The short term safety of COVID-19 vaccines in Australia: AusVaxSafety active surveillance, February - August 2021.

OBJECTIVE: To assess the short term safety of the COVID-19 vaccines Comirnaty (Pfizer-BioNTech BNT162b2) and Vaxzevria (AstraZeneca ChAdOx1) in Australia. DESIGN: Prospective observational cohort study; online surveys by AusVaxSafety, a national active vaccine safety surveillance system, three and eight days after vaccination. SETTING, PARTICIPANTS: People aged 16 years or more who received COVID-19 vaccines at sentinel vaccination hubs, general practices, or Aboriginal Community Controlled Health Organisation clinics, 22 February - 30 August 2021. MAIN OUTCOME MEASURES: Primary outcome: proportion of respondents who reported any adverse event following immunisation (AEFI) 0-3 days after vaccination. SECONDARY OUTCOMES: proportions of respondents who reported specific adverse events or medical review for AEFI within seven days of vaccination; impact on usual daily activities; recovery. RESULTS: 4 851 480 people received COVID-19 vaccines at participating sentinel sites during the study period (25% of all COVID-19 vaccine doses administered in Australia to 30 August 2021). 3 035 983 people responded to both surveys (response rate, 62.6%); 35.9% of respondents reported one or more AEFI 0-3 days after Comirnaty dose 1, 54.7% after Comirnaty dose 2, 52.8% after Vaxzevria dose 1, and 22.0% after Vaxzevria dose 2. Local pain, fatigue, headache, and myalgia were the most frequently reported symptoms. After adjusting for demographic characteristics, vaccination site type, jurisdiction, and self-reported medical conditions, the odds of reporting any AEFI were higher for women than men (range of adjusted odd ratios [aORs], by vaccine and dose, 1.53-1.84), for people with a history of anaphylaxis (aOR range, 1.28-1.45), and for people reporting certain underlying conditions, including obesity (aOR range, 1.15-1.75), immunodeficiency (aOR range, 1.04-2.24), or chronic inflammatory disease (aOR range, 1.05-1.75). 0.9% of respondents sought medical advice in the three days following vaccination, most frequently after Comirnaty dose 2 (1.4%) and Vaxzevria dose 1 (1.2%). CONCLUSION: AusVaxSafety active surveillance affirms the short term safety profile of Comirnaty and Vaxzevria vaccines in a large population sample during the first six months of the Australian COVID-19 vaccination program.

SmartStartAllergy: a novel tool for monitoring food allergen introduction in infants.

OBJECTIVES: To estimate the proportion of infants introduced to peanut and other common food allergens by 12 months of age; to collect information about parent-reported reactions to food. DESIGN, SETTING: Observational cohort study, applying the SmartStartAllergy SMS protocol and online questionnaire to parents of 12-month-old infants attending 69 Australian general practices between 21 September 2018 and 3 May 2019. PARTICIPANTS: 3374 parents recruited via the 69 participating general practices. MAIN OUTCOME MEASURES: Proportions of infants who had eaten peanut and other common food allergens; proportions with parent-reported reactions to food. RESULTS: 1940 of 3374 invited parents participated in the study (response rate, 57%), of whom 836 (46%) completed the online questionnaire. At 12 months of age, 1673 of 1940 infants had eaten peanut-including foods (86.2%; 95% confidence interval [CI], 84.6-87.7%); 235 of 1831 parents (12.8%; 95% CI, 11.3-14.5%) reported food-related reactions. Questionnaire responses indicated that dairy was the food type most frequently reported to cause a food-related reaction (72 of 835 exposed infants, 8.6%; 95% CI, 6.8-11%); peanut-related reactions were reported for 20 of 764 exposed children (2.6%; 95% CI, 1.6-4.0%). 97 of 250 parent-reported reactions to food (39%) did not include symptoms that suggested an IgE-mediated allergic reaction. CONCLUSION: Infant feeding practices in Australia have changed over the past decade; a large majority of infants are now fed peanut before 12 months of age. The SmartStartAllergy program allows monitoring of infant feeding practices in primary care, as well as of parent-reported reactions to food in infants.

