232 results found
Turner P, Patel N, 2022, Updated threshold dose-distribution data for sesame, Allergy, ISSN: 0105-4538
Turner P, Patel N, 2022, Reproducibility of food challenge to cow’s milk: a systematic review with individual participant data meta-analysis, Journal of Allergy and Clinical Immunology, ISSN: 0091-6749
Turner PJ, Patel N, Rodríguez Del Río P, 2022, Clarifying the categorization of anaphylaxis as an adverse event during oral immunotherapy., J Allergy Clin Immunol
Shaw RH, Liu X, Stuart ASV, et al., 2022, Impact of priming interval on reactogenicity, peak immunological response and waning after homologous and heterologous COVID-19 vaccine schedules: Exploratory analyses of Com-COV, a randomised control trial, The Lancet Respiratory Medicine, ISSN: 2213-2600
Background:Priming COVID-19 vaccine schedules have been deployed at variable intervals globally, which may influence immune persistence and the relative importance of third-dose ‘booster’ programmes. Here, we report on the impact of 4- versus 12-week priming intervals on reactogenicity and the persistence of immune response up to 6 months following homologous and heterologous priming schedules using BNT162b2 (BNT, tozinameran, Comirnaty, Pfizer/BioNTech) and ChAdOx1 nCoV-19 (ChAd, Vaxzevria, AstraZeneca).Methods:Com-COV is a participant-blinded, randomised immunogenicity trial. Results are reported here for the ‘General’ cohort, in which adults aged over 50 years were randomised to four homologous and heterologous schedules using BNT and ChAd with 4- or 12-week priming intervals. Immunogenicity analyses were on the intention-to-treat population (ITT), without evidence of COVID-19 infection at baseline or for the trial duration, with the purpose of describing the effect of priming interval on humoral and cellular immune response at peak and later timepoints, in addition to the effects on reactogenicity and safetyFindings:Between 11th–26th Feb 2021, 730 participants were randomised in the general cohort, with 77-89 per arm in the ITT analysis. At 28-days and 6-months post-second dose, the geometric mean concentration (GMC) of anti-SARS-CoV-2 spike IgG was significantly higher in 12- versus 4-week interval arms for homologous schedules. In heterologous arms, there was only a significant difference between intervals for the BNT/ChAd arm at 28-days. Pseudotyped virus neutralisation titres were significantly higher in all 12-week versus 4-week schedules, 28-days post-second dose, with geometric mean ratios 1.4 (95%CI: 1.1-1.8, BNT/BNT), 1.5 (95%CI: 1.2-1.9, ChAd/BNT), 1.6 (95%CI 1.3-2.1, BNT/ChAd) and2.4 (95%CI: 1.7-3.2, ChAd/ChAd). At 6 months post-second dose, anti-spike IgG GMCs fell to 0.17-0.24 of the 28-day post-second dose value acr
Turner PJ, Makwana N, Roberts G, et al., 2022, NICE and easy? Ensuring equitable access to NICE-approved treatments in children and young people., Arch Dis Child
Turner P, Patel N, Baseggio Conrado A, 2022, Risk factors for severe reactions in food allergy: rapid evidence review with meta‐analysis, Allergy, ISSN: 0105-4538
Turner P, Duca B, Vazquez-Ortiz M, 2022, IgE sensitisation predicts threshold but not anaphylaxis during oral food challenges to cow’s milk, Allergy, Vol: 77, Pages: 1291-1293, ISSN: 0105-4538
Nagendran S, Patel N, Turner P, 2022, Oral immunotherapy for food allergy in children: is it worth it?, Expert Review of Clinical Immunology, Vol: 18, Pages: 363-376, ISSN: 1744-666X
Introduction:Oral immunotherapy (OIT) is effective at inducing desensitization in food-allergic individuals, and is a valid therapeutic option for those allergic to peanut, cow’s milk and egg. However, there is a high rate of dose-related adverse events, and at least one fatality to OIT has been reported.Areas covered:We provide an update on the broader framework of issues which will impact on the availability and uptake of OIT.Expert opinion:The need for standardized products remains controversial. A licensed product exists for peanut-OIT, but OIT can also be safely achieved using peanut-containing foods at much lower cost. For other allergens, OIT can only be done with non-pharma products – something which has been done safely for over 2 decades. There is a need to develop personalized protocols for OIT, particularly for the 20% of patients unable to tolerate standard OIT. Cost-effectiveness is dependent on improved quality of life, but evidence for this is currently lacking, and is a key evidence gap. OIT is likely to be cost-effective, particularly if noncommercial products are used. There may be a trade-off: in patients with lower reaction thresholds, a commercial product may be needed for initial updosing, until a level of desensitization is achieved when they can be switched to natural food products.
