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1.
Hum Vaccin Immunother ; 19(1): 2209919, 2023 12 31.
Article in English | MEDLINE | ID: covidwho-20235641

ABSTRACT

During COVID-19 vaccination campaign, possible ChAdOx1-S-associated risks of thrombosis with thrombocytopenia syndrome led to implement ChAdOx1-S/BNT162b2 heterologous vaccination, despite the limited information on its reactogenicity and safety. We conducted a prospective observational post-marketing surveillance study to assess the safety of this heterologous schedule. A casually selected sample of recipients (n: 85; age: 18-60 years) of ChAdOx1-S/BNT162b2 at the vaccination hub of the Foggia Hospital, Italy, was matched with an equal sample of recipients of homologous BNT162b2. Safety was evaluated 7 days, 1 month and 14 weeks after the primary vaccination series using an adapted version of the "V-safe active surveillance for COVID-19 vaccine safety" CDC standardized questionnaire. After 7 days, local reactions were highly frequent (>80%) in both groups, and systemic reactions were less common (<70%). Moderate or severe pain at the injection site (OR = 3.62; 95%CI, 1.45-9.33), moderate/severe fatigue (OR = 3.40; 95%CI, 1.22-9.49), moderate/severe headache (OR = 4.72; 95%CI, 1.37-16.23), intake of antipyretics (OR = 3.05; 95 CI%, 1.35-6.88), inability to perform daily activities and work (OR = 2.64; 95%CI, 1.24-5.62) were significantly more common with heterologous than homologous vaccination. No significant difference in self-reported health status was recorded 1 month or 14 weeks after the second dose with BNT162b2 or ChAdOx1-S/BNT162b2. Our study confirms the safety of both heterologous and homologous vaccination, with a slight increase in some short-term adverse events for the heterologous regimen. Therefore, administering a second dose of a mRNA vaccine to the recipients of a previous dose of viral vector vaccine may have represented an advantageous strategy to improve flexibility and to accelerate the vaccination campaign.


Subject(s)
BNT162 Vaccine , COVID-19 , Humans , Adolescent , Young Adult , Adult , Middle Aged , COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Vaccination/adverse effects , Italy , Marketing
2.
Nutrients ; 15(10)2023 May 16.
Article in English | MEDLINE | ID: covidwho-20234826

ABSTRACT

Social media is a popular source of nutrition information and can influence food choice. Instagram is widely used in Australia, and nutrition is frequently discussed on Instagram. However, little is known about the content of nutrition information published on Instagram. The aim of this study was to examine the content of nutrition-related posts from popular Australian Instagram accounts. Australian Instagram accounts with ≥100,000 followers, that primarily posted about nutrition, were identified. All posts from included accounts, from September 2020 to September 2021, were extracted and posts about nutrition were included. Post captions were analysed using Leximancer, a content analysis software, to identify concepts and themes. Text from each theme was read to develop a description and select illustrative quotes. The final sample included 10,964 posts from 61 accounts. Five themes were identified: (1) recipes; (2) food and nutrition practices; (3) body goals; (4) food literacy and (5) cooking at home. Recipes and practical information about nutrition and food preparation are popular on Instagram. Content about weight loss and physique-related goals is also popular and nutrition-related Instagram posts frequently include marketing of supplements, food and online programs. The popularity of nutrition-related content indicates that Instagram may be a useful health-promotion setting.


Subject(s)
Marketing , Social Media , Humans , Australia , Health Promotion , Food , Dietary Supplements , Nutritive Value
3.
Int J Environ Res Public Health ; 20(9)2023 05 08.
Article in English | MEDLINE | ID: covidwho-2316612

