Phonna Maghfirah, S. Ked 2106111024: Preseptor: Dr. Dr. Indra Zachreini, Sp. THT-KL (K)

Vaccine side-effects and SARS-CoV-2 infection
after vaccination in users of the COVID

Symptom Study app in the UK: a prospective
observational study
Phonna Maghfirah, S. Ked

2106111024
Preseptor:
Dr. dr. Indra Zachreini, Sp. THT-KL (K)
Abstrak
Background The Pfizer-BioNTech (BNT162b2) and the
Oxford-AstraZeneca (ChAdOx1 nCoV-19) COVID-19
vaccines have shown excellent safety and efficacy in
phase 3 trials. We aimed to investigate the safety and
effectiveness of these vaccines in a UK community
setting.
Abstrak
 Methods In this prospective observational study, we examined the
proportion and probability of self-reported systemic and local side-
effects within 8 days of vaccination in individuals using the COVID
Symptom Study app who received one or two doses of the
BNT162b2 vaccine or one dose of the ChAdOx1 nCoV-19 vaccine.
We also compared infection rates in a subset of vaccinated
individuals subsequently tested for SARS-CoV-2 with PCR or lateral
flow tests with infection rates in unvaccinated controls. All analyses
were adjusted by age (≤55 years vs >55 years), sex, health-care
worker status (binary variable), obesity (BMI <30 vs >30kg/m2),
and comorbidities (binary variable, with or without comorbidities).
<
Findings
Between Dec 8, and March 10, 2021, Systemic side-
effects were reported by 13·5% (38155 of 282103) of
individuals after the first dose of BNT162b2, by 22·0% ,
after the second dose of Frizer, and by 33·7% after the
first dose of asrazeneca. Local side-effects were
reported by 71·9% of individuals after the first dose of
BNT162b2, by 68·5% after the second dose of
BNT162b2, and by 58·7% after the first dose of
ChAdOx1 nCoV-19.
Findings
Significant reductions in infection risk were
seen starting at 12 days after the first dose,
reaching 60% (95% CI 49–68) for
asrazeneca and 69% (66–72) for frizer at 21–
44 days and 72% (63–79) for frizer after 45–
59 days
Interpretation
Systemic and local side-effects after
BNT162b2 and ChAdOx1 nCoV-19
vaccination occur at frequencies lower
than reported in phase 3 trials. Both
vaccines decrease the risk of SARS-
CoV-2 infection after 12 days
Introduction
The UK’s Medicines and Healthcare products Regulatory
Agency has given emergency use authorisation to three
COVID-19 vaccines: the Pfizer-BioNTech mRNA vaccine
(BNT162b2), the Oxford-AstraZeneca adenovirusvectored
vaccine (ChAdOx1 nCoV-19), and the Moderna mRNA
vaccine (mRNA-1273). The first two vaccines have been
rolled out across the UK since Dec 8, 2020, and Jan 4,
2021, respectively. In late December, 2020, based on
advice from the Joint Committee on Vaccination and
Immunisation, the UK Government decided to delay the
administration of second doses.
Introduction
The aim of this study was to investigate the
adverse effects and infection rate of vaccinated
people in a community (general population app
users) scenario. We used data from 627383
individuals who received the BNT162b2 or
ChAdOx1 nCoV-19 vaccines between December,
2020, and March, 2021, and reported symptoms
in real-time via the COVID Symptom Study app.14
A subset of individuals also reported receiving a
PCR or lateral flow test.
Methods Study design and participants
The COVID Symptom Study app14 was
developed by health data company ZOE Global,
with input from King’s College London (London,
UK), the Massachusetts General Hospital
(Boston, MA, USA), Lund University (Lund,
Sweden), and Uppsala University (Uppsala,
Sweden). In the UK, it was launched in English on
March 24, 2020. The app enables self-reported
information related to SARS-CoV-2 infection to be
captured.
Outcomes
Our primary outcome was the proportion of app users
reporting adverse effects within 8 days after vaccination
and the probability of having an adverse event. Our
secondary outcome was infection rates in individuals after
receiving a first dose of either the BNT162b2 or ChAdOx1
nCoV-19 vaccines. We did not collect information on why
individuals were tested, so not all tested individuals were
necessarily experiencing COVID-19-associated symptoms
at testing, and some individuals might have been routinely
tested while being asymptomatic
Statistical analysis
Reseacher used χ² and Student’s t tests to compare the
demographic characteristics of individuals who received fizer
versus those who received asrazeneca. We investigated the
evolution of systemic and local adverse effects within 8 days
from the vaccination date, computing the percentage of users
experiencing side-effects after having received the vaccine.
Vaccinated individuals who logged their systemic or local
effects (or the absence of them) at least once within 8 days
from the vaccination date were included in the adverse
effects analysis (appendix p 2). We estimated the ratio of the
daily number of users reporting at least one adverse effect
(systemic or local) after vaccination to the total number of
vaccinated users logging into the app that day
Statistical analysis
Reseacher used χ² and Student’s t tests to compare the
demographic characteristics of individuals who received fizer
versus those who received asrazeneca. We investigated the
evolution of systemic and local adverse effects within 8 days
from the vaccination date, computing the percentage of users
experiencing side-effects after having received the vaccine.
Vaccinated individuals who logged their systemic or local
effects (or the absence of them) at least once within 8 days
from the vaccination date were included in the adverse
effects analysis (appendix p 2). We estimated the ratio of the
daily number of users reporting at least one adverse effect
(systemic or local) after vaccination to the total number of
vaccinated users logging into the app that day
Logistic regressions were used for each of
the specified strata to investigate whether
adverse effects varied across different
participant groups, and in individuals who
had previously reported a positive test for
COVID-19 (PCR or lateral flow positive at
least 6 months before vaccination, PCR or
lateral flow positive within the 6 months
before vaccination, and no previously
detected infection).
Result
Among vaccinated app users, (25·4%) and (66·2%) of
reported one or more local adverse effect (table). The
most commonly reported systemic side-effects were
fatigue and headache overall (table) and by strata.
These were most frequently reported within the first 24
h after vaccination and lasted a mean of 1·01 days
Tenderness and local pain around the injection site
were the most frequently reported local effects (table),
occurring most often on the day after injection and
lasting a mean of 1·02 days. Other side-effects,
including allergic skin reactions such as skin burning,
rashes, and red welts on the lips and face, were reported
by (1·7%) users across both types of vaccine
Thankyou..

Phonna Maghfirah, S. Ked 2106111024: Preseptor: Dr. Dr. Indra Zachreini, Sp. THT-KL (K)

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Vaccine side-effects and SARS-CoV-2 infection

after vaccination in users of the COVID

Phonna Maghfirah, S. Ked

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