Dribin TE, Schnadower D, Wang J, et al., 2022, Anaphylaxis knowledge gaps and future research priorities: a consensus report, Journal of Allergy and Clinical Immunology, Vol: 149, Pages: 999-1009, ISSN: 0091-6749
BACKGROUND: Despite a better understanding of the epidemiology, pathogenesis, and management of patients with anaphylaxis, there remain knowledge gaps. Enumerating and prioritizing these gaps would allow limited scientific resources to be directed more effectively. OBJECTIVE: To systematically describe and appraise anaphylaxis knowledge gaps and future research priorities based on their potential impact and feasibility. METHODS: We convened a 25-member multidisciplinary panel of anaphylaxis experts. Panelists formulated knowledge gaps/research priority statements in an anonymous electronic survey. Four anaphylaxis themed writing groups were formed to refine statements: 1) Population Science, 2) Basic & Translational Sciences, 3) Emergency Department Care/Acute Management, and 4) Long-Term Management Strategies & Prevention. Revised statements were incorporated into an anonymous electronic survey and panelists were asked to rate the impact and feasibility of addressing statements on a continuous 0-100 scale. RESULTS: The panel generated 98 statements across the four anaphylaxis themes: Population Science (29), Basic & Translational Sciences (27), Emergency Department Care/Acute Management (24), and Long-Term Management Strategies & Prevention (18). Median scores for impact and feasibility ranged from 50.0-95.0 and from 40.0-90.0. Key statements based on median rating for impact/feasibility included the need to refine anaphylaxis diagnostic criteria, identify reliable diagnostic, predictive, and prognostic anaphylaxis bioassays, develop clinical prediction models to standardize post-anaphylaxis observation periods and hospitalization criteria, and determine immunotherapy best practices. CONCLUSIONS: We identified and systematically appraised anaphylaxis knowledge gaps and future research priorities. This study reinforces the need to harmonize scientific pursuits to optimize the outcomes of patients with and at risk of anaphylaxis.
Turner P, Custovic A, 2022, Life-threatening anaphylaxis to peanut – impossible to predict?, Journal of Allergy and Clinical Immunology, Vol: 149, Pages: 1128-1129, ISSN: 0091-6749
Panwar K, Godi A, Cocuzza CE, et al., 2022, Binding antibody levels to vaccine (HPV6/11/16/18) and non-vaccine (HPV31/33/45/52/58) HPV antigens up to 7 years following immunization with either Cervarix® or Gardasil® vaccine, Vaccine, Vol: 40, Pages: 1198-1202, ISSN: 0264-410X
Human Papillomavirus (HPV) bivalent (Cervarix®) and quadrivalent (Gardasil®) vaccines demonstrate robust efficacy against vaccine types and cross-protection against related non-vaccine types. Here we evaluate the breadth, magnitude and durability of the vaccine-induced antibody response against vaccine (HPV6/11/16/18) and non-vaccine (HPV31/33/45/52/58) type antigens up to 7 years following vaccination of 12-15 year old girls in a three dose schedule and contrast these data with the levels of antibody typically seen in natural infection. Vaccine-type antibody levels waned over the 7-year follow up period but remained at least an order of magnitude above the typical antibody levels elicited by natural infection. Seropositivity to non-vaccine types remained high 7 years after initial vaccination, but antibody levels approached those typically generated following natural infection. Empirical data on the breadth, magnitude, specificity and durability of the immune response elicited by the HPV vaccines contribute to improving the evidence base supporting this important public health intervention.
