lancet-header

Preprints with The Lancet is a collaboration between The Lancet Group of journals and SSRN to facilitate the open sharing of preprints for early engagement, community comment, and collaboration. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early-stage research papers that have not been peer-reviewed. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. The findings should not be used for clinical or public health decision-making or presented without highlighting these facts. For more information, please see the FAQs.

Physiological Response to COVID-19 Vaccine: Evidence for Sex Differences?

26 Pages Posted: 15 Jun 2023

See all articles by Andjela Markovic

Andjela Markovic

Ava AG

Vladimir Kovacevic

Ava AG

Timo B. Brakenhoff

Julius Clinical

Duco Veen

Utrecht University - Department of Methodology & Statistics

Paul Klaver

Julius Clinical

Marianna Mitratza

Utrecht University - University Medical Center (Utrecht)

George S. Downward

Utrecht University - University Medical Center (Utrecht)

Diederick Grobbee

Utrecht University - University Medical Center (Utrecht)

Maureen Cronin

Ava AG

Brianna Goodale

Ava AG

COVID-19 Remote Early Detection (COVID-RED) Consortium

Independent

More...

Abstract

Background: Rapid development and implementation of vaccines constituted a crucial step in containing the COVID-19 pandemic. A comprehensive understanding of physiological responses to these vaccines is important to build trust in medicine.Methods: We investigated temporal dynamics before and after COVID-19 vaccination in four physiological parameters (breathing rate, wrist skin temperature, heart rate and heart rate variability) measured continuously by means of a wearable medical device for up to 9 months in a cohort of the general population in the Netherlands. Furthermore, we objectively assessed the duration of menstrual cycle phases before and after vaccination in menstruating participants.Findings: The recorded physiological signals demonstrated short-term increases in breathing rate and heart rate followed by a prompt rebound to baseline levels likely reflecting biological mechanisms accompanying the immune response to vaccination. No sex differences were evident in the measured physiological responses. In menstruating participants, we found a 0.8% decrease in the duration of the menstrual phase following vaccination.Interpretation: The observed short-term changes suggest that COVID-19 vaccines are not associated with long-term biophysical issues. Taken together, our work provides valuable insights into continuous fluctuations of physiological responses to vaccination and highlights the importance of digital solutions in health care.Funding: The COVID-RED project has received funding from the Innovative Medicines Initiative (https://www.imi.europa.eu) 2 Joint Undertaking under grant agreement No 101005177. This Joint Undertaking receives support from the European Union's Horizon 2020 (https://ec.europa.eu/programmes/horizon2020/) research and innovation programme and EFPIA (https://www.efpia.eu/).

Keywords: Wearable technology, biosignals, digital health, SARS-CoV-2, vaccine reactogenicity, menstrual cycle

Suggested Citation

Markovic, Andjela and Kovacevic, Vladimir and Brakenhoff, Timo B. and Veen, Duco and Klaver, Paul and Mitratza, Marianna and Downward, George S. and Grobbee, Diederick and Cronin, Maureen and Goodale, Brianna and Consortium, COVID-19 Remote Early Detection (COVID-RED), Physiological Response to COVID-19 Vaccine: Evidence for Sex Differences?. Available at SSRN: https://ssrn.com/abstract=4477224 or http://dx.doi.org/10.2139/ssrn.4477224

Timo B. Brakenhoff

Julius Clinical ( email )

Broederplein 41-43, 3703 CD Ze
Netherlands

Duco Veen

Utrecht University - Department of Methodology & Statistics ( email )

Paul Klaver

Julius Clinical ( email )

Marianna Mitratza

Utrecht University - University Medical Center (Utrecht) ( email )

Utrecht
Netherlands

George S. Downward

Utrecht University - University Medical Center (Utrecht) ( email )

6.119, PO Box 85500
Utrecht, 3508 GA
Netherlands

Diederick Grobbee

Utrecht University - University Medical Center (Utrecht) ( email )

Utrecht, 3584 CX
Netherlands

Maureen Cronin

Ava AG ( email )

Brianna Goodale

Ava AG ( email )

Click here to go to TheLancet.com

Paper statistics

Downloads
68
Abstract Views
601
PlumX Metrics