Vaccine specifics PfizerBio NTech COVID19 vaccine Vaccine Preventable

Vaccine specifics: Pfizer-Bio. NTech COVID-19 vaccine Vaccine Preventable Disease Programme Public Health Wales Version 5: 27 May 2021

Acknowledgments • The content of these core training slides have been produced by colleagues in Public Health England (PHE), the content has been reviewed and links to Public Health Wales resources have been added • Vaccine Preventable Disease Programme • Lois Lloyd - Lead pharmacist for COVID vaccine deployment • This COVID-19 Pfizer Bio. NTech vaccine specific slide set contains up to date information as of 27 May 2021 (V 5) • It is recommended that you also read the UK vaccine policy which can be found in the online publication commonly referred to as the "Green Book". This can be found on the Immunisation page of the GOV. UK website

C O V I D 1 9 V a c c i n a t i o n p r o g r a m m e : C o r e Contraindications to Pfizer-Bio. NTech COVID-19 vaccine The Pfizer-Bio. NTech COVID-19 vaccine should not be given to people who have had a previous systemic allergic reaction (including immediate-onset anaphylaxis) to a previous dose of the same COVID-19 vaccine or to any components (excipient) of the vaccine • In addition to the highly purified BNT 162 b 2 messenger RNA, the vaccine also contains: • • • ALC-0315 = (4 -hydroxybutyl) azanediyl)bis (hexane-6, 1 -diyl)bis(2 -hexyldecanoate) ALC-0159 = 2 -[(polyethylene glycol)-2000]-N*, N-ditetradecylacetamide 1, 2 -Distearoyl-sn-glycero-3 -phosphocholine cholesterol potassium chloride potassium dihydrogen phosphate sodium chloride disodium hydrogen phosphate dihydrate sucrose water for injections *Polyethylene glycol (PEG) is from a group of known allergens commonly found in medicines, household goods and cosmetics. Known allergy to PEG is rare but would contraindicate receipt of this and the Moderna vaccine.

C O V I D 1 9 V a c c i n a t i o n p r o g r a m m e : C o r e Pfizer-Bio. NTech COVID-19 vaccine • The vaccine does not contain preservative • No animal products are contained in the vaccine product • The vaccine does not contain latex, milk, lactose, gluten, egg, maize/corn or peanuts • Full product information about the COVID-19 m. RNA Vaccine BNT 162 b 2 is available at https: //www. gov. uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid 19/information-for-healthcare-professionals-on-pfizerbiontech-covid-19 -vaccine • Further useful information about this vaccine is available on the Specialist Pharmacy Service website at www. sps. nhs. uk/articles/excipients-information-for-pfizer-biontech-covid-19 -vaccine/ • Pfizer Bio. NTech COVID-19 m. RNA Vaccine BNT 162 b 2 Handling and preparation video and poster www. cvdvaccine. co. uk/

C O V I D 1 9 V a c c i n a t i o n p r o g r a m m e : C o r e Polyethylene glycol (PEG) • The Pfizer Bio. NTech COVID-19 vaccine contains polyethylene glycol (PEG) • PEGs (also known as macrogols) are a group of known allergens commonly found in medicines, many household products and cosmetics • Medicines containing PEG include some tablets, laxatives, depot steroid injections, and some bowel preparations used for colonoscopy • Known allergy to PEG is rare but would contraindicate receipt of the Pfizer Bio. NTech vaccine • It is unclear whether PEG is the only cause of allergic reactions in patients with systemic allergic symptoms after the first dose of this vaccine

C O V I D 1 9 V a c c i n a t i o n p r o g r a m m e : C o r e History of allergy • a very small number of individuals have experienced anaphylaxis when vaccinated with the Pfizer Bio. NTech COVID-19 vaccine and anaphylaxis events have also been reported after the Moderna vaccine • following close national surveillance, the MHRA is no longer advising that individuals with a history of anaphylaxis to any vaccine, medicine or food do not get the vaccine • anyone with a previous history of allergic reactions to the ingredients of the vaccine should not receive it, but those with any other allergies Green Book COVID-19 chapter 14 a (such as a food allergy) can now have the vaccine https: //www. gov. uk/government/publications/covid-19 -the-green(see table) book-chapter-14 a

C O V I D 1 9 V a c c i n a t i o n p r o g r a m m e : C o r e Allergic reaction to previous dose • the British Society for Allergy and Clinical Immunology (BSACI) has advised that individuals who have a reaction to the first dose of a COVID-19 vaccine may be able to receive a second dose of vaccine, as per the flowchart • individuals with non-allergic reactions (vasovagal episodes, non-urticarial skin reaction or non-specific symptoms) to the first dose of a COVID-19 vaccine can receive the second dose of vaccine in any vaccination setting Flowchart for managing patients who have allergic reactions to the first dose of COVID-19 vaccine

