Adverse Effects and Antibody Titers in Response to the BNT162b2 mRNA COVID-19 Vaccine in a Prospective Study of Healthcare Workers

  1. Si’Ana A Coggins
  2. Eric D Laing
  3. Cara H Olsen
  4. Emilie Goguet
  5. Matthew Moser
  6. Belinda M Jackson-Thompson
  7. Emily C Samuels
  8. Simon D Pollett
  9. David R Tribble
  10. Julian Davies
  11. Luca Illinik
  12. Monique Hollis-Perry
  13. Santina E Maiolatesi
  14. Christopher A Duplessis
  15. Kathleen F Ramsey
  16. Anatalio E Reyes
  17. Yolanda Alcorta
  18. Mimi A Wong
  19. Gregory Wang
  20. Orlando Ortega
  21. Edward Parmelee
  22. Alyssa R Lindrose
  23. Andrew L Snow
  24. Allison M W Malloy
  25. Andrew G Letizia
  26. Daniel Ewing
  27. John H Powers
  28. Kevin L Schully
  29. Timothy H Burgess
  30. Christopher C Broder
  31. Edward Mitre

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Abstract

Background

The relationship between postvaccination symptoms and strength of antibody responses is unclear. The goal of this study was to determine whether adverse effects caused by vaccination with the Pfizer/BioNTech BNT162b2 vaccine are associated with the magnitude of vaccine-induced antibody levels.

Methods

We conducted a single-center, observational cohort study consisting of generally healthy adult participants that were not severely immunocompromised, had no history of coronavirus disease 2019, and were seronegative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein before vaccination. Severity of vaccine-associated symptoms was obtained through participant-completed questionnaires. Testing for immunoglobulin G antibodies against SARS-CoV-2 spike protein and receptor-binding domain was conducted using microsphere-based multiplex immunoassays performed on serum samples collected at monthly visits. Neutralizing antibody titers were determined by microneutralization assays.

Results

Two hundred six participants were evaluated (69.4% female, median age 41.5 years old). We found no correlation between vaccine-associated symptom severity scores and vaccine-induced antibody titers 1 month after vaccination. We also observed that (1) postvaccination symptoms were inversely correlated with age and weight and more common in women, (2) systemic symptoms were more frequent after the second vaccination, (3) high symptom scores after first vaccination were predictive of high symptom scores after second vaccination, and (4) older age was associated with lower titers.

Conclusions

Lack of postvaccination symptoms after receipt of the BNT162b2 vaccine does not equate to lack of vaccine-induced antibodies 1 month after vaccination.

Article activity feed

  1. Version published to 10.1093/ofid/ofab575
  2. Rapid Reviews Infectious Diseases

    Alberto Modenese

    Review 2: "Adverse effects and antibody titers in response to the BNT162b2 mRNA COVID-19 vaccine in a prospective study of healthcare workers"

    This preprint investigates antibody titer and whether titer correlates with a variety of parameters, including age, weight, sex, and post-vaccine symptom severity. Reviewers deem date reliable with only minor revision to data analysis.

  4. Rapid Reviews Infectious Diseases

    Yang Xiaoming

    Review 1: "Adverse effects and antibody titers in response to the BNT162b2 mRNA COVID-19 vaccine in a prospective study of healthcare workers"

    This preprint investigates antibody titer and whether titer correlates with a variety of parameters, including age, weight, sex, and post-vaccine symptom severity. Reviewers deem date reliable with only minor revision to data analysis.

  5. ScreenIT

    SciScore for 10.1101/2021.06.25.21259544: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsIRB: The study protocol was approved by the Uniformed Services University Institutional Review Board.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Antibody testing: IgG antibodies against SARS-CoV-2 spike protein and receptor binding domain (RBD) were measured using microsphere-based multiplex immunoassays (MMIAs) built using Luminex xMAP-based technology as previously described (15) (Supplemental Methods).
    SARS-CoV-2 spike protein and receptor binding domain (RBD
    suggested: None
    Software and Algorithms
    SentencesResources
    PASS was initiated in August of 2020 with study participants seen monthly at the Naval Medical Research Center Clinical Trials Center.
    PASS
    suggested: (PASS, RRID:SCR_005490)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Another limitation is that the cohort consisted of healthy volunteers without substantial immunocompromising conditions. We anticipate that studies in other cohorts will further inform the relevance of vaccine-associated symptoms to other populations and whether duration of vaccine symptoms correlates with vaccine-induced antibody titers. In conclusion, this study demonstrates that BNT162b2 vaccinations are commonly associated with both local and systemic symptoms. Symptoms are greater after second vaccination, are more common in younger individuals, and do not correlate with vaccine-induced antiviral IgG titers. These findings suggest that patients receiving the BNT162b2 vaccine should be reassured that lack of symptoms does not necessarily equate to lack of desired vaccine function. This study also suggests that it may be possible to design future mRNA vaccines that confer robust antibody responses with lower frequencies of vaccine-associated symptoms. Indeed, emerging studies suggest the balance between vaccine immunogenicity and reactogenicity can be better tuned for COVID-19 mRNA-based vaccines as well (32).

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  6. Version published to 10.1101/2021.06.25.21259544v1 on medRxiv