COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study
Authors' conclusion
This study provides reassuring insights into the safety of COVID-19 vaccines administered to women with AID during the gestational and post-partum periods
Study context
- Population
- Pregnant and breastfeeding women with autoimmune diseases (AID), COVAD study6,787 (73.8%) women
- Participants
- 9,201 participants
- Exposure
- Pregnant and breastfeeding women with AID vs non-pregnant/non-breastfeeding patients and healthy controls (HC)
- Pregnant AIDn = 40
- Breastfeeding AIDn = 52
- Matched non-pregnant/non-breastfeeding AIDn = 262
- Outcome
- Delayed-onset (>7 days) vaccine-related AE, disease flares and AID-related treatment modifications
Methodological detailsself-administered online survey, age- and disease-matched comparison
- Self-administered online survey
- Age- and disease-matched comparison
Main finding
As reported in the abstract
Vaccine-related AE
Overall adverse events (AE)
45% vs 26%
P = 0.01
Pregnant AID
Minor AE
40% vs 25.9%
P = 0.03
Pregnant AID
Major AE
17.5% vs 4.6%
P < 0.01
Pregnant AID
Observational data: associations, not effects.
Further findings
Post-vaccination disease flares
Flare management in pregnant/breastfeeding patients
- Pregnant/breastfeeding patients with a flare requiring initiation or change in immunosuppressants, respectively
- 28.6% and 20%
- All pregnant/breastfeeding patients with a flare managed with GC
Original publication
COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study. Rheumatology (Oxford). Published 28 July 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →