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Pfizer BNT162b2 COMIRNATY Astrazeneca ADZ1222 VAXZEVRIA MODERNA-mRNA 1273 SPIKEVAX Excipeints

A compile of the Gene Therapies that were rolled out over 30 months ago, SpikeVax, Comirnaty and Vaxzevria

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Pfizer BNT162b2 COMIRNATY Astrazeneca ADZ1222 VAXZEVRIA MODERNA-mRNA 1273 SPIKEVAX Excipeints

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  1. 1 At the start of this year, this technology was rapidly repurposed to develop a vaccine for COVID-19 and in April we provided £20 million of further funding so that the Oxford clinical trials could commence immediately. Also in April, we established the UK government’s Vaccine Taskforce – or VTF for short – and since then, they have worked relentlessly to build a wide portfolio of different types of vaccine signing early deals with the most promising prospects. The VTF has also worked on our home-grown manufacturing capability, including what is referred to as ‘fill-finish’ process – in collaboration with Wokhardt, in Wrexham. All 4 UK Chief Medical Officersagreewiththe recommendation of the Joint Committee on Vaccination and Immunisation – the JCVI – to prioritise the first doses for as many people on the priority list as possible and administer second doses towards the end of the recommended vaccine dosing schedule of 12 weeks. This step will ensure the protection of the greatest number of at-risk people in the shortest possible time. Madam Deputy Speaker, we recognise that transparency about our vaccines plan will be central to maintaining public trustand we are committed to publishing clear and simple updates. From today (January 11, 2021), we are publishing daily data for England showing the total number vaccinated to date – and the first daily publication was this afternoon. And from Thursday – and then on a weekly basis – NHS England will publisha more detailed breakdown of vaccinations in England – including by region. But we’ve always known that a vaccine would be our best way out of this evil pandemic and that is the road we are now taking. We’re under no illusion as to the scale of the challenge ahead – the distance still yet to travel. But against the backdrop of a global pandemic – and a new more transmissible variant – it is a huge challenge. 2I set out earlier this week offering a slot for vaccination by15th of Februaryfor everyone in those key groups identified by the Joint Committee on Vaccination and Immunisation That’s over 12 million people in England, and 15 million in the UK And it is thanks to the arrival of the Oxford/AstraZeneca vaccine which can be stored at room temperature, that we can accelerate the pace of vaccination in care homes. We are using that vaccine in care homes for the first time today. Tocilizumab, sorry I’ll say it again, Tocilizumaband Sarilumab,they’ll shortly be on everybody’s lips 1https://www.gov.uk/government/news/moderna-covid-19-vaccine-authorised-by-uk-medicines-regulator 2 https://www.gov.uk/government/speeches/prime-ministers-statement-on-coronavirus-covid-19-7-january-2021

  2. January 30, 2020 WHO Declared Pandemic Public Health Emergency of International Concern (PHEIC). Gavi Health Secretary Matt Hancock March 3, 2020 – Handshaking Coronavirus Hosp. March 16-18, 2020 SAGE/Vallanceadvise‘lockdown’ (see SAGE minutes) March 2, 2020 £10.5 million March 19, 2020 6 promising coronavirusprojects Declared a Non-HCID March 23 2020 March 6, 2020 £5 million “Lockdown”, “MustStay at Home” – Schools Closed JIREP Joint Initiative on Research in Epidemic Preparedness March 26, 2020 The Health Protection (Coronavirus, Restrictions) (England) Regulations 2020 introduced There is no official definition of what a ‘lockdown’ is WHO R&D Blueprint UNICEF Health Emergencies Preparedness Initiative (HEPI) March 27 Alexander De Pfieffel Johnson & Matt Hancock test positive Chief Medical Adviser tested positive April 3, 2020 CEPI £250 million 1st Nightingale Hospital opened The Vaccine Taskforce April 6, 2020 (see Slide 9) Chief Scientific Adviser Sir Patrick Vallance Deputy Chief Medical Officer Professor Jonathan van Tam, Government Life Sciences Champion Sir John Bell, as well as AstraZeneca, and the Wellcome Trust. Alexander De Pfieffel Johnson taken to St Thomas’s Hospital. ReleasedApril 12, 2020 April 17, 2020 1To ensure compliance with the Government’s instruction to stay at home, we will immediately: Close all shops selling non-essential goods,​ including clothing and electronic stores and other premises including libraries, playgrounds and outdoor gyms, and places of worship; We will stop all gatherings of more than two people in public – excluding people you live with; and we’ll stop all social events​, including weddings, baptismsand other ceremonies, but excluding funerals. No Prime Minister wants to enact measures like this. I know the damage that this disruption is doing and will do to people’s lives UK Research & Innovation (UKRI Chief Executive, Professor Sir Mark Walport 21 Research Projects £14 million Oxford will trial an anti-malarial drug June 15, 2020 Non-essential shops could reopen July 4, 2020 Restaurants, pubs and hairdressers to reopen 1https://www.gov.uk/government/speeches/pm-address-to-the-nation-on-coronavirus-23-march-2020