ABSTRACT

This scoping review presents the extent and nature of the body of literature on illicit online pharmacies (IOPs) and identifies research gaps. Using the five-step framework developed by Arksey and O'Malley, we searched PubMed, Web of Science, EMBASE, CINAHL, Science Direct and PsycInfo to retrieve relevant studies published in English in peer-reviewed journals. The search strategy identified forty-three articles that met the inclusion criteria. Ten themes were identified and categorized into five clusters: patient risk, healthcare providers, marketing and supply chain, public health and society, and policy and regulation. Research into these clusters has evolved over time and has focused increasingly on issues related to specific drugs rather than the overall phenomenon. Data collection has been dominated by convenience sampling, online searches, content analysis and surveys. Data analysis remains primarily descriptive. Gaps within the extant literature suggest an agenda for future research into regulation and enforcement; public health awareness and education; healthcare services; risks to patients and public health; patient-, price- and product-related issues; website design; social media promotion; and supply chains and logistics. We conclude that IOPs are vastly understudied and suggest an urgent need for further empirical and conclusive research.


Subject(s)
Pharmaceutical Services, Online , Humans , Marketing , Public Health , Health Personnel , Health Services , Research Design
4.
Pediatr Obes ; 18(7): e13036, 2023 07.
Article in English | MEDLINE | ID: covidwho-2300938

ABSTRACT

BACKGROUND: Digital food marketing is increasing and has an impact on children's behaviour. Limited research has been performed in Latin America. OBJECTIVES: To determine the extent and nature of Mexican children's and adolescents' exposure to digital food and beverage marketing during recreational internet use. METHODS: A crowdsourcing strategy was used to recruit 347 participants during the COVID-19 lockdown. Participants completed a survey and recorded 45 minutes of their device's screen time using screen-capture software. Food marketing was identified and nutrition information for each marketed product was collected. Healthfulness of products was determined using the Pan-American Health Organization and the Mexican Nutrient Profile Model (NPM). A content analysis was undertaken to assess marketing techniques. RESULTS: Overall, 69.5% of children and adolescents were exposed to digital food marketing. Most frequently marketed foods were ready-made foods. Children and adolescents would typically see a median of 2.7 food marketing exposures per hour, 8 daily exposures during a weekday and 6.7 during a weekend day. We estimated 47.3 food marketing exposures per week (2461 per year). The most used marketing technique was brand characters. Marketing was appealing to children and adolescents yet most of the products were not permitted for marketing to children according to the NPMs (>90%). CONCLUSIONS: Mexican children and adolescents were exposed to unhealthy digital food marketing. The Government should enforce evidence-based mandatory regulations on digital media.


Subject(s)
COVID-19 , Internet , Child , Adolescent , Humans , Mexico/epidemiology , Food Industry , COVID-19/epidemiology , COVID-19/prevention & control , Communicable Disease Control , Beverages , Marketing , Food
5.
J Med Internet Res ; 25: e37237, 2023 04 24.
Article in English | MEDLINE | ID: covidwho-2294509

ABSTRACT

BACKGROUND: Within a few months, the COVID-19 pandemic had spread to many countries and had been a real challenge for health systems all around the world. This unprecedented crisis has led to a surge of online discussions about potential cures for the disease. Among them, vaccines have been at the heart of the debates and have faced lack of confidence before marketing in France. OBJECTIVE: This study aims to identify and investigate the opinions of French Twitter users on the announced vaccines against COVID-19 through sentiment analysis. METHODS: This study was conducted in 2 phases. First, we filtered a collection of tweets related to COVID-19 available on Twitter from February 2020 to August 2020 with a set of keywords associated with vaccine mistrust using word embeddings. Second, we performed sentiment analysis using deep learning to identify the characteristics of vaccine mistrust. The model was trained on a hand-labeled subset of 4548 tweets. RESULTS: A set of 69 relevant keywords were identified as the semantic concept of the word "vaccin" (vaccine in French) and focused mainly on conspiracies, pharmaceutical companies, and alternative treatments. Those keywords enabled us to extract nearly 350,000 tweets in French. The sentiment analysis model achieved 0.75 accuracy. The model then predicted 16% of positive tweets, 41% of negative tweets, and 43% of neutral tweets. This allowed us to explore the semantic concepts of positive and negative tweets and to plot the trends of each sentiment. The main negative rhetoric identified from users' tweets was that vaccines are perceived as having a political purpose and that COVID-19 is a commercial argument for the pharmaceutical companies. CONCLUSIONS: Twitter might be a useful tool to investigate the arguments for vaccine mistrust because it unveils political criticism contrasting with the usual concerns on adverse drug reactions. As the opposition rhetoric is more consistent and more widely spread than the positive rhetoric, we believe that this research provides effective tools to help health authorities better characterize the risk of vaccine mistrust.


