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MHRA seeks ‘expert advice’ on Oxford vaccine allergy risks


MHRA


The MHRA has sought ‘expert advice’ on the allergy risks associated with the Oxford/AstraZeneca vaccine, but said that current evidence suggests a specific monitoring period after vaccination remains unnecessary.

Under current guidance, GPs need to observe patients for 15 minutes after administering the Pfizer/BioNTech Covid vaccine – but do not need to with the Oxford/AstraZeneca version.

Recent data published by the medicine regulator showed that anaphylaxis or anaphylactoid reactions after an Oxford/AstraZeneca Covid vaccination were ‘very rare’, with 60 reports of this following five million jabs with this vaccine as of 7 February. 

By comparison, there were 151 reports of anaphylaxis or anaphylactoid reactions with the Pfizer/BioNTech Covid vaccine, following 7.5 million first dose jabs.

The MHRA told Pulse: ‘We have sought expert advice and keep this under review, however current evidence suggests that the risk associated with the Oxford/AstraZeneca vaccine is similar to most other vaccines for which a specific monitoring period is not required.’

The regulator, in its weekly publication, said it ‘closely monitors’ reports of anaphylaxis or anaphylactoid reactions, and that the AstraZeneca vaccine product information has been updated to mention that cases of anaphylaxis have been reported.

‘The overall safety experience with both vaccines is so far as expected from the clinical trials,’ it added.

The MHRA said though there has been an increase in the number of adverse reactions reported, this reflects higher vaccine coverage, adding that the overall number and nature of suspected reactions ‘are not unusual’ compared to other routinely used vaccines.

Last month, NHS England updated the standard operating procedures, stating that patients – including those with a history of anaphylaxis – can receive ‘any’ Covid vaccine as long as they are not allergic to any specific vaccine ingredients.

Recent Government guidance also stated that patients given the soon-to-be-deployed Moderna Covid vaccine will have to be observed for 15 minutes following the jab.

The MHRA published its first yellow card scheme summary report earlier this month, and said the findings were ‘reassuring’, and that the ‘vast majority’ of side effects were ‘mild and short lasting’.