Adverse reactions following Pfizer-Bio. NTech COVID-19 vaccine The following reactions were reported by the vaccine clinical trial participants Local reactions Over 80% reported pain at the injection site. Redness and swelling was also commonly reported Systemic reactions • The most frequently reported systemic reactions (reactions affecting the whole body) were tiredness (> 60%) headache (> 50%) muscle aches (> 30%) chills (> 30%) joint pain (> 20%) raised temperature (pyrexia)(> 10%) • these symptoms were usually mild or moderate in intensity and resolved within a few days after vaccination • medicines such as paracetamol can be given for post-vaccination pain or fever if required. • inform vaccinees these symptoms normally last less than a week but if their symptoms get worse or they are concerned, they should speak to their GP or call NHS 111

Presentation: Pfizer-Bio. NTech COVID-19 vaccine • The vaccine packs contain 195 vials of vaccine • The vaccine is contained in a multidose clear glass vial. The vial has a rubber (bromobutyl) stopper, aluminium seal and a flip-off plastic cap. The stopper does not contain latex • Each vial contains 0. 45 ml of vaccine and should be diluted with 1. 8 ml of Sodium Chloride 0. 9% Solution for Injection (normal saline) • If the dose-sparing needles and syringes being supplied with the vaccine are used, it should be possible to obtain 6 full 0. 3 ml doses from the vial. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial • Care should be taken to ensure a full 0. 3 ml dose will be administered to the patient from the same vial. If the amount of vaccine remaining in the vial cannot provide a full dose of 0. 3 ml, discard the vial and any excess volume. Do not pool excess vaccine from multiple vials

Diluent for Pfizer-Bio. NTech COVID-19 vaccine • Only Sodium Chloride 0. 9% Solution for Injection (normal saline) should be used as a diluent for this vaccine • A separate ampoule containing a minimum of 2 ml of normal saline is required for vaccine reconstitution • Each ampoule of diluent is single use and any remaining diluent must be discarded after 1. 8 ml has been withdrawn, regardless of the ampoule volume • There are no special storage requirements for the diluent and this can be stored with other ambient products (needles and syringes) in a dry environment away from direct sunlight

Ordering of Pfizer-Bio. NTech COVID-19 vaccine • Wales receive a direct delivery of the Pfizer-Bio. Ntech vaccine from the manufacturer in Belgium after each regulated batch release • Stock is held centrally in Wales by our specialist wholesalers with existing expertise of storing and distributing products at ultra low temperatures • Pharmacy leads at each Health Board or NHS Trust will be responsible for ordering vaccine requirements for their respective organisation via a dedicated electronic vaccine request form submitted to the specialist wholesaler and deployment lead pharmacist on a weekly basis • Each organisation has a specific twice weekly scheduled vaccine delivery day • Deliveries of this vaccine is direct to the vaccination centres via validated cold-chain transport due to the limited handling and transportation constraints

C O V I D 1 9 V a c c i n a t i o n p r o g r a m m e : C o r e Pfizer-Bio. NTech COVID-19 vaccine dose and schedule • A single dose is 0. 3 ml • Two doses of Pfizer-Bio. NTech COVID-19 vaccine are required with a minimum 21 -day interval between doses • Operationally, it is recommended that the second dose of COVID-19 vaccine should be routinely scheduled between four and 12 weeks after the first dose • This will allow more people to benefit from the protection provided from the first dose during the roll out phase and will have a greater impact in reducing mortality, severe disease and hospitalisation • Longer term protection will then be provided by the second dose

Pfizer-Bio. NTech COVID-19 vaccine – Wales arrangements Storage and transportation in a thawed state: • The vaccine will be delivered to where it is going to be administered thawed or mid-thawing and refrigerated between +2 and +8 o. C. A 195 vial pack may take 3 hours to thaw at 2 -8 ºC. • Refrigerated vaccine must be transferred immediately to a vaccine fridge on arrival and stored in a carefully monitored temperature range of +2 and +8 o. C. When removed from the freezer at the wholesaler, the undiluted vaccine has a maximum shelf life of up to *1 month (31 days) at +2 and +8 o. C and an additional 2 hours at temperatures up to 25 o. C in preparation for dilution • The vaccine outer carton will have a yellow label on the front stating the time it was removed from the freezer into storage at +2 and +8 o. C and the date and time by which it must be discarded 1 month (31 days) later if it has not been used • Vaccine should be stored in the original package to protect it from light. Exposure to room light should be minimised and exposure to direct sunlight and ultraviolet light should be avoided • Updated MHRA guidance on shelf life of thawed Pfizer – Bio. NTech COVID-19 vaccine 20 th May 2021: https: //www. gov. uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid 19/information-for-healthcare-professionals-on-pfizerbiontech-covid-19 -vaccine