  3. 1Through the Vaccines Taskforce, the UK has secured early access to 367 million doses of 7 of the most promising vaccines so far. To date, the government has invested over £230 million into manufacturinga successful vaccine. In the Chancellor’s Spending Review, published on 25 November, 2020it was announced that the government has made more than £6 billion available to develop and procure successful vaccines. BioNTech/Pfizer for 40 million doses Oxford/AstraZeneca for 100 million doses Moderna for 17 million doses GlaxoSmithKline and Sanofi Pasteur for 60 million doses Novavax for 60 million doses Janssen for 30 million doses Valnevafor 60 million doses The UK government invested £100 millionto fund a state-of-the-art manufacturing innovation centre in Braintree, Essex, in collaboration with the Cell and Gene Therapy Catapult, to accelerate the mass production of a successful COVID-19 vaccine in the UK. Due to open in December 2021, the centre will have the capacity to produce millions of doses of vaccines each month, ensuring the UK has the capabilities to manufacture both vaccines and advanced medicines, including for emerging diseases, far into the future. The government has also provided £4.7 million funding to the Catapult to ensure that the UK has the best skills and expertise in vaccine manufacturing and advanced therapies. The government has created the UK’s first dedicated Vaccine Manufacturing and Innovation Centre (VMIC) and accelerated its development with £93 million of investment. Once open, it will be able to manufacture 70 million vaccines doses in just 6 months – enough for the UK population. While VMIC is being built, the governmentestablished a Rapid Deployment Facility with £8.75 million of investment to manufacture at scale. The government has made a multi-million-pound investment in a manufacturing facility in Scotland, creating a major UK vaccine facility and to support rapid scale-up if its candidate is successful. This unique Biosafety Level 3 (BSL3) containment facility will establish a permanent UK capability to manufacture inactivated viral vaccines– one of the most proven, widely used vaccine formats and has the capacity to produce up to 200 million doses of COVID-19 viral vaccines in 2021. 1https://www.gov.uk/government/news/moderna-covid-19-vaccine-authorised-by-uk-medicines-regulator

  4. Pfizer/BioNTech (approvedDecember 2, Phase III Clinical Trials) - 40 million doses (Not from SARS-CoV-2) known as a messenger RNA (mRNA) vaccine. Conventional vaccines are produced using weakened forms of the virus, but mRNAs use only the virus's genetic code to enter cells and tells them to create antigens, which make them look like the coronavirus. Oxford University/AstraZeneca (approved 2020, Phase III Clinical Trials) -100 million doses. Chimpanzee Adenovirus which is genetically engineered to carry the genetics needed to create 'spike' proteins that make cells look like the coronavirus. Moderna (approved, Spring 2021) — 17 million doses ordered (Not from SARS-CoV-2) mRNA technology and works in a similar way to the Pfizer one Novavax (waiting approval in the coming weeks) — 60 million doses Researchers inserted a modified gene into a virus, called a baculovirus, and allowed it to infect insect cells. Spike proteins from these cells were then assembled into nanoparticles Janssen/Johnson and Johnson (waiting approval) — 30 million doses option of 22 million more. Uses the same adenovirus technology as the Oxford University vaccine, making it just as easy to transport and store, but requires just a single injection. To be rolled out in Britain by mid-February Valneva (in trials - end of 2021 if successful) — 60 million doses Inactivated whole virus vaccine' which uses a damaged version of the realcoronavirus GSK/Sanofi Pasteur vaccine (Phase I clinical trials - end of 2021) -60 million doses The UK has ordered an additional10 million dosesof the vaccine, taking its total to 17 million. Doses available for UK from spring 7 January 2021 – Alexander Johnson speech 8 January 2021 (MHRA) has authorised the Modernavaccine upon recommendation of the Commission on Human Medicines 1.5 million people in the UK have already been vaccinated with the Pfizer/BioNTechand Oxford University/AstraZeneca vaccines 11 January 2021 UK COVID-19 vaccines delivery plan The plan rests on 4 key pillars: supply, prioritisation, places and people. As of today, in England, 2.33 million vaccinationshave been given. With 1.96 million receiving their first dose, and 374,613 having already received both doses. We had already been heavily investing in the development of new vaccinessince 2016, including funding a vaccineagainst another coronavirus: the Middle East Respiratory Syndrome, MERS

