Objectives:
Although clinical data have shown that the BNT162b2 vaccine, which is widely used in many countries, is safe and effective as a protection against the SARS-CoV-2 infection, extant research in adverse reactions using real-world data of various sociodemographic characteristics is scant.

Methods:
We conducted a prospective cohort study to compare age differences in self-reported reactogenicity of BNT162b2 in Hong Kong. A total of 1,516 participants were intensively followed up for two weeks following both doses of BNT162b2 vaccination, during which their basic demographic, health conditions, and medication information were collected.

Results:
Results from the generalized mixed model showed that compared with adults aged 18 to 59 years, older adults aged 60 years or above had a lower risk of adverse reactions and adolescents aged 12 to 17 years had a moderately higher risk.

Conclusions:
Results of this study should be informative to parents considering BNT162b2 vaccination for their children in that moderately increased reactogenicity compared with adults is anticipated.published_or_final_versio

Chan, EWW

Chan, EWY

Chui, CSL

Ip, P

Lai, FTT

Lau, LKW

Leung, J

Leung, MTY

Li, X

Lum, D

Wan, EYF

Wong, CKH

Wong, ICK

Wong, RSM

International Journal of Infectious Diseases

English

HKU Scholars Hub

International Journal of Infectious Diseases 116 (2022) 47–50 Contents lists available at ScienceDirect International Journal of Infectious Diseases journal homepage: www.elsevier.com/locate/ijid Comparing self-reported reactogenicity between adolescents and adults following the use of BNT162b2 (Pfizer-BioNTech) messenger RNA COVID-19 vaccine: a prospective cohort study Edward Wai Wa Chan 1 , 2 , Miriam Tim Yin Leung 1 , Lauren Ka Wun Lau 1 , Janice Leung 2 , Dawn Lum 1 , Rosa Sze-Man Wong 1 , Xue Li 1 , 2 , 3 , Celine Sze Ling Chui 2 , 4 , 5 , Eric Yuk Fai Wan 1 , 2 , 6 , Carlos King Ho Wong 1 , 2 , Esther Wai Yin Chan 1 , 2 , Patrick Ip 7 , Ian Chi Kei Wong 1 , 2 , 8 , Francisco Tsz Tsun Lai 1 , 2 , ∗1 Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong, China 2 Laboratory of Data Discovery for Health (D ²4H), Hong Kong Science and Technology Park, Hong Kong, China 3 Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong, China 4 School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong, China 5 School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong, China 6 Department of Family Medicine and Primary Care, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong, China 7 Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong, China 8 Research Department of Practice and Policy, School of Pharmacy, University College London, London, United Kingdom a r t i c l e i n f o Article history: Received 1 December 2021 Revised 21 December 2021 Accepted 21 December 2021 Keywords: COVID-19 vaccine safety pharmacovigilance epidemiology pediatrics a b s t r a c t Objectives: Although clinical data have shown that the BNT162b2 vaccine, which is widely used in many countries, is safe and effective as a protection against the SARS-CoV-2 infection, extant research in ad- verse reactions using real-world data of various sociodemographic characteristics is scant. Methods: We conducted a prospective cohort study to compare age differences in self-reported reacto- genicity of BNT162b2 in Hong Kong. A total of 1,516 participants were intensively followed up for two weeks following both doses of BNT162b2 vaccination, during which their basic demographic, health con- ditions, and medication information were collected. Results: Results from the generalized mixed model showed that compared with adults aged 18 to 59 years, older adults aged 60 years or above had a lower risk of adverse reactions and adolescents aged 12 to 17 years had a moderately higher risk. Conclusions: Results of this study should be informative to parents considering BNT162b2 vaccination for their children in that moderately increased reactogenicity compared with adults is anticipated. © 2021 The Author(s). Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY license ( http://creativecommons.org/licenses/by/4.0/ ) iaC  AcaSHarpyrih1(The BNT162b2 messenger RNA COVID-19 vaccine, widely used n more than 100 countries worldwide, has been shown to be safe nd effective in protecting populations from the infection of SARS- oV-2 ( Polack et al., 2020 ; Thomas et al., 2021 ; Walsh et al., 2020 ).ccording to clinical trial data, more than 80% of BNT162b2 re- ipients reported post-vaccination adverse reactions such as pain nd tiredness, although an extremely small proportion of these re- ∗ Corresponding author at: Units 1201-1206, 1223 & 1225, 12/F, Building 19W, 19 cience Park West Avenue, Hong Kong Science Park, Pak Shek Kok, New Territories, ong Kong, China E-mail address: fttlai@hku.hk (F.T.T. Lai). ep(dattps://doi.org/10.1016/j.ijid.2021.12.354 201-9712/© 2021 The Author(s). Published by Elsevier Ltd on behalf of International Soc http://creativecommons.org/licenses/by/4.0/ ) ctions required medical interventions ( Polack et al., 2020 ). Cur- ent research seldom examined such adverse reactions in sub- opulations of various sociodemographic characteristics, however. Since the emergency use of BNT162b2 in adolescents aged 12 ears or above has been approved in an increasing number of ju- isdictions worldwide with few substitutes ( Frenck et al., 2021 ), ts self-reported reactogenicity as compared with adult recipi- nts in real-world settings should be examined to better inform arents’ decision to permit their children to receive the vaccine  Musa et al., 2021 ). This study aimed to assess the potential risk ifferences in the self-reported reactogenicity of BNT162b2 among dolescents, middle-aged adults, and older adults. iety for Infectious Diseases. This is an open access article under the CC BY license E.W.W. Chan, M.T.Y. Leung, L.K.W. Lau et al. International Journal of Infectious Diseases 116 (2022) 47–50 Table 1 Cohort characteristics. 12 to 17 years 18 to 59 years 60 + years P-value n 1,016 759 756 Gender = Male (%) 547 (53.8) 383 (50.9) 397 (52.5) 0.464 Educational attainment (%) < 0.001 Primary and below 28 (2.8) 4 (0.5) 157 (20.8) Secondary 985 (96.9) 139 (18.3) 327 (43.3) Post-secondary 1 (0.1) 88 (11.6) 84 (11.1) University or above 2 (0.2) 527 (69.5) 188 (24.9) Number of chronic medications (%) < 0.001 None 991 (97.5) 653 (87.0) 297 (39.3) 1-2 23 (2.3) 79 (10.5) 294 (38.9) 3-4 1 (0.1) 15 (2.0) 117 (15.5) 5-9 0 (0.0) 4 (0.5) 45 (6.0) 10 or more 1 (0.1) 0 (0.0) 3 (0.4) Chronic conditions (%) Asthma 19 (1.9) 16 (2.1) 10 (1.3) 0.492 Inflammatory bowel disease 0 (0.0) 0 (0.0) 1 (0.1) 0.309 Psoriasis 0 (0.0) 1 (0.1) 3 (0.4) 0.112 Rheumatoid arthritis 1 (0.1) 0 (0.0) 10 (1.3) < 0.001 Cancer under treatment 1 (0.1) 4 (0.5) 5 (0.7) 0.137 Cancer remission 0 (0.0) 3 (0.4) 15 (2.0) < 0.001 Hypertension 0 (0.0) 36 (4.7) 294 (38.9) < 0.001 Hypercholesterolemia 0 (0.0) 19 (2.5) 239 (31.6) < 0.001 Heart disease 2 (0.2) 5 (0.7) 48 (6.3) < 0.001 Diabetes 1 (0.1) 15 (2.0) 91 (12.0) < 0.001 Stroke 0 (0.0) 1 (0.1) 6 (0.8) 0.005 Neurologic disorder 0 (0.0) 3 (0.4) 2 (0.3) 0.158 Mental health disorder 5 (0.5) 7 (0.9) 19 (2.5) < 0.001 Liver problems 0 (0.0) 4 (0.5) 24 (3.2) < 0.001 Kidney problems 0 (0.0) 3 (0.4) 19 (2.5) < 0.001 Other chronic conditions 9 (0.9) 31 (4.1) 125 (16.5) < 0.001 MactdmssivctitanRaaoacopv48aotavfcictt9smlsDiila(rsctoeSmgsETHODS A prospective cohort design with self-reported data was dopted for this study. Data were collected on the first-dose vac- ination day as baseline. Participants were then followed up on he first, second, third, seventh, and fourteenth day following both oses of vaccination. Basic demographic, health conditions, and edication information were collected during baseline, and any elf-reported adverse reactions were collected throughout the ob- ervation period ∗. A generalized linear mixed model was performed to exam- ne the association between age group and self-reported ad- erse reactions † , adjusting for person-level and measurement-level ovariates ‡ . Listwise deletion was applied for missing data due o its relatively negligible proportion. Odds ratios and confidence ntervals were obtained for comparisons of risks between the richotomized age groups (adolescents, 12-17 years; middle-aged dults, 18-59 years; and older adults, 60 years or above) at .05 sig- ificant level by R Software (version 4.1.1). ESULTS As of August 12, 2021, we recruited 2,531 participants (1,016 ged 12-17 years, 759 aged 18-59 years, and 756 aged 60 years or bove) who had received BNT162b2. The follow-up success rates of ur study were 90.6%, 96.7%, and 72.0% for the adolescent, middle- ged adult, and older adult groups, respectively. Details of cohort haracteristics are shown in Table 1 . Among all participants, 1,516 (59.90%) reported the experience f adverse reactions after the first dose, and 1,278 (50.49%) re- orted adverse reactions following the second. The rates of ad- erse reactions on the seventh follow-up day of the first dose were .94%, 5.86%, and 5.71% (the same day after the second dose: 