Influence of mRNA Covid-19 vaccine dosing interval on the risk of myocarditis.

Myocarditis is the most salient serious adverse event following messenger RNA-based Covid-19 vaccines. The highest risk is observed after the second dose compared to the first, whereas the level of risk associated with more distant booster doses seems to lie in between. We aimed to assess the relation between dosing interval and the risk of myocarditis, for both the two-dose primary series and the third dose (first booster).

Risk of heavy menstrual bleeding following COVID-19 vaccination: A nationwide case-control study.

Background: COVID-19 vaccination has been inconsistently associated with an increased risk of heavy menstrual bleeding in previous studies. This study aimed to assess the risk of heavy menstrual bleeding requiring hospital care following COVID-19 vaccination according to the number of doses received and the time elapsed since vaccination.

Methods: Using comprehensive data of the French National Health Data System, we carried out a case-control study.

Long-Term Prognosis of Patients With Myocarditis Attributed to COVID-19 mRNA Vaccination, SARS-CoV-2 Infection, or Conventional Etiologies.

Importance: Although patients with myocarditis after COVID-19 mRNA vaccination appear to have a good prognosis near hospital discharge, their longer-term prognosis and management remain unknown.

Objective: To study the cardiovascular complications of post-COVID-19 mRNA vaccination myocarditis and other types of myocarditis during an 18-month follow-up, as well as disease management based on a study of the frequency of medical procedures and drug prescriptions.

Design, Setting, And Participants: In this cohort study based on the French National Health Data System, all individuals aged 12 to 49 years hospitalized for myocarditis in France between December 27, 2020, and June 30, 2022, were identified.

Risk factors for COVID-19 hospitalisation after booster vaccination during the Omicron period: A French nationwide cohort study.

Background: In spite of major effectiveness, a residual risk after COVID-19 primary vaccination was identified, in particular, for vulnerable individuals of advanced age or with comorbidities. Less is known about the Omicron period in people protected by a booster dose. We aimed to identify the characteristics associated with severe COVID-19 during the Omicron period in a population that had received a booster dose in France and to compare differences with the previous periods of the pandemic.

Medically Assisted Reproduction and Risk of Cancer Among Offspring.

Importance: Cancer is a leading cause of death among children worldwide. Treatments used for medically assisted reproduction (MAR) are suspected risk factors because of their potential for epigenetic disturbance and associated congenital malformations.

Objective: To assess the risk of cancer, overall and by cancer type, among children born after MAR compared with children conceived naturally.

Use of multiple sclerosis disease-modifying therapies during pregnancy in France: Nationwide study between 2010 and 2021.

Background: Multiple sclerosis (MS) frequently affects women of childbearing age and pregnant women.

Objective: To assess the use of MS disease-modifying therapies (DMTs) during pregnancy in France over the last decade, marked by an increasing DMTs availability.

Methods: All pregnancies ended from April 2010 to December 2021 in women with MS were identified based on the nationwide Mother-Child Register EPI-MERES, built from the French National Health Data System ( (SNDS)).

Pregnancy outcomes in women with rheumatoid arthritis: an 11-year French nationwide study.

Background: Rheumatoid arthritis (RA) can affect women of childbearing age. The management of patients with RA during pregnancy has evolved over the past decades, especially with the availability of new therapeutic molecules.

Objectives: To describe pregnancy in women with RA, to compare pregnancy outcomes with those of women in the general population and to compare pregnancy outcomes in women with active and inactive RA.

Safety of Vedolizumab and Ustekinumab Compared With Anti-TNF in Pregnant Women With Inflammatory Bowel Disease.

Background & Aims: Limited data are available on the consequences of prenatal exposure to vedolizumab and ustekinumab. We aimed to compare the safety of vedolizumab and ustekinumab with that of anti-tumor necrosis factor (TNF) in pregnant women with inflammatory bowel diseases (IBD).

Methods: Using nationwide, comprehensive data of the EPI-MERES registry, we identified pregnancies in women with IBD in France, exposed to anti-TNF, vedolizumab, and ustekinumab between 2014 and 2021.

Social determinants in prenatal antidepressant use and continuation: Systematic review and meta-analysis.

Introduction: Depression is one of the most common co-morbidities during pregnancy; with severe symptoms, antidepressants are sometimes recommended. Social determinants are often linked with antidepressant use in the general population, and it is not known if this is the case for pregnant populations. Our objective was to determine if social determinants are associated with prenatal antidepressant intake via a systematic review and meta-analysis.