  5. *Pfizer EUA: December 2, 2020 1st Dose - 1st Patient: *Margaret Keenan, 90 **2nd Dose: December 29, 2020 AstraZeneca EUA: December 30, 2020 1st Dose - 1st Patent: Brian Pinker, 82 (Dialysis) *Pfizer/AstraZeneca December 2-3, 2020 **December 29-30, 2020 Lockdown Ii November 5, 2020 Lockdown I March 23, 2020 Lockdown III January 5, 2021 The 1st lockdown began March 23 and was extended for another three weeks, before restrictions were eased slightly in May. Lockdown I was in place for around seven weeks. The 2nd lockdown began November 5 and lasted for four weeks. Lockdown II ended 12:01am December 2. Lockdown III to end March 8, 2021 (July 17)

  6. 1What COVID-19 mRNA Vaccine BNT162b2 contains This vaccinecontainspolyethylene glycol/macrogol (PEG) as part of ALC-0159 The other ingredients (Excipients)are: 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 Provided in a multi-dosevial of 6 doses in a 2 mL clear vial (type I glass), with a rubber stopper and a flip-off plastic cap with aluminium seal. Pack size: 195 vials 1 vial (0.45ml) contains at least 5 doses of 30 micrograms of BNT162b2 RNA (embedded in lipid nanoparticles). Vials may alternatively be labelled: • BNT162b2 (SARS-COV-2-mRNA vaccine), or • Pfizer-BioNTech COVID-19 vaccine Store in freezer at -80 °C to -60 °C. Once thawed the vaccine cannot be re-frozen. Take paracetamolfor vaccine injuration site/after affects If you receive one dose of COVID-19 mRNA Vaccine BNT162b2, you should receive a second dose of the same vaccine at least 21 days later to complete the vaccination series. Protectionagainst COVID-19 diseasemay not be maximally effective until at least 7 days after the second dose. Children and adolescents COVID-19 mRNA Vaccine BNT162b2 is not recommended for childrenunder 16 years. (Note: All clinical trials conducted never involved under 18’s as a cohort grouping See Pfizer BioNTech Protocol v02.00 and Mental Capacity Act 2005) Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. This medicinal product has been given authorisation for temporarysupplyby the UK Department of Health and Social Care (DHSC) and the Medicines & Healthcare products Regulatory Agency (MHRA) 1https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/information-for-uk-recipients-on-pfizerbiontech-covid-19-vaccine

