Evidence map›Paper›PMID 35804634›Full record

ArticleAnimals : an open access journal from MDPI2022

The Promises of Speeding Up: Changes in Requirements for Animal Studies and Alternatives during COVID-19 Vaccine Approval-A Case Study.

Merel Ritskes-Hoitinga, Yari Barella, Tineke Kleinhout-Vliek

Abstract read
In one paragraph

Article in Animals : an open access journal from MDPI, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Article
  3. Rupturing the Temporality of Pharmaceutical Patents: A Sketch for a New Temporal Economy of Pharmaceutical Markets.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2025
    Article
  4. Review
  5. Article
  6. 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

3 authors.

Merel Ritskes-HoitingaDepartment of Population Health Sciences, Institute for Risk Assessment Sciences (IRAS), Faculty of Veterinary Medicine, Utrecht University, Postbus 80163, 3508 TD Utrecht, The Netherlands.
Yari BarellaFaculty of Science, Radboud University, Postbus 9010, 6500 GL Nijmegen, The Netherlands.
Tineke Kleinhout-VliekCopernicus Institute of Sustainable Development, Utrecht University, Postbus 80.115, 3508 TC Utrecht, The Netherlands.ORCID 0000-0002-2292-8737

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

On 21 December 2020, the European Commission granted conditional marketing authorisation for the BNT162b2 COVID-19 vaccine 'Comirnaty', produced by Pfizer/BioNTech. This happened only twelve months after scientists first identified SARS-CoV-2. This stands in stark contrast with the usual ten years needed for vaccine development and approval. Many have suggested that the changes in required animal tests have sped up the development of Comirnaty and other vaccine candidates. However, few have provided an overview of the changes made and interviewed stakeholders on the potential of the pandemic's pressure to achieve a lasting impact. Our research question is: how have stakeholders, including regulatory agencies and pharmaceutical companies, dealt with requirements concerning in vivo animal models in the expedited approval of vaccine candidates such as 'Comirnaty'? We interviewed key stakeholders at the Dutch national and European levels (

Indexed as

alternativesanimal studiesCOVID-19efficacymRNAregulationssafetyvaccines

Identifiers

PMID35804634
PMCPMC9264994

What OpenQuestion holds

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LicenceCC BY
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.