Subject(s)
COVID-19 , Social Media , Humans , COVID-19 Vaccines , Pandemics , Marketing , Pharmaceutical Preparations
6.
J Sch Health ; 93(7): 638-643, 2023 07.
Article in English | MEDLINE | ID: covidwho-2286724

ABSTRACT

Digital marketing of unhealthy foods and beverages to children and adolescents is pervasive, highly effective, undermines healthy eating, and contributes to health inequities. Expanded use of electronic devices and remote learning during the COVID-19 pandemic has increased the urgency for policy interventions to limit digital food marketing in schools and on school-issued devices. The US Department of Agriculture provides little guidance to schools for how to address digital food marketing. Federal and state privacy protections for children are inadequate. Considering these policy gaps, state and local education authorities can incorporate strategies to reduce digital food marketing into school policies for: content filtering on school networks and on school-issued devices; digital instructional materials; student-owned device use during lunch; and school use of social media to communicate with parents and students. Model policy language is provided. These policy approaches can leverage existing policy mechanisms to address digital food marketing from a variety of sources.


Subject(s)
COVID-19 , Pandemics , Child , Adolescent , Humans , COVID-19/prevention & control , Beverages , Food , Marketing , Nutrition Policy , Students
7.
Matern Child Nutr ; 19(3): e13491, 2023 07.
Article in English | MEDLINE | ID: covidwho-2262847

ABSTRACT

Baby food marketing poses a substantial barrier to breastfeeding, which adversely affects mothers' and children's health. Over the last decade, the baby food industry has utilised various marketing tactics in Indonesia, including direct marketing to mothers and promoting products in public spaces and within the healthcare system. This study examined the marketing of commercial milk formula (CMF) and other breast-milk substitute products during the COVID-19 pandemic in Indonesia. Using a local, community-based reporting platform, information on publicly reported violations of the International Code of Marketing of Breast-milk Substitutes and subsequent World Health Assembly resolutions (the Code) was collected. It was found that a total of 889 reported cases of unethical marketing of such products were recorded primarily through social media from May 20 through December 31, 2021. Our results suggest that the COVID-19 pandemic has provided more opportunities for the baby food industry in Indonesia to attempt to circumvent the Code aggressively through online marketing strategies. These aggressive marketing activities include online advertisements, maternal child health and nutrition webinars, Instagram sessions with experts, and heavy engagement of health professionals and social media influencers. Moreover, product donations and assistance with COVID-19 vaccination services were commonly used to create a positive image of the baby food industry in violation of the Code. Therefore, there is an urgent need to regulate the online marketing of milk formula and all food and beverage products for children under the age of 3.


Subject(s)
COVID-19 , Milk Substitutes , Animals , Female , Humans , Infant , Breast Feeding , COVID-19/epidemiology , COVID-19 Vaccines , Indonesia/epidemiology , Marketing/methods , Milk , Pandemics , Infant, Newborn , Child, Preschool
9.
NPJ Prim Care Respir Med ; 33(1): 8, 2023 03 02.
Article in English | MEDLINE | ID: covidwho-2254901

ABSTRACT

Heated tobacco products have a rapid uptake, especially among young people, mostly where advertising is unregulated, as is the case in Romania. This qualitative study explores the influence of direct marketing methods of heated tobacco products on young people, their perception and behaviour towards smoking. We have carried out 19 interviews with smokers of heated tobacco products (HTPs) or/and combustible cigarettes (CCs) or non-smokers (NS), aged 18-26. Using the thematic analysis, we have identified three overarching themes: (1) people, places, and subjects of marketing, (2) engagement with risk narratives and (3) social body, family bonds, and autonomous self. Even if most of the participants have been exposed to a mix of marketing methods, they did not acknowledge the influence that marketing has on their decision to experience smoking. Young adults' decision to use heated tobacco products seems to be influenced by a cluster of reasons: overcoming the legislation gap which prohibits indoor use of combustible cigarettes but not heated tobacco products; the attractivity of the product (novelty, inviting appearance, technological appeal and price) and presumed less damaging effects on health.


Subject(s)
Marketing , Tobacco Products , Humans , Young Adult , Adolescent , Romania , Smoking , Tobacco Smoking , Tobacco Products/adverse effects
10.
Pediatr Obes ; 18(5): e13016, 2023 05.
Article in English | MEDLINE | ID: covidwho-2285077

ABSTRACT

Food and beverage marketing appealing to children and adolescents has an impact on their food preferences, purchases requests, consumption patterns, health outcomes, and obesity. The objective of this study was to assess the nature and extent of food and beverage marketing on Facebook, Instagram, and YouTube posts in Mexico. This was a content analysis that followed the World Health Organization CLICK methodology to comprehend the landscape of digital food marketing campaigns of the top-selling food products and brands and the most popular accounts carried out between September and October 2020. A total of 926 posts from 12 food and beverage products and 8 brands were included. Facebook was the social media platform with the most posts and greatest engagement. The most prevalent marketing techniques were brand logo, image of packaging, image of the product itself, hashtags, and engagement to consume. Fifty percent of the posts were assessed as appealing to children, 66% to adolescents, and 80% to either children or adolescents. Ninety-one percent of products (n = 1250) were classified as unhealthy according to the Mexican warning labels nutrient profile; 93% of the food promoted on posts appealing to either children or adolescents were unhealthy. Hashtags commonly referred to the COVID-19 pandemic. Most of the unhealthy food digital marketing features marketing techniques that appeal to children or adolescents; moreover, the use of the pandemic hashtag reflected brands' responsiveness to the environment at the time of the study. The present data contribute to evidence supporting the strengthening of food marketing regulations in Mexico.


Subject(s)
COVID-19 , Social Media , Adolescent , Child , Humans , Mexico , Pandemics , COVID-19/epidemiology , COVID-19/prevention & control , Marketing/methods
11.
PLoS One ; 18(2): e0281948, 2023.
Article in English | MEDLINE | ID: covidwho-2250130

ABSTRACT

Samgyeopsal is a popular Korean grilled dish with increasing recognition in the Philippines as a result of the Hallyu. The aim of this study was to analyze the preferability of Samgyeopsal attributes which includes the main entree, cheese inclusion, cooking style, price, brand, and drinks using Conjoint Analysis and market segmentation using k-means clustering. A total of 1018 responses were collected online through social media platforms by utilizing a convenience sampling approach. The results showed that the main entrée (46.314%) was found to be the most important attribute, followed by cheese (33.087%), price (9.361%), drinks (6.603%), and style (3.349%). In addition, k-means clustering identified 3 different market segments: high-value, core, and low-value consumers. Furthermore, this study formulated a marketing strategy that focused on enhancing the choice of meat, cheese, and price based on these 3 market segments. This study has significant implications for enhancing Samgyeopsal chain businesses and helping entrepreneurs with consumer preference on Samgyeopsal attributes. Finally, conjoint analysis with k-means clustering can be utilized and extended for evaluating food preferences worldwide.