Pfizer-Bio. NTech COVID-19 vaccine Thaw label The MHRA have updated guidance on the shelf life of thawed undiluted Pfizer Bio. NTech COVID-19 vaccine when stored refrigerated at at 2 °C to 8 °C. Regulation 174 has been updated to state: once removed from the freezer, the undiluted Pfizer – Bio. NTech COVID-19 vaccine has a maximum shelf life of up to 1 month (31 days) at 2 °C to 8 °C, and additional 2 hours at temperatures up to 25 °C in preparation for dilution Updated Regulation 174 information for UK healthcare professionals. 20 th May 2021.

Storage and use of Pfizer-Bio. NTech COVID-19 vaccine • The Pfizer-Bio. NTech COVID-19 vaccine has very specific storage, reconstitution and 'use within' requirements • All those involved in the delivery of the COVID-19 vaccination programme must be aware of the recommended storage requirements The vaccine must not be given if you are not confident that it has been stored or reconstituted as recommended by the manufacturer or as advised by a vaccine expert If the vaccine is stored incorrectly: Ø Label and isolate affected vaccines in the fridge and do not use until further notice Ø Seek advice from the manufacturer or a source of expert advice

Reconstitution: Pfizer-Bio. NTech COVID-19 vaccine + *(Multi-dose vial (MDV) Each vial contains 0. 45 m. L of vaccine • • • + 1. 8 m. L of **0. 9% Sodium Chloride + 21 G x 38 mm (1. 5 inch) needle with 2 m. L Syringe with graduations at 0. 1 m. L. Alcohol swabs Obtain 0. 9% Sodium Chloride Injection, for use as a diluent. Do not use any alternate diluents. Each ampoule of diluent is single use and any remaining diluent must be discarded after 1. 8 m. L has been withdrawn, regardless of the ampoule volume After dilution the vaccine should be used as soon as is practically possible. Reconstituted vaccine can be stored between +2 o. C and +25 o. C but must be used within 6 hours following dilution * Vaccine contains no preservative

Reconstituting: Pfizer-Bio. NTech COVID-19 vaccine (1) 1. Clean hands with alcohol-based gel or soap and water 2. Assemble one ampoule of Sodium Chloride 0. 9% Solution for Injection, a single use alcohol swab, a needle with a green hub and a 2 m. L syringe 3. From cold storage, remove one vial of vaccine 4. If removing the multidose vaccine vial directly from a ULT freezer, allow the vaccine to thaw at temperatures up to 25 o. C and reconstitute within 2 hours. 5. If removing the multidose vaccine vial from cold storage between +2 o. C and +8 o. C, check that it has not been stored there for longer than *1 month (31 days) and/or the vaccine is fully thawed. 6. When the thawed vaccine is at room temperature, gently invert the vial 10 times, One inversion means turning the vial upside down and back again prior to dilution. Do not shake. 7. Check the expiry date and the appearance of the vaccine. Prior to dilution, the thawed vaccine may contain white to off-white opaque amorphous particulates. Return the vial to the manufacturer if the appearance of the solution does notth match this description *Updated Regulation 174 information for UK healthcare professionals. 20 May 2021. REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS

Reconstituting: Pfizer-Bio. NTech COVID-19 vaccine (2) 8. Clean the vial stopper with the single use alcohol swab and allow to air dry fully. Connect the needle with a green hub to the 2 ml syringe 9. Draw up 1. 8 m. L of Sodium Chloride 0. 9% Solution for Injection, then discard the diluent ampoule and any remaining diluent in it. Do not use any other type of diluent 10. Add diluent to the vaccine vial. You may feel some pressure in the vial as you add the diluent. Equalise the vial pressure by withdrawing 1. 8 m. L of air into the empty diluent syringe before removing the needle from the vial 11. Gently invert the diluted solution 10 times. Do not shake

Pfizer-Bio. NTech COVID-19 vaccine (3) 12. The diluted vaccine should be an off-white solution with no particulates visible. 13. Return the vial to the manufacturer if particulates or discolouration are present 14. Dispose of green hub needle and syringe into yellow sharps bin 15. The diluted vial should be clearly labelled with the dilution date and time. 16. Reconstituted vaccine should ideally be used immediately and must be used within 6 hours following dilution 17. The dosing solution concentration is 0. 1 mg/m. L 18. A single dose is 30 mcg/0. 3 m. L 19. Each time the vial bung is punctured, this should be in a different location to previous points of puncture on the bung.

