key: cord-0719685-36v9euj3 authors: Butsch, W. Scott; Hajduk, Alexandra; Cardel, Michelle I.; Donahoo, William T.; Kyle, Theodore K.; Stanford, Fatima Cody; Zeltser, Lori M.; Kotz, Catherine M.; Jastreboff, Ania M. title: COVID‐19 vaccines are effective in people with obesity: A position statement from The Obesity Society date: 2021-09-13 journal: Obesity (Silver Spring) DOI: 10.1002/oby.23251 sha: 6106a4d9098f503d09a85cbd597d2e3b1389fca0 doc_id: 719685 cord_uid: 36v9euj3 The position statement is issued by The Obesity Society in response to published literature, as well as inquiries made to the Society by patients, providers, Society members, policy makers, and others regarding the efficacy of vaccines in persons with obesity against SARS‐CoV‐2, the virus that causes COVID‐19. The Obesity Society has critically evaluated data from published peer‐reviewed literature and briefing documents from Emergency Use Authorization applications submitted by Pfizer‐BioNTech, Moderna, and Johnson & Johnson. We conclude that these vaccines are highly efficacious, and their efficacy is not significantly different in people with and without obesity, based on scientific evidence available at the time of publication. The Obesity Society believes there is no definitive way to determine which of these three COVID‐19 vaccines is “best” for any weight subpopulation (because of differences in the trial design and outcome measures in the phase 3 trials, elapsed time between doses, and regional differences in the presence of SARS‐CoV‐2 variants [e.g., South Africa B.1.351 in Johnson & Johnson trial]). All three trials have demonstrated high efficacy against COVID‐19–associated hospitalization and death. Therefore, The Obesity Society encourages adults with obesity ≥18 years (≥16 years for Pfizer‐BioNTech) to undergo vaccination with any one of the currently available vaccines authorized for emergency use by the US Food and Drug Administration as soon as they are able. The disease of obesity is a recognized risk factor for increased morbidity (1, 2) and mortality (3, 4) in persons with COVID-19 subsequent to infection with SARS-CoV-2. In addition, obesity is associated with conditions that are independent risk factors and predictors of mortality from COVID-19, including diabetes and other cardiovascular, cerebrovascular, and pulmonary diseases (5) . Because of the increased likelihood of severe disease, hospitalization, and death, the Centers for Disease Control and Prevention (CDC) identified obesity (BMI ≥30 kg/m 2 ) as a high-risk medical condition in the COVID-19 pandemic (5) . On December 20, 2020, the CDC's Advisory Committee on Immunization Practices recommended that persons aged 16 to 64 years with obesity should be prioritized for vaccination in phase 1c of the phased allocation to provide guidance for federal, state, and local jurisdictions where vaccine supply was limited (6) . Past studies (7) (8) (9) (10) (11) (12) that demonstrated associations between obesity and an impaired immune response to vaccines have provoked concerns that SARS-CoV-2 vaccines might not be as effective in people with obesity. However, these assertions have not been substantiated to date (13) . Immunological memory, which is the basis for durable protection after vaccination, is complex (14) and not easily assessed by any one type of measure, i.e., antibodies (15) . Our understanding of humoral response and protective immunity against COVID-19 and after vaccination is evolving but has not yet been fully elucidated for all individuals, with or without obesity. The multinational double-blinded clinical trial using a modified mRNA vaccine (BNT162b2), which encodes the full-length SARS-CoV-2 spike(S) protein and instructs immune cells to make several copies of S protein (24) , included more than 43,000 adult participants (≥16 years old), who were randomized to receive two doses, Overall, there were no clinically significant differences in efficacy of the Pfizer-BioNTech vaccine among participants age ≥16 with obesity compared with those without obesity. The randomized, double-blinded, placebo-controlled clinical trial evaluating the efficacy of the mRNA-1273 vaccine, which contains information for the synthesis of the stabilized prefusion form of the SARS-CoV-2 S protein (24) , was conducted in multiple US sites and Overall, the vaccine showed similar protection for participants with obesity compared with individuals without obesity. The randomized, double-blinded, placebo-controlled clinical trials using AZD-1222 (ChAdOx1, AstraZeneca), an adenovirusvectored vaccine that codes for the S-glycoprotein of SARS-CoV-2, were conducted in adults (≥18 years old) in the United Kingdom This primary safety and efficacy analysis did not provide vaccine efficacy data in persons with obesity (26). The current vaccine efficacy outcomes in persons with obesity for the three available FDA-approved SARS-CoV-2 vaccines are shown in Table 1 . The authors would like to thank Kevin Hall, PhD, for discussions that contributed to this publication. Individuals with obesity and COVID-19: a global perspective on the epidemiology and biological relationships Body mass index and risk for COVID-19-related hospitalization, intensive care unit admission, invasive mechanical ventilation, and death -United States Obesity and mortality among patients diagnosed with COVID-19: results from an integrated health care organization CORONADO investigators. Relationship between obesity and severe COVID-19 outcomes in patients with type 2 diabetes: results from the CORONADO study Risk factors for coronavirus disease 2019 (COVID-19)-associated hospitalization: COVID-19-Associated Hospitalization Surveillance Network and Behavioral Risk Factor Surveillance System The Advisory Committee on Immunization Practices' Updated Interim Recommendation for Allocation of COVID-19 Vaccine -United States Obesity decreases B cell responses in young and elderly individuals Obesity as a predictor of poor antibody response to hepatitis B plasma vaccine Impaired immunogenicity of hepatitis B vaccine in obese persons Obesity is associated with impaired immune response to influenza vaccination in humans Incidence and variables associated with inadequate antibody titers after pre-exposure rabies vaccination among veterinary medical students Obesity impairs the adaptive immune response to influenza virus Initial observations on age, gender, BMI and hypertension in antibody responses to SARS-CoV-2 BNT162b2 vaccine Correlates of protection induced by vaccination Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection C4591001 Clinical Trial Group. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine COVE Study Group. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine Pfizer-ZER-BioNTech COVID-19 Vaccine. Vaccines and Related Biological Products Advisory Committee Meeting Moderna COVID-19 Vaccine. Vaccines and Related Biological Products Advisory Committee Meeting COV2.S Vaccine for the Prevention of COVID-19. Vaccines and Related Biological Products Advisory Committee Meeting Vaxzevria (previously COVID-19 Vaccine AstraZeneca, suspension for injection) COVID-19 Vaccine (ChAdOx1-S [recombinant Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK SARS-CoV-2 vaccine strategies: a comprehensive review of phase 3 candidates Pfizer-BioNTech COVID-19 Vaccine EUA Letter of Authorization reissued 05/10/2021 AZD1222 US Phase III primary analysis confirms safety and efficacy