COVID-19 Compounds(Molgenie)

Pregnant women were excluded from the initial phase 3 clinical trials of COVID-19 vaccines resulting in limited data on their efficacy and safety during pregnancy and postpartum. As a result, since December 2020, there has been conflicting advice from public health, governmental, and professional authorities on this matter. From the end of 2020 up to now, some consensus guidance has been published with a prevalent precautionary approach on the administration of vaccines in pregnant women, in breastfeeding ones, or for those who are planning a pregnancy (either spontaneously or with assisted technologies). After the first few months of vaccine administration in some countries, more permissiveness seems to prevail, although with inconsistencies. Some little indicative advice, their inconsistency around the world and their changes in a short time have probably disoriented both women and their health care providers and placed the burden of decision making upon women and their health care providers without information to assist in making an informed choice. We reviewed the COVID-19 vaccination guidance for pregnant and breastfeeding women published to date and evidence from cases of unplanned pregnancy during the course of vaccine trials, preclinical experimental and observational clinical studies, and discuss their implications. In this way, we have tried to identify the safety of COVID-19 vaccines for pregnant or breastfeeding women, and their offspring.

The objective of this study was to explore the prevalence, characteristics and risk factors of COVID-19 breakthrough infections (BIs) in idiopathic inflammatory myopathies (IIMs) using data from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study.

A validated patient self-reporting e-survey was circulated by the COVAD study group to collect data on COVID-19 infection and vaccination in 2022. BIs were defined as COVID-19 occurring ≥14 days after two vaccine doses. We compared BI characteristics and severity among patients with IIMs, patients with other autoimmune rheumatic and non-rheumatic diseases (AIRD, nrAID), and healthy controls (HCs). Multivariable Cox regression models were used to assess the risk factors for BI, severe BI ,and hospitalizations among patients with IIMs.

Among the 9449 included responses, BIs occurred in 1447 respondents (15.3%). The median age was 44 years [interquartile range (IQR) 21], 77.4% were female, and 182 BIs (12.9%) occurred among the 1406 patients with IIMs. Multivariable Cox regression among the data for patients with IIMs showed increasing age to be a protective factor for BIs [hazard ratio (HR) = 0.98, 95% CI = 0.97–0.99], and HCQ and SSZ use were risk factors (HR = 1.81, 95% CI = 1.24–2.64, and HR = 3.79, 95% CI = 1.69–8.42, respectively). Glucocorticoid use was a risk factor for a severe BI (HR = 3.61, 95% CI = 1.09–11.8). Non-white ethnicity (HR = 2.61, 95% CI = 1.03–6.59) was a risk factor for hospitalization. Compared with other groups, patients with IIMs required more supplemental oxygen therapy (IIMs = 6.0% vs AIRDs = 1.8%, nrAIDs = 2.2% and HCs = 0.9%), intensive care unit admission (IIMs = 2.2% vs AIRDs = 0.6%, nrAIDs and HCs = 0%), advanced treatment with antiviral or monoclonal antibodies (IIMs = 34.1% vs AIRDs = 25.8%, nrAIDs = 14.6% and HCs = 12.8%) and had more hospitalization (IIMs = 7.7% vs AIRDs = 4.6%, nrAIDs = 1.1% and HCs = 1.5%).

Patients with IIMs are susceptible to severe COVID-19 BIs. Age and immunosuppressive treatments were related to the risk of BIs.