Circulation . Risk of Myocarditis After Sequential Doses of COVID-19 Vaccine and SARS-CoV-2 Infection by Age and Sex

[tetano]

Circulation


. 2022 Aug 22.
doi: 10.1161/CIRCULATIONAHA.122.059970. Online ahead of print.
Risk of Myocarditis After Sequential Doses of COVID-19 Vaccine and SARS-CoV-2 Infection by Age and Sex


Martina Patone[SUP] 1 [/SUP], Xue W Mei[SUP] 1 [/SUP], Lahiru Handunnetthi[SUP] 2 [/SUP], Sharon Dixon[SUP] 1 [/SUP], Francesco Zaccardi[SUP] 3 [/SUP], Manu Shankar-Hari[SUP] 4 [/SUP], Peter Watkinson[SUP] 5 [/SUP], Kamlesh Khunti[SUP] 3 [/SUP], Anthony Harnden[SUP] 6 [/SUP], Carol A C Coupland[SUP] 7 [/SUP], Keith M Channon[SUP] 8 [/SUP], Nicholas L Mills[SUP] 9 [/SUP], Aziz Sheikh[SUP] 10 [/SUP], Julia Hippisley-Cox[SUP] 6 [/SUP]



Affiliations

• PMID: 35993236
• DOI: 10.1161/CIRCULATIONAHA.122.059970

Abstract

Background: Myocarditis is more common after severe acute respiratory syndrome coronavirus 2 infection than after COVID-19 vaccination, but the risks in younger people and after sequential vaccine doses are less certain.
Methods: A self-controlled case series study of people ages 13 years or older vaccinated for COVID-19 in England between December 1, 2020, and December 15, 2021, evaluated the association between vaccination and myocarditis, stratified by age and sex. The incidence rate ratio and excess number of hospital admissions or deaths from myocarditis per million people were estimated for the 1 to 28 days after sequential doses of adenovirus (ChAdOx1) or mRNA-based (BNT162b2, mRNA-1273) vaccines, or after a positive SARS-CoV-2 test.
Results: In 42 842 345 people receiving at least 1 dose of vaccine, 21 242 629 received 3 doses, and 5 934 153 had SARS-CoV-2 infection before or after vaccination. Myocarditis occurred in 2861 (0.007%) people, with 617 events 1 to 28 days after vaccination. Risk of myocarditis was increased in the 1 to 28 days after a first dose of ChAdOx1 (incidence rate ratio, 1.33 [95% CI, 1.09-1.62]) and a first, second, and booster dose of BNT162b2 (1.52 [95% CI, 1.24-1.85]; 1.57 [95% CI, 1.28-1.92], and 1.72 [95% CI, 1.33-2.22], respectively) but was lower than the risks after a positive SARS-CoV-2 test before or after vaccination (11.14 [95% CI, 8.64-14.36] and 5.97 [95% CI, 4.54-7.87], respectively). The risk of myocarditis was higher 1 to 28 days after a second dose of mRNA-1273 (11.76 [95% CI, 7.25-19.08]) and persisted after a booster dose (2.64 [95% CI, 1.25-5.58]). Associations were stronger in men younger than 40 years for all vaccines. In men younger than 40 years old, the number of excess myocarditis events per million people was higher after a second dose of mRNA-1273 than after a positive SARS-CoV-2 test (97 [95% CI, 91-99] versus 16 [95% CI, 12-18]). In women younger than 40 years, the number of excess events per million was similar after a second dose of mRNA-1273 and a positive test (7 [95% CI, 1-9] versus 8 [95% CI, 6-8]).
Conclusions: Overall, the risk of myocarditis is greater after SARS-CoV-2 infection than after COVID-19 vaccination and remains modest after sequential doses including a booster dose of BNT162b2 mRNA vaccine. However, the risk of myocarditis after vaccination is higher in younger men, particularly after a second dose of the mRNA-1273 vaccine.

