Vaccinations for Covid-19 during pregnancy
Joan made this Official Information request to Chris Hipkins
The request was refused by Chris Hipkins.
From: Joan
Dear Chris Hipkins,
I am addressing this to you as you are the Minister for COVID-19 Response.
A recent study ‘Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons’ published in the New England Medical Journal of June 2021’ showed that 104 out of 127 pregnant women who were vaccinated for Covid-19 with an mRNA vaccine in the first 20 weeks of their pregnancy then had a miscarriage. The report is linked below;
https://www.nejm.org/doi/pdf/10.1056/NEJ...
The Ministry of Health, in the COVID-19 update – 9th June, 2021, announced that pregnant people will now be routinely offered the Pfizer mRNA vaccine at any stage of pregnancy, and that data from around the world has shown that there are no additional concerns around vaccinating pregnant people with the Pfizer-BioNTech Covid-19 vaccine.
The government’s Covid-19 response is currently to encourage pregnant women to get the Covid-19 vaccination at any stage in their pregnancy and states that data from the large number of pregnant people already vaccinated globally shows that there are no additional safety concerns with giving COVID-19 vaccines.
The study ‘Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons’ published in the New England Medical Journal of June 2021’ is referred to in a ‘Stuff’ Whole Truth Covid-19 article that reiterates that The Ministry of Health recommends the Pfizer vaccine is offered at any stage of pregnancy.
However, some detail in Table 4 of the study I have referred to appears to have been missed or overlooked;
Note: Pregnancy is split into 3 trimesters; Trimester 1; 1 to 12 weeks, Trimester 2; 13 to 26 weeks and Trimester 3; 27 weeks to end of pregnancy.
In the report it says that ‘Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy.
Table 4 of the report states that 104 spontaneous abortions (miscarriages) occurred in the first two trimesters, (Spontaneous abortions <20 weeks) and divides this figure by 827 to get 12.6% miscarriage rate which ought to be troubling enough in itself. However as stated in the report, 700 of these 827 women did not receive the first dose of their covid vaccination until the third trimester, this being well after the 20 week mark in their pregnancy, and only 127 women received the vaccine in the first 20 weeks.
Of these 127 pregnant women who received their mRNA vaccination in the first two trimesters 104 of them had a spontaneous abortion (miscarriage). This study therefore shows an 81.8% rate of spontaneous abortions or miscarriages in expectant mothers given Covid-19 vaccines during their first or second trimesters.
Stated in the report; Pregnancy loss among participants with a completed pregnancy;
Spontaneous abortion <20 wk 104/827 (12.6%)
The 827 in this calculation includes the 700 women who weren’t even vaccinated at the 20-week mark but instead were vaccinated later in their third trimester. The calculation that accurately shows the percentage of spontaneous abortions up to 20 weeks of women vaccinated at that stage of their pregnancy is;
Spontaneous abortion <20 wk 104/127 (81.8%)
This accurately reflects the miscarriage rate (81.8%) for pregnant women vaccinated in the first 20 weeks in this study.
The final paragraph of the report (page 2280) concludes that there are no obvious safety signals with being vaccinated for Covid-19 in the third trimester but does not make the same claim with regard to the first and second trimesters.
Please note that in Russia, as of July 9, pregnant women can only be vaccinated against COVID-19 during the third trimester, when all organs and systems of the baby have already been formed.
The WHO are also much more cautious about pregnant women receiving the Covid-19 vaccine and mention the limitations of safety data in pregnant women.
Therefore, my questions are as follows;
1. What information do you currently hold that says it is safe or that there are no additional safety concerns with giving COVID-19 vaccines to pregnant women at any stage of their pregnancy?
2. Do you accept that the study ‘Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons’ published in the New England Medical Journal of June 2021’ shows that there were 104 spontaneous abortions or miscarriages in the 127 pregnant women who received Covid-19 vaccines during their first or second trimesters?
3. Do you agree that based on the results contained in this study and any other information you may have available that New Zealand’s Covid-19 response ought to be much more cautious about offering the Covid-19 vaccine to pregnant women in the first 20 weeks of their pregnancy?
4. Do you believe that it is safe for pregnant women to be given the Covid-19 vaccine at any stage in their pregnancy or that being vaccinated for Coivd-19 whilst pregnant poses no additional safety risks?
5. Based on the results of this study and possibly other available information will the Covid-19 response be changed to advise pregnant women against being vaccinated for Covid-19 in the first 20 weeks of their pregnancy?
Yours faithfully,
Joan
From: C Hipkins (MIN)
Chris Hipkins
Kia ora
Thank you for taking the time to write to Hon Chris Hipkins, Minister for
COVID-19 Response, Minister of Education, Minister for the Public Sector
and Leader of the House. We are receiving a significant amount of
correspondence at the moment and, although your email will be carefully
considered and noted, it is not possible to respond to each individual
email.
