I'm in Australia, here the governing body which approves medicine and vaccines is Therapeutic Goods Association. Two vaccines are currently conditionally approved here, the AstraZenica and Pfizer ones. The product information for each (these are not consumer PI but applicant PI) tell some interesting tales...
Product Information for Comirnaty (Pfizer) https://www.tga.gov.au/sites/default/files/auspar-bnt162b2-mrna-210125-pi.pdf
Section 4.6 is about pregnancy specifically, mentions determination for use in humans is based upon assessment of tests ran on lab rats. It is unknown if anything is excreted in human milk.
Public Assessment Report for Comirnaty (Pfizer) https://www.tga.gov.au/sites/default/files/auspar-bnt162b2-mrna-210125.pdf
Page 14 - "Antibodies and T cells in monkeys declined quickly over 5 weeks after the second dose of BNT162b2 (V9),18 raising concerns over long term immunity, which will be assessed by clinical studies according to the sponsor."
Page 19 - Is about Phase II / III trials which on the previous pages is mentioned as being the trial to assess its viability and safety on the larger population. Here are the list of excluded parties from the trials:
• Other medical or psychiatric conditions, including recent or active suicidal ideation/behaviour or laboratory abnormality that increased the risk of participation or, in the investigator’s judgment, made the participant inappropriate for the study.
• Immunocompromised individuals and individuals who received treatment with immunosuppressive therapy.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate IM injection.
• Participants who had previous clinical or microbiological diagnosis of COVID-19 disease.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the study intervention.
• Women who are pregnant or breastfeeding.
Page 28 - Although one of the least likely symptoms from receiving the vaccine, instances of Bell's Palsy has been reported.
Page 29 - "Pregnant women: at the time of the data cut-off (14 November 2020), a total of 23 participants had reported pregnancies in the safety database, including 9 participants who withdrew from the vaccination period of the study due to pregnancies. These participants continue to be followed for pregnancy outcomes. The data to support safety in pregnancy are inadequate at this stage." 23 - 9 = 14. Fourteen women trialed.
Page 34 - Risk management plan. Basically will tell you all the test data they haven't or can't provide at this stage.
Product Information for AstraZenica https://www.tga.gov.au/sites/default/files/auspar-chadox1-s-covid-19-vaccine-astrazeneca-210215-pi.pdf
Page 1 - "The vaccine is manufactured using material originally sourced from a human embryo (Human Embryonic Kidney cells: HEK293)" - Shit, right out the gate, eh?
Page 4 - They have no idea what it does long term to male and female fertility. Plus this...
"There are a limited amount of data from the use of COVID-19 Vaccine AstraZeneca in pregnant women, or women who became pregnant after receiving the vaccine. The data are insufficient to inform on vaccine associated risk. Animal reproductive toxicity studies have not been completed. As a precautionary measure, vaccination with COVID-19 Vaccine AstraZeneca is not recommended during pregnancy. Use of COVID-19 VaccineAstraZeneca in pregnant women should be based on an assessment of whether the benefits of vaccination outweigh the potential risks."
There's a ton more within and here is the final document. I won't list more, people should pour over it. Feel free to point out anything wrong or anything missed. I am human and am capable of mistakes although every care has been taken to ensure what I'm talking about seems to check out. That said, hold me to the same standard I hold others, scrutinize everything...
Oh, the final doc. Public Assessment for AstraZenica https://www.tga.gov.au/sites/default/files/auspar-chadox1-s-covid-19-vaccine-astrazeneca-210215.pdf
One last thing... Provisional approval for both vaccines is granted on the basis of the sponsor supplying TGA with new test data every 6 months. It also is approved because it has an Section 14 exemption from the 1989 Therapeutic Goods Act which is the standard that makes sure things are up to our standard. Based on what you see above, you see why.
