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COVID Vaccination Programme - Update 11 December

Publication date: December 2020

A number of key documents and updates have been published in relation to the COVID 19 vaccination programme over the last couple of days: 

The Standard Operating procedure: COVID-19 local vaccination services deployment in community settings has been published and describes the operating model and design requirements for the safe delivery of COVID-19 vaccines in the community.

View the document: https://www.england.nhs.uk/coronavirus/publication/standard-operating-procedure-covid-19-local-vaccination-services-deployment-in-community-settings/.

MHRA have issued further important guidance and advice about managing allergic reactions following COVID 19 vaccination with the Pfizer/ BionTech vaccine.  

This updated guidance and advice can be viewed in full at https://www.gov.uk/government/news/confirmation-of-guidance-to-vaccination-centres-on-managing-allergic-reactions-following-covid-19-vaccination-with-the-pfizer-biontech-vaccine

The MHRA have also explicitly advised that a 15 minute observation period needs to be reinstated. NHSE has stated that they are considering the operational consequences of this for vaccination centres.

MHRA Confirmation of Guidance to vaccination centres on managing allergic reactions following COVID-19 vaccination with the Pfizer/BioNTech vaccine: https://www.gov.uk/government/news/confirmation-of-guidance-to-vaccination-centres-on-managing-allergic-reactions-following-covid-19-vaccination-with-the-pfizer-biontech-vaccine

COVID-19 vaccination: Governance, handling, and preparation of vaccines by GP led Local Vaccination Centres (PCN designated sites)

The chief pharmaceutical officer Dr Keith Ridge has written to CCG lead pharmacists and chief officers to set out the principles and expectations necessary to maintain integrity, and therefore safety, quality and effectiveness, of the COVID-19 vaccines. The novel characteristics of the first vaccine (Pfizer/BioNTech Covid-19 mRNA Vaccine BNT 162b2) make it essential that very careful attention is given to its receipt, storage, movement / transportation, and preparation.

The letter sets out the legal basis and expectations of The Human Medicines Regulations 2012, Regulation 174 for temporary authorisation of the supply of vaccine products, and what this means for lead GPs, CCG lead pharmacists and other registered healthcare professionals in primary care teams.

It also provides a model NHS COVID-19 Primary Care Vaccine Handling and Management Policy which will support practices and primary care networks to implement good governance. All staff responsible for planning and managing the primary care COVID-19 vaccination programme in 2020/21, and all Pharmacy staff engaged in supporting and delivering the COVID-19 vaccination programme in 2020/21 should read the policy. The policy includes sections on legal framework and practice standards, roles and responsibilities, accountability and responsibility for vaccines, associated medicines and their supply chain, handling and management of vaccine and medicines in vaccination sites, staff authorisation to be supplied with and administer COVID-19 Vaccines, storage and transportation of vaccines and other important details.

Governance, handling, and preparation of vaccines by GP led Local Vaccination Centres (PCN designated sites): https://www.england.nhs.uk/coronavirus/publication/governance-handling-and-preparation-of-vaccines-by-gp-led-local-vaccination-centres-pcn-designated-sites/

Local pharmacy teams are available to work with vaccination sites and lead GPs in regards to addressing the details of this policy and the LMC would encourage vaccination sites and lead GPs to take up this offer of support.

Supply Inventory List for primary care: https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/12/C0914-Appendix-1_Supply-Inventory-List_Details_v2-7-December-2020.pdf

Standard operating procedure for the management of COVID-19 vaccination clinical incidents and enquiries:  https://www.england.nhs.uk/coronavirus/publication/standard-operating-procedure-management-of-covid-19-vaccination-clinical-incidents-and-enquiries/

The NHSE documents can also be found on the NHSE website at https://www.england.nhs.uk/coronavirus/covid-19-vaccination-programme/primary-care-guidance/

This continues to be a swiftly developing process; a number of documents are being updated so please follow the links to find the latest version available on respective websites.The LMC will be monitoring this closely and will publish further updates as soon as more information is available. If you have any queries please contact us at humberside.lmcgroup@nhs.net.

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