Rotateq Cause Rotavirus?

iVillage Member
Registered: 11-17-2007
Rotateq Cause Rotavirus?
3
Tue, 08-25-2009 - 7:01am
What are the chances that rotateq can cause a 9 week old baby to become ill with rotavirus? My friend's nephew was in the hosp for two days, and the whole time, the docs wouldn't tell her what was wrong, nor did they offer any kind of explanation for the illness. Not until it was almost time for him to be released. They said it was a "stomach bug" and sent her on her way. It wasn't until i questioned my friend about the nephew having any vaccines recently, did i raise an awareness of they ( the vax's) could have made him sick. Of course he did have his vaccines, 5 days earlier. All the usual things babies get at that time. ( I'm not sure how many anymore, it changes all the time). I did raise an awareness of the issue with my friend, and hopefully she will share the info with her sis. Unfortunately tho, so many new parents are brainwashed by their pedi, it's ridiculous.
How else would/could a stay at home baby become so ill with a virus like that?
iVillage Member
Registered: 07-17-2005
Wed, 08-26-2009 - 11:31am

What age is the first dose? 'Cause I'm wondering how anyone would know if the baby was immunocompromised at 9 weeks - wow, that's so young to be shot up with crap! This is the LAST vaccine I would ever consider for my kids.

If I were this Mom, I would familiarize myself with the term "Intussusception". That way she will at least know what to look for and what to talk to the dr about. The following came straight from the package insert (manufacturer's own words):

5 WARNINGS AND PRECAUTIONS

5.1 Immunocompromised Populations
No safety or efficacy data are available for the administration of RotaTeq to infants who are potentially immunocompromised including:


Infants with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system.

Infants on immunosuppressive therapy (including high-dose systemic corticosteroids). RotaTeq may be administered to infants who are being treated with topical corticosteroids or inhaled steroids.

Infants with primary and acquired immunodeficiency states, including HIV/AIDS or other clinical manifestations of infection with human immunodeficiency viruses; cellular immune deficiencies;
3 and hypogammaglobulinemic and dysgammaglobulinemic states. There are insufficient data from the clinical trials to support administration of RotaTeq to infants with indeterminate HIV status who are born to mothers with HIV/AIDS.

Infants who have received a blood transfusion or blood products, including immunoglobulins within 42 days. No data are available regarding potential vaccine virus transmission from vaccine recipient to non-vaccinated household or other contacts .

5.2 Gastrointestinal Illness
No safety or efficacy data are available for administration of RotaTeq to infants with a history of gastrointestinal disorders including infants with active acute gastrointestinal illness, infants with chronic diarrhea and failure to thrive, and infants with a history of congenital abdominal disorders, abdominal
surgery, and intussusception. Caution is advised when considering administration of RotaTeq to these infants.

5.3 Intussusception
Following administration of a previously licensed live rhesus rotavirus-based vaccine, an increased risk of intussusception was observed.1 In the Rotavirus Efficacy and Safety Trial (n=69,625), the data did not show an increased risk of intussusception for RotaTeq when compared to placebo. In post-
marketing experience, cases of intussusception have been reported in temporal association with RotaTeq.

5.4 Shedding and Transmission
Shedding was evaluated among a subset of subjects in REST 4 to 6 days after each dose and among all subjects who submitted a stool antigen rotavirus positive sample at any time. RotaTeq was shed in the stools of 32 of 360 vaccine recipients tested after dose 1; 0 of 249 vaccine recipients tested after dose 2; and in 1 of 385 vaccine recipients after dose 3. In phase 3 studies, shedding was observed as early as 1 day and as late as 15 days after a dose. Transmission was not evaluated.

Caution is advised when considering whether to administer RotaTeq to individuals with immunodeficient close contacts such as:

Individuals with malignancies or who are otherwise immunocompromised; or

Individuals receiving immunosuppressive therapy.
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.

5.5 Febrile Illness
Febrile illness may be reason for delaying use of RotaTeq except when, in the opinion of the physician, withholding the vaccine entails a greater risk. Low-grade fever (<100.5°F ) itself and mild upper respiratory infection do not preclude vaccination with RotaTeq.

5.6 Incomplete Regimen
The clinical studies were not designed to assess the level of protection provided by only one or two doses of RotaTeq.

5.7 Limitations of Vaccine Effectiveness
RotaTeq may not protect all vaccine recipients against rotavirus.

5.8 Post-Exposure Prophylaxis
No clinical data are available for RotaTeq when administered after exposure to rotavirus.

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience
71,725 infants were evaluated in 3 placebo-controlled clinical trials including 36,165 infants in the group that received RotaTeq and 35,560 infants in the group that received placebo. Parents/guardians were contacted on days 7, 14, and 42 after each dose regarding intussusception and any other serious adverse events. The racial distribution was as follows: White (69% in both groups); Hispanic-American (14% in both groups); Black (8% in both groups); Multiracial (5% in both groups); Asian (2% in both groups); Native American (RotaTeq 2%, placebo 1%); and Other (<1% in both groups). The gender distribution was 51% male and 49% female in both vaccination groups.