EDIT: Here is the original source pages, so users can look further and know it isn't just obscure PDFs referenced.
https://www.tga.gov.au/auspar/auspar-bnt162b2-mrna-comirnaty https://www.tga.gov.au/auspar/auspar-chadox1-s
I'm in Australia, here the governing body which approves medicine and vaccines is Therapeutic Goods Association. Two vaccines are currently conditionally approved here, the AstraZenica and Pfizer ones. The product information for each (these are not consumer PI but applicant PI) tell some interesting tales... Product Information for Comirnaty (Pfizer) https://www.tga.gov.au/sites/default/files/auspar-bnt162b2-mrna-210125-pi.pdf Section 4.6 is about pregnancy specifically, mentions determination for use in humans is based upon assessment of tests ran on lab rats. It is unknown if anything is excreted in human milk. Public Assessment Report for Comirnaty (Pfizer) https://www.tga.gov.au/sites/default/files/auspar-bnt162b2-mrna-210125.pdf Page 14 - "Antibodies and T cells in monkeys declined quickly over 5 weeks after the second dose of BNT162b2 (V9),18 raising concerns over long term immunity, which will be assessed by clinical studies according to the sponsor." Page 19 - Is about Phase II / III trials which on the previous pages is mentioned as being the trial to assess its viability and safety on the larger population. Here are the list of excluded parties from the trials: • Other medical or psychiatric conditions, including recent or active suicidal ideation/behaviour or laboratory abnormality that increased the risk of participation or, in the investigator’s judgment, made the participant inappropriate for the study. • Immunocompromised individuals and individuals who received treatment with immunosuppressive therapy. • Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate IM injection. • Participants who had previous clinical or microbiological diagnosis of COVID-19 disease. • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the study intervention. • Women who are pregnant or breastfeeding. Page 28 - Although one of the least likely symptoms from receiving the vaccine, instances of Bell's Palsy has been reported. Page 29 - "Pregnant women: at the time of the data cut-off (14 November 2020), a total of 23 participants had reported pregnancies in the safety database, including 9 participants who withdrew from the vaccination period of the study due to pregnancies. These participants continue to be followed for pregnancy outcomes. The data to support safety in pregnancy are inadequate at this stage." 23 - 9 = 14. Fourteen women trialed. Page 34 - Risk management plan. Basically will tell you all the test data they haven't or can't provide at this stage. Product Information for AstraZenica https://www.tga.gov.au/sites/default/files/auspar-chadox1-s-covid-19-vaccine-astrazeneca-210215-pi.pdf Page 1 - "The vaccine is manufactured using material originally sourced from a human embryo (Human Embryonic Kidney cells: HEK293)" - Shit, right out the gate, eh? Page 4 - They have no idea what it does long term to male and female fertility. Plus this... "There are a limited amount of data from the use of COVID-19 Vaccine AstraZeneca in pregnant women, or women who became pregnant after receiving the vaccine. The data are insufficient to inform on vaccine associated risk. Animal reproductive toxicity studies have not been completed. As a precautionary measure, vaccination with COVID-19 Vaccine AstraZeneca is not recommended during pregnancy. Use of COVID-19 VaccineAstraZeneca in pregnant women should be based on an assessment of whether the benefits of vaccination outweigh the potential risks." There's a ton more within and here is the final document. I won't list more, people should pour over it. Feel free to point out anything wrong or anything missed. I am human and am capable of mistakes although every care has been taken to ensure what I'm talking about seems to check out. That said, hold me to the same standard I hold others, scrutinize everything... Oh, the final doc. Public Assessment for AstraZenica https://www.tga.gov.au/sites/default/files/auspar-chadox1-s-covid-19-vaccine-astrazeneca-210215.pdf One last thing... Provisional approval for both vaccines is granted on the basis of the sponsor supplying TGA with new test data every 6 months. It also is approved because it has an Section 14 exemption from the 1989 Therapeutic Goods Act which is the standard that makes sure things are up to our standard. Based on what you see above, you see why. https://www.tga.gov.au/consent-import-supply-or-export-therapeutic-goods-do-not-comply-standards-information-industry
EDIT: Here is the original source pages, so users can look further and know it isn't just obscure PDFs referenced.
https://www.tga.gov.au/auspar/auspar-bnt162b2-mrna-comirnaty https://www.tga.gov.au/auspar/auspar-chadox1-s
I'm in Australia, here the governing body which approves medicine and vaccines is Therapeutic Goods Association. Two vaccines are currently conditionally approved here, the AstraZenica and Pfizer ones. The product information for each (these are not consumer PI but applicant PI) tell some interesting tales...
