Pfizer Comirnaty Package Insert

Posted on 8th September, 2021

 

COMIRNATY has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility. It is not known whether COMIRNATY is excreted in human milk.

 

The Pfizer Cominaty Package Insert (PDF), states:

  • Section 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
  • COMIRNATY has not been evaluated for the potential to cause carcinogenicity (CANCER), genotoxicity (GENE DAMAGE), or impairment of male fertility (REDUCTION OR LOSS OF FERTILITY). In a developmental toxicity study in rats with COMIRNATY there were no vaccine-related effects on female fertility [see Use in Specific Populations (8.1)]. (Also, carcinogenicity)
  • Section 8.2 Risk Summary
  • It is not known whether COMIRNATY is excreted in human milk (PASSED TO BREAST FED BABIES). Data are not available to assess the effects of COMIRNATY on the breastfed infant or on milk production/excretion.
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for COMIRNATY and any potential adverse effects on the breastfed child from COMIRNATY or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.

UK pregnancy leaflet (Link and PDF)

Public Health England Feb 2021 poster asking "Please help monitor COVID-19 vaccine safety in pregnancy", which states "The large trials which showed that these vaccines are safe and effective did not include pregnant women – as often happens in clinical trials (Link and PDF)

 

UK Govt commissioned a new Yellow Card system for the expected overwhelming reactions expected to occur (See blog FEB21)

  • UK government indicated that it is expecting a large number of side effects as indicated in their tender for a new COVID19 AI system (para II.1.4), "The MHRA urgently seeks an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) and ensure that no details from the ADRs’ reaction text are missed". On 19OCT20 MHRA paid Genpact UK Ltd £1.5million for the AI system (paras (paras V.2.3 & V.2.4).

See JCVI 07JUN21

  • "However, the JCVI currently advises that children under 16 years of age, even if they are clinically extremely vulnerable (CEV), are at low risk of serious morbidity and mortality and given the absence of safety and efficacy data on COVID-19 vaccines, are not currently recommended for routine COVID-19 vaccination." (PDF)

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09SEP21 - UK Pfizer Package Insert Related

Summary of Product Characteristics for COVID-19 Vaccine Pfizer/BioNTech (PDF)

  • Section 4.5 "No interaction studies have been performed. Concomitant administration of Comirnaty with other vaccines (e.g. flu, tetnus, etc?) has not been studied."
  • Section 5.3 "Genotoxicity/Carcinogenicity Neither genotoxicity nor carcinogenicity studies were performed"
  • Section 5.3 "Reproductive and developmental toxicity were investigated in rats ..." (not humans as the vaccines have only been around a few months and have not completed trials which take several years!!) 
  • Section 4.6 "Breastfeeding - It is unknown whether Comirnaty is excreted in human milk"
  • Section 4.6 "Pregnancy - There is limited experience with use of Comirnaty in pregnant women ..."
  • Section 4.2 "There are no data available on the interchangeability of Comirnaty with other COVID-19 vaccines ..." (what about the children that were unofficially vaccinated with non-Pfizer products?)
    • Section 4.4. "A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Comirnaty."
  • Section 4.4 "Special warnings and precautions for use"
    • Very rare cases of myocarditis and pericarditis
    • Urticaria and angioedema was Rare.
    • Rare: Acute peripheral facial paralysis (or palsy)
  • Section 4.8 "Undesirable Effects" NB: Definitions:
    • "Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data)"  Age Groups in the UK (PDF) [Extract of Children and Young Adults in the UK ]
    • NB UK Govt commissioned a new Yellow Card system for the expected overwhelming reactions expected to occur.
    • The UK government indicated that it is expecting a large number of side effects as indicated in their tender for a new COVID19 AI system (para II.1.4), "The MHRA urgently seeks an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) and ensure that no details from the ADRs’ reaction text are missed". On 19OCT20 MHRA paid Genpact UK Ltd £1.5million for the AI system (paras (paras V.2.3 & V.2.4).
  • Section 6.1 " List of excipients"

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