in

UK, Official guidelines

Green book, JCVI advises that breastfeeding women should be offered any suitable COVID-19 vaccine.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1098808/Greenbook-chapter-14A-17August2022.pdf

(Updated, 17th August, 2022)

Summary of the Public Assessment Report. For covid-19 vaccine, Pfizer/BioNTec

https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine

Women who are breastfeeding should also not be vaccinated.

(Updated, 16th August, 2022)

Summary of the Public Assessment Report

Authorisation for Temporary Supply, COVID-19 mRNA Vaccine BNT162b2 (BNT162b2 RNA) concentrate for solution for injection

Department of Health and Social Care (DHSC), Pfizer Limited & BioNTech Manufacturing, GmbH

https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine

Updated, 16th August, 2022

Reproductive and developmental toxicity

Fertility and early embryonic development and embryofoetal development

A combined fertility and developmental study (including teratogenicity and postnatal investigations) in rats is ongoing.

Prenatal and postnatal development, including maternal function

No such studies have been done.

Studies in which the offspring (juvenile animals) are dosed and/or further evaluated

No such studies have been done.

Local tolerance

No such studies have been done.

The assessments made as part of the general toxicity study should suffice and a separate study is not needed.

Other toxicity studies

No such studies have been done.

Toxicity conclusions

The absence of reproductive toxicity data is a reflection of the speed of development to first identify and select COVID-19 mRNA Vaccine BNT162b2 for clinical testing and its rapid development to meet the ongoing urgent health need.

In principle, a decision on licensing a vaccine could be taken in these circumstances without data from reproductive toxicity studies animals,

but there are studies ongoing and these will be provided when available.

In the context of supply under Regulation 174,

it is considered that sufficient reassurance of safe use of the vaccine in pregnant women cannot be provided at the present time:

however, use in women of childbearing potential could be supported,

provided healthcare professionals are advised to rule out known or suspected pregnancy prior to vaccination.

Women who are breastfeeding should also not be vaccinated.

Green book, updated 17th August 2022

Specific population groups

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1098808/Greenbook-chapter-14A-17August2022.pdf

Pregnancy

There is no known risk associated with giving inactivated, recombinant viral or bacterial vaccines or toxoids during pregnancy or whilst breastfeeding (Kroger et al, 2013).

Developmental and reproductivity testing of the Pfizer BioNTech, Moderna and AstraZeneca vaccines in animals have not raised any concerns.

JCVI has therefore advised that women who are pregnant should be recommended to receive primary immunisation,

and that pregnancy is considered a clinical risk group for the autumn booster programme.

Routine questioning about last menstrual period and/or pregnancy testing is not required before offering the vaccine.

Surveillance of the inadvertent administration of COVID-19 vaccines in early pregnancy is being conducted for the UK by the UK Health Security Agency Immunisation and Vaccine Preventable Diseases Division, to whom such cases should be reported.1

This surveillance is being undertaken to document safety in women who unknowingly receive a vaccine in early pregnancy

Breastfeeding

There is no known risk associated with being given a non-live vaccine whilst breastfeeding.

JCVI advises that breastfeeding women should be offered any suitable COVID-19 vaccine.

Written by Dr. John Campbell

Hello Everyone,My name is John Campbell and I am a retired Nurse Teacher and A and E nurse based in England. I also do some teaching in Asia and Africa when time permits. These videos are to help students to learn the background to all forms of health care. My PhD focused on the development of open learning resources for nurses nationally and internationally.

Comments

Leave a Reply
  1. untested newly developed vaccine…what could possibly go wrong? I mean it's not as if the pharma companies have a more than dodgey past record is it? and of course we can always sue them if anything bad happens…umm oh no we can't

  2. JCVI doesn't say they should be vaccinated, it says they should be OFFERED it. Those who don't know the Public Assessment information might accept at their own risk … but that's not fully informed consent. The devil is in the detail to avoid liability. Their body their choice, sadly! Thank you Dr John, it's no wonder you were promoting it at the start with all the confusing information.

