Anaphylaxis rates following mRNA COVID-19 vaccination in children and adolescents: Analysis of data reported to EudraVigilance

Maltezou, Helena C.; Hatziantoniou, Sophia; Theodoridou, Kalliopi; Vasileiou, Konstantinos; Anastassopoulou, Cleo; Tsakris, Athanasios

doi:10.1016/j.vaccine.2023.02.067

Cited by 8 publications

(7 citation statements)

References 25 publications

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“…The HVTN 133 trial was complicated by two notable AEs, one a delayed reaction of large local erythema at the injection sites one week after vaccination, and the other an occurrence of a delayed anaphylaxis reaction attributed to PEG in the immunogen, that interrupted the trial. Both types of allergic reactions have been associated with COVID mRNA/LNP vaccination (40, 41) with anaphylaxis occurring in adults in 5 per million doses (42) and in 12.8 per million in children and adolescents (43). One study has demonstrated basophils sensitized by anti-PEG antibodies in COVID vaccine recipients with a history of post-vaccine anaphylaxis (28).…”

Section: Discussionmentioning

confidence: 99%

A HIV-1 Gp41 Peptide-Liposome Vaccine Elicits Neutralizing Epitope-Targeted Antibody Responses in Healthy Individuals

Erdmann,

Williams,

Walsh

et al. 2024

Preprint

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Background: HIV-1 vaccine development is a global health priority. Broadly neutralizing antibodies (bnAbs) which target the HIV-1 gp41 membrane-proximal external region (MPER) have some of the highest neutralization breadth. An MPER peptide-liposome vaccine has been found to expand bnAb precursors in monkeys. Methods: The HVTN133 phase 1 clinical trial (NCT03934541) studied the MPER-peptide liposome immunogen in 24 HIV-1 seronegative individuals. Participants were recruited between 15 July 2019 and 18 October 2019 and were randomized in a dose-escalation design to either 500 mcg or 2000 mcg of the MPER-peptide liposome or placebo. Four intramuscular injections were planned at months 0, 2, 6, and 12. Results: The trial was stopped prematurely due to an anaphylaxis reaction in one participant ultimately attributed to vaccine-associated polyethylene glycol. The immunogen induced robust immune responses, including MPER+ serum and blood CD4+ T-cell responses in 95% and 100% of vaccinees, respectively, and 35% (7/20) of vaccine recipients had blood IgG memory B cells with MPER-bnAb binding phenotype. Affinity purification of plasma MPER+ IgG demonstrated tier 2 HIV-1 neutralizing activity in two of five participants after 3 immunizations. Conclusions: MPER-peptide liposomes induced gp41 serum neutralizing epitope-targeted antibodies and memory B-cell responses in humans despite the early termination of the study. These results suggest that the MPER region is a promising target for a candidate HIV vaccine.

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Section: Discussionmentioning

confidence: 99%

A HIV-1 Gp41 Peptide-Liposome Vaccine Elicits Neutralizing Epitope-Targeted Antibody Responses in Healthy Individuals

Erdmann,

Williams,

Walsh

et al. 2024

Preprint

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show abstract

“…This has recently been observed with COVID-19 vaccines, which have been associated with cutaneous and systemic reactions. However, the incidence of anaphylaxis after COVID-19 vaccines is comparable to that of other vaccines (36). Another rare AEFI found in children and adolescents, especially in male adolescents after receiving mRNA vaccines, is myocarditis/pericarditis (37).…”

Section: Vaccine Allergymentioning

confidence: 94%

Recent findings on drug hypersensitivity in children

Felix,

Kuschnir,

Boechat

et al. 2024

Front. Allergy

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Drug hypersensitivity reactions (DHR) in children have a significant impact on clinical practice and public health. Both under-diagnosis (due to under-reporting) and over-diagnosis (due to the overuse of the term “allergy”) are potential issues. The aim of this narrative review is to describe the most recent findings of DHR in children/adolescents and gaps regarding epidemiology, antibiotic allergy, antiepileptic hypersensitivity, vaccine allergy, and severe cutaneous adverse reactions (SCAR) in this age group.

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“…Whether they are induced by PEG per se or as a conjugated molecule, is not clear 76 . A recent study that measured anti‐PEG IgE in serum samples from individuals who presented anaphylaxis after COVID‐19 mRNA vaccines, did not find a difference respect to the control group, suggesting that anti‐PEG IgE may not be directly related to anaphylactic cases, 78 which agrees with previous observations 79 . Nonetheless, PEG could provoke allergic reactions through other pathways, such as complement activation‐related pseudo allergy (CARPA) 79,80 .…”

Section: Covid‐19 Vaccines and Main Serious Adverse Eventsmentioning

confidence: 99%

Incidence and management of the main serious adverse events reported after COVID‐19 vaccination

Padilla‐Flores,

Sampieri,

Vaca

2024

Pharmacology Res & Perspec

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Coronavirus disease 2019 (COVID‐19) caused by the severe acute respiratory syndrome coronavirus 2n first appeared in Wuhan, China in 2019. Soon after, it was declared a pandemic by the World Health Organization. The health crisis imposed by a new virus and its rapid spread worldwide prompted the fast development of vaccines. For the first time in human history, two vaccines based on recombinant genetic material technology were approved for human use. These mRNA vaccines were applied in massive immunization programs around the world, followed by other vaccines based on more traditional approaches. Even though all vaccines were tested in clinical trials prior to their general administration, serious adverse events, usually of very low incidence, were mostly identified after application of millions of doses. Establishing a direct correlation (the cause‐effect paradigm) between vaccination and the appearance of adverse effects has proven challenging. This review focuses on the main adverse effects observed after vaccination, including anaphylaxis, myocarditis, vaccine‐induced thrombotic thrombocytopenia, Guillain–Barré syndrome, and transverse myelitis reported in the context of COVID‐19 vaccination. We highlight the symptoms, laboratory tests required for an adequate diagnosis, and briefly outline the recommended treatments for these adverse effects. The aim of this work is to increase awareness among healthcare personnel about the serious adverse events that may arise post‐vaccination. Regardless of the ongoing discussion about the safety of COVID‐19 vaccination, these adverse effects must be identified promptly and treated effectively to reduce the risk of complications.

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Anaphylaxis rates following mRNA COVID-19 vaccination in children and adolescents: Analysis of data reported to EudraVigilance

Cited by 8 publications

References 25 publications

A HIV-1 Gp41 Peptide-Liposome Vaccine Elicits Neutralizing Epitope-Targeted Antibody Responses in Healthy Individuals

A HIV-1 Gp41 Peptide-Liposome Vaccine Elicits Neutralizing Epitope-Targeted Antibody Responses in Healthy Individuals

Recent findings on drug hypersensitivity in children

Incidence and management of the main serious adverse events reported after COVID‐19 vaccination

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