Side Effects of rotavirus vaccine: A Synthesis of Findings from 25 Studies

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Original Abstract of the Article

Major Research Findings

Rotavirus vaccines have been shown to be effective in preventing rotavirus infection in infants in many studies. 18 , 20 , 24 These vaccines have been shown to have a similar safety and reactogenicity profile compared to placebo. 18 However, some studies have reported rare side effects, such as intussusception. 18 , , 12 However, because rotavirus vaccines have the advantage of preventing deaths and serious complications from rotavirus infection in infants, they are recommended in many countries.

Reasons for side effects

Rotavirus vaccines use live attenuated viruses. 18 This virus enters the body and induces an immune response, increasing immunity to rotavirus infection. However, in rare cases, this attenuated virus can multiply in the gut, causing side effects such as intussusception. 18 It is also possible to have an allergic reaction to the ingredients in the vaccine.

Common side effects

Fever

Fever may occur after receiving the rotavirus vaccine. 18 This is due to an immune response to the vaccine's components. Fever is usually mild and can be relieved with fever reducers. 18

Vomiting

Vomiting may occur after receiving the rotavirus vaccine. 18 This is due to an immune response to the vaccine's components. Vomiting is usually mild and goes away quickly. 18

Diarrhea

Diarrhea may occur after receiving the rotavirus vaccine. 18 This is due to an immune response to the vaccine's components. Diarrhea is usually mild and goes away quickly. 18

Intussusception

Intussusception may occur rarely after receiving the rotavirus vaccine. 18 Intussusception is a condition where the intestine folds in on itself. Symptoms include severe abdominal pain, vomiting, and bloody stools. 18 Intussusception often occurs within a week of receiving the rotavirus vaccine. 18 Intussusception is a medical emergency that requires immediate treatment. 18 If you experience symptoms of intussusception, seek medical attention immediately. 18

Side effect management

Fever

If you are concerned about fever, take a fever reducer. 18

Vomiting

If vomiting continues, stay hydrated. 18

Diarrhea

If diarrhea continues, stay hydrated. 18

Intussusception

If you experience symptoms of intussusception, seek medical attention immediately. 18

Comparison of studies

Commonalities in research

Many studies have shown that rotavirus vaccines are effective in preventing rotavirus infection in infants. 18 , 20 , 24 These vaccines have also been shown to have a similar safety and reactogenicity profile compared to placebo. 18

Differences in research

The frequency of reporting rare side effects such as intussusception varies from study to study. 18 , , 12 This may be due to differences in research methods and subject populations.

Precautions for real-world application

Rotavirus vaccines are effective vaccines for preventing rotavirus infection in infants. 18 , 20 , 24 However, rare side effects such as intussusception may occur. 18 If you are considering rotavirus vaccination, talk to your doctor about these side effects. 18

Limitations of current research

There is still not enough research on the side effects of rotavirus vaccines. 18 , 20 , 24 In particular, long-term side effects are not yet fully understood. 18

Future research directions

Research is needed to assess the long-term safety and efficacy of rotavirus vaccines. 18 , 20 , 24 It is also important to further investigate rare side effects such as intussusception. 18

Conclusion

Rotavirus vaccines are effective vaccines for preventing rotavirus infection in infants. 18 , 20 , 24 However, rare side effects such as intussusception may occur. 18 If you are considering rotavirus vaccination, talk to your doctor about these side effects. 18

Literature analysis of 25 papers
Positive Content
25
Neutral Content
0
Negative Content
0
Article Type
8
0
0
5
25
1.

Parenteral, non-live rotavirus vaccine: recent history and future perspective.

Author: SongJae Min

Disease burden reduction
Rotavirus vaccine development

This review provides an overview of the development status and technology of parenteral, non-live rotavirus vaccines worldwide.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

2.

Smart Safety Surveillance (3S): Multi-Country Experience of Implementing the 3S Concepts and Principles.

