS method, used in the NEJM study, compares the incidence of an adverse event during a high-risk period following vaccination (the 21 days immediately after) to the incidence of intussusception in the same infant (28-365 days old) during a control period.
By comparing the number of intussusception cases during the high-risk period to the number of cases during the control period, researchers can see if there’s an increased risk of intussusception shortly after vaccination.
The NEJM study determined that the risk of intussusception in the high-risk window, defined as 21 days after any dose of the vaccine, was comparable to the background risk.
Puliyel and Hooker used several alternate statistical approaches, including one called self-controlled risk interval (SCRI), to reevaluate the data from the 2020 NEJM study.
To minimize confounding by age, the SCRI method compares the incidence of an adverse event during a high-risk period to the incidence during a control period closer in time to the vaccination.
Puliyel and Hooker’s study limited the observation period to 180 days of age. Intussusception is rare during this period, normally peaking at around age 7 months.
They also conducted a novel analysis of time-to-intussusception from the last vaccination. They found that the number of babies developing intussusception was highest within a month after vaccination, with risks tapering off over time.
Specifically, there were 92 cases of intussusception in the first 30 days compared to 63 in the next 30 days, a statistically significant difference that suggests a vaccine-related risk.
Puliyel and Hooker suggest that the SCCS method may be ineffective in detecting the risk of intussusception when vaccination causes the condition to occur earlier.
Regarding the NEJM study findings, Puliyel told The Defender, “We do not suggest that there was a deliberate attempt to mislead the public. … Once the error is understood and there is open reevaluation of the data, it will help bolster public confidence in the evaluation of vaccine safety.”
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U.S. rotavirus vaccines may also cause intussusception
Rotavirus causes severe diarrhea in children and infants. It spreads from the fecal waste of an infected person to the mouth, often through the contamination of hands or objects such as toys.
Worldwide, an estimated 444,000 children under age 5 die annually from rotavirus, according to the Johns Hopkins Bloomberg School of Public Health. Nearly all the deaths occur in low- and middle-income countries.
The risk of rotavirus diarrhea causing serious harm is much less in the U.S. than in India, according to Puliyel. For the majority, it is a mild illness and most cases can be managed with oral rehydration using a solution of salt and sugar, plus rest and fever relief.
Before the first rotavirus vaccine — Wyeth Pharmaceuticals’ RotaShield — was introduced in the U.S. in 1998, the infection caused 200,000 emergency room visits and as many as 60 deaths annually in children under 5 in the U.S.
RotaShield was withdrawn in 1999 due to its association with intussusception. This led to a gap in rotavirus vaccination until the Merck and GSK vaccines were introduced.
Both the Merck and GSK rotavirus vaccines are recommended for routine infant immunization in the U.S. and are administered via oral drops through a two-dose series (Rotarix at 2 and 4 months old) or a three-dose series (RotaTeq at ages 2, 4 and 6 months).
Only nine states — Idaho, Louisiana, North Dakota, Ohio, Pennsylvania, Rhode Island, Virginia, West Virginia, and Wyoming — require the rotavirus vaccine for childcare entry, according to Immunize.org.
Studies of rotavirus vaccination in the U.S. claim a 74-90% decrease in rotavirus-positive tests and substantial reductions in hospitalizations and emergency department visits due to rotavirus infections.
A search of the Vaccine Adverse Event Reporting System (VAERS) for any kind of rotavirus vaccine associated with intussusception from 1999 to the present found 2,212 cases reported in infants through 11 months old. However, with other vaccines often administered at the same time, determining clear causation is impossible.
Kawasaki disease, decreased blood platelets among U.S. rotavirus vaccine risks
RotaTeq’s (Merck) patient information document includes a warning about the infant developing intussusception: “A study conducted after approval of RotaTeq showed an increased risk of intussusception in the 21 days after the first dose of RotaTeq, but especially in the first 7 days.”
Other listed side effects include bad vomiting, bad diarrhea, severe stomach pain, blood in the stool — all symptoms of intussusception — plus allergic reactions such as face and mouth swelling, difficulty breathing and skin rashes.
The final side effect listed is Kawasaki disease, which the document states is “a serious condition that can affect the heart; symptoms may include fever, rash, red eyes, red mouth, swollen glands, swollen hands and feet and, if not treated, death can occur.”
Rotarix’s (GSK) provider information document warns that one of the vaccine side effects is intussusception.
Clinical trial participants reported adverse reactions through day 8, which included fussiness/irritability, cough/runny nose, fever, loss of appetite, vomiting and diarrhea. Unsolicited reactions through day 31 included many of the same symptoms.
Severe adverse reactions included 68 deaths (0.19%) in the experimental group (out of 36,755) within 31 days after vaccination, compared to 50 deaths (0.15%) in the placebo group (out of 34,454), most commonly from pneumonia.
A one-year follow-up of clinical trial vaccinees noted no increased risk of intussusception, but Kawasaki disease was reported in 18 (0.035%) Rotarix recipients versus 9 (0.021%) placebo recipients.
However, in a post-marketing study of the Rotarix vaccine in Mexico, researchers found the risk of intussusception was about 6 times higher in the first 7 days and almost 2 times higher in the 31 days after the first dose.
Under “severe adverse events,” the document also lists idiopathic thrombocytopenic purpura (decreased blood platelets that could lead to bleeding gums and internal bleeding) but offers no further data.
The Rotarix document also warns about vaccine shedding, stating, “One clinical trial demonstrated that vaccinees transmit vaccine virus to healthy seronegative contacts.”
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New study highlights need to reevaluate previous studies
The findings of the Puliyel and Hooker study highlight the importance of using appropriate statistical methods and continued monitoring in vaccine safety studies.
“The original SCCS analysis [of India’s Rotavec vaccine] had missed the risk and all previous SCCS studies may need to be re-evaluated,” the authors said in the press release.
Puliyel told The Defender that he and Hooker are still seeking center-specific data from the 2020 NEJM multi-center study so they can perform further analyses. One of the centers, Vellore, showed a 20-fold increased risk compared to the Delhi center.
Puliyel said:
“Once the risk of IS [intussusception] is recalculated, it will allow policymakers to look at benefits of rotavirus vaccination against these risks and decide what is beneficial for infants.
“It must be emphasized that the implications for policymakers in India are different. Post-marketing surveillance can only indicate if there is an increased risk immediately after vaccination. Randomized control studies are needed to evaluate the magnitude of this risk.”
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