Symptom profile of patients receiving antibiotics for upper respiratory tract infections in general practice: an observational study using smartphone technology.

BACKGROUND: Upper respiratory tract infections (URTIs) are a common presentation in general practice and are linked to high rates of inappropriate antibiotic prescription. There is limited information about the trajectory of patients with this condition who have been prescribed antibiotics. OBJECTIVE: To document the symptom profile of patients receiving antibiotics for URTIs in Australian general practice using smartphone technology and online surveys. METHODS: In total, 8218 patients received antibiotics after attending one of the 32 general practice clinics in Australia from June to October 2017: 4089 were identified as URTI presentations and were the cohort studied. Patients completed the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) 3 and 7 days after visiting their general practitioner (GP). RESULTS: Six hundred fourteen URTI-specific patients responded to at least one symptom survey (RR 15%). The majority of patients reported moderate to mild symptoms at 72 hours [median global symptom severity score 37 (IQR 19, 59)] post-GP visit which reduced to very mild symptoms or not sick by day 7 [11 (IQR 4, 27)]. Patients receiving antibiotics for URTI reported the same level of symptom severity as patients in previous studies receiving no treatment. CONCLUSIONS: The recovery of most patients within days of receiving antibiotics for URTI mimics the trajectory of patients with viral URTIs without treatment. Antibiotics did not appear to hasten recovery. Monitoring of patients in this context using smart phone technology is feasible but limited by modest response rates.

Real-time safety surveillance of seasonal influenza vaccines in children, Australia, 2015.

Increased febrile reactions in Australian children from one influenza vaccine brand in 2010 diminished confidence in influenza immunisation, highlighting the need for improved vaccine safety surveillance. AusVaxSafety, a national vaccine safety surveillance system collected adverse events in young children for 2015 influenza vaccine brands in real time through parent/carer reports via SMS/email. Weekly cumulative data on 3,340 children demonstrated low rates of fever (4.4%) and medical attendance (1.1%). Fever was more frequent with concomitant vaccination.

Using automated text messages to monitor adverse events following immunisation in general practice.

OBJECTIVE: To assess the performance of SmartVax, a prototypic active monitoring system for adverse events following immunisation (AEFI) using short message service (SMS) text messages and clinical data extracted from commercially available medical practice management software. DESIGN, SETTING AND PARTICIPANTS: Between 11 November 2011 and 10 June 2013, adult patients and parents of paediatric patients receiving routine vaccinations in general practice were sent an SMS by SmartVax enquiring if they had experienced any AEFI and requesting a reply by SMS. Attempts were made to telephone patients who did not reply by SMS. MAIN OUTCOME MEASURES: The proportion of patients sent an SMS who replied by SMS, and the proportion of respondents indicating possible AEFI. RESULTS: Of 3281 vaccinated patients, 3226 (98.3%) had a mobile telephone number on record and were sent an SMS. Of 2342 patients (72.6%; 95% CI, 70.0%-75.1%) who responded by SMS, 264 (11.3%; 95 CI, 9.9%-12.7%) reported possible AEFI. The response rate was ≥ 70% for both paediatric and adult patients. Eighty-per cent of SMS replies were received within 2 hours of transmission of the query SMS. There was no significant difference in the proportion reporting possible AEFI between patients who replied by SMS and those who did not respond by SMS but were subsequently contacted by a telephone call (P = 0.99). CONCLUSIONS: More than 70% of patients responded by SMS to an SMS query about whether they had any vaccine reactions, with the data received in near real-time. Active surveillance of AEFI using SMS has the capacity to complement existing passive reporting systems, potentially permitting more rapid identification of emerging safety signals.

Post-marketing surveillance of 10,392 herpes zoster vaccines doses in Australia.

