This @NEJM paper did long-term follow-up on 3958 #pregnant ppl who received a #COVID19 #vaccine.

๐Ÿ‘‰๐Ÿป No increased risk of pregnancy-specific adverse events (including #miscarriage).

So why are ppl claiming it shows a 24x increased risk of miscarriage? ๐Ÿงต

10.1056/NEJMoa2104983
The rate of miscarriages reported in the paper is 12.6%.

But is that higher than we would normally see?

No... 2/
The normal range quoted in the paper, based on these references, is 10 - 26%.

The range is large because lots of things affect miscarriage rate, so it varies a lot between studies.

But note the rate in the vaccinated population is within this normal range. 3/
If we want a tighter estimate of miscarriage rates in the general population, the best one (in my opinion) is from this recent review in @TheLancet - 15.3%.

Compared to 12.6% in the COVID vaccine safety study. 4/

thelancet.com/journals/lanceโ€ฆ
Some people might be surprised that the miscarriage rate is as high as that. We perhaps have an artificially low view of how common miscarriage is because we tend not to talk about it.

But thatโ€™s a conversation for another time. Back to the paper... 5/
So the paper shows no increase in miscarriages following vaccination.

(Or preterm birth, or stillbirth.) 6/
So where does this claim of a 24-fold increase in miscarriages come from? 7/
Okay, letโ€™s take a look at that dataset from the CDC, that it is claimed shows the rate of miscarriage at only 0.59%... 8/

cdc.gov/nchs/data/nvsrโ€ฆ
The paper is actually about *stillbirths* (fetal loss after 20 weeks), rather than miscarriage, which occurs before 20 weeks. 9/
So that 24-fold figure comes from comparing miscarriages (loss before 20 weeks) with stillbirth (loss after 20 weeks). But we know that miscarriage is much more common than stillbirth, so this is what we would expect for such a comparison. 10/
If we compare miscarriages in the vaccinated population with miscarriages in the general (unvaccinated) population, the rates are the same.

That is to say, there is no increased risk of #miscarriage associated with #COVID19 #vaccination. 11/
I hope this clears up where this idea has come from, as well as setting out the actual rates.

As always, happy to talk to ppl who feel like they need more info in order to make their decision on this. 12/12
PS. I managed to give the DOI for the NEJM paper we are discussing, rather than the link. Oops! Hereโ€™s the link...

nejm.org/doi/full/10.10โ€ฆ

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More from @VikiLovesFACS

10 May
"If #COVID19 #vaccines are so safe, why aren't the manufacturers accepting liability for any potential injuries?"

It's a fair question. And it's clearly bothering a lot of people, judging by my inbox.

But actually the answer differs depending on where you are... ๐Ÿงต
Starting in the UK... ๐Ÿ‡ฌ๐Ÿ‡ง

In the mid-70s, ppl became concerned about the potential for long-term injuries associated with the whooping cough vaccine (although it turned out there was no problem). To bolster confidence, the govt passed the Vaccine Damage Payment Act in 1979. 2/
This makes a payment of (now) ยฃ120,000 to anyone who suffers permanent injury as a result of a govt-recommended vaccination. Following approval, COVID19 vaccines were added to the list of vaccines for which the govt accepts liability under the act. 3/

gov.uk/vaccine-damageโ€ฆ
Read 14 tweets
5 May
There are already lots of studies showing that antibodies pass into breastmilk after #COVID19 #vaccination. But this new preprint looks at the properties of those antibodies in more detail, as well as reporting for the first time on T cells... ๐Ÿ’‰๐Ÿคฑ๐Ÿฟ๐Ÿงต

medrxiv.org/content/10.110โ€ฆ
First - in agreement with the other studies - anti-Spike IgA and IgG are found in breast milk following vaccination.

(Milk shown in purple, plasma in orange). 2/
Next, they looked at what kind of IgA it was. Is it monomeric (M) like IgA in blood? Or oligomeric (O), suggesting it is produced at a mucosal surface?

The IgA in milk is mostly oligomeric, suggesting it is produced locally in the breast. 3/
Read 8 tweets
5 May
@Brigitt73701323 Thatโ€™s a good explanation of how mRNA vaccines (or shots, if you prefer) work. It seems to me that the reason you donโ€™t want to call them โ€œvaccinesโ€ is two-fold.

First, to do with the approach. Second, to do with the level of protection. 1/
@Brigitt73701323 In the beginning, we had both live attenuated (weakened) and inactivated (real pathogen, but killed) vaccines. Examples of this are the smallpox vaccine (1798) and the anthrax vaccine (1904), respectively. 2/
@Brigitt73701323 Later, we started making vaccines that were just a single protein from the pathogen (diphtheria, 1942).

More recently, we have started to take approaches using engineered proteins (Hep B, 1982) sometimes assembled to look like viruses (HPV, 2008). 3/
Read 14 tweets
4 May
@willowwriter @hejaro14 @naomirwolf I guess you are arguing - as many have - that pregnant ppl should have been included in the clinical trials from the outset. We have the PREVENT guidance, developed in the context of Ebola and Zika, to help us do this. 1/

sciencedirect.com/science/articlโ€ฆ
@willowwriter @hejaro14 @naomirwolf Now, we can have a discussion about why it was felt that pregnant ppl should not have been included in the trials. But the long and the short of it is that they were not. 2/
@willowwriter @hejaro14 @naomirwolf This put each regulatory body in a position where it had to make its own decision about what to recommend... balancing potential risks of vaccination on one side against the known risks of COVID in pregnancy on the other. 3/

bmj.com/content/370/bmโ€ฆ
Read 10 tweets
23 Apr
A lot of people are asking me...

โ€œI feel like my baby and I are coming towards the end of #breastfeeding. But I just got my #COVID19 #vaccine! Should I keep going to give my baby protection against COVID19?โ€

๐Ÿ’‰๐Ÿคฑ๐Ÿพ๐Ÿงต ...
(By the way, in this thread, I will say "breastfeeding" for short, but this also includes people who are giving their babies pumped breastmilk.) 2/
I have breastfed two babies myself and I know that stopping breastfeeding is *such* a personal thing. So I canโ€™t possibly give a yes/no answer to that question. But what I can do is give you a framework for making your own decision... 3/
Read 16 tweets
21 Apr
Iโ€™m getting a lot of questions about #COVID19 vaccination and the menstrual cycle. Does the #vaccine affect your #period? And does that mean there will be an effect on #fertility? ๐Ÿ’‰๐Ÿฉธ ๐Ÿงต

(Short answer upfront: Maybe, and no.)
Does the #COVID19 #vaccine affect #periods? Well, a lot of people are reporting this and I like to start from a position of believing what people say about their own bodies. So I think it is likely that this is a side-effect in some people. 2/
But research is being done to find this out! I know at least 2 studies - the biggest is run by @KateClancy. You can read about her study, and participate if you want, here. Ppl who used to have periods but no longer do are also invited to participate! 3/

Read 18 tweets

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