Kotsapas C, Nicolaou N, Haider S, et al., 2022, Early-life predictors and risk factors of peanut allergy, and its association with asthma in later-life: Population-based birth cohort study, CLINICAL AND EXPERIMENTAL ALLERGY, ISSN: 0954-7894
Shamji M, Layhadi J, Turner P, et al., 2022, Virus Like Particle (VLP) Based Peanut Allergen Immunotherapy Candidate Display A Decreased Activation And Histamine Release From CRTH2+Basophils: A Proof of Concept Study, Publisher: MOSBY-ELSEVIER, Pages: AB37-AB37, ISSN: 0091-6749
Turner P, Darbar R, Shamji M, et al., 2022, Longer Duration Of Peanut Oral Immunotherapy At A Reduced Dosing Frequency Increases The Rate Of Sustained Unresponsiveness Without Reducing Clinical Efficacy, Publisher: MOSBY-ELSEVIER, Pages: AB139-AB139, ISSN: 0091-6749
Layhadi J, Palmer E, Drazdauskaite G, et al., 2022, Modulation of T and B cell Responses by Virus-like particle (VLP) Expressing Peanut Allergen Ara h 2: A Novel Vaccine Candidate for Peanut Allergy, Publisher: MOSBY-ELSEVIER, Pages: AB320-AB320, ISSN: 0091-6749
Turner P, Durham S, Skypala I, et al., 2022, No apparent impact of incremental dosing on eliciting dose at double-blind, placebo-controlled peanut challenge, Allergy, Vol: 77, Pages: 667-670, ISSN: 0105-4538
Turner PJ, Patel N, Ballmer-Weber BK, et al., 2022, Peanut can be used as a reference allergen for hazard characterization in food allergen risk management: A rapid evidence assessment and meta-analysis, Journal of Allergy and Clinical Immunology: In Practice, Vol: 10, Pages: 59-70, ISSN: 2213-2198
Regional and national legislation mandates the disclosure of “priority” allergens when present as an ingredient in foods, but this does not extend to the unintended presence of allergens due to shared production facilities. This has resulted in a proliferation of precautionary allergen (“may contain”) labels (PAL) which are frequently ignored by food allergic consumers. Attempts have been made to improve allergen risk management to better inform the use of PAL, but a lack of consensus has led to variety of regulatory approaches and non-uniformity in the use of PAL by food businesses. One potential solution would be to establish internationally-agreed “reference doses”, below which no PAL would be needed. However, if reference doses are to be used to inform the need for PAL, then it is essential to characterize the hazard associated with these low-level exposures. For peanut, there are now published data relating to over 3000 double-blind, placebo-controlled challenges in allergic individuals, but a similar level of evidence is lacking for other priority allergens. We present the results of a rapid evidence assessment and meta-analysis for the risk of anaphylaxis to low-level allergen exposure for priority allergens. On the basis of this analysis, we propose that peanut can and should be considered an exemplar allergen for the hazard characterization at low-level allergen exposure.
Anagnostou A, Sharma V, Herbert L, et al., 2022, Fatal food anaphylaxis: distinguishing fact from fiction., Journal of Allergy and Clinical Immunology: In Practice, Vol: 10, Pages: 11-17, ISSN: 2213-2198
Although there is a general perception that the prevalence of food allergy is increasing, data supporting this are limited. Food is the least common cause of fatal anaphylaxis, and fortunately, it is a very rare event; however, it is also unpredictable. There is widespread consensus that severe reactions cannot be predicted in a clinically meaningful way. Certain food triggers are more frequently associated with fatal anaphylaxis than others. In observational studies, peanut and tree nuts account for at least 30% to 50% of fatalities, with seafood and cow's milk also associated with fatal reactions. Fatal food-induced anaphylaxis is most likely to occur during adolescence and young adulthood, although the reasons for this are unclear. International guidelines agree that intramuscular (IM) epinephrine is the treatment of choice for managing food-triggered anaphylaxis and has a good safety profile when given by the IM route. However, fatalities still occur despite the timely administration of epinephrine. Food-allergic individuals must navigate a world that requires daily vigilance for allergens and preparedness for allergic reactions. Although the actual risk of fatal reactions is minimal, it is not zero, and severe reactions are unpredictable. Clinicians need to help patients better understand the very low but real risk of fatal reaction and enable them to lead as normal a life as possible through appropriate education, safety netting, and risk reduction.