BACKGROUND: Immunisation against herpes zoster is recommended for adults aged ≥ 50 years. Two vaccines, a live attenuated (ZVL, Zostavax®) and an adjuvant recombinant subunit (HZ/su, Shingrix®), are available in Australia. Immunisation guidelines are shifting their recommendations towards HZ/su because of higher efficacy in preventing herpes zoster and associated complications. However, there are limited post-marketing data comparing the safety profiles of these vaccines. METHODS: Data from SmartVax, an active surveillance system for monitoring adverse events following immunisation (AEFIs) utilised by > 450 clinics throughout Australia, were analysed. Data from patients aged ≥ 50 years, who received ZVL or HZ/su, from 1 June 2021 to 31 May 2022, at clinics that utilised SmartVax were included. The proportion of records where patients who reported any, local, and systemic AEFIs after receiving ZVL or HZ/su were compared using multivariable logistic regression models. RESULTS: Data from 10,392 immunisation records (n = 8341 ZVL; n = 2051 HZ/su) were included. The proportion of AEFIs reported was higher with HZ/su (41.9 % [any], 33.8 % [local], 25.2 % [systemic]) than with ZVL (8.7 % [any], 6.2 % [local], 3.5 % [systemic]). After controlling for demographic variables, HZ/su presented a 6-fold increase in the odds (OR 6.44; 95 %CI: 5.57-7.46) of a reported AEFI compared to ZVL. Only 59 (0.6 %) of vaccinations lead to medical attention being sought due to an AEFI. CONCLUSIONS: While rates of AEFIs was higher with HZ/su than ZVL, most AEFIs were mild and did not require medical attention. Our findings support the change in vaccine recommendations and the use of HZ/su in immunisation programs.

The AuTOMATIC trial: a study protocol for a multi-arm Bayesian adaptive randomised controlled trial of text messaging to improve childhood immunisation coverage.

BACKGROUND: While most Australian children are vaccinated, delays in vaccination can put them at risk from preventable infections. Widespread mobile phone ownership in Australia could allow automated short message service (SMS) reminders to be used as a low-cost strategy to effectively 'nudge' parents towards vaccinating their children on time. METHODS: AuTOMATIC is an adaptive randomised trial which aims to both evaluate and optimise the use of SMS reminders for improving the timely vaccination of children at primary care clinics across Australia. The trial will utilise high levels of digital automation to effect, including eligibility assessment, randomisation, delivery of intervention, data extraction and analysis, thereby allowing healthcare-embedded trial delivery. Up to 10,000 parents attending participating primary care clinics will be randomised to one of 12 different active SMS vaccine reminder content and timing arms or usual practice only (no SMS reminder). The primary outcome is vaccine receipt within 28 days of the scheduled date for the index vaccine (the first scheduled vaccine after randomisation). Secondary analyses will assess receipt and timeliness for all vaccine occasions in all children. Regular scheduled analyses will be performed using Bayesian inference and pre-specified trial decision rules, enabling response adaptive randomisation, suspension of any poorly performing arms and early stopping if a single best message is identified. DISCUSSION: This study will aim to optimise SMS reminders for childhood vaccination in primary care clinics, directly comparing alternative message framing and message timing. We anticipate that the trial will be an exemplar in using Bayesian adaptive methodology to assess a readily implementable strategy in a wide population, capable of delivery due to the levels of digital automation. Methods and findings from this study will help to inform strategies for implementing reminders and embedding analytics in primary health care settings. TRIAL REGISTRATION: ANZCTR: ACTRN12618000789268 .

Making a SmartStart for peanut introduction to support food allergy prevention guidelines for infants.

Background: Food allergy affects up to 10% of Australian infants. It was hypothesized that if parents follow the Australasian Society of Clinical Immunology and Allergy guidelines, Australian food allergy rates may stabilize or decline. Objective: This project aimed to determine whether SmartStartAllergy influenced parental introduction of peanut by age 12 months, including in high-risk infants. Methods: SmartStartAllergy integrates with general practice management software to send text messages to parents via participating general practices. The intervention group participants were sent text messages when their child was aged 6, 9, and 12 months; the control group participants were parents of 12-month-old infants. When their child was aged 12 months, all participants completed a questionnaire regarding eczema and family history of atopy. Infants with severe eczema and/or a family history of atopy were considered high-risk. Results: Between 21 September 2018 and 26 April 2022, a total of 29,092 parents were enrolled in SmartStartAllergy as intervention (n = 18,090) and control (n = 11,002) group members The intervention group was more likely to introduce peanut by 12 months (crude odds ratio = 5.18; P < .0001; 95% CI = 4.35-6.16). After adjustment for the infants' level of risk and family history of atopy and food allergy, the intervention group was more likely to introduce peanut by 12 months of age (adjusted odds ratio = 5.34; P < .01; 95% CI = 4.48-6.37). Conclusion: SmartStartAllergy appears to be an effective tool for encouraging parental introduction of peanut. The ability to provide parents with credible allergy prevention information, along with the capacity to collect simple responses via text along with additional information via an online questionnaire, make this a useful public health tool.