Subject(s)
Consumer Behavior , Taste , Humans , Cluster Analysis , Marketing , Food Preferences , Republic of Korea
12.
Int J Environ Res Public Health ; 20(4)2023 Feb 17.
Article in English | MEDLINE | ID: covidwho-2243196

ABSTRACT

Popular social media platforms have been actively used by ultra-processed food companies to promote their products. Being exposed to this type of advertising increases the consumption of unhealthy foods and the risk of developing obesity and other non-communicable diseases (NCDs). Thus, monitoring commercial content on social media is a core public health practice. We aimed to characterize the methods used for monitoring food advertising on social media and summarize the investigated advertising strategies via a scoping review of observational studies. This study is reported according to the MOOSE Statement, and its protocol was registered with the PROSPERO International Prospective Register of Systematic Reviews (registration nº. CRD42020187740). Out of the 6093 citations retrieved, 26 met our eligibility criteria. The studies were published from 2014 to 2021, mostly after 2018. They focused on Australia, Facebook, strategies aimed at children and adolescents, and advertising practices of ultra-processed food companies. We grouped strategies in eight classes: post features (n = 18); connectivity and engagement (n = 18); economic advantages, gifts, or competitions (n = 14); claims (n = 14); promotional characters (n = 12); brand in evidence (n = 8); corporate social responsibility or philanthropy (n = 7); and COVID-19 (n = 3). We found similarities in the investigation of strategies regardless of the type of social media. Our findings can contribute to the designing of tools for monitoring studies and regulatory mechanisms to restrict the exposure of food advertising.


Subject(s)
COVID-19 , Social Media , Humans , Advertising , Beverages , Food , Food Industry , Marketing/methods , Public Health , Observational Studies as Topic
13.
Int J Environ Res Public Health ; 20(3)2023 01 29.
Article in English | MEDLINE | ID: covidwho-2216036

ABSTRACT

Generational theory assumes that generational cohorts develop similar attitudes and beliefs. The Generation Y/Millennials group is currently one of the most important generations in the market as they have a presence in the labour market with a high income of their own, which creates higher demand for products, especially in the food market which is very sensitive to consumer decisions. The aim of this study was to show the consumer behaviour of Generation Y in the market for innovative food products and to propose marketing models created on the basis of research on a Polish sample of Millennials. The research was conducted in the period before the COVID-19 pandemic on a group of 544 selected respondents. Descriptive statistics of the SPSS program were used to process the results obtained. Among the most important of the results was identifying the decision-makers who are purchasing innovative products and the influence of third parties on their decision. In the first instance, consumers look for innovative food products in large retail chains (hypermarkets and supermarkets), however, they pay attention to both the quality of the products on offer and the price. Values such as freshness and taste also play a role in their purchasing decisions. Sources of information about innovative products in the Polish food market include culinary blogs recommending innovative products, and the opinions of dieticians and nutritionists.


Subject(s)
COVID-19 , Consumer Behavior , Humans , Pandemics , COVID-19/epidemiology , Food , Marketing
14.
JMIR Public Health Surveill ; 7(3): e25202, 2021 03 12.
Article in English | MEDLINE | ID: covidwho-2197886

ABSTRACT

BACKGROUND: Emerging evidence demonstrates that obesity is associated with a higher risk of COVID-19 morbidity and mortality. Excessive alcohol consumption and "comfort eating" as coping mechanisms during times of high stress have been shown to further exacerbate mental and physical ill-health. Global examples suggest that unhealthy food and alcohol brands and companies are using the COVID-19 pandemic to further market their products. However, there has been no systematic, in-depth analysis of how "Big Food" and "Big Alcohol" are capitalizing on the COVID-19 pandemic to market their products and brands. OBJECTIVE: We aimed to quantify the extent and nature of online marketing by alcohol and unhealthy food and beverage companies during the COVID-19 pandemic in Australia. METHODS: We conducted a content analysis of all COVID-19-related social media posts made by leading alcohol and unhealthy food and beverage brands (n=42) and their parent companies (n=12) over a 4-month period (February to May 2020) during the COVID-19 pandemic in Australia. RESULTS: Nearly 80% of included brands and all parent companies posted content related to COVID-19 during the 4-month period. Quick service restaurants (QSRs), food and alcohol delivery companies, alcohol brands, and bottle shops were the most active in posting COVID-19-related content. The most common themes for COVID-19-related marketing were isolation activities and community support. Promotion of hygiene and home delivery was also common, particularly for QSRs and alcohol and food delivery companies. Parent companies were more likely to post about corporate social responsibility (CSR) initiatives, such as donations of money and products, and to offer health advice. CONCLUSIONS: This is the first study to show that Big Food and Big Alcohol are incessantly marketing their products and brands on social media platforms using themes related to COVID-19, such as isolation activities and community support. Parent companies are frequently posting about CSR initiatives, such as donations of money and products, thereby creating a fertile environment to loosen current regulation or resist further industry regulation. "COVID-washing" by large alcohol brands, food and beverage brands, and their parent companies is both common and concerning. The need for comprehensive regulations to restrict unhealthy food and alcohol marketing, as recommended by the World Health Organization, is particularly acute in the COVID-19 context and is urgently required to "build back better" in a post-COVID-19 world.