 

[sharon sanders]

bump this

 

[Emily]

https://arxiv.org/pdf/2210.14955.pdf
Misleading assertions, unjustified assumptions, and additional limitations of
a study by Patone et al., described in the article “Risk of Myocarditis After
Sequential Doses of COVID-19 Vaccine and SARS-CoV-2 Infection by Age
and Sex”
Paul Bourdon1, PhD; Spiro Pantazatos2, PhD

...

Suppose you are a parent of a child, say between 12 and 15, and you read the two sentences from
Patone et al’s “Discussion” section quoted above. Wouldn’t you conclude that your child’s risk of
myocarditis is “substantially higher” after SARS-CoV-2 infection than after vaccination with, e.g.,
Pfizer’s BNT162b2? Data in eTable 7 from a recently published study by Karlstad et al. inJAMA
Cardiologyshows 0 cases of myocarditis following SARS-CoV-2 infection for males and females in
the age range 12–15.6Thus, it’s clear that Patone et al’s assertion that myocarditis risk following
infection is substantially higher than the increased risk after Pfizer vaccination is quite unlikely
to be true for children in the age range 12–15. In a discussion of limitations of their study in the
penultimate paragraph of their article, Patone et al. do state the following:
Third, although we were able to include 2 230 058 children age 13 to 17 years in this analysis,
the number of myocarditis events was small (56 events in all periods and 16 events in the 1
to 28 days after vaccination) in this subpopulation and precluded a separate evaluation of
risk.
However, the authors certainly should have cited other studies suggesting that for those in 13–
15 age range, myocarditis risk following infection is highly likely to be lower than that following
vaccination, perhaps substantially lower.
...

Before concluding, we would like emphasize that comparing the risk of myocarditis following SARS-
CoV-2 infection to the risk following individual doses of vaccines provides an incomplete assessment of
risks. “Vaccination” with an mRNA vaccine necessary includes risks associated with two doses, and likely
booster doses. Thus, myocarditis risk following infection should be compared to the combined risk of at
least doses 1 and 2 of an mRNA vaccine.Of course, there are risks unrelated to myocarditis associated
with both infection and vaccination.Finally, a comparison of a risk associated with infection to the
same risk associated with vaccination should not be restricted to only the 28 days following infection or
vaccination. If vaccination prevented infection and repetition of vaccination weren’t required, then limiting
risk assessment of infection versus vaccination to a short window during which adverse outcomes typically
occur seems reasonable, However, in the long run, COVID vaccination provides little or no protection
from infection.7Thus, an analysis of risks versus benefits of vaccination must assess to what extent will
vaccination reduce the number of infections a vaccinated person will experience and to what extent, if any,
will vaccination reduce the incidence and/or severity of adverse outcomes associated with infections.
6.Conclusion
Patone et al’s definition of SARS-CoV-2 infection is not reasonable in the context of their study, re-
sulting in exaggerated myocarditis incidence rates associated with infection. We have shown that Patone
et al.’s assessment of the risk of myocarditis among the unvaccinated in the general population after a
positive COVID test depends on the unjustified assumption that the probabilitiespAandpBdiscussed in
Section 3 are approximately equal; ifpAis larger thanpB, the result is further exaggeration of myocarditis
incidence rates among the unvaccinated associated with SARS-CoV-2 infection. Because of the unexam-
ined relationship betweenpAandpBas well as the underascertainment of COVID infections occurring in
members of the study population while unvaccinated, Patone and et al. have not established that for those
unvaccinated under 40 the risk of myocarditis is greater after SARS-CoV-2 infection than after COVID-19
vaccination. Moreover, in Section 4, we established that the authors’ decision, apparently made while their
Circulationsubmission was under review for publication, to provide an assessment of myocarditis risk for
the unvaccinated is inconsistent with the structure of their study and resulted in a failure to report or to
categorize properly positive-test associated-myocarditis deaths in their study population. Finally, Patone
et al.’sCirculationarticle should not influence public-health policy for the reasons described in Section 5...