Evidence map›Paper›PMID 38407186›Full record

ReviewHuman vaccines & immunotherapeutics2024

Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data.

Frank van den Ouweland, Nicola Charpentier, Özlem Türeci, Ruben Rizzi, Federico J Mensa, Claudia Lindemann, Shanti Pather

Open access · goldAbstract readReview
In one paragraph

Review in Human vaccines & immunotherapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
6.2field-weighted citation impact, top 3% 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

10 citing papers in PubMed, 16 citations in OpenAlex.

  1. Article
  2. Immunology of RNA-based vaccines: The critical interplay between inflammation and expression.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  3. Molecular mechanisms of SARS-CoV-2 entry: implications for biomedical strategies.Microbiology and molecular biology reviews : MMBR · 2025
    Review
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. Molecular Mechanisms of Innate Immune Sensing of Exogenous RNAs.Methods in molecular biology (Clifton, N.J.) · 2025
    Review
  10. Review
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

7 authors at 2 institutions in 2 countries.

Frank van den OuwelandMedical Safety and Pharmacovigilance, BioNTech, Mainz, Germany.
Nicola CharpentierRisk Management, BioNTech, Mainz, Germany.
Özlem TüreciBioNTech, Mainz, Germany.
Ruben RizziGlobal Regulatory Affairs, BioNTech, Germany, Germany.
Federico J MensaClinical Development, Infectious Diseases, BioNTech, Mainz, Germany.
Claudia LindemannNon-Clinical Safety, BioNTech, Mainz, Germany.
Shanti PatherGlobal Medical Affairs, BioNTech, Mainz, Germany.
BioNTech (Germany) · DEBioNTech (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to urgent actions by innovators, vaccine developers, regulators, and other stakeholders to ensure public access to protective vaccines while maintaining regulatory agency standards. Although development timelines for vaccines against SARS-CoV-2 were much quicker than standard vaccine development timelines, regulatory requirements for efficacy and safety evaluations, including the volume and quality of data collected, were upheld. Rolling review processes supported by sponsors and regulatory authorities enabled rapid assessment of clinical data as well as emergency use authorization. Post-authorization and pharmacovigilance activities enabled the quantity and breadth of post-marketing safety information to quickly exceed that generated from clinical trials. This paper reviews safety and reactogenicity data for the BNT162 vaccine candidates, including BNT162b2 (Comirnaty, Pfizer/BioNTech COVID-19 vaccine) and bivalent variant-adapted BNT162b2 vaccines, from preclinical studies, clinical trials, post-marketing surveillance, and real-world studies, including an unprecedentedly large body of independent evidence.

Indexed as

BNT162 VaccineCOVID-19COVID-19 VaccinesHumansMarketingPharmacovigilanceSARS-CoV-2Vaccines, CombinedBNT162 VaccineCOVID-19 VaccinesVaccines, Combinedpost-marketing surveillancereactogenicityreal-world studiessafetySARS-CoV-2vaccine development

Identifiers

PMID38407186
PMCPMC10900268
OpenAlexW4392157285

What Socratic holds

Textmetadata
LicenceCC BY-NC
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.