Subject(s)
COVID-19 , Food Industry , Marketing/methods , Marketing/statistics & numerical data , Social Media/statistics & numerical data , Alcoholic Beverages/statistics & numerical data , Australia/epidemiology , Food/statistics & numerical data , Humans
15.
Health Econ ; 32(4): 822-852, 2023 04.
Article in English | MEDLINE | ID: covidwho-2172917

ABSTRACT

In this paper, we analyze economic costs and consequences of local non-pharmaceutical interventions (NPIs) aimed at containing the Covid-19 pandemic. Using comprehensive data on municipal and regional policies in Norway, we implement a difference-in-differences framework identifying impacts of local NPIs from discontinuous differential shifts in outcomes following the implementation of new policies. In treated municipalities, local NPIs lead to persistent reductions in mobility, persistent increases in unemployment, and transient reductions in consumer spending. Analyses of spatial spillovers show that the implementation of local NPIs increases retail mobility in untreated neighboring municipalities. Overall, our findings suggest that local NPIs have economic consequences for local economies and induce residents to shift their consumption of goods and services to neighboring municipalities.


Subject(s)
COVID-19 , Humans , Pandemics/prevention & control , Consumer Behavior , Marketing , Norway
16.
Int J Environ Res Public Health ; 19(24)2022 12 15.
Article in English | MEDLINE | ID: covidwho-2163392

ABSTRACT

Allowing there to be an undersupply of medical resources and infection amid the social workforce, this paper proposes a theory to show how panic buying is induced and how bad the workforce status could be. By developing a novel general equilibrium model, we find that for any retail price that is higher than the buyer's reserve value, the buying competition will be induced and the medical resources supply will further be tightened. Moreover, if the transmission rate of COVID-19 surpasses the theoretical threshold that is proposed by this paper, the whole workforce in our simulated economy will inevitably be infected.


Subject(s)
COVID-19 , Humans , COVID-19/epidemiology , Panic , Marketing , Consumer Behavior , Workforce
18.
Tob Control ; 31(e2): e96-e98, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-2138121

Subject(s)
Tobacco Use , Tobacco , Humans , Marketing
19.
Vaccine ; 40(52): 7622-7630, 2022 Dec 12.
Article in English | MEDLINE | ID: covidwho-2096120