Risk of Guillain-Barré Syndrome Following COVID-19 Vaccines: A Nationwide Self-Controlled Case Series Study.

Background And Objectives: Guillain-Barré syndrome (GBS) has been inconsistently associated with some coronavirus disease 2019 (COVID-19) vaccines. We aimed to quantify the risk of GBS according to the type of COVID-19 vaccine in a large population.

Methods: Using the French National Health Data System linked to the COVID-19 vaccine database, we analyzed all individuals aged 12 years or older admitted for GBS from December 27, 2020, to May 20, 2022.

Proton Pump Inhibitor Use and Risk of Serious Infections in Young Children.

Importance: Proton pump inhibitor (PPI) use may lead to infections through alteration of the microbiota or direct action on the immune system. However, only a few studies were conducted in children, with conflicting results.

Objective: To assess the associations between PPI use and serious infections in children, overall and by infection site and pathogen.

Persistence of second-line biologics in psoriasis after first-line biologic failure: a nationwide cohort study from the French health insurance database (SNDS).

Background: Many biologics are available for psoriasis and have been compared in real-life studies based on their persistence (i.e. time between initiation and discontinuation).

Spatio-temporal changes in pre-exposure prophylaxis uptake among MSM in mainland France between 2016 and 2021: a Bayesian small area approach with MSM population estimation.

Introduction: In France, oral pre-exposure prophylaxis (PrEP) for HIV prevention has been publicly available since 2016, mainly targeting at men who have sex with men (MSM). Reliable and robust estimations of the actual PrEP uptake among MSM on a localized level can provide additional insights to identify and better reach marginalized MSM within current HIV prevention service provision. This study used national pharmaco-epidemiology surveillance data and regional MSM population estimations to model the spatio-temporal distribution of PrEP uptake among MSM in France 2016-2021 to identify marginalized MSM at risk for HIV and increase their PrEP uptake.

Effectiveness of BNT162b2, mRNA-1273, and ChAdOx1-S vaccines against severe covid-19 outcomes in a nationwide mass vaccination setting: cohort study.

Objective: To estimate the effectiveness of the three covid-19 vaccines by Pfizer-BioNTech (BNT162b2), Moderna (mRNA-1273), and Oxford-AstraZeneca (ChAdOx1-S) in people after receiving two doses.

Design: Cohort study.

Setting: Nationwide, population based data in France, from the French National Health Data System (Système National des Données de Santé), between 27 December 2020 and 30 April 2021.

Roll-out and effectiveness of HIV pre-exposure prophylaxis in France: An overview.

Context: Oral HIV pre-exposure prophylaxis (PrEP) has been available and fully reimbursed for people at high risk of sexually acquired HIV infection in France since January 2016.

Objective: To evaluate the roll-out of PrEP use in France and its real-life effectiveness. The main results of two previously published studies were presented at the second e-congress of the EPI-PHARE scientific interest group on pharmacoepidemiology and public decision support held in June 2022, and are reported in this article.

Contribution of real-life studies in France during the COVID-19 pandemic and for the national pharmaco-epidemiological surveillance of COVID-19 vaccines.

During the COVID-19 pandemic, EPI-PHARE, a scientific group in pharmaco-epidemiology created by the French National Agency for the Safety of Medicines and Health Products (ANSM) and the French National Health Insurance (Cnam), has reoriented its work program to enlighten health authorities in this health crisis. By exploiting massive and complex data of the French Health Data System (SNDS) from the beginning of the first lockdown in France in March 2020, we were able to publish numerous results on the use, benefits and risks of medicines, on the risk factors of COVID-19 before and after vaccination, and on the benefits and risks of COVID-19 vaccines. Our results were widely taken into account by the French health authorities and allowed them to take informed decision in this pandemic situation in order to ensure the health of the population.

Impact of coronavirus disease 2019 on contraception use in France.

To limit the spread of the coronavirus disease 2019 (COVID 19), sanitary restrictions have been established since March 2020 in France. These restrictions and the waves of contamination may have had consequences on the use of health products in general, and on the use of contraceptives in particular. We aimed to assess the impact of COVID 19 pandemic from March 16th 2020 to April 30th 2021 in France on reimbursed contraceptives.