Safety profile comparison of chimeric live attenuated and Vero cell-derived inactivated Japanese encephalitis vaccines through an active surveillance system in Australia.

Limited information is available about post-marketing safety of Japanese encephalitis (JE) vaccines. Using data from SmartVax, an active surveillance system for monitoring vaccine safety, adverse events following immunizations (AEFIs) were compared between the two JE vaccines available in Australia (a chimeric live attenuated vaccine [Imojev] and a Vero cell-derived inactivated vaccine [JEspect]). Data from 2756 patients (1855 Imojev and 901 JEspect) were included. Overall (7.0%), systemic (2.8%), and local (1.9%) AEFIs were uncommon. There were no significant differences in the odds of overall (OR = 1.27; 95%CI: 0.91-1.77), systemic (OR = 1.23; 95%CI: 0.74-2.06), or local (OR = 1.20; 95%CI: 0.65-2.22) AEFIs with Imojev compared to JEspect. There was an increase in odds of overall AEFI in patients aged <5 years (OR = 2.39; 95%CI: 1.10-5.19) compared to those aged >50 years. Both JE vaccines available in Australia are safe and well tolerated. Odds of AEFIs were age-dependent, young children should be carefully observed for AEFIs after vaccination.

Adverse events following influenza immunization: understanding the role of age and sex interactions.

BACKGROUND: Reduction of adverse events following immunization (AEFI) could improve vaccine uptake. Evidence suggests sex and age affect AEFI rates but, with limited understanding of their interaction, groups at higher risk for adverse reaction cannot be identified. RESEARCH DESIGN AND METHODS: Using deidentified data (n = 308,481) from Australians receiving influenza vaccinations in the 2020 calendar year, we analyzed the effects of independent predictors (i.e. age and sex), on experiencing an AEFI using logistic regression generalized additive modeling to capture any nonlinear relationships and adjusting for vaccine brand and concomitant vaccination. RESULTS: The overall reaction rate was 5.5%. Modeling revealed significant effects of age (p < 0.001), sex (p < 0.001), and age × sex (p < 0.001). Females were more likely than males to experience AEFIs between 7.5 and 87.5 years of age and exhibited peak odds at about 53 years, while peak odds for males occurred in infancy. CONCLUSION: The results suggest there is a need for targeting AEFI reduction in females, particularly in 30-70-year-olds, to improve the vaccination experience. The results further suggest that reducing concomitant vaccination and choosing less reactogenic vaccine brands could reduce risk of AEFI, however, retaining concomitant vaccination may optimize vaccine uptake.

Safety of Four COVID-19 Vaccines across Primary Doses 1, 2, 3 and Booster: A Prospective Cohort Study of Australian Community Pharmacy Vaccinations.

Four COVID-19 vaccines are approved for use in Australia: Pfizer-BioNTech BNT162b2 (Comirnaty), AstraZeneca ChAdOx1 (Vaxzevria), Moderna mRNA-1273 (Spikevax) and Novavax NVX-CoV2373 (Nuvaxovid). We sought to examine adverse events following immunisation (AEFI) at days 3 and 42 after primary doses 1, 2, 3 and booster. We conducted active vaccine safety surveillance from 130 community pharmacies in Australia integrated with AusVaxSafety, between August 2021-April 2022. Main outcomes: AEFI at 0-3 days post-vaccination; medical review/advice at 3 days and 42 days post-vaccination; SARS-CoV-2 breakthrough infection by day 42. Of 110,024 completed day 3 surveys (43.6% response rate), 50,367 (45.8%) reported any AEFI (highest proportions: Pfizer 42%, primary dose 3; AstraZeneca 58.3%, primary dose 1; Moderna 65.4% and Novavax 58.8%, both primary dose 2). The most common AEFI reported across all doses/vaccines were local reactions, systemic aches and fatigue/tiredness. Overall, 2172/110,024 (2.0%) and 1182/55,329 (2.1%) respondents sought medical review at days 3 and 42, respectively, and 931/42,318 (2.2%) reported breakthrough SARS-CoV-2 infection at day 42. We identified similar AEFI profiles but at lower proportions than previously reported for Pfizer, AstraZeneca, Moderna and Novavax COVID-19 vaccines. Moderna vaccine was the most reactogenic and associated with higher AEFI proportions across primary doses 2, 3, and booster.