For the latest updates on COVID-19, we encourage you to regularly check
the dedicated [1]COVID-19 and [2]Ministry of Health websites regularly.
They will be updated as soon as new information is available.
If your query is in regards to the COVID-19 vaccine, there are substantive
resources about our COVID-19 vaccine planning and our COVID-19 vaccine
strategy on the dedicated COVID-19 website
here: [3]https://covid19.govt.nz/health-and-wellb...
or the Ministry of Health website
here: [4]https://www.health.govt.nz/our-work/dise....
Please remember to take care, and be kind. We have beaten COVID-19 before,
and we can do it again.
Ngā mihi,
Office of Hon Chris Hipkins
Minister for COVID-19 Response | Minister of Education | Minister for the
Public Sector | Leader of the House | MP for Remutaka
show quoted sections
Joan left an annotation ()
So Ross, what is your point exactly? That prior to June vaccinators were told not to vaccinate pregnant women? This April advice is obviously no longer current as in June the Ministry of Health advised that pregnant people will now be routinely offered the Pfizer mRNA vaccine at any stage of pregnancy based on studies around the world that show no additional safety concerns. This is the current advice and which is the subject of my request, not what the previous advice was before the current advice.
Joan left an annotation ()
References;
1. ‘Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons’ published in the New England Medical Journal of June 2021’
https://www.nejm.org/doi/pdf/10.1056/NEJ...
2. The Ministry of Health, COVID-19 update – 9th June, 2021 1.15pm, at 10mins, 30secs of this;
https://www.youtube.com/watch?v=a1pQMRzs...
3. The government’s current Covid-19 response is currently to encourage pregnant women to get the Covid-19 vaccination at any stage in their pregnancy…..
https://www.health.govt.nz/our-work/dise...
4. ‘Stuff’ Whole Truth Covid-19 article that reiterates that The Ministry of Health recommends the Pfizer vaccine is offered at any stage of pregnancy.
https://interactives.stuff.co.nz/2021/th...
5. World Health Organisation advice regarding giving COVID-19 vaccines to pregnant women
https://www.who.int/news-room/feature-st...
I have added these references to assist anyone reading the request.
From: Lydia Verschaffelt
Kia ora Joan
On behalf of Hon Chris Hipkins, Minister for COVID-19 Response, thank you for your request of 12 July 2021 under the Official Information Act 1982 (the Act).
The information requested appears to be more closely associated with the functions and responsibilities of the Ministry of Health. Accordingly, I am transferring your request to the Ministry under section 14(b)(ii) of the Act, and you can expect a response from them in due course.
You have the right, under section 28 of the Act, to ask the Ombudsman to review this decision to transfer your request for information.
Thank you again for writing.
Ngā mihi
Lydia Verschaffelt | Health Private Secretary
Office of Hon Chris Hipkins
Minister for COVID-19 Response | Minister of Education | Minister for the Public Service | Leader of the House
Parliament Buildings, Private Bag 18041, Wellington 6160, New Zealand
show quoted sections
Joan left an annotation ()
Hopefully the Ministry of Health will respond promptly to my request which has been transferred to them by Chris Hipkins.
Some additional research information to inform my request and the document linked as follows;
F. Pregnancy Adverse Drug Reactions
Given that vaccinated pregnant women comprise a small proportion of the vaccinated
population in the UK up to 26th May 2021, there appear to be a high number of Pregnancy ADRs
(307 ADRs), including one maternal death, 12 stillbirths (reported as 6 stillbirths and 6 foetal
deaths, but only 3 listed as fatal(?)), one newborn death following preterm birth, and 150
spontaneous abortions. We have submitted a FOI request as to the cause of the maternal death
and will look into pregnancy and congenital ADRs in more detail in our next report.
https://trialsitenews.com/wp-content/upl...
Joan left an annotation ()
The UK's Yellow Card Reporting System may help the Ministry of Health's response as at 30 June it shows 169 spontaneous abortions (miscarriages) in the COVID-19 mRNA Pfizer- BioNTech vaccine analysis print document and these numbers are for the same Covid-19 vaccine that New Zealand is using.
https://assets.publishing.service.gov.uk...
I don't have any more research to add so I will await the response from the Ministry of Health as advised.
Joan left an annotation ()
Unless anyone else has the results of studies or information that may help then that would be most appreciated.
Joan left an annotation ()
Hopefully they might hold off vaccinating pregnant women in the first two semesters until they sort this out or attend to my request as there does seem to be a problem here.
Joan left an annotation ()
In the New Zealand safety report #16 spreadsheet included with the week of June 19 2021 there is one instance of abortion on line 8154 following abdominal pain although it is not referred to as a 'spontaneous' abortion otherwise known as a miscarriage.
https://www.medsafe.govt.nz/COVID-19/AEF...