Turner PJ, Baumert JL, Beyer K, et al., 2021, “Too high, too low”: the complexities of using thresholds in isolation to inform precautionary allergen (“may contain”) labels, Allergy, ISSN: 0105-4538
Stuart ASV, Shaw RH, Liu X, et al., 2021, Immunogenicity, safety, and reactogenicity of heterologous COVID-19 primary vaccination incorporating mRNA, viral-vector, and protein-adjuvant vaccines in the UK (Com-COV2): a single-blind, randomised, phase 2, non-inferiority trial, The Lancet, Vol: 399, Pages: 36-49, ISSN: 0140-6736
BACKGROUND: Given the importance of flexible use of different COVID-19 vaccines within the same schedule to facilitate rapid deployment, we studied mixed priming schedules incorporating an adenoviral-vectored vaccine (ChAdOx1 nCoV-19 [ChAd], AstraZeneca), two mRNA vaccines (BNT162b2 [BNT], Pfizer-BioNTech, and mRNA-1273 [m1273], Moderna) and a nanoparticle vaccine containing SARS-CoV-2 spike glycoprotein and Matrix-M adjuvant (NVX-CoV2373 [NVX], Novavax). METHODS: Com-COV2 is a single-blind, randomised, non-inferiority trial in which adults aged 50 years and older, previously immunised with a single dose of ChAd or BNT in the community, were randomly assigned (in random blocks of three and six) within these cohorts in a 1:1:1 ratio to receive a second dose intramuscularly (8-12 weeks after the first dose) with the homologous vaccine, m1273, or NVX. The primary endpoint was the geometric mean ratio (GMR) of serum SARS-CoV-2 anti-spike IgG concentrations measured by ELISA in heterologous versus homologous schedules at 28 days after the second dose, with a non-inferiority criterion of the GMR above 0·63 for the one-sided 98·75% CI. The primary analysis was on the per-protocol population, who were seronegative at baseline. Safety analyses were done for all participants who received a dose of study vaccine. The trial is registered with ISRCTN, number 27841311. FINDINGS: Between April 19 and May 14, 2021, 1072 participants were enrolled at a median of 9·4 weeks after receipt of a single dose of ChAd (n=540, 47% female) or BNT (n=532, 40% female). In ChAd-primed participants, geometric mean concentration (GMC) 28 days after a boost of SARS-CoV-2 anti-spike IgG in recipients of ChAd/m1273 (20 114 ELISA laboratory units [ELU]/mL [95% CI 18 160 to 22 279]) and ChAd/NVX (5597 ELU/mL [4756 to 6586]) was non-inferior to that of ChAd/ChAd recipients (1971 ELU/mL [1718 to 2262]) with a GMR of 10·2 (one-sided 98·75% CI 8&middo
Turner P, Patel N, Baseggio Conrado A, 2021, Global patterns in anaphylaxis due to specific foods: a systematic review, Journal of Allergy and Clinical Immunology, Vol: 148, Pages: 1515-1525.e3, ISSN: 0091-6749
BackgroundThere are increasing global data relating to prevalence of food allergy and food-induced anaphylaxis, however this is often based on surrogate measures of sensitization rather than objective symptoms at food challenge. In terms of protecting food-allergic consumers from reactions, there has been no global survey assessing geographical differences in the proportion of anaphylaxis triggered by specific foods.ObjectiveTo identify common triggers for food-induced anaphylaxis, and how these vary from country to country.MethodsSystematic review of relevant reports published between January 2010 and November 2020. Results were reported following PRISMA guidelines. Publications were screened and data extracted by two independent reviewers, and risk of bias assessed.ResultsSixty-five studies (encompassing 41 countries and all 6 regions as defined by the Food & Agriculture Organization of the United Nations) were included. Significant regional variations in the most common triggers of food-anaphylaxis were seen, however, in general there was good agreement between local legislative requirements for allergen disclosure and the commonest allergens for each region/nation.ConclusionsLocal legislation for allergen disclosure generally reflect those allergens commonly responsible for food-anaphylaxis. Cow’s milk and crustacea appear to be cause a higher proportion of anaphylaxis compared to peanut in some regions.