Adverse Events Following Immunization With Combined vs Concurrent Monovalent Hepatitis A and Typhoid Vaccines in Children.

Combined hepatitis A and typhoid vaccine is available in Australia, but licensed for use from age 16 years; however it is used "off-label" in children. The combined vaccine is well tolerated in children aged 2-16 years and the risk of adverse events is similar to those receiving concurrent monovalent vaccines.

Active vaccine safety surveillance of seasonal influenza vaccination via a scalable, integrated system in Western Australian pharmacies: a prospective cohort study.

OBJECTIVES: We integrated an established participant-centred active vaccine safety surveillance system with a cloud-based pharmacy immunisation-recording program in order to measure adverse events following immunisation (AEFI) reported via the new surveillance system in pharmacies, compared with AEFI reported via an existing surveillance system in non-pharmacy sites (general practice and other clinics). DESIGN: A prospective cohort study. PARTICIPANTS AND SETTING: Individuals >10 years receiving influenza immunisations from 22 pharmacies and 90 non-pharmacy (general practice and other clinic) sites between March and October 2020 in Western Australia. Active vaccine safety surveillance was conducted using short message service and smartphone technology, via an opt-out system. OUTCOME MEASURES: Multivariable logistic regression was used to assess the primary outcome: differences in proportions of AEFI between participants immunised in pharmacies compared with non-pharmacy sites, adjusting for confounders of age, sex and influenza vaccine brand. A subgroup analysis of participants over 65 years was also performed. RESULTS: Of 101 440 participants (6992 from pharmacies; 94 448 from non-pharmacy sites), 77 498 (76.4%) responded; 96.1% (n=74 448) within 24 hours. Overall, 4.8% (n=247) pharmacy participants reported any AEFI, compared with 6% (n=4356) non-pharmacy participants (adjusted OR: 0.87; 95% CI: 0.76 to 0.99; p=0.039). Similar proportions of AEFIs were reported in pharmacy (5.8%; n=31) and non-pharmacy participants (6; n=1617) aged over 65 years (adjusted OR: 0.94; 95% CI: 0.65 to 1.35; p=0.725). The most common AEFIs in pharmacy were: pain (2%; n=104), tiredness (1.9%; n=95) and headache (1.7%; n=88); and in non-pharmacy sites: pain (2.3%; n=1660), tiredness (1.9%; n=1362) and swelling (1.5%; n=1121). CONCLUSIONS: High and rapid response rates demonstrate good participant engagement with active surveillance in both pharmacy and non-pharmacy participants. Significantly fewer AEFIs reported after pharmacist immunisations compared with non-pharmacy immunisations, with no difference in older adults, may suggest different cohorts attend pharmacy versus non-pharmacy immunisers. The integrated pharmacy system is rapidly scalable across Australia with global potential.

Safety of live attenuated herpes zoster vaccine in Australian adults 70-79 years of age: an observational study using active surveillance.