Pfizer-Bio. NTech COVID-19 vaccine Reconstituted vaccine can be returned to the fridge/cool box and stored between +2 o. C and +8 o. C but must be used within 6 hours following dilution

Preparing the syringes • Combined needle and syringe (CNS) sourced at UK level • GBUK product sourced which has 0. 1 m. L graduations • Two sizes, 23 g and 25 g. Plan to use 23 g until exhausted and then switch to 25 g

What to do if you discover or suspect a faulty medical device during vaccination e. g. syringe, needle, sharps box ? You need to: • Record batch number, expiry date, size and type of the device, the person who discovered it the Health Board/Trust, vaccination site MVC GP etc. • Save the device for examination with original packaging - if this is not possible because it is contaminated e. g. been used on an individual then try and photograph the fault/device before disposal • Record, in detail, the nature of defect and how it was discovered e. g. in use or when assembling, • Detail the impact/harm on any individual e. g. vaccinator, the person being vaccinated, loss or delay in dose • Report to both NWSSP at NWSSPProcurement. Teams@wales. nhs. uk and also Covid 19 PHEsupplies@phe. gov. uk as well as normal reporting systems e. g. Datix • These steps are essential to ensure so that any defects are quickly investigated and possible unsafe devices are quarantined and/or removed from service across Wales swiftly if deemed as a risk

Dose preparation: Pfizer-Bio. NTech COVID-19 vaccine • If the vaccine has previously been reconstituted, check that the time of reconstitution was within the last 6 hours • Clean top of vial with a single use alcohol swab and allow to air dry fully • Unwrap one of the 1 m. L combined 23 g/25 mm blue hub needle and syringes provided (recommended needle length depends on body mass of patient. Longer length (38 mm) needles are recommended and being supplied for morbidly obese individuals to ensure the vaccine is injected into muscle). • Withdraw a dose of 0. 3 m. L of diluted product for each vaccination. Ensure correct dose is drawn up • Any air bubbles should be removed before removing the needle from the vial in order to avoid losing any of the vaccine dose • The same needle and syringe should be used to draw up and administer the dose of vaccine to prevent under dosing of the vaccine to the person • The needle should only be changed between the vial and the patient if it is contaminated or damaged

Disposal of consumables after vaccination • Needles, syringes, used vials and ampoules should be disposed of immediately after use in a yellow punctureresistant sharps bin • The yellow sharps bin should be sealed when it is two-thirds full and replaced with a new one • Any blood-stained gauze or cotton wool should be placed in a offensive waste stream “tiger stripe bag” • Vaccine cardboard packaging should be placed in the general waste in a black bag, Vigilance is required with waste management of commercially sensitive material e. g. packaging is potentially a target/concern in relation to counter fraud. This packaging must be disposed of as confidential waste stream so that it is destroyed • COVID 19 Vaccine Astra. Zeneca contains genetically modified organisms (GMOs). Sharps waste and empty vials should be placed into yellow lidded waste bins and sent for incineration; there is no need for specific designation as GMO waste. An appropriate viricidal disinfectant should be available for managing spills in all settings where vaccination is administered. Potentially contaminated gloves and aprons can be disposed of in “tiger stripe bag” offensive waste bags • Local policy should be followed for disposal of PPE • How to manage healthcare waste from mass vaccination clinics – COVID-19. Approved guidance to support the management of waste from mass vaccination clinics, it will be subject to review and will be updated as guidance changes. [updated 26 February 2021]

Source of information • UK vaccine policy can be found in the online publication commonly referred to as the "Green Book". Green Book recommendations are based upon JCVI’s expert opinion and should always be followed, even when they differ from those in the vaccine manufacturer. • PHE COVID-19 immunisation programme Information for healthcare practitioners This document provides additional information, answers to frequently asked questions and actions to take in the event of inadvertent errors • It is important to read this document before you start vaccinating and also to refer to it regularly as it will be updated as more information becomes available and to address any issues or frequently arising questions as COVID-19 vaccines are delivered more widely.

Further sources of information • VPDP COVID-19 vaccination programme: http: //nww. immunisation. wales. nhs. uk/covid-19 -vaccination-programme (intranet only) • PHW COVID-19 micro-site: https: //phw. nhs. wales/topics/immunisation-andvaccines/covid-19 -vaccination-information/ • VPDP e. Learning www. wales. nhs. uk/immslearning • VPDP Immunisation e-Bulletin http: //nww. immunisation. wales. nhs. uk/current-e-bulletin • PHW COVID-19 dashboard includes a COVID-19 vaccine uptake tab • MHRA Information for healthcare professionals and the public about the Pfizer/Bio. NTech vaccine • MHRA Safety summary Coronavirus vaccine - weekly summary of Yellow Card reporting - GOV. UK (www. gov. uk)