Turner PJ, d'Art YM, Duca B, 2021, Single-Dose Oral Challenges to Validate Eliciting Doses in Children With Cow's Milk Allergy, Publisher: AMER ACAD PEDIATRICS, Pages: S28-S29, ISSN: 0031-4005
Campbell DE, Turner PJ, Turner P, 2021, Food protein enterocolitis syndrome: underdiagnosed, not treated optimally, ARCHIVES OF DISEASE IN CHILDHOOD, ISSN: 0003-9888
Turner PJ, Muraro A, Roberts G, 2021, Pharmacokinetics of adrenaline autoinjectors., Clinical and Experimental Allergy, Vol: 52, Pages: 18-28, ISSN: 0954-7894
Anaphylaxis is a medical emergency with adrenaline acknowledged as the first line therapy. It is therefore important that patients have access to self-injectable adrenaline in the community. Manufacturers have been requested by European Medicine Regulators to generate pharmacokinetic data for these autoinjector devices. For the first time, these data provide an insight into how individual devices work in different populations, and how they compare. We undertook a thorough literature search and also accessed grey literature, using searches of medicine regulators' websites and freedom of information requests. The data demonstrate that it takes at least 5-10 minutes to achieve early peak plasma concentration for most devices. The specific autoinjector device seems to be the most important determinant of pharmacokinetics, with different devices giving rise to different plasma adrenaline profiles. Needle length does not seem to be the most important factor; rather, the force and speed of injection (which varies from one device to another) is likely to be of greater importance. In general, peak plasma adrenaline concentration is lower and time-to-peak concentration longer with increased skin-to-muscle depth. However, it is difficult to draw conclusions with the current available data, due to a lack of head-to-head comparisons, small numbers of study participants, and the failure to acknowledge the biphasic nature of intramuscular adrenaline absorption for analysis purposes.
Patel N, Chong KW, Yip AYG, et al., 2021, Use of multiple epinephrine doses in anaphylaxis: A systematic review and meta-analysis, Journal of Allergy and Clinical Immunology, Vol: 148, Pages: 1307-1315, ISSN: 0091-6749
Background:Regulatory bodies recommend that all patients at risk of anaphylaxis be prescribed 2 epinephrine autoinjectors, which they should carry at all times. This is in contrast to some guidelines. The proportion of anaphylaxis reactions that are treated with multiple doses of epinephrine has not been systematically evaluated.Objective:Our aim was to undertake a systematic review and meta-analysis of published studies reporting epinephrine treatment for anaphylaxis in which data relating to the number of doses administered were available.Methods:We searched the Medline, Embase, and Cochrane databases for relevant studies reporting at least 10 anaphylaxis events (due to food or venom) from 1946 until January 2020. Data were extracted in duplicate for the meta-analysis, and the risk of bias was assessed. The study was registered under the PROSPERO identifier CRD42017069109.Results:A total of 86 studies (36,557 anaphylaxis events) met the inclusion criteria (20 of the studies [23%] were prospective studies; 64 [74%] reported reactions in the community, and 22 [26%] included food challenge data). Risk of bias was assessed as low in 50 studies. Overall, 7.7% of anaphylaxis events from any cause (95% CI = 6.4-9.1) were treated with multiple doses of epinephrine. When only epinephrine-treated reactions for which subsequent doses were administered by a health care professional were considered, 11.1% of food-induced reactions (95% CI = 9.4-13.2) and 17.1% of venom-induced reactions (95% CI = 11.3-25.0) were treated with at least 1 epinephrine dose. Heterogeneity was moderate to high in the meta-analyses, but at sensitivity analysis it was not affected by study design or anaphylaxis definition.Conclusion:Around 1 in 10 anaphylaxis reactions are treated with at least 1 dose of epinephrine.
