15-minute observation period following COVID-19 vaccination

The 15-minute observation period following a vaccination with COVID-19 vaccine Pfizer/BioNTech or Moderna will be temporarily suspended as part of measures to increase the booster rollout, according to the MHRA. Regulatory documents remain unchanged.

For community pharmacies, the PGDs and national protocols for, both, Pfizer and Moderna vaccines have now been updated and the 15-minute wait can be suspended.

Please note: The 15-minute observation period after vaccination remains in place for the small number of people who may have previously suffered anaphylaxis or other allergic reactions to a food, insect sting and most medicines or vaccines.

• Update 17/01/2022 Extending the post-thaw expiry date of specific batches of Comirnaty® (30 microgram/dose) for adults and adolescents https://www.england.nhs.uk/coronavirus/publication/extending-the-post-thaw-expiry-date-of-specific-batches-of-comirnaty-30-microgram-dose-for-adults-and-adolescents/
• Update 10/01/2022 Generating local demand – delivering the maximum available vaccinations https://www.england.nhs.uk/coronavirus/publication/generating-local-demand-delivering-the-maximum-available-vaccinations/
• Update 23/12/2021 Updated JCVI advice for the vaccination of children and young people https://www.england.nhs.uk/coronavirus/publication/updated-jcvi-advice-for-the-vaccination-of-children-and-young-people/
• Update 21/12/2021 COVID-19 vaccination: information for healthcare practitioners https://www.gov.uk/government/publications/covid-19-vaccination-programme-guidance-for-healthcare-practitioners
• Update 17/12/2021 A new national mission for the NHS: boosting our defences against Omicron https://www.england.nhs.uk/coronavirus/publication/a-new-national-mission-for-the-nhs-boosting-our-defences-against-omicron/
• Update 14/12/2021 Temporary waiver of 15-minute observation period after COVID-19 mRNA vaccines https://www.gov.uk/government/news/temporary-waiver-of-15-minute-observation-period-after-covid-19-mrna-vaccines
• Update 13/12/2021 Second phase for children and young people aged 12 to 15: next steps for COVID-19 vaccine deployment https://www.england.nhs.uk/coronavirus/publication/second-phase-for-children-and-young-people-aged-12-to-15-next-steps-for-covid-19-vaccine-deployment/
• Preparing the NHS for the potential impact of the Omicron variant and other winter pressures https://www.england.nhs.uk/coronavirus/publication/preparing-the-nhs-for-the-potential-impact-of-the-omicron-variant-and-other-winter-pressures/
• National call: Next steps for the NHS COVID-19 vaccine deployment https://www.england.nhs.uk/coronavirus/publication/national-call-next-steps-for-the-nhs-covid-19-vaccine-deployment/
• Update 11/12/2021 COVID-19 vaccination: booster dose resources https://www.gov.uk/government/publications/covid-19-vaccination-booster-dose-resources
• COVID-19 vaccination: a guide to booster vaccination for individuals aged 18 years and over and those aged 16 years and over who are at risk https://www.gov.uk/government/publications/covid-19-vaccination-booster-dose-resources/covid-19-vaccination-a-guide-to-booster-vaccination-for-individuals-aged-18-years-and-over
• Update 10/12/2021 Monitoring reports of the effectiveness of COVID-19 vaccination https://www.gov.uk/guidance/monitoring-reports-of-the-effectiveness-of-covid-19-vaccination
• Update 09/12/2021 Update to the National protocol for Spikevax (formerly COVID-19 Vaccine Moderna) https://www.gov.uk/government/publications/national-protocol-for-covid-19-vaccine-moderna
• Update to the Patient Group Direction for Spikevax (formerly COVID-19 Vaccine Moderna) https://www.england.nhs.uk/coronavirus/publication/patient-group-direction-for-covid-19-vaccine-moderna/
• Update to the National protocol for Comirnaty® COVID-19 mRNA vaccine https://www.gov.uk/government/publications/national-protocol-for-comirnaty-covid-19-mrna-vaccine
• Update to the Patient group direction for Comirnaty® (Pfizer BioNTech) https://www.england.nhs.uk/coronavirus/publication/patient-group-direction-for-comirnaty-pfizer-biontech/
• Update 06/12/2021 Vaccination as a condition of deployment (VCOD) for healthcare workers: Phase 1 – Planning and preparation https://www.england.nhs.uk/coronavirus/publication/vaccination-as-a-condition-of-deployment-for-healthcare-workers-phase-1-planning-and-preparation/
• Update 03/12/2021 JCVI advice in response to the emergence of the B.1.1.529 (Omicron) variant: next steps for deployment https://www.england.nhs.uk/coronavirus/publication/jcvi-advice-in-response-to-the-emergence-of-the-b-1-1-529-omicron-variant-next-steps-for-deployment/
• Update 29/11/2021 JCVI advice on COVID-19 booster vaccines for those aged 18 to 39 and a second dose for ages 12 to 15 https://www.gov.uk/government/news/jcvi-advice-on-covid-19-booster-vaccines-for-those-aged-18-to-39-and-a-second-dose-for-ages-12-to-15
• COVID-19 vaccination and rare side effects https://www.gov.uk/government/collections/covid-19-vaccination-and-rare-side-effects
• Myocarditis and pericarditis after COVID-19 vaccination https://www.gov.uk/government/publications/myocarditis-and-pericarditis-after-covid-19-vaccination
• UK vaccine response to the Omicron variant: JCVI advice https://www.gov.uk/government/publications/uk-vaccine-response-to-the-omicron-variant-jcvi-advice

