Viki Male Profile picture
Oct 4, 2022 11 tweets 3 min read Read on X
Just out! A new meta-analysis of 81,349 ppl receiving #CovidVaccine during #pregnancy compared to 255,346 unvaccinated. Vaccination...

👉🏻 Protects against infection

👉🏻 Lowers chance of stillbirth by 27%

👉🏻 Lowers chance of babies needing NICU by 12%

jamanetwork.com/journals/jamap…
I’ve been asked for some additional context around whether the 27% reduction in stillbirth reported by this paper is likely to be an overestimate…

🧵
This is particularly worth considering because a similar meta-analysis found that the rate of stillbirth was reduced by 15% among those vaccinated in pregnancy - rather less than the 27% reported here… 2/

nature.com/articles/s4146…
As I’ve mentioned before, people who take medical advice and get vaccinated in pregnancy are also likely to be taking care of their health in other ways which might improve outcomes, and this might make vaccination look better than it really is. 3/
Most studies try to take this into account by controlling or matching on factors that we know are correlated with or indicative of healthcare seeking behaviour, such as socioeconomic status or whether a person has got their flu vaccine. 4/
This gives us what is called an adjusted odds ratio, or aOR. What Alex is asking here is why the stillbirth rate in this meta-analysis was calculated using the unadjusted odds ratio, or OR, for one of the biggest studies. Won’t that inflate the apparent effect? 5/
Yes, and that’s probably why this meta-analysis finds a larger protective effect than the previous one.

So why have they used this approach? Two reasons… 6/
First, not all the studies included in the meta-analysis have an aOR, and this one instead gives an adjusted Hazard Ratio. aHR cannot be converted into aOR so the authors have taken the raw data and calculated an OR from it. But the paper contains insufficient data to adjust. 7/
2. They pre-specified that this would be their approach. So even if - as Alex suggested to me in DM - they decided to change their statistical approach after the fact to take account of this, this would not be ethical… 8/

crd.york.ac.uk/prospero/displ…
… since the whole point of a systematic review and meta-analysis is that we publish what we will do before we start. This prevents cherry picking of data, or fiddling analyses if we don’t like what we find. 9/
I hope you found this trip into the bowels of SR and MA helpful! 10/10

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More from @VikiLovesFACS

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
May 11, 2023
@davidicke Hi David. Independently-generated data looking at safety of COVID vaccines in more than 360,000 people vaccinated in pregnancy find no increased risk of any pregnancy problems.

How do we reconcile that with the spontaneous reporting in your video?... 🧵

docs.google.com/document/d/19F… Image
@davidicke First, for context... it would probably help you to realise that those 458 spontaneous reports were out of approximately 48,000 people who had been vaccinated in pregnancy at that time. 2/

nejm.org/doi/full/10.10…

jamanetwork.com/journals/jama/…
@davidicke And these are reports of events that occurred after vaccination. There is no requirement that the events are thought to have occurred because of vaccination.

That's actually explained in the report. 3/

phmpt.org/wp-content/upl… Image
Read 8 tweets
Apr 26, 2023
@MarkWar16520311 To understand adverse effects of vaccines, it helps to think about the phases of the immune response. First, we have the innate response, which we might think of (roughly) as being inflammation. This lasts from minutes after vaccination to 48 hours-ish. 1/
@MarkWar16520311 Most adverse events happen in this timeframe and whenever we see inflammation-type symptoms (sore arm, fever, myocarditis), we should straight away be thinking: that might be the vaccine. 2/
@MarkWar16520311 Of course, some of those are so well-established (and mild) that we don't even investigate them anymore (sore arm, fever). But this logic is one of the reasons that myocarditis was taken quite seriously as a potential side effect (and indeed turned out to be one - rarely). 3/
Read 10 tweets

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