As of the 13th September, the registry contained 5096 participants. 2/
After they have joined, the participants are interviewed in every trimester, shortly after giving birth, and again when their babies are more than three months old. 3/
First, they go through the data showing that, among 2456 people vaccinated before 20 weeks, the risk of miscarriage was normal.
This has been recently published and you can read about it in more detail here... 4/
But there is one additional graphic that is quite nice. This compares the week-by-week miscarriage rate in those who received the COVID vaccine, vs two studies of miscarriage rates from before the pandemic.
You can see that post-vax miscarriage rates are bang in the middle. 5/
The next section looks at outcomes for babies at birth.
The registry contains 1634 live born babies. 70% born following 3rd trimester vaccination and 30% following second trimester vaccination. 6/
Among these babies, the rates of preterm birth, being small for gestational age, admission to neonatal intensive care and infant death are all normal. 7/
45 babies had a birth defect. The types and rates of birth defects were consistent with what is usually seen in the USA. So no evidence of an increased risk of birth defects following vaccination in this cohort. 8/
That's all from the V-safe pregnancy registry! I'm off to do the school run now, but I'll be back later with an update from the Vaccine Safety Datalink... 9/9
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I'll start by saying that this isn't the first mechanism I would investigate myself. As the authors acknowledge, other vaccines - notably COVID vaccines that do not leave the site of injection - have the same effect. This suggests an effect mediated by the immune response. 2/
But there's something to be said for looking at a direct effect, just in case. So the authors add vaccine directly to cultures of ovarian cells.
Props to them for making an effort to use a plausible concentration of vaccine that might get to the ovaries "end organ dose". 3/
👍🏾 No increased risk of any adverse outcomes in pregnancy or to babies.
2/
Great to see an updated systematic review on this!
And I particularly like this one because the authors have used only the highest quality studies in their primary analysis, and report on lower quality studies separately. This gives us both reliability and transparency. 3/
mRNA degrades quickly, so it’s possible we haven't detected vaccine mRNA in the placenta because we didn’t look quickly enough.
To address this, the authors look at placentas for two babies born two and ten days after their mothers received a dose of COVID vaccine. 2/
The authors used a much more sensitive form of PCR than has been used in previous studies, called ddPCR. This technique also tells us whether the mRNA is intact. 3/
This came out while I was away last month, so I didn't post about it at the time. But I talk about it on @SkepticJonGuy's video released last night, which prompted me to share a few (belated!) thoughts... 2/
RSV is the leading cause of death in babies <6 mo, and is implicated in 50% of hospitalisations for respiratory illness, so development of a vaccine is a priority.
I should declare an interest here... my baby son was very sick with RSV 😢 and I would have loved to avoid that. 3/