Vaccine specifics COVID19 Vaccine Moderna Vaccine Preventable Disease
Vaccine specifics: COVID-19 Vaccine Moderna Vaccine Preventable Disease Programme Public Health Wales Version 1: 29 March 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 Vaccine Moderna vaccine specific slide set contains up to date information as of 29 th March 2021 (V 1) • 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
Contraindications to COVID-19 Vaccine Moderna The COVID-19 Vaccine Moderna should not be given to people who have had a confirmed anaphylactic reaction to a previous dose of the same vaccine or to any components of the vaccine In addition to the highly purified messenger RNA, the vaccine also contains: • Lipid SM-102 • Cholesterol • 1, 2 -distearoyl-sn-glycero-3 -phosphocholine (DSPC) • 1, 2 -Dimyristoyl-rac-glycero-3 -methoxypolyethylene glycol*-2000 (PEG 2000 -DMG) • Trometamol (Tris) • Trometamol hydrochloride (Tris HCl) • Acetic acid • Sodium acetate trihydrate • Sucrose • Water for injections Polyethylene glycol (PEG) is from a group of known allergens commonly found in medicines, many household goods and cosmetics. Known allergy to PEG is rare but would contraindicate receipt of this and the Pfizer vaccine.
Polyethylene glycol (PEG) • The Moderna 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 Moderna COVID -19 vaccine
History of allergy • 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 (such as a food allergy) can now have the vaccine (see table) Green Book COVID-19 chapter 14 a https: //www. gov. uk/government/publications/covid -19 -the-green-book-chapter-14 a
COVID-19 Vaccine Moderna • The vaccine does not contain preservative • No animal products are contained in the vaccine product • Full product information about the COVID-19 Vaccine Moderna is available at www. gov. uk/government/publications/regulatory-approval-of-covid-19 -vaccine-moderna
Adverse reactions following COVID-19 Vaccine Moderna • The following reactions were reported by the vaccine clinical trial participants Local reactions • 92% reported pain at the injection site. Swelling (15%) and redness (10%) was also reported. Systemic reactions • The most frequently reported systemic reactions (reactions affecting the whole body) were • tiredness (70%) headache (65%) • muscle aches (62%) chills (46%) • joint pain (46%) raised temperature (fever)(16%) • These symptoms were usually mild or moderate in intensity and resolved within a few days after vaccination • A slightly lower rate of reactions was seen in older age groups (those aged 65 years and above) than in those aged 18 to under 65 years. Reactions were more frequently reported after the second dose than the first dose • Medicines such as paracetamol can be given for post-vaccination pain or fever if required
COVID-19 Vaccine Moderna presentation • The vaccine packs contain 10 multidose vials of vaccine • The vaccine is contained in a multidose clear glass vial. The vial has a rubber (chlorobutyl) stopper, aluminium seal and a flip-off plastic cap. The stopper does not contain latex • If the dose-sparing needles and syringes supplied via NWSSP consumable packs are used, it should be possible to obtain at least 10 full 0. 5 ml doses from the vial
Combined needle and syringe (CNS) for Administration • Same CNS arrangements as the AZ vaccine • BD CNS sourced at UK level • BD is fixed needle (therefore can’t switch needle) • 0. 5 ml IM dose. BD product is 0. 25 ml graduations • 23 g (1 inch)
Alternative Needles Morbidly Obese • GBUK (Prosum) CNS 23 g x 38 mm (1. 5 inch) with 1 ml syringe with graduations at 0. 1 ml and 0. 25 ml. 100 pack. Order on demand via NWSSP consumables order form as a supplementary item. Needle not fixed.
COVID-19 Vaccine Moderna NHS Wales Deployment Arrangements 11
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 Ordering COVID-19 Vaccine Moderna • Wales will place central orders for the vaccine via PHE's Imm. Form platform. • Stock will be held centrally in Wales by our specialist wholesalers with existing expertise of storing and distributing products at low temperatures. • Pharmacy leads at each Health Board 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. • A TWICE a week delivery schedule will be available for this vaccine. • Deliveries of this vaccine is direct to the vaccination centres or hospital pharmacy department via validated refrigerated cold-chain transport due to the limited handling and transportation constraints. • The ‘Regulation 174 Information for UK recipients’ leaflets will be provided with each vaccine pack on delivery
COVID-19 vaccine Moderna dose and schedule • A single dose is 0. 5 ml • Two doses of COVID-19 Vaccine Moderna are required with a minimum 28 -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
Storage of COVID-19 Vaccine Moderna in a thawed state • The vaccine will be delivered to vaccination centres thawed but refrigerated between +2ºC and +8ºC • Refrigerated vaccine must be transferred immediately to a vaccine refrigerator on arrival and stored in a carefully monitored temperature range of +2ºC and +8ºC • Once thawed, the unopened vaccine may be stored refrigerated at +2ºC to +8ºC, protected from light, for up to 30 days. • The vaccine pack should have a thaw label on the front stating the time it was removed from the freezer into storage at +2ºC to +8ºC and the date and time by which it must be discarded 30 days later if it has not been used
Moderna (Temperature Stability) Thaw Label • It is a Condition of Authorisation that a secondary label must be affixed by the deployment distribution chain to capture the new storage condition expiration when moving from frozen to chilled/refrigerated storage. • A pale blue thaw label (same format as photo) will be applied by the specialist wholesaler onto the vaccine pack. • If this label is not present on the vaccine outer pack the vaccine should be quarantined in a refrigerator and the lead pharmacist notified.
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 Vaccine dose preparation (1) • COVID-19 Vaccine Moderna does not require reconstitution • Before drawing up a dose of vaccine from the multidose vial, clean hands with alcohol-based gel or soap and water • Each multidose vial should be clearly labelled with the date and time of expiry (which will be 6 hours from when it was first punctured) • Do not use the vaccine if the time of first puncture was more than 6 hours previously • Check the appearance of the vaccine. It should be white to off-white and may contain white or translucent product-related particulates. Discard the vaccine if particulates or discolouration are present. • Swirl the vial gently after thawing and between each withdrawal. Do not shake the vaccine vial • The vial bung should be wiped with an alcohol swab and allowed to air-dry fully
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 Vaccine dose preparation (2) • A 1 ml dose-sparing syringe with a 23 g, 25 mm fixed-needle should be used to draw up and administer the Moderna vaccine (these will available to order from NWSSP) • Separate 38 mm length needles and syringes should be used for morbidly obese patients to ensure the vaccine can be injected into the muscle • Withdraw a dose of 0. 5 ml for each vaccination. Take particular care to ensure the correct dose is drawn up as a partial dose may not provide protection • Any air bubbles should be removed before removing the needle from the vial in order to avoid losing any of the vaccine dose
Disposal of consumables after vaccination • Needles, syringes, used vials and ampoules should be disposed of immediately after use in a yellow puncture-resistant 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 • 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]
Observation post vaccination • Close observation for at least 15 minutes is recommended following Moderna COVID-19 vaccination.
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 (updated 25 th February 2021 ) • 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 on the COVID-19 vaccine Moderna
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