Turner P, 2021, Development and validation of the food allergy severity score, Allergy, ISSN: 0105-4538
BackgroundThe heterogeneity and lack of validation of existing severity scores for food allergic reactions limit standardization of case management and research advances. We aimed to develop and validate a severity score for food allergic reactions.MethodsFollowing a multidisciplinary experts consensus, it was decided to develop a food allergy severity score (FASS) with ordinal (oFASS) and numerical (nFASS) formats. oFASS with 3 and 5 grades were generated through expert consensus, and nFASS by mathematical modeling. Evaluation was performed in the EuroPrevall outpatient clinic cohort (8232 food reactions) by logistic regression with request of emergency care and medications used as outcomes. Discrimination, classification, and calibration were calculated. Bootstrapping internal validation was followed by external validation (logistic regression) in 5 cohorts (3622 food reactions). Correlation of nFASS with the severity classification done by expert allergy clinicians by Best-Worst Scaling of 32 food reactions was calculated.ResultsoFASS and nFASS map consistently, with nFASS having greater granularity. With the outcomes emergency care, adrenaline and critical medical treatment, oFASS and nFASS had a good discrimination (receiver operating characteristic area under the curve [ROC-AUC]>0.80), classification (sensitivity 0.87–0.92, specificity 0.73–0.78), and calibration. Bootstrapping over ROC-AUC showed negligible biases (1.0 × 10−6–1.23 × 10−3). In external validation, nFASS performed best with higher ROC-AUC. nFASS was strongly correlated (R 0.89) to best-worst scoring of 334 expert clinicians.ConclusionFASS is a validated and reliable method to measure severity of food allergic reactions. The ordinal and numerical versions that map onto each other are suitable for use by different stakeholders in different settings.
Turner P, Larson H, Dube E, et al., 2021, Vaccine hesitancy: drivers and how the allergy community can help, Journal of Allergy and Clinical Immunology: In Practice, Vol: 9, Pages: 3568-3574, ISSN: 2213-2198
Vaccine hesitancy—defined by the World Health Organization (WHO) as a “delay in acceptance or refusal of vaccines despite availability of vaccination services”—is not a recent phenomenon. Historical records indicate that vaccine hesitancy existed by the 18th century in Europe and even resulted in violent riots. The drivers of vaccine hesitancy have evolved over the last 200 years but not, perhaps, as much as one might expect. More problematic are the means by which concerns over vaccine hesitancy are communicated by a new landscape of digital communication, generating what has been described as an “infodemic” in which an overabundance of information—both factual and misinformation—contributes to hesitancy. In this review, we discuss the background and current drivers of vaccine hesitancy and the evidence base for strategies to combat this. We highlight the important role the allergy/immunology community could have in working to mitigate vaccine hesitancy, particularly with respect to the current coronavirus disease 2019 (COVID-19) pandemic.
Turner P, 2021, Identifying key priorities for research to protect the consumer with food hypersensitivity: a UK Food Standards Agency Priority Setting Exercise, Clinical and Experimental Allergy, Vol: 51, Pages: 1322-1330, ISSN: 0954-7894
IntroductionFood hypersensitivity (FHS), including food allergy, coeliac disease and food intolerance, is a major public health issue. The Food Standards Agency (FSA), an independent UK Government department working to protect public health and consumers’ wider interests in food, sought to identify research priorities in the area of FHS.MethodsA priority setting exercise was undertaken, using a methodology adapted from the James Lind Alliance—the first such exercise with respect to food hypersensitivity. A UK-wide public consultation was held to identify unanswered research questions. After excluding diagnostics, desensitization treatment and other questions which were out of scope for FSA or where FSA was already commissioning research, 15 indicative questions were identified and prioritized by a range of stakeholders, representing food businesses, patient groups, health care and academia, local authorities and the FSA.Results295 responses were received during the public consultation, which were categorized into 70 sub-questions and used to define 15 key evidence uncertainties (‘indicative questions’) for prioritization. Using the JLA prioritization framework, this resulted in 10 priority uncertainties in evidence, from which 16 research questions were developed. These could be summarized under the following 5 themes: communication of allergens both within the food supply chain and then to the end consumer (ensuring trust in allergen communication); the impact of socio-economic factors on consumers with FHS; drivers of severe reactions; mechanism(s) underlying loss of tolerance in FHS; and the risks posed by novel allergens/processing.DiscussionIn this first research prioritization exercise for food allergy and FHS, key priorities identified to protect the food-allergic public were strategies to help allergic consumers to make confident food choices, prevention of FHS and increasing understanding of socio-economic impacts. Diagnosis and trea
