Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination

被引:41
作者
Goddard, Kristin [1 ]
Lewis, Ned [1 ]
Fireman, Bruce [1 ]
Weintraub, Eric [3 ]
Shimabukuro, Tom [3 ]
Zerbo, Ousseny [1 ]
Boyce, Thomas G. [2 ]
Oster, Matthew E. [3 ,4 ]
Hanson, Kayla E. [2 ]
Donahue, James G. [2 ]
Ross, Pat [1 ]
Naleway, Allison [5 ]
Nelson, Jennifer C. [6 ]
Lewin, Bruno [7 ]
Glanz, Jason M. [8 ]
Williams, Joshua T. B. [9 ]
Kharbanda, Elyse O. [10 ]
Yih, W. Katherine [11 ]
Klein, Nicola P. [1 ,12 ]
机构
[1] Kaiser Permanente Northern Calif, Kaiser Permanente Vaccine Study Ctr, Oakland, CA USA
[2] Marshfield Clin Res Inst, Marshfield, WI USA
[3] CDCP, Immunizat Safety Off, Atlanta, GA USA
[4] Emory Univ Sch Med, Childrens Healthcare Atlanta, Atlanta, GA USA
[5] Kaiser Permanente Northwest, Ctr Hlth Res, Portland, OR USA
[6] Kaiser Permanente Washington Hlth Res Inst, Seattle, WA USA
[7] Kaiser Permanente Southern Calif, Res & Evaluat, Pasadena, CA USA
[8] Kaiser Permanente Colorado, Inst Hlth Res, Denver, CO USA
[9] Denver Hlth & Hosp Author, Ambulatory Care Serv, Denver, CO USA
[10] HealthPartners Inst, Minneapolis, MN USA
[11] Harvard Pilgrim Hlth Care Inst, Boston, MA USA
[12] Kaiser Permanente Vaccine Study Ctr, 1 Kaiser Plaza 16th Floor, Oakland, CA 94612 USA
关键词
Myocarditis; Pericarditis; COVID-19; SARS-CoV2; Vaccine safety; Relative vaccine safety; Vaccine Safety Datalink; Rapid cycle analysis; Messenger ribonucleic acid (mRNA); vaccines; PRACTICES INTERIM RECOMMENDATION; UNITED-STATES; ADVISORY-COMMITTEE;
D O I
10.1016/j.vaccine.2022.07.007
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Background: Evidence indicates that mRNA COVID-19 vaccination is associated with risk of myocarditis and possibly pericarditis, especially in young males. It is not clear if risk differs between mRNA-1273 ver-sus BNT162b2. We assessed if risk differs using comprehensive health records on a diverse population.Methods: Members 18-39 years of age at eight integrated healthcare-delivery systems were monitored using data updated weekly and supplemented with medical record review of myocarditis and pericarditis cases. Incidence of myocarditis and pericarditis events that occurred among vaccine recipients 0 to 7 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated con-current comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by conditional Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. Head-to-head comparison directly assessed risk following mRNA-1273 versus BNT162b2 during 0-7 days post-vaccination.Results: From December 14, 2020 - January 15, 2022 there were 41 cases after 2,891,498 doses of BNT162b2 and 38 cases after 1,803,267 doses of mRNA-1273. Cases had similar demographic and clinical characteristics. Most were hospitalized for <= 1 day; none required intensive care. During days 0-7 after dose 2 of BNT162b2, the incidence was 14.3 (CI: 6.5-34.9) times higher than the comparison interval, amounting to 22.4 excess cases per million doses; after mRNA-1273 the incidence was 18.8 (CI: 6.7- 64.9) times higher than the comparison interval, amounting to 31.2 excess cases per million doses. In head-to-head comparisons 0-7 days after either dose, risk was moderately higher after mRNA-1273 than after BNT162b2 (RR: 1.61, CI 1.02-2.54).Conclusions: Both vaccines were associated with increased risk of myocarditis and pericarditis in 18-39 -year-olds. Risk estimates were modestly higher after mRNA-1273 than after BNT162b2.(c) 2022 The Authors. Published by Elsevier Ltd.
引用
收藏
页码:5153 / 5159
页数:7
相关论文
共 37 条
[1]  
Abraham N, 2022, VACCINE, DOI [10.1016/j.vaccine.2022.05.04, DOI 10.1016/J.VACCINE.2022.05.04, 10.1016/j.vaccine.2022.05.048, DOI 10.1016/J.VACCINE.2022.05.048]
[2]  
Alkousaa R.., 2021, GERMANY RECOMMENDS O
[3]  
[Anonymous], 2021, COVID 19 VAST WORK G
[4]  
[Anonymous], 2021, SPIKEVAX POSSIBLE LI
[5]  
[Anonymous], 2021, COVID 19 HAS SPECIFI
[6]  
[Anonymous], 2021, COVID 19 SUBC WHO GL
[7]  
[Anonymous], 2021, COVID 19 VACCINATION
[8]  
[Anonymous], 2021, EMA FINDS COMIRNATY
[9]  
[Anonymous], 2021, SUMM HLTH NAT ADV CO
[10]   The Vaccine Safety Datalink: A Model for Monitoring Immunization Safety [J].
Baggs, James ;
Gee, Julianne ;
Lewis, Edwin ;
Fowler, Gabrielle ;
Benson, Patti ;
Lieu, Tracy ;
Naleway, Allison ;
Klein, Nicola P. ;
Baxter, Roger ;
Belongia, Edward ;
Glanz, Jason ;
Hambidge, Simon J. ;
Jacobsen, Steven J. ;
Jackson, Lisa ;
Nordin, Jim ;
Weintraub, Eric .
PEDIATRICS, 2011, 127 :S45-S53