  7. 1Guidance - National protocol for COVID-19 mRNA vaccine BNT162b2 (Pfizer/BioNTech) Special considerations / additional information Ensure there is immediate access to adrenaline(epinephrine) 1 in 1,000 injections in case of an anaphylactic event. The health professionals overseeing the immunisation service must be trained to recognise an anaphylactic reaction and be familiar with techniques for resuscitation of an individual with anaphylaxis. Cautions including any relevant action to be taken Syncope(fainting) can occur following, or even before, anyvaccinationespecially in adolescentsas a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints. Individuals with a bleeding disorder may develop a haematoma at the injection site. Past history of COVID-19 infection There is no evidence of any safety concerns from vaccinating individuals with a past history of COVID-19 infection, or with detectable COVID-19 antibody. Vaccinationof individuals who may be infected but asymptomaticor incubatingCOVID-19infectionis unlikely to have a detrimental effect on the illness. Action to be taken if the patient or carer declines treatment Informed consent, from the individual or a person legally able to act on the person’s behalf, must be obtained for each administration and recorded appropriately. Where a person lacks the capacity, in accordance with the Mental Capacity Act 2005, a decision to vaccinate may be made in the individual’s best interests. Advise the individual/carer about the protective effects of the vaccine, the risks of infection and potential complications if not immunised. 2The vaccineis 94% effective in preventing disease (2020, January 8) There are no data available on the interchangeabilityofCOVID-19 mRNA Vaccine BNT162b2with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of COVID-19 mRNA Vaccine BNT162b2 should receive a second dose of COVID-19 mRNA Vaccine BNT162b2 to complete the vaccination series. It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility. 1https://www.gov.uk/government/publications/national-protocol-for-covid-19-mrna-vaccine-bnt162b2-pfizerbiontech 2https://www.gov.uk/government/news/moderna-covid-19-vaccine-authorised-by-uk-medicines-regulator

  8. AstraZeneca/Oxford: COVID-19 Vaccine (ChAdOx1-S* recombinant) *Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS CoV 2 Spike (S) glycoprotein. Produced in genetically modified human embryonic kidney(HEK) 293 cells. This product contains genetically modified organisms (GMOs). Two separate doses of 0.5 ml each. The second dose should be administered between 4 and 12 weeks after the first dose. Paediatric population The safety and efficacy of COVID-19 Vaccine AstraZeneca in children and adolescents(aged <18 years old) have not yet been established. No data are available. Concomitant administration of COVID-19 Vaccine AstraZeneca with other vaccines has not been studied Preliminary animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryofetaldevelopment, parturition or post natal development; definitive animal studies have not been completed yet.The full relevance of animal studies to human risk with vaccines for COVID-19 remains to be established. Breastfeeding It is unknown whether COVID-19 Vaccine AstraZeneca is excreted in human milk. In studies COV001 and COV002 (but not COV003), licensed seasonal influenza and pneumococcal vaccinations were permitted (at least 7 days before or after their study vaccine). 6.1 List of excipients L-Histidine L-Histidine hydrochloride monohydrate Magnesium chloride hexahydrate Polysorbate 80 Ethanol Sucrose Sodium chloride Disodium edetatedihydrate Water for injections Children and adolescents No data are currently available on the use of COVID 19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age. Disposal COVID-19 Vaccine AstraZeneca contains genetically modified organisms (GMOs). Any unused vaccine or waste material should be disposed of in accordance with local requirements. Spills should be disinfected with an appropriate antiviral disinfectant. https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/information-for-healthcare-professionals-on-covid-19-vaccine-astrazeneca

  9. Moderna COVID-19 mRNA Vaccine (nucleoside modified)- COVID-19 mRNA vaccine is single-stranded, 5’-capped messenger RNA (mRNA) produced using cell-free in vitro transcription, encoding the pre-fusion stabilized Spike (S) glycoprotein of SARS-CoV-2. One dose (0.5 mL) contains 0.10 mg of mRNA (embedded in lipid nanoparticles). There are no data available on the interchangeability of COVID-19 Vaccine Moderna with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of COVID-19 Vaccine Moderna should receive a second dose of COVID-19 Vaccine Moderna to complete the vaccination series. Paediatric population The safety and efficacy of COVID-19 Vaccine Moderna in children and adolescentsless than 18 years of age have not yet been established. No data are available Pregnancy There is limited experience with use of COVID-19 Vaccine Moderna in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development Breast-feeding It is unknown whether COVID-19 Vaccine Moderna is excreted in human milk. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity The list of excipients is: Lipid SM-102 Cholesterol 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) 1,2-Dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 (PEG2000-DMG) Trometamol (Tris) Trometamol hydrochloride (TrisHCl) Acetic acid Sodium acetate trihydrate Sucrose Water for injections https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna/information-for-healthcare-professionals-on-covid-19-vaccine-moderna#pharmaceutical-particulars – 26 January, 2021

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