Greenhawt M, Abrams EM, Shaker M, et al., 2021, The risk of allergic reaction to SARS-CoV-2 vaccines and recommended evaluation and management: a systematic review, meta-analysis, GRADE assessment, and international consensus approach, Journal of Allergy and Clinical Immunology: In Practice, Vol: 9, Pages: 3546-3567, ISSN: 2213-2198
Concerns for anaphylaxis may hamper SARS-CoV-2 immunization efforts. We convened a multi-disciplinary group of international experts in anaphylaxis comprised of allergy, infectious disease, emergency medicine, and front-line clinicians to systematically develop recommendations regarding SARS-CoV-2 vaccine immediate allergic reactions. Medline, EMBASE, Web of Science, the WHO global coronavirus database, and the grey literature (inception-March 19, 2021) were systematically searched. Paired reviewers independently selected studies addressing anaphylaxis after SARS-CoV-2 vaccination, polyethylene glycol (PEG) and polysorbate allergy, and accuracy of allergy testing for SARS-CoV-2 vaccine allergy. Random effects models synthesized the data to inform recommendations based on the GRADE approach, agreed upon using a modified Delphi panel. The incidence of SARS-CoV-2 vaccine anaphylaxis is 7.91 cases/million (n=41,000,000 vaccinations, 95%CI 4.02-15.59; 26 studies, moderate certainty), the prevalence of PEG allergy is 103 cases/million (95%CI 88-120; 2 studies, very low certainty), and the sensitivity for PEG skin testing is poor though specificity is high (15 studies, very low certainty). We recommend vaccination over either no vaccination or performing SARS-CoV-2 vaccine/excipient screening allergy testing for individuals without history of a severe allergic reaction to the SARS-CoV-2 vaccine/excipient, and a shared decision-making paradigm in consultation with an allergy specialist for individuals with a history of a severe allergic reaction to the SARS-CoV-2 vaccine/excipient. We recommend further research to clarify SARS-CoV-2 vaccine/vaccine excipient testing utility in individuals potentially allergic to SARS-CoV2 vaccines or their excipients.
Liu X, Shaw RH, Stuart ASV, et al., 2021, Safety and immunogenicity of heterologous versus homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine (Com-COV): a single-blind, randomised, non-inferiority trial., The Lancet, Vol: 398, Pages: 856-869, ISSN: 0140-6736
BACKGROUND: Use of heterologous prime-boost COVID-19 vaccine schedules could facilitate mass COVID-19 immunisation. However, we have previously reported that heterologous schedules incorporating an adenoviral vectored vaccine (ChAdOx1 nCoV-19, AstraZeneca; hereafter referred to as ChAd) and an mRNA vaccine (BNT162b2, Pfizer-BioNTech; hereafter referred to as BNT) at a 4-week interval are more reactogenic than homologous schedules. Here, we report the safety and immunogenicity of heterologous schedules with the ChAd and BNT vaccines. METHODS: Com-COV is a participant-blinded, randomised, non-inferiority trial evaluating vaccine safety, reactogenicity, and immunogenicity. Adults aged 50 years and older with no or well controlled comorbidities and no previous SARS-CoV-2 infection by laboratory confirmation were eligible and were recruited at eight sites across the UK. The majority of eligible participants were enrolled into the general cohort (28-day or 84-day prime-boost intervals), who were randomly assigned (1:1:1:1:1:1:1:1) to receive ChAd/ChAd, ChAd/BNT, BNT/BNT, or BNT/ChAd, administered at either 28-day or 84-day prime-boost intervals. A small subset of eligible participants (n=100) were enrolled into an immunology cohort, who had additional blood tests to evaluate immune responses; these participants were randomly assigned (1:1:1:1) to the four schedules (28-day interval only). Participants were masked to the vaccine received but not to the prime-boost interval. The primary endpoint was the geometric mean ratio (GMR) of serum SARS-CoV-2 anti-spike IgG concentration (measured by ELISA) at 28 days after boost, when comparing ChAd/BNT with ChAd/ChAd, and BNT/ChAd with BNT/BNT. The heterologous schedules were considered non-inferior to the approved homologous schedules if the lower limit of the one-sided 97·5% CI of the GMR of these comparisons was greater than 0·63. The primary analysis was done in the per-protocol population, who were seronegative a
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