There are 146 instances of abdominal pain in females under 50 so I am assuming that if any of them had been pregnant and had a miscarriage then a report of this would have been included there.
From: OIA Requests
Kia ora Joan,
Thank you for your request for official information which was transferred
from Minister Chris Hipkins and received by the Ministry of Health on 12
July 2021. The Ministry’s reference number for your request is H202108431.
If you need to contact us at any stage about your request, please quote
this reference number in your correspondence. You requested:
“1. What information do you currently hold that says it is safe or that
there are no additional safety concerns with giving COVID-19 vaccines to
pregnant women at any stage of their pregnancy?
[1]http://scanmail.trustwave.com/?c=15517&a...
you accept that the study ‘Preliminary Findings of mRNA Covid-19 Vaccine
Safety in Pregnant Persons’ published in the New England Medical Journal
of June 2021’ shows that there were 104 spontaneous abortions or
miscarriages in the 127 pregnant women who received Covid-19 vaccines
during their first or second trimesters?
[2]http://scanmail.trustwave.com/?c=15517&a...
you agree that based on the results contained in this study and any other
information you may have available that New Zealand’s Covid-19 response
ought to be much more cautious about offering the Covid-19 vaccine to
pregnant women in the first 20 weeks of their pregnancy?
[3]http://scanmail.trustwave.com/?c=15517&a...
you believe that it is safe for pregnant women to be given the Covid-19
vaccine at any stage in their pregnancy or that being vaccinated for
Coivd-19 whilst pregnant poses no additional safety risks?
5.Based on the results of this study and possibly other available
information will the Covid-19 response be changed to advise pregnant women
against being vaccinated for Covid-19 in the first 20 weeks of their
pregnancy?”
Your request has been logged and you can expect a reply no later than 9
August 2021 as required under the Official Information Act 1982.
Ngâ mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [4][email address]
show quoted sections
References
Visible links
1. http://scanmail.trustwave.com/?c=15517&a...
2. http://scanmail.trustwave.com/?c=15517&a...
3. http://scanmail.trustwave.com/?c=15517&a...
4. mailto:[email address]
Joan left an annotation ()
Data from the United States VAERS (Vaccine Adverse Event Reaction System) reports the following number of spontaneous abortions or miscarriages entered in the system as possible adverse reaction to an mRNA Covid-19 vaccine as at 14 July 2021;
Count of VAERS ID Column Labels
Row Labels MODERNA PFIZER\BIONTECH Total
18-29 years 44 60 104
30-39 years 157 265 422
40-49 years 18 48 66
Grand Total 220 373 592
Information entered into VAERS should be treated with caution however as it is stated that Healthcare providers, vaccine manufacturers, and the public can submit reports to VAERS. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness.
However, due to the many detailed and comprehensive descriptions of these adverse events it is certainly worth reviewing what is there.
Joan left an annotation ()
The VAERS link is here; https://wonder.cdc.gov/vaers.html
Apologies as the table in my previous annotation didn't come out very well but at least it is there.
From: OIA Requests
Kia ora Joan,
Please find attached a letter regarding your request for information.
Ngā mihi
OIA Services Team
[1]Ministry of Health information releases
[2]Unite against COVID-19
show quoted sections
References
Visible links
1. https://www.health.govt.nz/about-ministr...
2. https://covid19.govt.nz/
Joan left an annotation ()
Question to the Ministry of Health
What information do you currently hold that says it is safe or that there are no additional safety concerns with giving COVID-19 vaccines to pregnant women at any
stage of their pregnancy?
Answer from the Ministry of Health: I am refusing your request under section 18(g)(i) of the Act as the information requested is not held by the Ministry and there are no grounds for believing it is held by another agency…..
Joan left an annotation ()
They have referred to breastfeeding twice in their answer where they refuse my request but I never mentioned breastfeeding in my request as it was clearly just about pregnant women only.
Joan left an annotation ()
According to Medsafe there have now been 25 spontaneous abortions or miscarriages reported as adverse events after vaccination and they have raised a safety signal. However their finding is that there is no evidence to suggest an increased risk of miscarriage after vaccination. There seems no point in replying to Nick Allen as based on his original response it doesn’t appear that he would be interested in reconsidering his response.
From: Joan
Dear OIA Requests,
With regard to the request reply from Nick Allan, according to Medsafe safety reports there have now been 25 spontaneous abortions or miscarriages reported as adverse events after vaccination and they have raised a safety signal. However their finding is that there is no evidence to suggest an increased risk of miscarriage after vaccination.
Please provide the analysis or reports that have led Medsafe to come to this finding subsequent to the safety signal being raised following the 25 miscarriages.