4 Because clinical trials are conducted under conditions that may not be typical of those observed in clinical practice, the adverse reaction rates presented below may not be reflective of those observed in clinical practice.

Serious Adverse Events

Serious adverse events occurred in 2.4% of recipients of RotaTeq when compared to 2.6% of placebo recipients within the 42-day period of a dose in the phase 3 clinical studies of RotaTeq. The most frequently reported serious adverse events for RotaTeq compared to placebo were:

bronchiolitis (0.6% RotaTeq vs. 0.7% Placebo),
gastroenteritis (0.2% RotaTeq vs. 0.3% Placebo),
pneumonia (0.2% RotaTeq vs. 0.2% Placebo),
fever (0.1% RotaTeq vs. 0.1% Placebo), and
urinary tract infection (0.1% RotaTeq vs. 0.1% Placebo).

Deaths

Across the clinical studies, 52 deaths were reported. There were 25 deaths in the RotaTeq recipients compared to 27 deaths in the placebo recipients. The most commonly reported cause of death was
sudden infant death syndrome, which was observed in 8 recipients of RotaTeq and 9 placebo recipients.

Intussusception

In REST, 34,837 vaccine recipients and 34,788 placebo recipients were monitored by active surveillance to identify potential cases of intussusception at 7, 14, and 42 days after each dose, and
every 6 weeks thereafter for 1 year after the first dose.

For the primary safety outcome, cases of intussusception occurring within 42 days of any dose, there were 6 cases among RotaTeq recipients and 5 cases among placebo recipients (see Table 1). The data did not suggest an increased risk of intussusception relative to placebo.

Table 1
Confirmed cases of intussusception in recipients of RotaTeq as compared with placebo recipients during REST

RotaTeq (n=34,837) Placebo (n=34,788)
Confirmed intussusception cases within 42 days of any dose 6 5
Relative risk (95% CI) * 1.6 (0.4, 6.4)
Confirmed intussusception cases within 365 days of dose 1 13 15
Relative risk (95% CI) 0.9 (0.4, 1.9)

*
Relative risk and 95% confidence interval based upon group sequential design stopping criteria employed in REST.

Among vaccine recipients, there were no confirmed cases of intussusception within the 42-day period after the first dose, which was the period of highest risk for the rhesus rotavirus-based product (see Table 2).

Table 2
Intussusception cases by day range in relation to dose in REST

Dose 1 Dose 2 Dose 3 Any Dose
Day Range RotaTeq Placebo RotaTeq Placebo RotaTeq Placebo RotaTeq Placebo
1-7 0 0 1 0 0 0 1 0
1-14 0 0 1 0 0 1 1 1
1-21 0 0 3 0 0 1 3 1
1-42 0 1 4 1 2 3 6 5

All of the children who developed intussusception recovered without sequelae with the exception of a 9-month-old male who developed intussusception 98 days after dose 3 and died of post-operative sepsis. There was a single case of intussusception among 2,470 recipients of RotaTeq in a 7-month-old male in the phase 1 and 2 studies (716 placebo recipients).

Hematochezia

Hematochezia reported as an adverse experience occurred in 0.6% (39/6,130) of vaccine and 0.6% (34/5,560) of placebo recipients within 42 days of any dose. Hematochezia reported as a serious adverse experience occurred in <0.1% (4/36,150) of vaccine and <0.1% (7/35,536) of placebo recipients within 42 days of any dose.

Seizures

All seizures reported in the phase 3 trials of RotaTeq (by vaccination group and interval after dose) are shown in Table 3.

5

Table 3
Seizures reported by day range in relation to any dose in the phase 3 trials of RotaTeq

Day range 1-7 1-14 1-42
RotaTeq 10 15 33
Placebo 5 8 24

Seizures reported as serious adverse experiences occurred in <0.1% (27/36,150) of vaccine and <0.1% (18/35,536) of placebo recipients (not significant). Ten febrile seizures were reported as serious
adverse experiences, 5 were observed in vaccine recipients and 5 in placebo recipients.

Kawasaki Disease

In the phase 3 clinical trials, infants were followed for up to 42 days of vaccine dose. Kawasaki disease was reported in 5 of 36,150 vaccine recipients and in 1 of 35,536 placebo recipients with unadjusted relative risk 4.9 (95% CI 0.6, 239.1).

Most Common Adverse Events

Solicited Adverse Events

Detailed safety information was collected from 11,711 infants (6,138 recipients of RotaTeq) which included a subset of subjects in REST and all subjects from Studies 007 and 009 (Detailed Safety
Cohort). A Vaccination Report Card was used by parents/guardians to record the child’s temperature and any episodes of diarrhea and vomiting on a daily basis during the first week following each vaccination.

Table 4 summarizes the frequencies of these adverse events and irritability.

