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These are the key facts about the Pfizer-Biontech product’s assessment under Reg174 at the MRHA:

  • This medicinal product does not have a UK marketing authorisation but has been given authorisation for temporary supply by the UK Department of Health and Social Care
  • It has no approval at all for people aged under 16
  • The administration of COVID-19 mRNA Vaccine BNT162b2 should be postponed in individuals suffering from acute severe febrile illness
  • No interaction or contraindication studies have been performed. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products
  • No interaction or contraindication studies have been performed. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products
  • COVID-19 mRNA Vaccine BNT162b2 is not recommended during pregnancy. For women of childbearing age, pregnancy should be excluded before vaccination
  • It is unknown whether COVID-19 mRNA Vaccine BNT162b2 is excreted in human milk
  • The effects of the vaccine on fertility are unknown

Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the Coronavirus Yellow Card reporting site https://coronavirus-yellowcard.mhra.gov.uk/

The MHRA was given just five days to study the mRNA Vaccine BNT162b2.
Hancock called this “the closest scrutiny”.

Its safety and effectiveness have not been “clearly established”.

The Pfizer product has been given a temporary, narrow approval under the emergency Covid19 legal instruments so eagerly approved by our braindead MPs earlier this year.

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