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<p>The Department has not directly received data from AstraZeneca regarding potential
adverse effects of their COVID-19 vaccine Vaxzevria, as it is not the appropriate
body to receive this information. It instead relies on the expert advice of the Medicines
and Healthcare products Regulatory Agency (MHRA).</p><p>All vaccine manufacturers
have a legal responsibility to mitigate risk and monitor the safety and performance
of vaccines throughout the product lifecycle. This includes a legal responsibility
to transmit reports of suspected adverse reactions received directly to the MHRA.
Following the MHRA’s receipt of the first Yellow Card reports of suspected thrombosis
and associated thrombocytopaenia associated with the Vaxzevria vaccine in February
2021, AstraZeneca provided the Commission on Human Medicines’ Vaccine Benefit Risk
Expert Working Group an analysis of the age stratified risk of thrombosis with thrombocytopenia
associated with the AstraZeneca vaccine. This was assessed by the Commission on Human
Medicines, with the Patient Information updated to state the risks of these events.</p>
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