Evidence map›Paper›PMID 42477513›Full record

ArticleClinical and translational science2026

Anti-PEG Antibodies From mRNA COVID-19 Vaccines Affect In Vitro Measurements of Pegylated Drug Levels.

Elizaveta A Svyatova, Zhuoming Liu, Robyn E Becker, Jungeun M Sung, Adetunji P Fayomi, Jeffry A Florian, James L Weaver, Rodney Rouse, Kristina E Howard

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical and translational science, 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. Article
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

9 authors.

Elizaveta A SvyatovaDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0001-5320-0098
Zhuoming LiuDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0002-8466-3199
Robyn E BeckerDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, Maryland, USA.ORCID 0009-0000-7590-9217
Jungeun M SungDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, Maryland, USA.ORCID 0009-0007-1408-1680
Adetunji P FayomiDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0001-6574-9635
Jeffry A FlorianDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, Maryland, USA.ORCID 0009-0000-1984-8026
James L WeaverDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0001-8601-4216
Rodney RouseDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0003-0463-9699
Kristina E HowardDivision of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food & Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0001-8891-754X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The recent adoption of mRNA-based technology for vaccine development has led to widespread exposure to new vaccine components, such as polyethylene glycol (PEG), against which antibodies may be made. This study assesses the presence of anti-PEG antibodies in human serum following SARS-CoV-2 vaccination, and if these antibodies could interfere with drug level assessment of PEG containing drugs. Elevated anti-PEG antibody titers with prolonged prevalence were detected in individuals who received the mRNA-1273 vaccine as compared to control samples. Anti-PEG antibody levels were approximately 10-fold higher post-vaccination compared to pre-vaccination in approximately 33% of assessed mRNA-1273 vaccine recipients. Elevated anti-PEG antibody levels persisted for over 6 months. Serum from those who received the BNT162b2 or Ad26.COV2.S vaccines had anti-PEG antibody levels similar to control samples. Serum from individuals with elevated anti-PEG antibodies, regardless of study group, typically showed decreased detection of the pegylated drug, pegfilgrastim. This study demonstrates that anti-PEG antibodies have the potential to interfere with bioanalytical assays used for pharmacokinetic drug measurement during the development of pegylated pharmaceutical products, as well as during the establishment of comparability to pegylated reference products during development of biosimilar drug products.

Indexed as

COVID-19COVID-19 VaccinesPolyethylene GlycolsSARS-CoV-22019-nCoV Vaccine mRNA-1273AdultAgedBNT162 VaccineFemaleHumansMaleMiddle Aged2019-nCoV Vaccine mRNA-1273BNT162 VaccineCOVID-19 VaccinesPolyethylene Glycolsanti‐PEG antibodiesbioanalytical interferencebiosimilarsimmunogenicitylipid nanoparticle technologySARS‐CoV‐2 vaccine

Identifiers

PMID42477513
PMCPMC13385214

What Socratic 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 Socratic graph.