Chris Inquires What Data AstraZeneca Sent About Covid Vaccine Damage
Christopher Chope Conservative, Christchurch
To ask the Secretary of State for Health and Social Care, whether (a) his Department and (b) the Medicines and Healthcare products Regulatory Agency has received data from Astra Zeneca on the potential serious adverse effects of its covid-19 vaccine for a small number of recipients.
Maria Caulfield The Parliamentary Under-Secretary for Health and Social Care, Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
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).
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.
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