Subcutaneous diphtheria and tetanus vaccines in children with haemophilia: A pilot study and review of the literature

Schaefer, Beverly A.; Gruppo, Ralph A.; Mullins, Eric S.; Tarango, Cristina

doi:10.1111/hae.13316

Cited by 3 publications

(6 citation statements)

References 58 publications

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“…A recent retrospective analysis found no significant difference in the immunogenicity of HBV vaccine in children (n = 767) with bleeding disorders who received the vaccine subcutaneously compared with those who received it intramuscularly, but there was a higher incidence of local haematoma formation in those receiving intramuscular vaccination . A pilot study investigating the immunogenicity of 3‐4 doses of subcutaneous diphtheria and tetanus vaccines in children with haemophilia (aged <6 years; n = 8) reported the development of a positive antibody titre to both antigens, thus confirming the feasibility of the subcutaneous route for diphtheria and tetanus vaccines in this population …”

Section: Resultsmentioning

confidence: 96%

“…A number of issues related to vaccination of patients with haemophilia remain controversial, including the immunogenicity and tolerability of off‐label subcutaneous administration of vaccines, and the risk of inhibitor formation with vaccination in patients receiving coagulation factor replacement therapy . The risk of bleeding in patients with coagulation disorders needs to be carefully evaluated before intramuscular administration of any vaccine, and the subcutaneous route should only be used if the efficacy is similar to that of the intramuscular route .…”

Section: Introductionmentioning

confidence: 99%

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Consensus statements on vaccination in patients with haemophilia—Results from the Italian haemophilia and vaccinations (HEVA) project

et al. 2019

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Vaccination against communicable diseases is crucial for disease prevention, but this practice poses challenges to healthcare professionals in patients with haemophilia. Poor knowledge of the vaccination requirements for these patients and safety concerns often result in vaccination delay or avoidance. In order to address this issue, a panel of 11 Italian haemophilia and immunization experts conducted a Delphi consensus process to identify the main concerns regarding the safe use of vaccines in patients with haemophilia. The consensus was based on a literature search of the available evidence, which was used by the experts to design 27 consensus statements. A group of clinicians then rated these statements using the 5‐point Likert‐type scale (1 = strongly disagree; 5 = strongly agree). The main issues identified by the expert panel included vaccination schedule for haemophilic patients; protocol and optimal route of vaccine administration; vaccination of haemophilic patients with antibodies inhibiting coagulation factor VIII (inhibitors); and vaccination and risk of inhibitor development. This manuscript discusses these controversial areas in detail supported by the available literature evidence and provides evidence‐ and consensus‐based recommendations. Overall, participants agreed on most statements, except those addressing the potential role of vaccination in inhibitor formation. Participants agreed that patients with haemophilia should receive vaccinations according to the institutional schedule for individuals without bleeding disorders; however, vaccination of patients with haemophilia requires comprehensive planning, taking into account disease severity, type and route of vaccination, and bleeding risk. Data also suggest vaccination timing does not need to take into consideration when the patient received factor VIII replacement.

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Section: Resultsmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 99%

Consensus statements on vaccination in patients with haemophilia—Results from the Italian haemophilia and vaccinations (HEVA) project

et al. 2019

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“…At the time, when the WFH issued its recommendation to give vaccination in persons with haemophilia preferably via the subcutaneous route, an increasing body of evidence supported the subcutaneous administration is as effective as intramuscular and did not require factor prophylaxis. This had been demonstrated for both hepatitis vaccination and diphtheria and tetanus vaccines in children and adults 19–22 . The situation changed when SARS‐CoV2 vaccines were first licenced during the unfolding COVID‐19 pandemic.…”

Section: Discussionmentioning

confidence: 99%

“…This had been demonstrated for both hepatitis vaccination and diphtheria and tetanus vaccines in children and adults. 19 , 20 , 21 , 22 The situation changed when SARS‐CoV2 vaccines were first licenced during the unfolding COVID‐19 pandemic. Although it cannot be excluded that these vaccines would also be safe and effective when given subcutaneously, the available evidence and the urgency of effective vaccination did not allow to recommend other than the established intramuscular route of administration.…”