Product Information for Comirnaty (Pfizer) https://www.tga.gov.au/sites/default/files/auspar-bnt162b2-mrna-210125-pi.pdf
Section 4.6 is about pregnancy specifically, mentions determination for use in humans is based upon assessment of tests ran on lab rats. It is unknown if anything is excreted in human milk.
Public Assessment Report for Comirnaty (Pfizer) https://www.tga.gov.au/sites/default/files/auspar-bnt162b2-mrna-210125.pdf
Page 14 - "Antibodies and T cells in monkeys declined quickly over 5 weeks after the second dose of BNT162b2 (V9),18 raising concerns over long term immunity, which will be assessed by clinical studies according to the sponsor."
Page 19 - Is about Phase II / III trials which on the previous pages is mentioned as being the trial to assess its viability and safety on the larger population. Here are the list of excluded parties from the trials:
• Other medical or psychiatric conditions, including recent or active suicidal ideation/behaviour or laboratory abnormality that increased the risk of participation or, in the investigator’s judgment, made the participant inappropriate for the study.
• Immunocompromised individuals and individuals who received treatment with immunosuppressive therapy.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate IM injection.
• Participants who had previous clinical or microbiological diagnosis of COVID-19 disease.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the study intervention.
• Women who are pregnant or breastfeeding.
Page 28 - Although one of the least likely symptoms from receiving the vaccine, instances of Bell's Palsy has been reported.
Page 29 - "Pregnant women: at the time of the data cut-off (14 November 2020), a total of 23 participants had reported pregnancies in the safety database, including 9 participants who withdrew from the vaccination period of the study due to pregnancies. These participants continue to be followed for pregnancy outcomes. The data to support safety in pregnancy are inadequate at this stage." 23 - 9 = 14. Fourteen women trialed.
Page 34 - Risk management plan. Basically will tell you all the test data they haven't or can't provide at this stage.
Product Information for AstraZenica https://www.tga.gov.au/sites/default/files/auspar-chadox1-s-covid-19-vaccine-astrazeneca-210215-pi.pdf
Page 1 - "The vaccine is manufactured using material originally sourced from a human embryo (Human Embryonic Kidney cells: HEK293)" - Shit, right out the gate, eh?
Page 4 - They have no idea what it does long term to male and female fertility. Plus this... "There are a limited amount of data from the use of COVID-19 Vaccine AstraZeneca in pregnant women, or women who became pregnant after receiving the vaccine. The data are insufficient to inform on vaccine associated risk. Animal reproductive toxicity studies have not been completed. As a precautionary measure, vaccination with COVID-19 Vaccine AstraZeneca is not recommended during pregnancy. Use of COVID-19 VaccineAstraZeneca in pregnant women should be based on an assessment of whether the benefits of vaccination outweigh the potential risks."
There's a ton more within and here is the final document. I won't list more, people should pour over it. Feel free to point out anything wrong or anything missed. I am human and am capable of mistakes although every care has been taken to ensure what I'm talking about seems to check out. That said, hold me to the same standard I hold others, scrutinize everything...
Oh, the final doc.
Public Assessment for AstraZenica https://www.tga.gov.au/sites/default/files/auspar-chadox1-s-covid-19-vaccine-astrazeneca-210215.pdf
One last thing...
Provisional approval for both vaccines is granted on the basis of the sponsor supplying TGA with new test data every 6 months. It also is approved because it has an Section 14 exemption from the 1989 Therapeutic Goods Act which is the standard that makes sure things are up to our standard. Based on what you see above, you see why.