Adventitious agents in viral vaccines: Lessons learned from 4 case studies

“The four cases are: a) SV40 in polio vaccines; b) bacteriophage in measles and polio vaccines; c) reverse transcriptase in measles and mumps vaccines; and d) porcine circovirus and porcine circovirus DNA sequences in rotavirus vaccines.”

#Contamination #SV40 #Polio #Vaccine #MedScienceResearch
#Rotavirus #Measles #MMR

An analysis of rotavirus vaccine reports to the vaccine adverse event reporting system: more than intussusception alone?

#Gastrointestinal #Rotavirus #Intussusception #Vaccine #MedScienceResearch

Detection of fecal shedding of rotavirus vaccine in infants following their first dose of pentavalent rotavirus vaccine.

#Shedding #Rotavirus #Failure #Gastrointestinal #Vaccine #MedScienceResearch

Differentiation of RotaTeq(®) vaccine strains from wild-type strains using NSP3 gene in reverse transcription polymerase chain reaction assay.

“However, shedding of the virus used in RotaTeq(®) has been detected in the feces of children following vaccination by the oral route, possibly affecting community immunity.”

#Shedding #Rotavirus #Vaccine #MedScienceResearch

The first case of Kawasaki disease in a 20-month old baby following immunization with rotavirus vaccine and hepatitis A vaccine in China: A case report.

“Herein, we describe a 20-month-old child who developed Kawasaki disease after receiving her second dose of Lanzhou lamb rotavirus vaccine (LLR) and her first dose of freeze-dried live attenuated hepatitis A vaccine.”

#Kawasaki #Rotavirus #Hepatitis A #Vaccine #MedScienceResearch

Gastrointestinal immunopathology and food allergy.

“In contrast to the beneficial expressions of gastrointestinal-associated lymphoid tissue, which are seen with relevance to newer methods of delivery of vaccines directly applied to the gastrointestinal mucosal surfaces (eg, oral poliovirus, rotavirus, Salmonella typhi vaccines), the adverse consequences of a mucosal immune response gone astray are evidenced in many diseases such as FA. A classification of clinical disorders associated with FA based on classic mechanisms of immunologic injury is presented, which includes the following: (1) IgE-mediated, (2) non-IgE-mediated, and (3) mixed IgE- and non-IgE-mediated disorders. Our study of immunologic disturbance in patients with non-IgE FA revealed a pattern of increased CD4+ and decreased TH1 cell counts in peripheral blood mononuclear cells in contrast to patients with celiac disease, where a pattern of increased CD8+ and TH1 cell counts in peripheral blood mononuclear cells and increased CD8+ cell counts was seen.”

#Food #Allergies #Gastrointestinal #Polio #Rotavirus #Immune #Vaccine

Horizontal transmission of a human rotavirus vaccine strain–a randomized, placebo-controlled study in twins.

#Shedding #Rotavirus #Vaccine #Failure #MedScienceResearch

Horizontal transmission of rhesus monkey rotavirus-based quadrivalent vaccine during a phase 3 clinical trial in Caracas, Venezuela.

#Shedding #Rotavirus #Gastrointestinal #Vaccine #Failure #MedScienceResearch

Need for new technologies for detection of adventitious agents in vaccines and other biological products.

“From an industrial perspective, the conventional in vitro and in vivo assays used for detection of viral contaminants have shown their limitations, as illustrated by the unfortunate detection of porcine circovirus contamination in a licensed rotavirus vaccine.”

#Contamination #Rotavirus #Vaccine #MedScienceResearch

Persistent rotavirus vaccine shedding in a new case of severe combined immunodeficiency: A reason to screen.

#Shedding #Rotavirus
#Vaccine #Failure #Gastrointestinal

Porcine circovirus (PCV) removal by Q sepharose fast flow chromatography.

“The recently discovered contamination of oral rotavirus vaccines led to exposure of millions of infants to porcine circovirus (PCV). PCV was not detected by conventional virus screening tests. Regulatory agencies expect exclusion of adventitious viruses from biological products. Therefore, methods for inactivation/removal of viruses have to be implemented as an additional safety barrier whenever feasible. However, inactivation or removal of PCV is difficult. PCV is highly resistant to widely used physicochemical inactivation procedures. Circoviruses such as PCV are the smallest viruses known and are not expected to be effectively removed by currently-used virus filters due to the small size of the circovirus particles. Anion exchange chromatography such as Q Sepharose(®) Fast Flow (QSFF) has been shown to effectively remove a range of viruses including parvoviruses. In this study, we investigated PCV1 removal by virus filtration and by QSFF chromatography. As expected, PCV1 could not be effectively removed by virus filtration. However, PCV1 could be effectively removed by QSFF as used during the purification of monoclonal antibodies (mAbs) and a log10 reduction value (LRV) of 4.12 was obtained.
© 2013 American Institute of Chemical Engineers.”