• Update 04/11/2021 Regulatory approval of COVID-19 Vaccine Janssen https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-janssen

• Update 21/09/2021 Update to the National protocol for COVID-19 mRNA vaccine BNT162b2 (Pfizer/BioNTech) https://www.gov.uk/government/publications/national-protocol-for-covid-19-mrna-vaccine-bnt162b2-pfizerbiontech
  
• Update to the Patient Group Direction for COVID-19 mRNA vaccine BNT162b2 (Pfizer/BioNTech) https://www.england.nhs.uk/coronavirus/publication/patient-group-direction-for-covid-19-mrna-vaccine-bnt162b2-pfizer-biontech/
• Update to the Patient group direction for Comirnaty® (Pfizer BioNTech) https://www.england.nhs.uk/coronavirus/publication/patient-group-direction-for-comirnaty-pfizer-biontech/
• Update 17/09/2021 NHSE published Community pharmacy local enhanced service COVID-19 vaccination programme: phase 3 2021/22: https://www.england.nhs.uk/coronavirus/publication/community-pharmacy-local-enhanced-service-specification-phase-3-coronavirus-vaccination/
• Update 15/09/2021 Letter issued by NHSE&I: Vaccination of healthy children and young people aged 12 to 15 https://www.england.nhs.uk/coronavirus/publication/vaccination-of-healthy-children-and-young-people-aged-12-to-15/
• Letter issued by NHSE&I setting out actions to take to immediately start administering booster vaccinations https://www.england.nhs.uk/coronavirus/publication/immediate-action-required-for-phase-3-booster-vaccinations/
• Update 14/09/2021 JCVI issues updated advice on COVID-19 booster vaccination https://www.gov.uk/government/news/jcvi-issues-updated-advice-on-covid-19-booster-vaccination?utm_medium=email&utm_campaign=govuk-notifications&utm_source=6e9ce89f-3d60-4c70-abb9-4d7ab13a4713&utm_content=immediately
• Update 19/07/2021  JCVI advises that children at increased risk of serious COVID-19 disease should be offered the COVID-19 vaccine: https://www.gov.uk/government/news/jcvi-issues-advice-on-covid-19-vaccination-of-children-and-young-people 
• DHSC: JCVI interm advice on a potential COVID-19 booster vaccine programme for winter 2021 : https://www.gov.uk/government/publications/jcvi-interim-advice-on-a-potential-coronavirus-covid-19-booster-vaccine-programme-for-winter-2021-to-2022
• DHSC press release: Most vulnerable could be offered booster COVID-19 vaccine from September: https://www.gov.uk/government/news/most-vulnerable-could-be-offered-booster-covid-19-vaccines-from-september 
• Update 17/06/2021: Letter issued by NHSE&I to invite all adults to get the COVID-19 jab in final push: https://www.england.nhs.uk/2021/06/nhs-invites-all-adults-to-get-a-covid-jab-in-final-push/
• NHS COVID Pass: https://www.nhs.uk/conditions/coronavirus-covid-19/covid-pass/ 
• NHSE&I COVID-19 publications COVID-19 vaccination now available for those ages over 21 years

DHSC useful links:

• Vaccine Uptake Plan
• Vaccine Delivery Plan
• Latest vaccination data
• Bristol University ‘Global experts urge everyone to talk about COVID-19 vaccines responsibly’
• Covid-19 PHE The Green Book – updated with new advice on pregnancy
• Action fraud
• NHS Covid vaccine

NPA webinar – Understanding COVID-19 vaccinations and addressing vaccine hesitancy