ABSTRACT

INTRODUCTION: The safety profiles of COVID-19 vaccines are incompletely evaluated in Japan. OBJECTIVES: To examine the risk of serious adverse effects after COVID-19 mRNA vaccination (BNT162b2 and mRNA-1273) in cohort studies and self-controlled case series (SCCS). METHODS: Using an administrative claims database linked with the COVID-19 vaccination registry in a city in Japan between September 2020 and September 2021, we identified health insurance enrolees aged ≥ 18 years. We evaluated the risk of acute myocardial infarction, appendicitis, Bell's palsy, convulsions/seizures, disseminated intravascular coagulation, immune thrombocytopenia, pulmonary embolism, haemorrhagic or ischemic stroke, venous thromboembolism, and all-cause mortality, 21 days following any COVID-19 mRNA vaccination, compared with non-vaccination periods. For the cohort studies, we estimated incidence rate ratios (IRRs) by Poisson regression and rate differences (IRDs) by weighted least-squares regression, adjusting for sex, age, and Charlson comorbidity index. We applied a modified SCCS design to appropriately treat outcome-dependent exposures. For the modified SCCS, we estimated within-subject IRRs by weighted conditional Poisson regression. Subgroup analyses stratified by sex and age were also conducted. RESULTS: We identified 184,491 enrolees [male: 87,218; mean (standard deviation) age: 64.2 (19.5) years] with 136,667 first and 127,322 s dose vaccinations. The risks of any outcomes did not increase in any analyses, except for the fact that the modified SCCS indicated an increased risk of pulmonary embolism after the first dose in women (within-subject IRR [95%CI]: 3.97 [1.18-13.32]). CONCLUSION: The findings suggested that the COVID-19 mRNA vaccine was generally safe, whilst a signal of pulmonary embolism following the first dose of the COVID-19 mRNA vaccine was observed.


Subject(s)
COVID-19 , Pulmonary Embolism , Female , Male , Humans , Middle Aged , COVID-19 Vaccines/adverse effects , BNT162 Vaccine , COVID-19/epidemiology , COVID-19/prevention & control , Japan/epidemiology , Registries , Marketing , RNA, Messenger
20.
Drug Saf ; 45(8): 891-908, 2022 08.
Article in English | MEDLINE | ID: covidwho-2060118

ABSTRACT

INTRODUCTION: As chimeric antigen receptor T-cell therapies are becoming increasingly available in the armamentarium of the hematologist, there is an emerging need to monitor post-marketing safety. OBJECTIVE: We aimed to better characterize their safety profile by focusing on cytokine release syndrome and identifying emerging signals. METHODS: We queried the US Food and Drug Administration Adverse Event Reporting System (October 2017-September 2020) to analyze suspected adverse drug reactions to tisagenlecleucel (tisa-cel) and axicabtagene ciloleucel (axi-cel). Disproportionality analyses (reporting odds ratio) were performed by comparing chimeric antigen receptor T-cell therapies with (a) all other drugs (reference group 1) and (b) other onco-hematological drugs with a similar indication, irrespective of age (reference group 2), or (c) restricted to adults (reference group 3). Notoriety was assessed through package inserts and risk management plans. Adverse drug reaction time to onset and cytokine release syndrome features were investigated. RESULTS: Overall, 3225 reports (1793 axi-cel; 1433 tisa-cel) were identified. The reported toxicities were mainly: cytokine release syndrome (52.2%), febrile disorders (27.7%), and neurotoxicity (27.2%). Cytokine release syndrome and neurotoxicity were often co-reported and 75% of the events occurred in the first 10 days. Disproportionalities confirmed known adverse drug reactions and showed unexpected associations: for example, axi-cel with cardiomyopathies (reporting odds ratio = 2.3; 95% confidence interval 1.2-4.4) and gastrointestinal perforations (2.9; 1.2-7.3), tisa-cel with hepatotoxicity (2.5; 1.1-5.7) and pupil disorders (15.3; 6-39.1). CONCLUSIONS: Our study confirms the well-known adverse drug reactions and detects potentially emerging safety issues specific for each chimeric antigen receptor T-cell therapy, also providing insights into a stronger role for tisa-cel in inducing some immunodeficiency-related events (e.g., hypogammaglobulinemia, infections) and coagulopathies, and for axi-cel in neurotoxicity.


Subject(s)
Adverse Drug Reaction Reporting Systems , Drug-Related Side Effects and Adverse Reactions , Immunotherapy, Adoptive , Receptors, Chimeric Antigen , Adult , Antigens, CD19/adverse effects , Cytokine Release Syndrome , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/etiology , Humans , Immunotherapy, Adoptive/adverse effects , Marketing , Product Surveillance, Postmarketing , Receptors, Chimeric Antigen/therapeutic use , T-Lymphocytes , United States , United States Food and Drug Administration
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