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NHSE awaiting MHRA approval to allow Covid booster delivery at GP practice level

extend shelf life vaccine batches

NHS England has said it is seeking MHRA approval for GPs to deliver Covid booster vaccines at an individual practice level.

The specification for the enhanced service, published last month, said that GPs wishing to participate in the booster programme must do so in PCN groupings as it is ‘not operationally feasible’ to offer the vaccinations at an individual practice level.

However, NHS England told GPs at a webinar about the programme the following day that it is ‘working with the MHRA’ to allow this.

NHS England medical director for primary care Dr Nikki Kanani said: ‘The requirement around primary care networks as recipients of delivery is just so that we can use that logistical supply chain in a sensible way. Rather than delivering to 6,700 practices we need to do that at a little bit of scale.

‘But providing the MHRA supports us and all of you in the system and the supply allows, we really want to get down to practice level.’

And NHS England director of primary care vaccination Caroline Temmink added that NHS England is ‘working with the MHRA to make sure that PCNs will be permitted to transport and administer vaccines at a practice level’.

NHS England is ‘hopeful’ that vaccine movement arrangements will be ‘as flexible as possible to allow people to deliver this in the best way for their population’, she said.

However, it remains unclear what exactly MHRA approval is needed for and what more it will permit above the arrangements in phases one and two of the programme.

NHS England has been approached for clarification.

Since January, PCN groupings have been permitted to move supply of the Oxford/AstraZeneca vaccine around individual practices to ‘improve patient access or increase vaccination capacity’.

And last month, NHS England announced that GPs could transport Pfizer Covid vaccines away from their main site for pop-up clinics.

Dr Kanani later added that while vaccine stock will be delivered to PCNs, GPs ‘will be able to move the vaccine in the way that we’ve already been able to’ where ‘equitable uptake’ needs to be ensured.

She said: ‘We are certainly not sitting here wanting vaccine to be stuck in one place, in fact, we want to get it out into every bit of the community as quickly and as safely as possible because that’s our best chance of getting people protected.’

And Dr Kanani reassured GPs there is ‘absolutely not’ a ‘deliberate move to reduce GP PCN involvement in phase three by restricting the number of sites but opening the doors to all community pharmacies’.

She said: ‘We know that general practice and community pharmacy have been placed under a huge amount of pressure already – let alone us heading into winter. 

‘We’re trying to get that balance right to look after the service rather than to restrict it’.

In a recent GP Committee bulletin, the BMA said that local community delivery of both Covid and flu vaccines is ‘essential to the success of [the] programme’ and that local systems ‘must support practices to do this’.

It said: ‘It is very disappointing that NHSE/I is not listening to practices and has not done more to enable local groups to safely transfer vaccines delivered to PCN sites onto member practice sites should they choose to do so. 

‘Yet at the same time, we have seen vaccines safely delivered in care homes, through buses, pop-up sites and smaller pharmacies. Moreover, vaccines have been provided to practices to deliver to their patients elsewhere in the UK.’

It added: ‘We will continue to challenge this unnecessary restriction which could lead to poorer uptake.’

The news comes as almost 60% of GP partners taking part in the Covid vaccination programme want to administer the jabs from their own site but have not had the opportunity.

The Pulse survey of GP partners also found that 5% of practices that were taking part in phase one of the Covid vaccination programme opted out of phase two because they were unable to administer the jabs themselves

In May, the UK LMCs conference also voted in favour of individual practices being contracted for future Covid vaccine direct enhanced services

And former health secretary Matt Hancock previously said that he would investigate the possibility of Covid vaccinations being administered from individual GP practices

Meanwhile, Dr Kanani also suggested in the webinar that the 15-minute observation period for the Pfizer vaccine is under review and that GP practices should still be able to deliver flu jabs even if they don’t sign up to give Covid booster vaccines.

Unveiling the 2021/22 flu vaccination enhanced service specification for GP practices earlier this week, NHS England said it was inviting ‘all practices’ to opt in to the programme over the next two weeks.

In recent months GPs have been ‘actively encouraged’ by NHS England to pool flu vaccines between practices to enable possible co-administration with the Covid vaccine at a PCN grouping level.

And the flu programme specification reiterated that a GP practice which is a member of a PCN grouping ‘may choose to work together with the GP practices in that PCN grouping to deliver [flu] vaccinations in accordance with this ES’.

A GP practice ‘may require the ability to sub-contract the delivery of the required clinical services to another GP practice in the PCN grouping or another party,’ it added.

Final guidance on whether flu and Covid booster jabs will be co-administered will be issued following JCVI advice, which is awaiting the results of a clinical trial.


Mark Essop 4 August, 2021 12:21 pm

Pressumably individual pharmacies will recieve their own deliveries so why is this not possible for individual practices? It seems that the need for the MHRA to change the regulations has been created by the policy to restrict deliveries to PCN level so why not just change the policy?

Vinci Ho 4 August, 2021 12:44 pm

Finally , NHS England is talking a bit more like a human being with common sense(not to forgive how they ‘defended’ general practice last 18 months ).
My question remains, have they looked into the potential vaccine hesitancy of co-administration of Covid booster and flu vaccines ? The implications of that could be significant to GPs .

terry sullivan 4 August, 2021 1:33 pm

just say no! gps have their own insurance–when the claims come in you will be the scapegoats

Patrufini Duffy 4 August, 2021 4:08 pm

In 5 years time, you’ll look back and shred all those emails and protocols and think – no one ever cared less what you did. Mould yourself better.