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Viki Male Profile picture
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Aug 30 • 9 tweets • 6 min read
If you are #pregnant in the UK, the @NHSuk strongly recommends that you get the #CovidVaccine if you are not already protected.

The advice has not changed!

So why are some people saying that it has? 🤔

🧵...

nhs.uk/conditions/cor…
In December 2020, Pfizer submitted data on its vaccine to the MHRA for temporary approval, which was granted. The documents on this are in the public domain... 2/

gov.uk/government/pub…
Periodically, Pfizer sends the MHRA some more data. On 16 August, they sent some additional data on boosting with different brands of vaccine. The documents were updated accordingly. 3/

gov.uk/government/pub…
The data on pregnancy has not been updated since Dec 2020. This is because Pfizer has not sent additional data on this topic to the MHRA. However, independently-done studies on more than 135,000 ppl vaccinated in pregnancy show vaccination is safe... 4/

drive.google.com/file/d/1_wHIYX…
... and reduces the risk of stillbirth. 5/

nature.com/articles/s4146…
Because the August update of the Public Assessment Report still contains the December 2020 information - that Pfizer have not submitted pregnancy data to the MHRA - some ppl have interpreted this as being new information that supercedes the NHS advice - but it isn't! 5/
The @NHSuk advice - as well as advice from @RCObsGyn and @MidwivesRCM - strongly recommending #CovidVaccination in #pregnancy is based on the independently-generated data showing that vaccination is safe and effective in pregnancy. 6/

rcog.org.uk/guidance/coron…
In short...

👉 Public Assessment Report summarises data from Pfizer - very little on pregnancy submitted and no update since Dec 20.

👉 NHS guidance takes into account all safety data (not just from Pfizer)

👉 Recommends #CovidVaccination in #pregnancy

👉 Has not changed.

7/
(This thread adds more information to one I tapped out super quickly last night, and in which there was an error - which I corrected in the thread. If you are sharing a thread on this, please consider sharing this one!) 8/8

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More from @VikiLovesFACS

Viki Male Profile picture
Sep 1
Most of the very extensive data showing that #CovidVaccines are safe and effective in #pregnancy was collected in the general rollout.

Is this okay? Shouldn’t we have trial data?

Let’s talk about the ethics of vaccine trials in pregnancy! 🧵…

drive.google.com/file/d/1_wHIYX… Image
First, let’s note that we do have some data on pregnancy from the COVID vaccine trials. Participants were asked not to become pregnant, but some did by accident. The outcomes for these pregnancies were monitored as part of the trials, with no concerns emerging. 2/
Because…

1. What little data we had was reassuring

2. What we know of 💉 biology suggested there would not be any problems in 🤰🏻

3. COVID 🦠 *does* cause problems in pregnancy

… some countries 🇺🇸 🇮🇱 opted to offer the 💉 and let 🤰🏻 decide

3/
Read 14 tweets
Viki Male Profile picture
Aug 31
If you are #pregnant, the #CovidVaccine is strongly recommended and you will soon be offered a booster. #BoostTheBump

The recommendation is made on the basis of extensive data that the vaccine is safe and effective, by the following bodies… 1/

drive.google.com/file/d/1_wHIYX… Image
The UK government… 2/

gov.uk/government/pub…
The @NHSuk… 3/
Read 8 tweets
Viki Male Profile picture
Aug 29
If you are #pregnant in the UK, the NHS strongly recommend that you get the #CovidVaccine if you are not yet protected.

The advice has not changed!

nhs.uk/conditions/cor…
There seems to be some confusion because the full approval documents for the Pfizer vaccine - published a few weeks ago - note that Pfizer did not themselves do any studies of the vaccine in pregnancy.

Here's the relevant document... 2/

gov.uk/government/pub…
But this document describes only the data that Pfizer submitted to the MHRA, not the independently generated data we have from universities and government bodies, which track vaccine safety in more than 315,000 pregnant people and find no problem. 3/

drive.google.com/file/d/1_wHIYX… Image
Read 5 tweets
Viki Male Profile picture
Aug 18
85,162 ppl giving birth in 🇨🇦May - Dec ‘21, of whom 43,099 had a #CovidVaccine during #pregnancy.

👉🏻 No increased risk of stillbirth, preterm birth or being born smaller than expected following vaccination.

1/
bmj.com/content/bmj/37…
In fact, the authors found a slight reduction in the risk of stillbirth and very preterm birth among those vaccinated. Although they controlled for known confounders, they didn’t feel confident that this wasn’t due to residual confounding. 2/
However, it is in line with the findings from other large studies which show a reduced risk of stillbirth following vaccination… 3/

nature.com/articles/s4146…
Read 4 tweets
Viki Male Profile picture
Aug 18
For those interested in the miscarriage rate among those who became pregnant during the trial of the Pfizer #CovidVaccine….

👉🏻 Vaccine group 7%

👉🏻 Control group 15%

👉🏻 These rates are not significantly different from each other, or from normal

1/
fda.gov/media/152256/d…
These data were published about a year ago, but ppl are talking about it today because Naomi Wolf has looked at the FOI data and claims she has found a miscarriage rate of 44%. Unclear how she has done this but seems to be a combination of… 2/
👉🏻 Accidentally counting everything twice (oops)

👉🏻 Counting some ppl who didn’t have miscarriages (eg. males)

👉🏻 Counting miscarriages among the control group (ie. ppl who did not get vaccinated). 3/3
Read 4 tweets
Viki Male Profile picture
Jul 7
New preprint looking at 32,536 ppl giving birth in Melbourne 🇦🇺of whom 17,356 received a #CovidVaccine in #pregnancy

👉🏻 Congenital abnormalities, preterm birth and stillbirth all significantly *lower* in the vaccinated group.

medrxiv.org/content/10.110…
🤓 Section

Though this is in line with what we expect, I was surprised to see such clear results in a single study - albeit a big one. Is there a bias here?

In this cohort the vaccinated are generally healthier and wealthier, but the authors adjust for this. 2/
They also restrict the sample to ppl for whom weeks 20-43 following LMP fall entirely within the study period, to avoid fixed cohort bias. 3/
Read 8 tweets

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