  3. This sort of thing happens to liars quite a bit I imagine. Eventually they forget what they have already said and are caught. They then must come clean or double-down on the previous nonsense and spin yet more lies in a vain attempt to cover themselves. But again, they have forgotten what they said and when they've said it and so the new lie conflicts with yet another older lie and they are caught again. Of course what we see with the government and the media is they often simply choose to ignore that they been caught and pretend like its not happening. They have put their money on everyone forgetting…and believing a still newer lie.

  4. As we've said all throughout this, the most medical misinformation has come from the media and authoritative sources – like government and their advisors. Just look at Fauci's innumerable contradictions. It's why it makes me so sick that YouTube threaten and censor people like John – because he's sincere.

  5. Shockingly clear contradictions in advice. Thank you for pointing this out – I've already decided not to have the 'autumn booster'. I had two vaccines and have not had any boosters since… I've also not contracted Covid in any variant. I'll happily have my autumn flu vaccine in October, so not anti-vax in any way. I'm just anti covid vaccine.

  6. It’s insane watching a good doctor like this so obviously have to walk a nonsense line where he is forced to leave important perspective out, so he doesn’t get chastised and punished.

  7. Never underestimate the dark side of these folks there are so many corrupt individuals out there it' s sickening. We never believed in this jab still don't and the sick minds in the world leaders are so transparent just lots of weak followers out there.

  8. This is the biggest ass covering I have ever seen. Total contradictions from start to finish. "Pregnant women should not be vaccinated but also should be vaccinated". What nonsense. Either our health professionals are incompetent or just plain stupid.

  9. When enough people sign a petition demanding the return of free speech and take it through the court system, free speech will return. That is holding the governments to account, but only when the people decide and get angry enough will this occur, and I believe that big tech will also have to be held to account for their free will choice to prevent free speech! We need lawyers who actually believe in free speech to come forward and stand up for the "People". I am sure the "People" would be willing to fund them. So, I am here challenging any lawyer who is watching this to step and start the process.

  10. Thanks for the info.

    For me personally, whom is thrice vaccinated, our family all still got omicron after the Christmas holiday (very low symptoms, 3 year old had a sleepy two days and a mild fever. Not going to get him vaccinated after he caught the virus). At this point, I don't see any need for more vaccinations unless something changes.

  11. The box in the heading of the MHRA report says they haven't changed the text since its original publication. This doesn't mean they haven't changed their advice. The note also says their latest advice is accessed via the two links in the box. The Yellow Card link has an extensive analysis of experience with vaccination of pregnant women. They conclude there is no greater risk of adverse outcomes in vaccinated women compared to those who weren't. This is a real world update so should be good. The only thing that might throw a spanner in the works is under reporting, but with such large numbers in the study, it seems like the effect would be small. I do think leaving the original text as the first thing you see is all too easy to misinterpret. It would have been better to publish the updated view with the original in an archive.

  12. 14:10 "I will be looking in the comments if I've completely misunderstood something. Do please let me know."
    MHRA "The Public Assessment Report summarises the initial assessment at the time of approval in December 2020. The text in the original report remains unchanged.
    Our advice is regularly updated on the basis of significant new data and our latest advice can be found in the Summary of Product Characteristics on this page and the Summary of Coronavirus Yellow Card reporting." It's on the page John kindly provided a link to (Summary of the Public Assessment Report).

  13. Dr John are you able to address what is being presented in the news. They are saying the updated report is referring to boosters not advisable for pregnant and breastfeeding women? They say people are misinterpreting the info. Something is not right here? Hope you can clarify.

  14. There should be no confusion. By both recommending breastfeeding women do get vaccinated and also recommending they do not get vaccinated it provides those making the recommendation an out if things should go badly. In case things go badly they can direct the media to their statements that breastfeeding women should not be vaccinated. The media will dutifully accept this information without asking difficult questions and those who made the recommendation/disrecommendation can avoid accountability. It is called muddying the waters.

Leave a Reply

Your email address will not be published.

Loading…

0