Viki Male Profile picture
Sep 28, 2021 9 tweets 4 min read Read on X
Let's take a look at the data from the @CDCgov ACIP meeting last week on #COVID19 #vaccine safety in #pregnancy.

It continues to be reassuring!

First, let's take a look at the new data from the V-safe pregnancy registry... 🧵

cdc.gov/vaccines/acip/…
As of the 13th September, the registry contained 5096 participants. 2/ Among 5096 people in the re...
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/ Participants are interviewe...
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/ Miscarriage rates in people...
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/ Flow diagram showing that 1...
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/ Among babies born to V-safe...
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/ Image
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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More from @VikiLovesFACS

Jul 2
COVID vaccination causes short-lived increases to menstrual cycle length in some people. But how?

A new paper has come out that examines the possibility that this occurs via a direct effect on the ovaries. But does it show that?

(TLDR: Not really...) 🧵

nature.com/articles/s4154…
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/
Read 13 tweets
May 22
67 studies including 723,988 ppl who received a #CovidVaccine during #pregnancy!

😷 61% less likely to be infected

🏥 94% less likely to be hospitalised

🤰🏻 12% less likely to have a hypertensive disorder and 9% less likely to have a C section

1/

gh.bmj.com/content/9/4/e0…
👶🏻 Babies 8% less likely to be admitted to NICU

👍🏾 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/
Read 5 tweets
Feb 8
Studies looking for evidence that mRNA COVID vaccines cross the placenta have not found it (192 babies).

A case report finds degraded vaccine mRNA in umbilical cord blood from one baby, born 2d after their mother was vaccinated.

What does this mean? 🧵

ajog.org/article/S0002-…
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/
Read 11 tweets
Oct 23, 2023
🇨🇦 85,650 babies born after #CovidVaccination in #pregnancy vs 56,336 babies from unvaccinated pregnancies

👉🏻 Risk of death and disease lower in newborns from vaccinated pregnancies

👉🏻 No difference in hospital admission up to six months old

1/

jamanetwork.com/journals/jamap…
Image
This was designed as a safety study and the results are reassuring.

This is unsurprising, given the very extensive evidence we already have on the safety of mRNA COVID vaccines in pregnancy. 2/

docs.google.com/document/d/19F…
Image
But the finding that outcomes at birth are actually better for babies from vaccinated pregnancies is interesting!

Vaccinated families do tend to have better healthcare, but even when the study team take account of this in their analysis, the finding remains. 🤔

3/
Read 7 tweets
Sep 12, 2023
👩🏿‍🔬 RCT of Pfizer #CovidVaccine given at 24-34 weeks of #pregnancy, with babies followed to six months old.

🤰🏽 173 vaccinated vs 173 saline control

🏥 No difference in rate of severe AEs

👶🏼 No difference in babies' health at birth or up to 6 months

🧵

classic.clinicaltrials.gov/ct2/history/NC…
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/

x.com/SkepticJonGuy/…
Some points to note! This trial is not designed to look at effects of mRNA COVID vaccination in early pregnancy.

We have some data on that from the main trials, showing no difference in pregnancy outcomes between vaccinated and control groups... 3/

fda.gov/media/152256/d…
Image
Read 15 tweets
Aug 23, 2023
🇺🇸 Yesterday, the FDA approved an RSV vaccine for use in pregnancy.

There was a non-significant difference in preterm birth in the trial, which patients will be informed about.

Let's look at the minutes of the meeting to understand these decisions... 🧵

fda.gov/news-events/pr…
Before we start, here are links to the trial report...



And the meeting minutes... 2/

nejm.org/doi/10.1056/NE…
fda.gov/media/169361/d…
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/
Read 15 tweets

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