Table 4
Solicited adverse experiences within the first week after doses 1, 2, and 3 (Detailed Safety Cohort)

Adverse experience

Elevated temperature*

Vomiting

RotaTeq
n=5,616
17.1%
n=6,130
6.7%
Dose 1
Placebo
n=5,077
16.2%
n=5,560
5.4%
RotaTeq
n=5,215
20.0%
n=5,703
5.0%
Dose 2
Placebo
n=4,725
19.4%
n=5,173
4.4%
RotaTeq
n=4,865
18.2%
n=5,496
3.6%
Dose 3
Placebo
n=4,382
17.6%
n=4,989
3.2%
Diarrhea 10.4% 9.1% 8.6% 6.4% 6.1% 5.4%
Irritability 7.1% 7.1% 6.0% 6.5% 4.3% 4.5%

*Temperature ³100.5°F rectal equivalent obtained by adding 1 degree F to otic and oral temperatures and 2 degrees F to axillary temperatures

Other Adverse Events

Parents/guardians of the 11,711 infants were also asked to report the presence of other events on the Vaccination Report Card for 42 days after each dose.

Fever was observed at similar rates in vaccine (N=6,138) and placebo (N=5,573) recipients (42.6% vs. 42.8%). Adverse events that occurred at a statistically higher incidence (i.e., 2-sided p-value <0.05) within the 42 days of any dose among recipients of RotaTeq as compared with placebo recipients are shown in
Table 5.

Table 5
Adverse events that occurred at a statistically higher incidence within 42 days of any dose among recipients of RotaTeq as compared with placebo recipients

RotaTeq Placebo
Adverse event N=6,138 N=5,573
n (%) n (%)
Diarrhea 1,479 (24.1%) 1,186 (21.3%)
Vomiting 929 (15.2%) 758 (13.6%)
Otitis media 887 (14.5%) 724 (13.0%)
Nasopharyngitis 422 (6.9%) 325 (5.8%)
Bronchospasm 66 (1.1%) 40 (0.7%)

Safety in Pre-Term Infants

RotaTeq or placebo was administered to 2,070 pre-term infants (25 to 36 weeks gestational age, median 34 weeks) according to their age in weeks since birth in REST. All pre-term infants were followed for serious adverse experiences; a subset of 308 infants was monitored for all adverse experiences. There were 4 deaths throughout the study, 2 among vaccine recipients (1 SIDS and 1 motor vehicle accident) and 2 among placebo recipients (1 SIDS and 1 unknown cause). No cases of intussusception were reported. Serious adverse experiences occurred in 5.5% of vaccine and 5.8% of placebo recipients.

6

The most common serious adverse experience was bronchiolitis, which occurred in 1.4% of vaccine and 2.0% of placebo recipients. Parents/guardians were asked to record the child’s temperature and any episodes of vomiting and diarrhea daily for the first week following vaccination. The frequencies of these adverse experiences and irritability within the week after dose 1 are summarized in Table 6.

Table 6
Solicited adverse experiences within the first week of doses 1, 2, and 3 among pre-term infants

Adverse event
Elevated temperature*
Vomiting
RotaTeq
N=127
18.1%
N=154
5.8%
Dose 1
Placebo
N=133
17.3%
N=154
7.8%
RotaTeq
N=124
25.0%
N=137
2.9%
Dose 2
Placebo
N=121
28.1%
N=137
2.2%
RotaTeq
N=115
14.8%
N=135
4.4%
Dose 3
Placebo
N=108
20.4%
N=129
4.7%
Diarrhea 6.5% 5.8% 7.3% 7.3% 3.7% 3.9%
Irritability 3.9% 5.2% 2.9% 4.4% 8.1% 5.4%

*Temperature 100.5°F rectal equivalent obtained by adding 1 degree F to otic and oral temperatures and 2 degrees F to axillary temperatures

6.2 Post-Marketing Experience
The following adverse events have been identified during post-approval use of RotaTeq from reports to the Vaccine Adverse Event Reporting System (VAERS).

Reporting of adverse events following immunization to VAERS is voluntary, and the number of doses of vaccine administered is not known; therefore, it is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to vaccine exposure using VAERS data.

In post-marketing experience, the following adverse events have been reported in infants who have received RotaTeq:
Gastrointestinal disorders:

Intussusception (including death)

Hematochezia

Skin and subcutaneous tissue disorders:

Urticaria

Infections and infestations:

Kawasaki disease

iVillage Member
Registered: 12-10-2008
Tue, 08-25-2009 - 8:46pm

Like pp said, it's a live virus vaccine so it's definitely possible. I know it made my son sick for 3 weeks afterwards, not sick enough he had to be hospitalized, thankfully, but it still made him sick!

We didn't give him that vaccine again after that!

Lilypie - Personal pictureLilypie







iVillage Member
Registered: 03-25-2004
Tue, 08-25-2009 - 10:21am
I am sorry about your friend's baby. Since Rotateq is a live virus vaccine, it is perfectly logical that the baby could have actually caught the virus. That's the danger of live virus vaccines. If I was your friend, I'd get the medical records from the hospital and read them. If she can't decipher them, maybe she knows someone in the medical field who can help her.
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