@hartgroup_org @ClareCraigPath
@MHRAgovuk have confirmed that the @Pfizer_UK BA4/5 vaccine was approved based on BA1 data.
Even more worrying this was not a Regulation 174 temporary authorisation, it is full marketing authorisation.
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@MHRAgovuk have confirmed that the @Pfizer_UK BA4/5 vaccine was approved based on BA1 data.
Even more worrying this was not a Regulation 174 temporary authorisation, it is full marketing authorisation.
👇
Regarding the authorisation of Comirnaty Original/Omicron BA4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified – PLGB 53632/0012), the following information is on the European Medicines Agency (EMA) website (ema.europa.eu/en/medicines/h…)
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“Apart from containing mRNA matching different, but closely related, Omicron subvariants, Comirnaty Original/BA1 and Comirnaty Original/Omicron BA.4-5 have the same composition. Therefore, based on clinical studies showing that Comirnaty Original/Omicron BA.1 triggers an immune👇
response to the original strain and Omicron BA.1, Comirnaty Original/Omicron BA.4-5 is expected to generate an immune response against both the original strain and the subvariants BA.4 and BA.5.
In particular, Comirnaty Original/Omicron BA.4-5 is
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In particular, Comirnaty Original/Omicron BA.4-5 is
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expected to be more effective than Comirnaty at triggering an immune response against the BA.4 and BA.5 subvariants. These data are further supported by non-clinical laboratory data on the ability of Comirnaty Original/Omicron BA.4-5 to trigger an adequate immune response.”
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The above medicinal product has not been granted temporary authorisation via Regulation 174, it has been granted a marketing authorisation. Further information, including the Public Assessment Report (PAR) published by the EMA is available via the link above. 👇
The UK Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) is available via the below link, a PAR will be published for this product in the next 60 calendar days.
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Even more reason to sign this
Petition: Launch a Public Inquiry into the approval process for covid-19 vaccines petition.parliament.uk/petitions/6281…
And write to your MP
#MHRAFromWatchdogToEnabler
Write to your MP too docs.google.com/document/d/1-w…
Petition: Launch a Public Inquiry into the approval process for covid-19 vaccines petition.parliament.uk/petitions/6281…
And write to your MP
#MHRAFromWatchdogToEnabler
Write to your MP too docs.google.com/document/d/1-w…
@threadreaderapp unroll
Sorry the link to the PIL & Summary of Product Characteristics was missing from the FOI response (an error by @MHRAgovuk), it is here
gov.uk/government/pub…
gov.uk/government/pub…
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