Evidence map›Paper›PMID 42437699›Full record

Observational studyPharmacoepidemiology and drug safety2026

Novel Recruitment, Data Collection, and Safety Reporting Methods in the Era of COVID-19: Design of a Post-Emergency Use Authorization COVID-19 Vaccination Safety-Surveillance Study.

Cherise Wong, Katherine Kendrick, Laura Webb, Lauren Cohen, M Patricia McAdams, Heather Rubino, Patrick Caubel, Emily O'Brien

Abstract readObservational Study
In one paragraph

Observational study in Pharmacoepidemiology and drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. Observational
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

8 authors.

Cherise WongPfizer Inc., Worldwide Safety, New York, New York, USA.
Katherine KendrickPfizer Inc., Worldwide Safety, New York, New York, USA.ORCID https://orcid.org/0000-0003-1794-2670
Laura WebbDuke Clinical Research Institute, Durham, North Carolina, USA.
Lauren CohenDuke Clinical Research Institute, Durham, North Carolina, USA.
M Patricia McAdamsDuke Clinical Research Institute, Durham, North Carolina, USA.
Heather RubinoPfizer Inc., Worldwide Safety, New York, New York, USA.
Patrick CaubelPfizer Inc., Worldwide Safety, New York, New York, USA.
Emily O'BrienDuke Clinical Research Institute, Durham, North Carolina, USA.

Funding

Pfizer
6 · The paper itself

Abstract

purposeWithin one week of the Food and Drug Administration granting the COVID-19 vaccine Emergency Use Authorization, the HERO-Together study launched. We describe how the study utilized novel methods for streamlined enrollment and longitudinal data collection to efficiently monitor early and long-term safety of the COVID-19 vaccine.

methodsHERO-Together is a fully remote, prospective observational cohort study, conducted through an online portal. Participants were recruited from an existing online community of healthcare workers that expanded to family and community members as vaccine eligibility expanded, as well as through marketing and point-of-vaccination efforts. Individuals received notifications to submit data at scheduled intervals for two years, and automated reminders prompted participants with missed check-ins, with centralized call center outreach for non-responders.

resultsMultiple recruitment approaches were adopted, including direct outreach, national and local media campaigns, downloadable enrollment toolkits (e.g., social media), social media influencer partnerships, and pharmacy referrals. A study population of n = 19, 858 was enrolled within nine months of emergency use authorization, most self-reporting as white, female, working in healthcare, and all for whom variable survey completion was observed.

conclusionCollectively, diverse recruitment strategies, data collection through the online portal, and electronic consent enabled rapid, decentralized enrollment of study participants in order to remotely monitor COVID-19 vaccine safety during the early days of the pandemic.

trial registrationEUPAS38671.

Indexed as

Adverse Drug Reaction Reporting SystemsCOVID-19COVID-19 VaccinesEmergency Use AuthorizationProduct Surveillance, PostmarketingAdultData CollectionFemaleHumansMaleMiddle AgedPatient SelectionProspective StudiesUnited StatesVaccinationCOVID-19 VaccinesCOVID‐19 vaccineobservationalrecruitmentremotesafety

Identifiers

PMID42437699
PMCPMC13357033

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.