OBJECTIVES: To assess the safety of live attenuated herpes zoster vaccine live (ZVL) through cumulative analysis of near real-time, participant-based active surveillance from Australia's AusVaxSafety system. DESIGN AND SETTING: ZVL was funded in Australia for adults aged 70 years from November 2016, with a time-limited catch up programme for those up to 79 years. This cohort study monitored safety in the first two programme years through active surveillance at 246 sentinel surveillance immunisation sites. PARTICIPANTS: Adults aged 70-79 years vaccinated with ZVL who responded to an opt-out survey sent via automated short message service (SMS) 3 days following vaccination (n=17 458) or contributed supplementary data through a separate, opt-in online survey at 16 and 24 days following vaccination (n=346). PRIMARY AND SECONDARY OUTCOME MEASURES: Rates of overall and prespecified adverse events following immunisation (AEFI) by sex, concomitant vaccination and underlying medical condition. Signal detection methods (fast initial response cumulative summation and Bayesian updating analyses) were applied to reports of medical attendance. RESULTS: The median age of participants was 72 years; 53% were female. The response rate following automated SMS was high (73% within 7 days of vaccination). Females were more likely than males to report any adverse event within 7 days of vaccination (RR 2.07, 95% CI 1.86 to 2.31); injection site reaction was the most commonly reported (2.3%, n=377). Concomitant vaccination was not associated with higher adverse event rates (RR 1.05, 95% CI 0.93 to 1.18). Rates of medical attendance were low (0.3%) with no safety signals identified. Supplementary opt-in survey data on later onset adverse events did not identify any difference in AEFI rates between those with and without underlying medical conditions. CONCLUSIONS: ZVL has a very good safety profile in the first week after vaccination in older adults. Active, participant-based surveillance in this primary care cohort is an effective method to monitor vaccine safety among older adults and will be used as a key component of COVID-19 vaccine safety surveillance in Australia.

Smartphone-based active vaccine safety surveillance (SmartVax) at a Swiss adult vaccination clinic - a pilot study.

INTRODUCTION: Post-licensure surveillance of adverse events following immunisation (AEFI) is critical for detecting rare but severe AEFI. SmartVax software, using smartphone technology, actively solicits reports of AEFI via automated, opt-out SMS surveys to vaccine recipients in the days following immunisation. We report on a pilot study to test the feasibility and acceptance of SmartVax in Switzerland. METHODS: Between February and September 2020, consecutive subjects immunised at an adult immunisation clinic and the employee health service at the University Hospital of Basel were screened. Participants included three subgroups: healthcare workers (HCW), subjects with immune-mediated inflammatory diseases (IMID) and clients of the regular adult immunisation clinic. Three days after vaccination, participants received an SMS inquiring if they had any AEFI. In the case of an AEFI, subjects received an automated SMS with a link to an online survey assessing the type and temporal evolution of the AEFI. Descriptive statistics of response rate, time-to-response, frequency and type of AEFI by vaccine and clinical subgroup were performed. RESULTS: Of 293 subjects screened, 276 were included (46.6% routine vaccination check-up visits, 33.3% HCW, 20.1% IMID patients) receiving 625 vaccinations during 360 immunisation visits. The SMS response rate was high (90.3%), with a median time-to-respond of 47 minutes (interquartile range11-205). After 29.8% of immunisation visits at least one AEFI was reported. There were no differences in frequency or type of AEFI between the three clinical subgroups. The recombinant, adjuvanted zoster vaccine Shingrix® was associated with the highest rate of local and systemic reactions. CONCLUSION: Monitoring post-licensure vaccine safety using the active SMS-based surveillance system SmartVax is feasible in Switzerland. We observed a high acceptance in the diverse study population, including healthcare workers and IMID patients. High response rates in the elderly and reliable monitoring almost in real-time make SmartVax a promising tool for COVID-19 vaccine safety monitoring.

Immunisation provider experiences with an automated short message service-based active surveillance system for monitoring adverse events following immunisation: A qualitative descriptive study.

OBJECTIVE: Currently, active surveillance systems to monitor adverse events following immunisation are limited to hospitals, and medical and immunisation clinics. Globally, community pharmacies represent a significant destination for immunisation services. However, until recently, pharmacies lacked active surveillance systems. We therefore wished to explore pharmacists' experiences with SmartVax: an active surveillance system that has recently been integrated for use in Australian community pharmacies. Specifically, we wished to explore pharmacists' perceived (1) benefits of using SmartVax, (2) areas for improvement in the system, and (3) issues with future/ongoing access to the system. METHODS: The present study forms the qualitative arm of a convergent mixed-methods pilot study. In the present study, we performed semi-structured interviews with pharmacist immunisers after a 21- to 22-week trial period with SmartVax. Thematic analysis of interview transcripts was performed independently by two researchers in QSR NVivo 12, using the framework method. RESULTS: Fifteen participants completed the semi-structured interviews. A broad range of perceived benefits were cited by participants, including the usability of SmartVax, the ease of patient follow-up facilitated by the system, and enhancement to the patient-pharmacist relationship. Participants voiced a desire for the system to have more granularity and a faster response time in the report generated for pharmacies. When asked about issues with future/ongoing access to SmartVax, cost concerns of the system were the prevailing theme. CONCLUSIONS: The present study suggests that, among pharmacist immuniser end-users of SmartVax, the system is perceived to be easy-to-use, facilitates patient follow-up, and enhances the patient-pharmacist relationship.