7.12%, .29%, and 7.72%) for adolescents, middle-aged adults, and older dults, respectively. For all examined age groups, the proportion f participants reporting any type of adverse reactions peaked on 48 he first follow-up day (first dose: 63.44%, second dose: 62.22%) fter both doses of vaccination and gradually declined, with only ery few reports of adverse reactions toward the fourteenth day of ollow-up (first dose: 4.44%, second dose: 4.12%). Results from generalized linear mixed model indicated that ompared with middle-aged adults, older adults had reduced odds n any (adjusted odds ratio [aOR] = 0.557, 95% CI 0.440-0.706), lo- al (aOR = 0.469, 95% CI 0.362-0.608), and systemic adverse reac- ions (aOR = 0.472, 95% CI 0.365-0.611). For the adolescent group, he results showed there were increased risks in any (aOR = 1.411, 5% CI 1.096-1.816), local (aOR = 1.343, 95% CI 1.020-1.770), and ystemic (aOR = 1.427, 95% CI 1.088-1.874) adverse reactions. Esti- ates for severe adverse reactions were imprecise due to relatively ow incidence for both adolescents and older adults. The model re- ults are summarized in Figure 1 . ISCUSSIONS Although previous clinical trials have reported the reactogenic- ty of BNT162b2 ( Frenck et al., 2021 ), there has been little ex- sting research reporting the reactogenicity of BNT162b2 in ado- escents in the literature. A plausible explanation of the observed ge differences is that, consistent with previous research evidence  Woudenberg et al., 2021 ), the immune response triggered by a vi- al infection or vaccines in individuals of a younger age is typically tronger than in those of an older age. Study limitations that need to be taken into consideration in- lude the design of a serial self-reported online survey, which en- ails a risk of omitting the follow-up survey of who had more seri- us adverse reactions and required medical interventions or were ven hospitalized, as evidenced by the imperfect response rates. elf-reported bias may also exist in the reactogenicity data, which ight partially be induced by the educational gap across the age roups. The results of this study should be informative to parents con- idering BNT162b2 vaccination for their children in that moder- E.W.W. Chan, M.T.Y. Leung, L.K.W. Lau et al. International Journal of Infectious Diseases 116 (2022) 47–50 Figure 1. Self-reported adverse reactions over 14-day post-vaccination of both doses for adolescents and older adults compared with middle-aged adults among BNT162b2 recipients. aaovbrpBtFr2gwvvwpticannpprronctc(ohdAfitdFHCCurmJKtBCIotSssBaiRtely increased reactogenicity compared with adults is anticipated nd that severe adverse reactions are rare. Considering the entirety f the existing body of knowledge about the reactogenicity and ad- erse events following the use of BNT162b2, we believe that the enefits of receiving the vaccine still far outweigh the associated isks. The findings should inform the choice of vaccine uptake for arents of eligible adolescents. Footnote: ∗Participants aged 18 or above receiving the first dose of NT162b2 at government-operated community vaccination cen- ers were recruited since vaccine distribution was commenced on ebruary 23, 2021. For adolescent participants aged 12 to 17 years, ecruitment commenced upon vaccine distribution on June 24, 021. The data collection period for all age groups ended on Au- ust 22, 2021. We supplemented the active in-person recruitment ith flyers including a quick-response (QR) link to the online sur- ey distributed at health care facilities. The link to follow-up sur- eys was sent to participants via instant text messages and surveys ere conducted online using Qualtrics, an online data collection latform. Only those participants who were scheduled to complete he fourteenth-day follow-up survey for the second dose accord- ng to the recommended interval between the two doses were in- luded in the analysis. Participants could withdraw from the study nytime. † Self-reported adverse reactions include local (numbness, sore- ess, pain, swelling, redness, and itch), systemic (sore throat, tired- ess, fever, chills, sweating, cough, headache, muscle pain, joint ain, pain in limbs, abdominal pain, diarrhea, nausea, vomiting, oor appetite, insomnia, feeling unwell, enlarged lymph nodes, ash, and temporary one-sided facial drooping), and severe allergic eactions (hypotension, dizziness, itchy skin rash, swelling of face r tongue, and wheezing/shortness of breath). ‡ Person-level covariates include gender, educational attainment, umber of