NPA updates

• 13/12/2021 NPA update on the COVID-19 Response: Omicron variant (Scotland)
• 10/12/2021 IMPORTANT update following activation of Plan B in England
• 10/12/2021 NPA update on the COVID-19 vaccination programme (ENGLAND)
• 08/12/2021 Updated Northern Ireland Community Pharmacy Vaccination Service (CPVS) SOP V5 December 2021
• 02/12/2021 Superintendent update on COVID-19 costs claims PPV, new measures due to the COVID-19 Omicron variant, COVID-19 vaccinations and more
• 01/12/2021 NPA update: JCVI advice on COVID-19 vaccination programme
• 23/11/2021 NPA update: Change to Community Pharmacy COVID Vaccination Service (CPVS) in Northern Ireland to include booster vaccine
• 17/11/2021 NPA update: Government announces mandatory COVID-19 vaccinations for NHS frontline staff in England
• 08/11/2021 Updated guidance on the COVID-19 vaccine booster programme
  03/11/2021 NPA update: COVID-19 vaccination requirement for people working in or entering a care home
• 03/11/2021 NPA update on COVID-19 vaccinations for 12-15 year olds through certain community pharmacy-led vaccination sites
• 30/10/2021 NPA update: Children and young people aged 12 to 15 years to be offered one dose of the Pfizer/BioNTech COVID-19 vaccine
• 29/09/2021 NPA update on information for the Pfizer/BioNTech COVID-19 vaccine
• 21/09/2021 NPA update: Change to Community Pharmacy COVID Vaccination Service (CPVS) in Northern Ireland
• 10/09/2021 Indemnity insurance updates for COVID-19 vaccinations and booster injections
• 07/09/2021 Guidance in relation to DBS checks, and specifically to requirements for vaccination services
• 23/08/2021 NPA update Pfizer/BioNTech COVID-19 vaccine approved for use in children aged 12-15 years
• 16/07/2021 NPA update England COVID-19 vaccination programme: Phase 3 2021/22- Local Enhanced Service Specification and designation process for community pharmacy contractors 
• 25/2/2021 – Webinar on COVID-19 vaccination programme community pharmacy designated process (recorded on 23/2/2021) is now available to watch here. You may also find the experiences of member Olivier Picard, of Newdays Pharmacy, helpful. Olivier opened a pharmacist-led vaccination centre in Marlow in January 2021, and shares his experiences here
• 18/02/2021 COVID-19 vaccination programme: designation process opened again for community pharmacy contractors- key points and considerations
• 29/01/2021 Superintendent update: End of month update (January 2021) – includes key updates on COVID-19 (testing, vaccinations including legal mechanisms, professional indemnity and insurance, vaccine comparison chart
• 15/01/2021 COVID-19: IMPORTANT UPDATES and FAQS on COVID-19 antigen testing, COVID-19 vaccinations, and lockdown actions (England) covers COVID-19 vaccinations and FAQs, including professional indemnity and insurance and COVID-19 vaccination – legal mechanisms for administration
• 30/11/2020 IMPORTANT UPDATE: COVID-19 vaccination programme 2020/21 – key points and considerations for preparation for community pharmacy to contribute to a potential COVID-19 vaccination programme

NPA Resources

• 07/09/2021 – Guidance in relation to DBS checks, and specifically to requirements for vaccination services
• 24/2/2021 – A new cross-sector guidance (made up with NPA, CCA, PSNC, RPS and AIM) has been developed on the considerations pharmacy contractors in England should undertake before applying to provide the COVID-19 vaccination service. The latest version can be accessed here.
• COVID-19 risk assessments – to support individual and workplace risk assessment assist assessed, identified and mitigated in the workplace.
• COVID -19 vaccination risk assessments – to support pharmacy premises and offsite vaccinations
• Standard operating procedures– including infection prevention, hand hygiene,  needle stick injury and biohazard spillages, administration adrenaline and cold chain.
• COVID-19 vaccination pre-screen questionnaire
• Chaperone policy documents
• COVID-19 vaccine characteristic comparison chart –This resource provides a quick reference of the vaccine characteristics and excipients information for the three COVID-19 vaccines currently temporary authorised.
• COVID-19 vaccination programme vaccination site key considerations and risk assessment
• Summary Care Record (SCR) resources – guidance and support for accessing patients SCR.
• Safeguarding vulnerable adults and children– guidance and SOP.
• Accessible Information Standard– brief guide, SOP and FAQs to support the Standard in your pharmacy.
• Radicalisation and terrorism prevention guidance– resource to support pharmacy teams in identifying individuals, both patients and other team members, who may be subject to radicalisation and how to raise these concerns.