Viki Male

#Vaccination against whooping cough, RSV and flu during #pregnancy saves babies lives, but expectant parents are sometimes unsure. How do I know it's safe? Will it protect my baby? To answer these questions, we've created vaccinesinpregnancy.org 1/

#Vaccination against whooping cough, RSV and flu during #pregnancy saves babies lives, but expectant parents are sometimes unsure. How do I know it's safe? Will it protect my baby? To answer these questions, we've created vaccinesinpregnancy.org 1/

Thanks to the IMPRINT network for supporting this project @UKRI_News for funding and colleagues Bet Holder and Sara Barnett. You've all been great to work with! 3/3

The website also has a collection of resources for midwives and other healthcare professionals, to help make conversations about this important topic easier and more impactful. Please take a look and share with your patients and colleagues! 2/

@hamandpineappl1 @MarkDavidsonAfr @RetsefL My thoughts on this from another thread... x.com/VikiLovesFACS/…

@MarkDavidsonAfr @RetsefL @VikiLovesFACS Hope she has, as it is full of confounding

BREAKING: 
 Analysis of over 220K pregnancies in Israel during 2016- 2022 found that mRNA COVID-19 vaccination during gestational weeks 8-13 was associated with a higher-than-expected number of eventual fetal losses (miscarriages, abortions & stillbirths)! Pregnant women vaccinated with dose 1 during weeks 8-13 had nearly 3.9 (95% CI: [2.55-5.14]) additional fetal losses above expected per 100 pregnancies. Most of the excess fetal losses occurred after gestational week 20 and nearly half occurred after gestational week 25. In contrast, pregnant women vaccinated for influenza during weeks 8-27 exhibited a consistently lower-than-expected observed number of fetal losses, likely the result of healthy vaccinee bias. Women vaccinated for COVID-19 or influenza prior to pregnancy exhibited according-to-expected or lower-than-expected numbers of fetal losses. The study used innovative observed-to-expected methodology, where data from prior years were leveraged to determine the expected number of fetal losses based on the individual characteristics of the pregnant women who vaccinated and their week of vaccination.

@jsm2334 @joshg99 @RetsefL PS. I'm not here so often these days. Indeed I spotted this by chance when popping back to find a link to a paper I saw posted on here. But given that I anticipate some discussion around this, I will try to remember to drop by!

@jsm2334 @joshg99 @RetsefL But in the meantime, it’s worth remembering that the many peer-reviewed analyses that *do* take account of maternal risk factors, don’t find any increased risk of pregnancy loss associated with COVID vaccination in the first trimester. 9/9 x.com/VikiLovesFACS/…

A new preprint has posted online assessing potential safety signals for pregnancy loss after mRNA vaccination during pregnancy using Israeli electronic health records (EHR data), with first author @joshg99 and senior author @RetsefL (newly appointed member of CDC's ACIP). Their primary conclusions were that pregnant women vaccinated for COVID in the second half of the first trimester (wk8-13) had greater observed pregnancy loss rates than expected from the pre-pandemic regression model computable from EHR. They also found that pregnant women vaccinated for COVID in the second trimester (wk14-27) and pregnant women vaccinated for flu from wk8-13 or wk14-27 had significantly lower-than-expected observed pregnancy loss rates during the pandemic, and that women vaccinated for COVID or flu before pregnancy had slightly lower-than-expected pregnancy loss rates. They attribute these results to residual confounding (i.e. healthy vaccinee effect HVE) The paper is exceptionally well written and introduces a rigorous approach for identifying potential safety signals from EHR data, an active reporting approach that avoids the key limitations of passive reporting systems (like VAERs in USA, AEFI in Israel): (1) reporting bias and (2) the lack of control group.(poorly understood limitations of these systems that I have harped upon ad nauseum on social media) However, the paper has some key omissions that limit the ability to carefully interpret the results, including: 1. Failure to investigate and fully account for pandemic-related calendar time varying confounders. 2. Lack of assessment of whether women remaining unvaccinated throughout pregnancy during the pandemic had higher- or lower-than expected pregnancy loss. 3. No assessment of whether COVID-19 infections later in pregnancy were factors in post-vaccination pregnancy losses, especially for the primary cohorts. 4. Incomplete summary of results of vaccination before pregnancy 5. Lack of assessment of whether women vaccinated before week 8 of their pregnancy had higher- or lower-than-expected pregnancy loss. 6. Lack of summary of which type of pregnancy loss outcomes (spontaneous abortion, induced abortion, stillbirth) dominated the events for each modeled cohort. The authors’ observed-expected analysis approach could be readily applied to perform each of these suggested analyses. Given that the primary vaccinated subgroups driving their conclusions are very small (e.g. 1st dose wk8-13 cohort being 1.9% of pregnancies and 1.8% of pregnancy losses) and with pregnancies during specific times during the pandemic (e.g. ~90% of 1st dose wk8-13 having last menstrual period (LMP) between 10/2020 and 1/2021), there is concern for remaining residual confounding in these cohorts, from pandemic-related or medically-related confounders, and these analyses could shed more light on whether this concern is significant or not. The inclusion of these results would provide a more complete and transparent picture of potential COVID vaccine effects on pregnancy loss. It is not valid to dismiss any results showing lower-than-expected pregnancy loss in vaccinated subgroups as driven by residual confounding (by claiming HVE) without acknowledging that the higher-than-expected pregnancy loss in one small vaccinated subgroup (covid vaccinated wk8-13) could similarly be driven by residual confounding. This thread will walk through the key details of their study and results, and elaborate some on these concerns.

Vaccination in pregnancy to protect the newborn bit.ly/4lK6jWm

PS. Popping back to post this because *so many* of you tweeple have asked about it over the years, so I wanted to be sure to share here! But I am mostly over at 🦋now - same handle!

Finally, why did we do all this? Because ppl living with #LongCOVID and #MECFS asked us to! Big thanks to collaborators @HarryLeeming and @RorPreston from @visible_health who made it possible. Thanks to the MRC for funding. And congrats to lead author Abi Goodship! 5/5

948 users prospectively entered #MenstrualCycle & #LongCovid #MECFS symptom data into tracking app @visible_health. 👉🏻 Crashes more likely during menstruation 👉🏻 Crashes less common in people taking combined hormonal contraception 🧵 medrxiv.org/content/10.110…