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MHRA to ‘retain’ 15-minute post-Covid jab observation requirement ‘at this time’

No 'immediate' need for second Covid booster, say Government vaccine advisers

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The UK medicines regulator has given a ‘clear steer’ that the requirement to keep patients for a 15-minute observation after mRNA Covid vaccination is not being relaxed ‘at this time’.

NHS England chief executive Amanda Pritchard had promised last week that the requirement would be reviewed, as part of the Government’s bid to speed up the Covid booster jab campaign.

The requirement applies to the Pfizer and Moderna jabs, the two main options for use in the booster campaign, and aims to allow health professionals to rule out anaphylaxis.

But speaking at an NHS England GP webinar yesterday evening, NHS England primary care medical director Dr Nikki Kanani said a review had determined no change for now.

Dr Kanani told GPs: ‘The 15-minute wait has been reviewed – it is currently not changing. This might change, but currently it is not changing as of today.

She added: ‘I know that it is frustrating for many [but] as I said, it is a clear steer from MHRA that they will maintain the 15-minute observation period at this stage, so please use that in a way that can be helpful for you and your patient – whether it is a “making every contact count” intervention or wider care.’

She also said that if is impacting efficiency, GPs should talk to their commissioners.

‘But, having said that, if it is impacting on your throughput essentially, let your commissioner know. There are lots of things that we can do to support you in terms of your workforce and your throughput.’

She also acknowledged that it was problematic for GPs vaccinating patients in their homes.

Dr Kanani said: ‘I recognise that that puts some visiting teams in difficulty when it comes to visiting our housebound but we need to get our housebound protected. It is as simple as that.’

She added: ‘We do have St John’s ambulance – some people have found them really helpful in going round and supporting vaccination in homes, doing the observations, but others have found it useful to do a home visit, do a vaccination and deliver care processes at the same time.’

It follows BMA England’s GP Committee lobbying the MHRA for the removal of the requirement to observe patients for 15 minutes after vaccination with the Pfizer Covid jab.

The observation period was introduced in the first week of the vaccine rollout, following news that two healthcare professionals that were vaccinated on the first day with the Pfizer vaccine suffered an allergic reaction.

It does not apply to the Oxford/AstraZeneca vaccine, but GPs giving patients the Moderna jab must also observe them for at least 15 minutes.

It comes as Prime Minister Boris Johnson last week announced a target for the NHS to give booster Covid jabs to all over-18s within two months.

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Dave Haddock 10 December, 2021 1:17 pm

The “you can’t be too careful” virus is remarkably virulent.

James Mitchell 10 December, 2021 1:39 pm

So how many more lives will the 15 minute observation time cost?
Reduces the vaccination rate massively in surgery’s (as we give them the third dose of something many had twice already) and the most vulnerable , elderly housebound wait longer by weeks. Dr Kanani said: I recognise that that puts some visiting teams in difficulty. No it doesn’t , they just sit and chat for 15 minutes so the number of vulnerable people vaccinated drops to a maximum of 3 an hour per nurse when it might have been 6-8. Still the extra illness will be less this time than in spring when it really slowed delivery

Paul Scott 10 December, 2021 1:54 pm

That is just about the most unsafe excessive safety decision by a non-patient facing body ever, that will significantly delay and harm patient safety in totality. It is not a holistic decision.

David Banner 10 December, 2021 4:07 pm

So you’ve had 2 doses without anaphylaxis, but still need 15 minutes wait after a 3rd identical jab.

Patrufini Duffy 10 December, 2021 10:57 pm

Surprised it wasn’t reduced to 14 minutes to “reduce” GP bureaucracy and burden. That would’ve been game changing and set out in a 47 page document.