Author: IessaNoha, Macolic SarinicViola, GhazaryanLilit, RomanovaNaira, AlemuAsnakech, RungapiromnanWatcharee, JiamsuchonPorntip, PokhagulPattreya, CastroJose Luis, Macias Saint-GeronsDiego, GhukasyanGayane, TeferiMengistab, GuptaMadhur, PalShanthi Narayan

Improved pharmacovigilance

The Smart Safety Surveillance (3S) concept recommends countries to invest judiciously in pharmacovigilance, focusing on new priority products, sharing work and resources with other countries, and building national competence for non-delegatable activities.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Current and new rotavirus vaccines.

Author: BurkeRachel M, TateJacqueline E, KirkwoodCarl D, SteeleA Duncan, ParasharUmesh D

Increased vaccine choice
Reduced mortality
Rotavirus prevention
Intussusception
Vaccine shortage

Four rotavirus vaccines are currently prequalified by the WHO for use worldwide. They have proven effective and safe, with a favorable risk-benefit profile. Continued monitoring for intussusception, a rare but serious adverse event, is needed. A recent vaccine shortage has been addressed with the prequalification of two additional vaccines.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

4.

Dilemmas With Rotavirus Vaccine: The Neonate and Immunocompromised.

Author: ChiuMelissa, BaoCarol, SadaranganiManish

Decreased hospitalization
Improved infant health
Adverse events

Rotavirus vaccines are safe and effective for most infants, including preterm babies.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

5.

Rotavirus vaccination and short-term risk of adverse events in US infants.

Author: LaytonJ Bradley, ButlerAnne M, PanozzoCatherine A, BrookhartM Alan

Not applicable
Otitis media

Rotavirus vaccine (RV) was not consistently associated with an increased risk of intussusception or other adverse events. A small increased risk of otitis media was observed, particularly in the two-dose monovalent RV1.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

Safety and immunogenicity of a parenteral P2-VP8-P[8] subunit rotavirus vaccine in toddlers and infants in South Africa: a randomised, double-blind, placebo-controlled trial.

Author: GroomeMichelle J, KoenAnthonet, FixAlan, PageNicola, JoseLisa, MadhiShabir A, McNealMonica, DallyLen, ChoIksung, PowerMaureen, FloresJorge, CryzStanley

Rotavirus vaccination

This study assessed the safety and immunogenicity of the P2-VP8-P[8] subunit rotavirus vaccine at different doses in South African toddlers and infants. The efficacy of live oral rotavirus vaccines is reduced in low-income settings, so this parenteral non-replicating vaccine may offer benefits.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

Safety and immunogenicity of a live attenuated pentavalent rotavirus vaccine in HIV-exposed infants with or without HIV infection in Africa.

Author: LevinMyron J, LindseyJane C, KaplanSusan S, SchimanaWerner, LawrenceJody, McNealMonica M, Bwakura-DangarembiziMutsa, OgwuAnthony, MpabalwaniEvans M, SatoPaul, SiberryGeorge, NelsonMargaret, HilleDarcy, WeinbergGeoffrey A, WeinbergAdriana

Rotavirus vaccine safety

This abstract discusses the limited prospective data on the safety and immunogenicity of live rotavirus vaccines in HIV-infected (HIV+) and HIV-exposed but uninfected (HEU) infants.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

10.

Post-marketing safety surveillance conducted in Korea (2008-2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix™).

Author: ShinSon Moon, KimChun Soo, KarkadaNaveen, LiuAixue, JayadevaGirish, HanHtay Htay

Rotavirus prevention

This study conducted a 6-year post-marketing surveillance of Rotarix™ vaccine (RIX4414) in over 3000 Korean infants. The study found that the vaccine was well-tolerated and no new safety concerns were identified.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

[Anti-rotavirus and intussusception: no evidence to discontinue the universal vaccination policy].

Author: BonanniPaolo, SignorelliCarlo

Improved cost-effectiveness
Intussusception

This report analyzes the serious side effects of rotavirus vaccine, concluding that there are no reasons to suspend the universal offer of vaccination to infants.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : Italian

12.

Post-marketing monitoring of intussusception after rotavirus vaccination in Japan.

Author: BauchauVincent, Van HolleLionel, MahauxOlivia, HollKatsiaryna, SugiyamaKeiji, BuyseHubert

Prevents rotavirus gastroenteritis
Increased risk of intussusception

A statistically significant excess of intussusception (IS) cases was observed within 7 days post-dose 1 of Rotarix(TM) vaccination, but not post-dose 2.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

13.