chronic medications, and a range of specified chronic onditions, namely autoimmune diseases (ankylosing spondyli- is, psoriasis, rheumatoid arthritis, systemic lupus erythematosus), ancer (both remission and under treatment), respiratory diseases J49 asthma, chronic obstructive pulmonary disease, and others), and ther common chronic illnesses, including hypertension, hyperc- olesterolemia, heart disease, diabetes, stroke, neurologic disor- ers, mental health disorders, liver problems, and kidney problems. t the measurement level, specific follow-up days (vaccination day, rst-, second-, third-, seventh-, and fourteenth-day after vaccina- ion) of both doses were also adjusted for the given anticipated ay-dependent reactogenicity. UNDING This work was supported by the Food and Health Bureau of the ong Kong Special Administration Region Government, Hong Kong, hina [Ref: COVID19F01]. OMPETING INTERESTS F.T.T.L. has been supported by the RGC Postdoctoral Fellowship nder the Hong Kong Research Grants Council. X.L. has received esearch grants from the Food and Health Bureau of the Govern- ent of the Hong Kong SAR, research and educational grants from anssen and Pfizer; internal funding from the University of Hong ong, and consultancy fee from Merck Sharp & Dohme, unrelated o this work. C.S.L.C. has received grants from the Food and Health ureau of the Hong Kong Government, Hong Kong Research Grant ouncil, Hong Kong Innovation and Technology Commission, Pfizer, QVIA, and Amgen; personal fee from Primevigilance Ltd., outside f the submitted work. E.Y.F.W. has received research grants from he Food and Health Bureau of the Government of the Hong Kong AR and the Hong Kong Research Grants Council, outside of the ubmitted work. I.C.K.W. reports research funding outside of the ubmitted work from Amgen, Bristol-Myers Squibb, Pfizer, Janssen, ayer, GSK, Novartis, the Hong Kong RGC, the Hong Kong Health nd Medical Research Fund, National Institute for Health Research n England, European Commission, National Health and Medical esearch Council in Australia and also received speaker fees from anssen and Medice in the previous 3 years. E.W.Y.C. reports hono- E.W.W. Chan, M.T.Y. Leung, L.K.W. Lau et al. International Journal of Infectious Diseases 116 (2022) 47–50 rcaWgHEtCmRF  MPTW  W  arium from Hospital Authority, grants from Research Grants Coun- il (RGC, Hong Kong), the Research Fund Secretariat of the Food nd Health Bureau, the National Natural Science Fund of China, the ellcome Trust, Bayer, Bristol-Myers Squibb, Pfizer, Janssen, Am- en, Takeda, and the Narcotics Division of the Security Bureau of KSAR, outside of the submitted work. THICS APPROVAL AND CONSENT TO PARTICIPATE Our study was approved by the Institutional Review Board of he University of Hong Kong/Hospital Authority Hong Kong West luster (UW-21-090) and the Department of Health Ethics Com- ittee (LM 21/2021). EFERENCES renck Jr RW, Klein NP, Kitchin N, Gurtman A, Absalon J, Lockhart S, Gruber WC.Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Ado- lescents. N Engl J Med 2021;385(3):239–50. doi: 10.1056/NEJMoa2107456 . 50 usa S, Dergaa I, Abdulmalik MA, Ammar A, Chamari K, Saad HB. BNT162b2 COVID- 19 Vaccine Hesitancy among Parents of 4023 Young Adolescents (12–15 Years) in Qatar. Vaccines 2021;9(9). doi: 10.3390/vaccines9090981 . olack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Gruber WC. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. New England Journal of Medicine 2020;383(27):2603–15. doi: 10.1056/NEJMoa2034577 . homas SJ, Moreira ED, Kitchin N, Absalon J, Gurtman A, Lockhart S, Jansen KU. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. New England Journal of Medicine 2021;385(19):1761–73. doi: 10.1056/NEJMoa2110345 . alsh EE, Frenck RW, Falsey AR, Kitchin N, Absalon J, Gurtman A, Gruber WC. Safetyand Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates. New Eng- land Journal of Medicine 2020;383(25):2439–50. doi: 10.1056/NEJMoa2027906 . oudenberg T, Pelleau S, Anna F, Attia M, Donnadieu F, Gravet A, White M. 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Comparing self-reported reactogenicity between adolescents and adults following the use of BNT162b2 (Pfizer-BioNTech) messenger RNA Covid-19 vaccine: a prospective cohort study

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Comparing self-reported reactogenicity between adolescents and adults following the use of BNT162b2 (Pfizer-BioNTech) messenger RNA Covid-19 vaccine: a prospective cohort study

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