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Safety of Pfizer covid-19 vaccine for pregnancy and breastfeeding women

Caitlin Smith made this Official Information request to Ministry of Health

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From: Caitlin Smith

Dear Ministry of Health,

On the Medsafe website (https://www.medsafe.govt.nz/COVID-19/q-a...) it states that there is limited information available on the safety of the Comirnaty vaccine for pregnant women. As I understand it the Pfizer clinical trials have not been completed for use of the Comirnaty vaccine in pregnant and breastfeeding women. Yet the Ministry of Health website states that the vaccine is safe for pregnant and breastfeeding women: https://www.health.govt.nz/our-work/dise...

Why is there contradictory information being provided here? How can the Ministry of Health State that the covid vaccine is safe for pregnant and breastfeeding women when the Medsafe website states that there is limited information on the safety of the vaccine for pregnant women? Where is the Ministry of Health of getting the data from for clinical trials on pregnant and breastfeeding women? Has the FDA approved the use of the Pfizer covid vaccine for use in pregnant and breastfeeding women?
Please could you provide the safety data, including clinical trial data collected in New Zealand and overseas that proves the safety of and authorisation for use of the Pfizer covid vaccine in pregnant and breastfeeding women?

Yours faithfully,
Caitlin

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Kia ora Caitlin,

 

Thank you for your email.

 

The Datasheet for Comirnaty contains some information about Fertility,
Pregnancy, Breast
feeding. - [1]https://www.medsafe.govt.nz/profs/Datash...

Datasheets contain information about the medicine, including the approved
indication and information from clinical trials which have been run. 

 

I have copied the relevant part for you here:

4.6 Fertility, pregnancy and lactation

 

Fertility

In a combined fertility and developmental toxicity study, female rats were
intramuscularly administered COMIRNATY prior to mating and during
gestation (4 full human doses of 30 μg each, spanning between pre-mating
day 21 and gestation day 20). SARS-CoV-2 neutralising antibodies were
present in maternal animals from prior to mating to the end of the study
on postnatal day 21 as well as in fetuses and offspring. There were no
vaccine related effects on female fertility and pregnancy rate.

 

Pregnancy

There is limited experience with use of COMIRNATY in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with
respect to pregnancy, embryo/fetal development, parturition or post-natal
development (see Fertility). Administration of COMIRNATY in pregnancy
should only be considered when the potential benefits outweigh any
potential risks for the mother and fetus.

Lactation
It is unknown whether BNT162b2 [mRNA] is excreted in human milk. A
combined fertility and developmental toxicity study in rats did not show
harmful effects on offspring development before weaning (see Fertility).

Pfizer is currently running a study on pregnant woman; some details can be
found here - 

[2]https://www.clinicaltrials.gov/ct2/show/...

There is limited data available about the outcome because the trial is
still running. 

 

It is important to remember that all medicines contain risk and benefits,
however real world evidence of the use of the vaccine in pregnant woman to
date suggests that the benefits are likely to outweigh the risks.  Some
further information can be found
here:  [3]https://www.health.gov.au/resources/publ...

 

You may also be interested in the COVID-19 Immunisations handbook
here: [4]https://www.health.govt.nz/our-work/immu...

 

The Ministry also regularly updates the Science News page for up to
date information regarding COVID-19 and the
Vaccine: [5]https://www.health.govt.nz/our-work/dise...
 

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: [6][email address] or by calling 0800
802 602.

 

Ngā mihi 

OIA Services Team 

  

[7]Ministry of Health information releases 

[8]Unite against COVID-19 

 

 

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This is an Official Information request made via the FYI website.

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References

Visible links
1. https://www.medsafe.govt.nz/profs/Datash...
2. https://www.clinicaltrials.gov/ct2/show/...
3. https://www.health.gov.au/resources/publ...
4. https://www.health.govt.nz/our-work/immu...
5. https://www.health.govt.nz/our-work/dise...
6. mailto:[email address]
7. https://www.health.govt.nz/about-ministr...
8. https://covid19.govt.nz/
9. https://www.medsafe.govt.nz/COVID-19/q-a...
10. https://www.health.govt.nz/our-work/dise...
11. https://scanmail.trustwave.com/?c=15517&...
12. https://scanmail.trustwave.com/?c=15517&...

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victor left an annotation ()

https://www.nejm.org/doi/full/10.1056/NE...

MOH and MEDSAFE have been at odds on this issue since the provisional approval in which pregnancy breastfeeding and lactating are classified as 'missing'

The NEJM published study needed to be corrected and is still propagating misleading dangerous information by misrepresenting the datasets used as the denominator to determine the spontaneous abortion (miscarriage) percentages in the trial.

NEJM is still obscuring the proper calculation.

Letter to Editor – Comment on “mRNA Covid-19 Vaccine Safety in Pregnant Women”, Shimabukuro et al. (NEJM Apr 2021)

TO THE EDITOR

The article by Shimabukuro et al. 2021 presents preliminary safety results of coronavirus 2019 mRNA vaccines used in pregnant women from the V-Safe Registry.1 These findings are of particular importance, as pregnant women were excluded from the phase III trials assessing mRNA vaccines.

In table 4, the authors report a rate of spontaneous abortions <20 weeks (SA) of 12.5% (104 abortions/827 completed pregnancies). However, this rate should be based on the number of women who were at risk of an SA due to vaccine receipt and should exclude the 700 women who were vaccinated in their third-trimester (104/127 = 82%). We acknowledge this rate will likely decrease as the pregnancies of women who were vaccinated <20 weeks complete but believe the rate will be higher than 12.5%.

However, given the importance of these findings we feel it important to report these rates accurately. Additionally, the authors indicate that the rate of SAs in the published literature is between 10% and 26%.3-5 However, the upper cited rate includes clinically-unrecognized pregnancies,3 which does not reflect the clinically-recognized pregnancies of this cohort and should be removed.

END

This subject is total abragation by NZ MOH

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victor left an annotation ()

The FDA assured the public that it will provide transparency for any COVID-19 vaccine it approves. That promise would surely include letting the public know what is in the vial being injected into the arms of millions of people.

Nonetheless, the FDA has chosen to hide from the public an ingredient that constitutes more than 20% of the undiluted vial of each Pfizer vaccine!

Upon licensure of the Pfizer vaccine, the FDA authorized a fact sheet to be given to the public, which includes a list of ingredients in the vaccine. https://www.fda.gov/media/144414/download Amazingly, this list doesn’t mention a secret ingredient.

What is the secret ingredient?

Nobody knows other than Pfizer and the FDA. In the technical documentation that is not intended for general public distribution, the FDA disclosed that this secret ingredient constitutes about 22% of the undiluted vial (0.45 mL of 2 mL) but completely redacted the name of the secret ingredient. https://www.fda.gov/media/151733/download

ICAN’s attorneys immediately contacted the FDA and asked for the redaction to be lifted. However, the FDA refused to do so without a formal demand. Therefore, ICAN, through its attorneys, submitted a formal demand to the FDA to disclose the identity of the secret ingredient.

ICAN believes that the public has a right to know what makes up over 20% of the undiluted volume of each Pfizer vaccine that federal, state, and local governments in the United States, and in other countries around the world, are mandating their citizens receive.

We will never stop demanding full transparency from government agencies and officials because without transparency, informed consent is not possible.

https://www.icandecide.org/wp-content/up...

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