Deaths following vaccination: What does the evidence show?

Author: MillerElaine R, MoroPedro L, CanoMaria, ShimabukuroTom T

Vaccine safety
Anaphylaxis
Eczema vaccinatum
Guillain-Barré syndrome
Intussusception
Progressive vaccinia

This study discussed the safety of vaccines in the United States, particularly in light of unsubstantiated claims of deaths caused by vaccines. The study reviewed epidemiologic data on deaths following vaccination, noting that while serious adverse reactions are rare, coincidental events do occur. The study emphasized the importance of relying on scientific evidence rather than anecdotal reports to assess vaccine safety.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

14.

Reactogenicity and safety of the human rotavirus vaccine, Rotarix™ in The Philippines, Sri Lanka, and India: a post-marketing surveillance study.

Author: BravoLulu, ChitrakaAmarjeet, LiuAixue, ChoudhuryJaydeep, KumarKishore, BerezoLennie, CimafrancaLeonard, ChatterjeePallab, GargPankaj, SiriwardenePrasanna, BernardoRommel, MehtaShailesh, BalasubramanianSundaram, KarkadaNaveen, Htay HanHtay

Rotavirus prevention

Post-marketing surveillance studies in The Philippines, Sri Lanka, and India demonstrated that two doses of Rotarix™ were well tolerated in infants, with most adverse events being mild and transient.

Clinical Trial, Phase IVPost-marketing surveillance. Monitors long-term safety/efficacy after approval.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

15.

Safety and immunogenicity of pentavalent rotavirus vaccine in a randomized, double-blind, placebo-controlled study in healthy elderly subjects.

Author: LawrenceJody, HeSu, MartinJason, SchödelFlorian, CiarletMax, MurrayAlexander V

Rotavirus prevention

A study assessed the safety and immunogenicity of the live pentavalent rotavirus vaccine (RV5) in healthy elderly adults. RV5 was well tolerated, with 9% of placebo and 27% of RV5 recipients experiencing mild or moderate vaccine-related adverse events. A single dose of RV5 boosted immune responses in this population, suggesting potential for further evaluation as a candidate vaccine for elderly individuals.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

17.

Impact of rotavirus vaccine on premature infants.

Author: RouéJean-Michel, NowakEmmanuel, Le GalGrégoire, LemaitreThomas, OgerEmmanuel, PoulhazanElise, GirouxJean-Dominique, GarenneArmelle, GagneurArnaud

Rotavirus protection

This study evaluated the impact of a rotavirus vaccination campaign on hospitalizations for rotavirus gastroenteritis in premature infants. The vaccination program led to a significant reduction in hospitalizations for rotavirus diarrhea in this population. These findings highlight the importance of rotavirus vaccination for premature infants and suggest that vaccination programs can effectively reduce the burden of rotavirus disease in this vulnerable group.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

18.

The human rotavirus vaccine Rotarix™ in infants: an integrated analysis of safety and reactogenicity.

Author: BuyseHubert, VinalsCarlota, KarkadaNaveen, HanHtay Htay

Rotavirus vaccine
Intussusception

The human rotavirus vaccine Rotarix™ demonstrated a reactogenicity and safety profile comparable to placebo in a large integrated analysis of 28 clinical trials. The incidence of solicited and unsolicited adverse events was similar between vaccinated and placebo groups, with a significantly lower proportion of serious adverse events in the vaccinated group.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

19.

Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China: randomized, double-blind, placebo-controlled Phase I studies.

Author: LiRong-Cheng, LiYan-Ping, MoZhao-Jun, LuoDong, HuangTeng, KongJi-Lian, WangLao-Hong, SongNing-Sheng, LiuAixue, ZhangHelen, LiaoXueyan, KarkadaNaveen, HanHtay Htay

Rotavirus vaccination

A liquid formulation of the human G1P[8] rotavirus (RV) vaccine (RIX4414) was found to be safe and well-tolerated in adults, children, and infants. In infants, the anti-RV IgA antibody seroconversion rate after two vaccine doses was 86.7%.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

20.

Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial.

Author: IwataSatoshi, NakataShuji, UkaeSusumu, KoizumiYoshitugu, MoritaYasuyuki, KurokiHaruo, TanakaYoshiyuki, ShizuyaToshiyuki, SchödelFlorian, BrownMichelle L, LawrenceJody

Reduced healthcare utilization
Reduced rotavirus gastroenteritis

Rotavirus is a common cause of severe gastroenteritis in children. This study evaluated the efficacy and safety of a rotavirus vaccine (RV5) in Japanese infants. The results showed that RV5 was effective in preventing rotavirus gastroenteritis and was well-tolerated.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

21.

Immunogenicity and safety of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine (PRV) in Indian infants.

Author: LokeshwarM R, BhaveSheila, GuptaAshok, GoyalV K, WaliaAnuj

Rotavirus immunity
None reported

A 3-dose regimen of pentavalent rotavirus vaccine was immunogenic and well tolerated in healthy Indian infants.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

22.

Postmarketing surveillance of intussusception following mass introduction of the attenuated human rotavirus vaccine in Mexico.

Author: VelázquezF Raúl, ColindresRomulo E, GrajalesConcepción, HernándezM Teresa, MercadilloMaría Guadalupe, TorresF Javier, Cervantes-ApolinarMariaYolanda, DeAntonio-SuarezRodrigo, Ortega-BarriaEduardo, BlumMaxim, BreuerThomas, VerstraetenThomas

Reduced rotavirus infections
Increased risk of intussusception

A temporal increase in the risk for intussusception was seen within 7 days of administration of the first dose of Rotarix, an attenuated human rotavirus vaccine. The study was the largest surveillance study for intussusception after rotavirus vaccination to date.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

23.

A dose-escalation safety and immunogenicity study of a new live attenuated human rotavirus vaccine (Rotavin-M1) in Vietnamese children.

Author: DangDuc Anh, NguyenVan Trang, VuDinh Thiem, NguyenThi Hien Anh, NguyenDuc Mao, YuhuanWang, BaomingJiang, NguyenDang Hien, LeThi Luan,

Rotavirus infection prevention

This study evaluated the safety and immunogenicity of a candidate live, oral, rotavirus vaccine (Rotavin-M1™) in infants. Rotavin-M1 was found to be safe and immunogenic in Vietnamese infants. The highest rotavirus IgA seroconversion rate (73%, 95%CI (58-88%)) was achieved with two doses of Rotavin-M1 (10(6.3)FFU/dose) given two months apart.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

24.

Methodology and lessons-learned from the efficacy clinical trial of the pentavalent rotavirus vaccine in Bangladesh.

Author: ZamanK, YunusM, El ArifeenShams, AzimTasnim, FaruqueA S G, HuqEhsanul, HossainIlias, LubyStephen P, VictorJohn C, DallasMichael J, LewisKristen D C, RiversStephen B, SteeleA Duncan, NeuzilKathleen M, CiarletMax, SackDavid A

Rotavirus gastroenteritis prevention

This clinical trial in rural Bangladesh evaluated the efficacy and safety of a pentavalent rotavirus vaccine (PRV), RotaTeq(®), in infants. The vaccine was well accepted in the community and successfully completed. A total of 1128 infants received 3 doses of PRV/placebo and efficacy follow-up was conducted for a median of 554 days. The efficacy of PRV against severe rotavirus gastroenteritis was 42.7% and serum anti-rotavirus IgA response was 78.1%. There were 39 serious adverse events, including 6 deaths, among study participants.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

25.

Postmarketing evaluation of the short-term safety of the pentavalent rotavirus vaccine.

Author: LoughlinJeanne, MastT Christopher, DohertyMichael C, WangFlorence T, WongJudy, SeegerJohn D

Rotavirus vaccine
Intussusception

An observational study assessed the occurrence of intussusception (IS) among infants who received a pentavalent rotavirus vaccine (RV5) in routine use.

Clinical Trial, Phase IVPost-marketing surveillance. Monitors long-term safety/efficacy after approval.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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