Active SMS-based surveillance of adverse events following immunisation with influenza and pertussis-containing vaccines in Australian pregnant women using AusVaxSafety.

BACKGROUND: Maternal immunisation is important to protect both mother and baby, but safety concerns can lead to low uptake. AusVaxSafety participant-based surveillance actively monitors adverse events following immunisation (AEFI) in Australia. We aimed to analyse AEFI in the days following vaccination with seasonal inactivated influenza vaccine (IIV) and/or reduced antigen diphtheria-tetanus-acellular pertussis vaccine (dTpa) in pregnant women in Australia. METHODS: De-identified AEFI reports were solicited from vaccine recipients via automated SMS survey (using SmartVax software) following routine vaccination with IIV and/or dTpa at 219 national sentinel surveillance sites from 2015 to 2018. AEFI rates were compared by vaccine group (IIV alone, dTpa alone, or IIV and dTpa together), vaccine brand, trimester (IIV only) and vaccination period (April to August 2016-2018; IIV only). Women who had two vaccination encounters during surveillance were identified and AEFI rates compared for each dose. RESULTS: Among 13,758 participants, overall AEFI rates were lower following IIV (4.9%) than dTpa (6.4%) or IIV and dTpa given concomitantly (7.4%). The AEFI profile was similar for both vaccines, with injection site reactions, tiredness, and headache most commonly reported. Injection site pain and swelling/redness were significantly more common in women who received dTpa than IIV. Reports of medical attendance following immunisation were similar (0.3%) for each vaccine group. AEFI rates did not differ by IIV brand (FluQuadri®, Fluarix® Tetra), dTpa brand (Boostrix®, Adacel®), or by trimester. Among women with sequential dTpa vaccinations, 6.0% (7/116) had an AEFI following their second dTpa dose. CONCLUSIONS: Self-reported AEFI rates did not differ by trimester (IIV), or by vaccine brand (IIV or dTpa). Concomitant influenza and pertussis vaccination was associated with more frequent, but low rates of minor, expected AEFI. These real world 'citizen science-based' data provide further reassuring evidence of the safety of maternal vaccination.

Vaccination reaction rate is unaltered by ambient temperature on the day.

Minor reactions are often experienced following the human papillomavirus (HPV) vaccination and negative vaccination experiences may discourage individuals from seeking future vaccinations. Ambient temperature is suggested to be linked to reaction rates. Optimising immunisation programs requires understanding associations of temperature and reactions. To investigate a potential association between temperature and reactions, logistic regressions were performed on data obtained for a two-year period from a vaccine safety monitoring system for children (ages 10-15 years) who received the HPV vaccination (n = 20466) and from publicly available meteorological records in Australia. Reaction rate was 8.3% overall and higher with concomitant vaccination versus HPV alone (9.3% vs 7.8%, p=<0.001). Logistic regression found no relationship between reactions and maximal temperature on the day of vaccination (p = 0.581); controlling for concomitant vaccination, age and gender did not alter the temperature-reaction relationship (p = 0.851) but did identify concomitant vaccination as a significant predictor. Our results suggest immunisation programs must weigh the advantages of improved vaccination coverage resulting from concomitant vaccination against an increase in reaction rates and, importantly, can be safely administered across a range of temperatures.

Early impact of the Australian national shingles vaccination program with the herpes zoster live attenuated vaccine.