Yours sincerely,
Joan
From: OIA Requests
Kia ora,
Thank you for your Official Information Act (the Act) request. This is
an automatic reply to let you know we received it.
Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. We
will endeavour to acknowledge your request as soon as possible. Further
information about COVID-19 can be found on our
website: [1]https://www.health.govt.nz/our-work/dise...
In accordance with the Act, we'll let you know our decision within no more
than 20 working days. If you'd like to calculate the timeframe, you can
use the Ombudsman's online calculator
here: [2]http://www.ombudsman.parliament.nz/
If you have any questions while we're processing your request, please let
us know via [3][email address]
Ngā mihi
OIA Services Team
[4]Ministry of Health information releases
[5]Unite against COVID-19
show quoted sections
References
Visible links
1. https://www.health.govt.nz/our-work/dise...
2. http://scanmail.trustwave.com/?c=15517&a...
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/
From: OIA Requests
Kia ora Joan,
Thank you for your email.
Thousands of pregnant people have been vaccinated against COVID-19 in New
Zealand. Given that in general, 10-20% of clinically recognised
pregnancies result in miscarriage, the small number of reports of
miscarriage received does not suggest an increased risk. This experience
is consistent with that of international medicine regulators. Critical
review of the scientific literature has not identified evidence supporting
an increased risk of adverse pregnancy outcomes. As approximately 90
percent of the people in New Zealand over the age of 12 have now received
at least one dose of Comirnaty, there is a high probability that anyone
who develops an illness or condition in New Zealand will have been
recently vaccinated.
Please refer to the following references for further information:
1. Shimabukuro TT, Kim SY, Myers TR, et al. 2021. Preliminary Findings of
mRNA Covid-19 Vaccine Safety in Pregnant Persons. New England Journal
of Medicine 384(24): 2273-2282. DOI: 10.1056/NEJMoa2104983
2. Zauche LH, Wallace B, Smoots AN, et al. 2021. Receipt of mRNA Covid-19
Vaccines and Risk of Spontaneous Abortion. New England Journal of
Medicine 385(16): 1533-1535. DOI: 10.1056/NEJMc2113891
3. Bleicher I, Kadour-Peero E, Sagi-Dain L, et al. 2021. Early
exploration of COVID-19 vaccination safety and effectiveness during
pregnancy: interim descriptive data from a prospective observational
study. Vaccine 39(44): 6535-6538.
DOI: [1]https://doi.org/10.1016/j.vaccine.2021.0...
4. Blakeway H, Prasad S, Kalafat E, et al. COVID-19 Vaccination During
Pregnancy: Coverage and Safety. American Journal of Obstetrics &
Gynecology URL:https://doi.org/10.1016/j.ajog.2021.08.007,
DOI:10.1016/j.ajog.2021.08.007
5. Trostle ME, Limaye MA, Avtushka V, et al. 2021. COVID-19 vaccination
in pregnancy: early experience from a single institution. American
Journal of Obstetrics & Gynecology MFM 3(6): 100464.
DOI: [2]https://doi.org/10.1016/j.ajogmf.2021.10...
Under section 28(3) of the Act you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [3][email address] or by calling 0800
802 602.
Ngā mihi
OIA Services Team
[4]Ministry of Health information releases
[5]Unite against COVID-19
------------------------------------------------------------------------
From: Joan <[FOI #16031 email]>
Sent: Thursday, 25 November 2021 13:39
To: OIA Requests <[email address]>
Subject: Re: OIA H202108431 Response
Dear OIA Requests,
With regard to the request reply from Nick Allan, according to Medsafe
safety reports there have now been 25 spontaneous abortions or
miscarriages reported as adverse events after vaccination and they have
raised a safety signal. However their finding is that there is no evidence
to suggest an increased risk of miscarriage after vaccination.
Please provide the analysis or reports that have led Medsafe to come to
this finding subsequent to the safety signal being raised following the 25
miscarriages.
Yours sincerely,
Joan
show quoted sections
Things to do with this request
- Add an annotation (to help the requester or others)
- Download a zip file of all correspondence
Offensive? Unsuitable?
Requests for personal information and vexatious requests are not considered valid requests for Official Information (read more).
If you believe this request is not suitable, you can report it for attention by the site administrators
Report this requestAct on what you've learnt
Similar requests
Information provided to Covid-19 vaccinators about vaccinating pregnant people
To Andrew Little by Joan
Ross Francis left an annotation ()
Joan,
In April 2021, vaccinators - as part of their online education course - were advised:
"To date, clinical studies have not investigated the mRNA vaccine in pregnancy. ... It is recommended to delay vaccination until after delivery if [the] pregnant woman is at low risk of exposure..." Clearly, there is low risk of exposure in New Zealand.
Ross
Link to this