#Contamination #Rotavirus
#Vaccine #MedScienceResearch

Post-rotavirus vaccine intussusception in identical twins: A case report.

“Two infants aged 3 months, vaccinated against rotavirus. After about a week, one of the 2 identical infants presented inconsolable crying, vomiting, loose stools mixed with blood, and was diagnosed with bowel obstruction with intussusception. He was operated in urgency. After a few hours, his brother presented vomiting, and was admitted to our Hospital for suspected intussusception.”

#Rotavirus #Gastrointestinal #Intussusception #Vaccine #MedScienceResearch

Rectal Bleeding and Abdominal Pain Following Vaccination in a 4-Month-Old Infant.

#Gastrointestinal #Rotavirus #Vaccine #MedScienceResearch

Risk of intussusception following rotavirus vaccination: An evidence based meta-analysis of cohort and case-control studies. (2017)

“RESULTS: Six cohort studies involving 4506265 total first doses and five case-control studies involving a total sample of 9643 children were included in this analysis. The cohort data revealed that there was an associated increased risk of intussusception after the first 7days post first dose of the vaccine (RR:3.71, 95% CI:1.08-12.69) and after receiving all doses of the rotavirus vaccine (RR:3.47, 95% CI:1.23-9.78). Similarly, the case-control data found an increased risk of intussusception following the first dose (OR: 8.45, 95% CI: 4.08-17.50) and following all doses (OR: 1.59, 95% CI: 1.11-2.27).

CONCLUSIONS: Findings of this meta-analysis suggest that the rotavirus vaccine is associated with an increased risk on the development of intussusception, principally seen after administration of the first dose of vaccine.”

#Rotavirus #Intussusception
#Vaccine #MedScienceResearch

RotaTeq vaccine adverse events and policy considerations.

“RESULTS: From February 3, 2006 through July 31, 2007, a total of 160 (of the 165 reported) intussusception and 11 (of the 16 reported) Kawasaki disease adverse event reports were identified when RotaTeq was administered or co-administered with other vaccines. Time-trend analyses showed that there were significant increases in the total number of intussusception and Kawasaki disease adverse events entered into VAERS in comparison to previous years.

CONCLUSIONS: These observations, coupled with limited rotavirus disease burden, cost-effectiveness, and potential contact viral transmission concerns, raise serious questions regarding the use of RotaTeq in the US. Healthcare providers should diligently report adverse events following RotaTeq vaccination to VAERS, and those who have experienced a vaccine-associated adverse event should be made aware that they may be eligible for compensation from the no-fault National Vaccine Injury Compensation Program (NVICP).”

#Kawasaki #Rotavirus #Gastrointestinal
#VAERS #Vaccine #MedScienceResearch

Rotavirus shedding in premature infants following first immunization.

#Shedding #Rotavirus #Failure #Gastrointestinal #Premature #Vaccine #MedScienceResearch

Rotavirus vaccine-derived shedding and viral reassortants.

#Shedding #Rotavirus #Failure #Gastrointestinal #Vaccine #MedScienceResearch

Rotavirus vaccines: viral shedding and risk of transmission.

#Shedding #Rotavirus #Failure #Gastrointestinal #Vaccine #MedScienceResearch

Safety and immunogenicity of RV3-BB human neonatal rotavirus vaccine administered at birth or in infancy: a randomised, double-blind, placebo-controlled trial.

“A serum IgA response was detected in 19 (63%) of 30 participants and 20 (74%) of 27 participants, and stool shedding of RV3-BB was detected in 21 (70%) of 30 participants and 21 (78%) of 27 participants in the neonatal and infant schedule groups, respectively.”

#Shedding #Rotavirus #Vaccine #MedScienceResearch

Safety of live vaccinations on immunosuppressive therapy in patients with immune-mediated inflammatory diseases, solid organ transplantation or after bone-marrow transplantation – A systematic review of randomized trials, observational studies and case reports.

“However, some serious vaccine-related adverse events occurred. 32 participants developed an infection with the vaccine strain; in most cases the infection was mild. However, in two patients fatal infections were reported”

#Death #Vaccine #Failure
#MMR #Polio #Rotavirus #BCG #Varicella #Smallpox #Typhoid #Shingles #Yellow #Fever