Herpes zoster (shingles) is a painful condition resulting from reactivation of latent varicella zoster virus (VZV). The Australian National Shingles Vaccination Program (commenced November 2016) provides free herpes zoster vaccination for eligible adults aged 70 years, with a 5-year catch-up program (until October 2021) for adults aged 71-79 years. Patterns and impact of the program were evaluated by analysis of vaccine distribution and delivery data and specific antiviral prescription data from the Pharmaceutical Benefits Scheme. During the first 2 years, uptake of funded live attenuated shingles vaccine ZOSTAVAX® (Zoster Virus Vaccine Live; ZVL) was high across the ongoing and catch-up programs. Before program implementation (2006-2016), herpes zoster coded antiviral prescription rates increased by 2.2% per year (95% CI: 1.5, 2.9) in the 70-79 years age group. In the two years since program launch, herpes zoster antiviral prescription rates declined substantially in this age group, by an average of 13.6% per year (95% CI: 1.5, 24.2). These results indicate that the National Shingles Vaccination Program has been highly successful in vaccinating a considerable proportion of Australian adults aged 70-79 years against herpes zoster and suggest that vaccine uptake was associated with decreased incidence of herpes zoster.

Comparative Postmarket Safety Profile of Adjuvanted and High-Dose Influenza Vaccines in Individuals 65 Years or Older.

Importance: Every year, influenza vaccines are administered to millions of people worldwide to reduce morbidity and mortality from influenza. As new vaccine formulations are increasingly used, monitoring and comparing safety, in addition to vaccine effectiveness, in target populations are essential. Objective: To assess the postmarketing safety profile of 2018 Southern Hemisphere influenza vaccines, particularly 2 new enhanced trivalent inactivated influenza vaccines: an adjuvanted trivalent inactivated influenza vaccine (aIIV3) and high-dose trivalent inactivated influenza vaccine (HD-IIV3), among Australian individuals 65 years or older. Design, Setting, and Participants: This cohort study used solicited short message service-based self-reported survey data on adverse events occurring within 3 to 5 days after receipt of an influenza vaccination. Participants included individuals 65 years or older who received routinely recommended influenza vaccines at 1 of 265 sentinel immunization sites, including primary care, hospital, and community-based clinics, participating in Australia's AusVaxSafety active vaccine safety surveillance system from April 1 to August 31, 2018. Data were analyzed from September 1, 2018, to June 30, 2019. Exposure: Any licensed 2018 influenza vaccine administered in clinical practice. Main Outcomes and Measures: Rates (overall, by brand, and by concomitant vaccine receipt) of adverse events, including medical attendance as a proxy for serious adverse events. Results: Of 72 013 individuals 65 years or older who received an influenza vaccine in 2018, 50 134 individuals (69.6%) responded to the initial survey regarding adverse events experienced after vaccination (median [interquartile range] age, 71 [68-76] years; 27 056 [54.0%] women). Most individuals received an enhanced trivalent inactivated influenza vaccine, including 28 003 individuals (55.9%) who received aIIV3 and 19 306 individuals (38.5%) who received HD-IIV3; 2208 individuals (4.4%) received a quadrivalent inactivated influenza vaccine. Individuals who received HD-IIV3 reported significantly higher rates of any adverse event compared with individuals who received aIIV3 (1716 individuals [8.9%] vs 1796 individuals [6.4%]; P < .001) as well as specific adverse events, including fever (195 individuals [1.1%] vs 164 individuals [0.6%]; P < .001), injection site pain (383 individuals [2.1%] vs 350 individuals [1.3%]; P < .001), and injection site swelling or redness (256 individuals [1.4%] vs 248 individuals [0.9%]; P < .001). Adverse event rates reported by those receiving any quadrivalent inactivated influenza vaccine were similar to rates reported by those receiving aIIV3. Rates of medical care seeking for adverse events associated with aIIV3 and HD-IIV3 were low and comparable (80 individuals [0.3%] vs 56 individuals [0.3%]; P = .91). Conclusions and Relevance: The findings of this large-scale participant-based postmarketing assessment of the safety of 2 new enhanced influenza vaccines used in individuals 65 years or older provide reassuring near-real-time and cumulative data to inform and support confidence in ongoing vaccine use.