Section: Discussionmentioning

confidence: 99%

Safety of intramuscular COVID‐19 vaccination in patients with haemophilia

et al. 2022

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Background Guidelines recommend that patients with haemophilia should preferably receive vaccination subcutaneously. COVID‐19 and other vaccines, however, are only licenced for intramuscular application. Aims To assess the safety of intramuscular COVID‐19 vaccination in patients living with haemophilia. Methods Part A of this prospective observational study enrolled consecutive patients with haemophilia A (HA) and B (HB) of all ages and severities and assessed injection site bleeding and other complications within 30 days of vaccination. Part B enrolled patients providing informed consent for detailed data collection including medication and prophylaxis around the time of vaccination. Logistic regression was performed to assess potential risk factors for bleeding. Results Four hundred and sixty‐one patients were enrolled into part A. The primary endpoint injection site bleeding occurred in seven patients (1.5%, 95% confidence interval .7–3.1%). Comprehensive analysis of 214 patients (404 vaccinations, part B) revealed that 97% of patients with severe haemophilia had prophylaxis before vaccination, either as part of their routine prophylaxis or using additional doses. 56% and 30% of patients with moderate and mild haemophilia, respectively, received prophylaxis before vaccination. Among the seven bleeds recorded, three occurred when intramuscular vaccination was done without prophylaxis (odds ratio 12). Conclusions This is the first prospective study reporting on the safety of intramuscular vaccination in haemophilia. The rate of injection site bleeding was low in mild haemophilia, and in moderate and severe haemophilia if patients received factor prophylaxis.

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“…Although SQ injections carry a lower risk of bleeding, they may not stimulate sufficient antibodies. Many vaccines containing adjuvants are administered via the IM route primarily due to decreased local reactions and optimised immunogenicity 19 . For SQ injections, poor vascularity may result in slow mobilisation and processing of antigen, which may affect the production of protective antibodies 20 .…”

Section: Discussionmentioning

confidence: 99%

Present status of scheduled vaccinations and vaccination‐related bleeding in Chinese children with haemophilia

Li,

Zhou,

et al. 2024

J Paediatrics Child Health

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AimMany countries have detailed recommendations for haemophilia patients to reduce the risk of vaccination‐related bleeding. However, data from developing countries are lacking. We investigated scheduled vaccinations and vaccination‐related bleeding complications in Chinese children with haemophilia and analysed issues related to vaccinations.MethodsChildren with haemophilia in the PUMCH Haemophilia Treatment Centre were contacted via telephone. We distributed a vaccination questionnaire to their parents. The severity of haemophilia, coagulation factor infusions before vaccination, injection mode, and vaccination‐related complications were analysed.ResultsA total of 440 valid questionnaires were received from 27 of 34 provinces in China. 31.3% (138/440) of the children with haemophilia did not receive all of their vaccinations. Among the children who received vaccinations, 48.1% (197/409) experienced bleeding complications. In patients with severe haemophilia, those on regular prophylaxis had a lower incidence of local hematoma compared to those on intermittent or no prophylaxis (14.3% vs. 26.5% vs. 39.7%, P < 0.05). The incidence of local hematomas was lower by subcutaneous (SQ) injections than by intramuscular injections (24.6% vs. 35.3%, P < 0.05).ConclusionThe vaccination rate is quite insufficient in Chinese children with haemophilia. Missed vaccinations are related to vaccination‐related bleeding complications. Prophylaxis before vaccination and SQ injections would help reduce bleeding complications.

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Subcutaneous diphtheria and tetanus vaccines in children with haemophilia: A pilot study and review of the literature

Abstract: SQ administration of diphtheria and tetanus vaccination appears to be immunogenic in a pilot study of Haemophilia patients and supports this practice as the standard of care for this population.

Cited by 3 publications

References 58 publications

Consensus statements on vaccination in patients with haemophilia—Results from the Italian haemophilia and vaccinations (HEVA) project

Consensus statements on vaccination in patients with haemophilia—Results from the Italian haemophilia and vaccinations (HEVA) project

Safety of intramuscular COVID‐19 vaccination in patients with haemophilia

Present status of scheduled vaccinations and vaccination‐related bleeding in Chinese children with haemophilia

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