Evidence map›Paper›PMID 36195472›Full record

ArticleVaccine2022

Near real-time surveillance of safety outcomes in US COVID-19 vaccine recipients aged 12 to 64 years.

Patricia C Lloyd, Mao Hu, Hui-Lee Wong, Azadeh Shoaibi, Cindy Ke Zhou, An-Chi Lo, Kandace Amend, Daniel C Beachler, Cheryl N McMahill-Walraven, Elizabeth R Smith and 17 more

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.0field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 21 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 6 institutions in 1 country.

Patricia C LloydUS Food and Drug Administration, Silver Spring, MD, USA.
Mao HuAcumen LLC, Burlingame, CA, USA.
Hui-Lee WongUS Food and Drug Administration, Silver Spring, MD, USA.
Azadeh ShoaibiUS Food and Drug Administration, Silver Spring, MD, USA.
Cindy Ke ZhouUS Food and Drug Administration, Silver Spring, MD, USA.
An-Chi LoAcumen LLC, Burlingame, CA, USA.
Kandace AmendOptum Epidemiology, Boston, MA, USA.
Daniel C BeachlerHealthCore, Inc, Wilmington, DE, USA.
Cheryl N McMahill-WalravenCVS Health Clinical Trial Services, Blue Bell, PA , USA.
Elizabeth R SmithAcumen LLC, Burlingame, CA, USA.
John SeegerOptum Epidemiology, Boston, MA, USA.
Alex SecoraIQVIA, Falls Church, VA, USA.
Djeneba Audrey DjiboCVS Health Clinical Trial Services, Blue Bell, PA , USA.
Joyce ObidiUS Food and Drug Administration, Silver Spring, MD, USA.
Yuhui FengAcumen LLC, Burlingame, CA, USA.
Jennifer SongOptum Epidemiology, Boston, MA, USA.
Christian ReichIQVIA, Falls Church, VA, USA.
Charalynn HarrisCVS Health Clinical Trial Services, Blue Bell, PA , USA.
Sandia AkhtarAcumen LLC, Burlingame, CA, USA.
Robin CliffordOptum Epidemiology, Boston, MA, USA.
Nandini SelvamIQVIA, Falls Church, VA, USA.
Jennifer L PigogaCVS Health Clinical Trial Services, Blue Bell, PA , USA.
Yixin JiaoAcumen LLC, Burlingame, CA, USA.
Yoganand ChillarigeAcumen LLC, Burlingame, CA, USA.
Thomas MaCurdyAcumen LLC, Burlingame, CA, USA.
Richard ForsheeUS Food and Drug Administration, Silver Spring, MD, USA.
Steven A AndersonUS Food and Drug Administration, Silver Spring, MD, USA. Electronic address: steven.anderson@fda.hhs.gov.
Acumen (United States) · USUnited States Food and Drug Administration · USMontgomery County Community College · USNew England College of Optometry · USIQVIA (United States) · USWilmington University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundActive monitoring of safety outcomes following COVID-19 vaccination is critical to understand vaccine safety and can provide early detection of rare outcomes not identified in pre-licensure trials. We present findings from an early warning rapid surveillance system in three large commercial insurance databases including more than 16 million vaccinated individuals.

methodsWe evaluated 17 outcomes of interest following COVID-19 vaccination among individuals aged 12-64 years in Optum, HealthCore, and CVS Health databases from December 11, 2020, through January 22, 2022, January 7, 2022, and December 31, 2021, respectively. We conducted biweekly or monthly sequential testing and generated rate ratios (RR) of observed outcome rates compared to historical (or expected) rates prior to COVID-19 vaccination.

findingsAmong 17 outcomes evaluated, 15 did not meet the threshold for statistical signal in any of the three databases. Myocarditis/pericarditis met the statistical threshold for a signal following BNT162b2 in two of three databases (RRs: 1.83-2.47). Anaphylaxis met the statistical threshold for a signal in all three databases following BNT162b2 vaccination (RRs: 4.48-10.86) and mRNA-1273 vaccination (RRs: 7.64-12.40). DISCUSSION: Consistent with published literature, our near-real time monitoring of 17 adverse outcomes following COVID-19 vaccinations identified signals for myocarditis/pericarditis and anaphylaxis following mRNA COVID-19 vaccinations. The method is intended for early detection of safety signals, and results do not imply a causal effect. Results of this study should be interpreted in the context of the method's utility and limitations, and the validity of detected signals must be evaluated in fully adjusted epidemiologic studies.

Indexed as

AnaphylaxisCOVID-19MyocarditisPericarditisBNT162 VaccineCOVID-19 VaccinesHumansRNA, MessengerVaccinationBNT162 VaccineCOVID-19 VaccinesRNA, MessengerCOVID-19 vaccine safety surveillanceSARS-CoV-2Sequential testing

Identifiers

PMID36195472
PMCPMC9513329
OpenAlexW4297371805

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.