UK Covid-19 Vaccine Procurement: Notes - 9 December 2020 Jay Patel Global Health Governance Programme Usher Institute of Population Health ...
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UK Covid-19 Vaccine Procurement: Notes 9 December 2020 Jay Patel Global Health Governance Programme Usher Institute of Population Health Sciences and Informatics University of Edinburgh
Global Health Governance Programme 9 Dec 2020 Jay Patel
UK Government Press Release
Government welcomes the MHRA review into Pfizer and BioNTech vaccine1
Published 23 November 2020
The government has purchased 7 different types of vaccine in advance and procured 355
million doses. Through the government’s Vaccines Taskforce, the UK has secured early
access to over 355 million doses of 7 of the most promising vaccine candidates, including:
1. BioNTech/Pfizer for 40 million doses
2. Oxford/AstraZeneca for 100 million doses
3. Moderna for 5 million doses
4. GlaxoSmithKline & Sanofi Pasteur for 60 million doses
5. Novavax for 60 million doses
6. Janssen/Johnson & Johnson for 30 million doses
7. Valneva for 60 million doses
[Ref 2] Guardian. UK scrambles to buy 5m doses of Covid breakthrough vaccine.
November 16, 2020. https://www.theguardian.com/world/2020/nov/16/uk-in-advanced-
discussions-to-buy-moderna-covid-vaccineGlobal Health Governance Programme 9 Dec 2020 Jay Patel [Ref 3] Financial Times. Covid vaccine tracker: How do the leading jabs compare? December 4, 2020. https://www.ft.com/content/ac5e5ef8-bccb-482b-9f8d- 0dab5cac6f9a?shareType=nongift
Global Health Governance Programme 9 Dec 2020 Jay Patel Overview of the front-runners: Primarily these data derived from the following FT article, but other sources have been synthesised for a fuller picture: [Ref 3] Financial Times. Covid vaccine tracker: How do the leading jabs compare? December 4, 2020. https://www.ft.com/content/ac5e5ef8-bccb-482b-9f8d-0dab5cac6f9a?shareType=nongift BioNTech/Pfizer Germany/US UK are underway administering their supply of 800,000 Pfizer vaccines (in accordance with JCVI guidance) and have advance orders for 40m doses of the Pfizer / Fosun Pharma / BioNTech. The primary completion date was expected by 13 June 2021 but positive interim results were announced on 9 November. On 16 November, the companies announced to have met all the primary outcomes necessary to demonstrate efficacy. Experts were cautious, highlighting uncertainties regarding the nature of the protection, storage requirements and how to meet global demand. However, data were sufficient for approval in UK, Bahrain, and Canada. 95% “efficacy” according to press release on phase 3 trial data. Full details are published (though not necessarily peer-reviewed) in the FDA report, but I have not read through. Regulatory approval confirmed in the UK (by MHRA on December 2nd), Bahrain (by Bahrain NHRA on December 4th), and Canada (by Health Canada on December 9th). Pending approval in the EU (expected on December 29th) and the US (expected December 10*)4 *The FDA published the briefing document on the Pfizer/BioNTech vaccine on December 9th, guiding the Vaccines and Related Biological Products Committee meeting to be held on December 10th 2020. Available at: https://www.fda.gov/media/144246/download) Production: 1.3bn doses in 2021. Manufacturing will take place in Mainz, Idar-Oberstein and Marburg in Germany, Puurs in Belgium and Kalamazoo, Michigan. Global Distribution: Expected to be distributed to the UK, EU, US and Japan. Storage requirements: Must be transported at -75C. Has a lifespan of five days when refrigerated at between 2C and 8C.
Global Health Governance Programme 9 Dec 2020 Jay Patel Moderna US 94.1% “efficacy” according to press release on phase 3 trial data. UK have orders for 5m doses of the Moderna candidate. The primary completion date is expected by 27 October 2022, but positive interim results were announced on 16 November. At a glance: expected dates of vaccine approval: USA: December 17th EU: January 12th Moderna applied on November 30th to the US FDA for emergency authorisation of their vaccine. The FDA meeting which will conclude its assessment will be held on December 17th.5,6 If approved, vaccination programme could begin on December 21st. (New York Times) For a sense of time, Pfizer submitted their application to FDA on November 20th, and approval pending (but likely TBC on December 10th) Moderna also applied to EU EMA for “conditional marketing” of their vaccine on December 1st (meeting, which conclude its assessment, to be held on January 12th).7 Production: Between 500m and 1bn doses in 2021, manufactured in the US, Switzerland and Spain. Global Distribution: Expected to be available in most developed countries. Storage requirements: Must be transported at -20C. Has a lifespan of 30 days when refrigerated at between 2C and 8C.
Global Health Governance Programme 9 Dec 2020 Jay Patel Oxford University/AstraZeneca UK UK has advance orders for 100m doses. The primary completion date is expected for 22 December 2020, but AstraZeneca announced a press release on interim results for Phase 3 on 23 November, with peer-reviewed data published on December 8th in the Lancet. Trials are ongoing and data on whether the vaccine can SARS-CoV-2 infection, especially in the elderly are not yet available. ~70% mean efficacy according to phase 3 trial data published in The Lancet. At a glance: expected dates of vaccine approval: UK: under review with MHRA, could approve in December. EU: under review, approval expected mid-January. USA: approval expected in 2021. Interim trial data is currently under review in the UK and EU. A phase 3 trial in the US in ongoing and approval is not expected until next year. It appears no dates have been given for expected approval. Chief Executive of the MHRA said she was unable to give a “firm date” on when the review would be completed. Production: 3bn doses in 2021, which will be manufactured in various locations including the UK, India and Brazil. Global Distribution: Distribution is expected to be worldwide once approved. It is cheap to produce and requires less refrigeration — an advantage in many developing countries, where AstraZeneca has promised to sell it at cost. Storage requirements: Needs to be refrigerated between 2C and 8C but does not expire.
Global Health Governance Programme 9 Dec 2020 Jay Patel Johnson & Johnson/Janssen US UK has advance orders for 30m doses. The earliest primary completion date is expected for 10 May 2022. Unknown efficacy, phase 3 trials ongoing in the US, with interim data expected in January. At a glance: expected dates of vaccine approval: UK: under review with MHRA, could approve in December. EU: under review, approval expected mid-January. USA: approval expected in 2021. In the UK and EU early trial results are under rolling review but phase 3 results have not been submitted anywhere. The EMA started a rolling review of the vaccine on December 1st based on preliminary results from laboratory studies and early clinical studies in adults. Expected to seek US FDA approval first, in February, if the phase 3 data are positive. Production: 3bn doses in 2021, which will be manufactured in various locations including the UK, India and Brazil. Global Distribution: Distribution is expected to be worldwide once approved. It is cheap to produce and requires less refrigeration — an advantage in many developing countries, where AstraZeneca has promised to sell it at cost. Storage requirements: Needs to be refrigerated between 2C and 8C but does not expire.
Global Health Governance Programme 9 Dec 2020 Jay Patel Novavax US UK has advance orders for 60m doses of the Novavax candidate. The primary completion date is expected for January 2021 in the UK. Unknown efficacy, phase 3 trials are ongoing in Mexico, UK, and a larger trial in the US, which was granted $1.6bn of government funding, expected to start in December. Production: 1bn to 2bn doses in 2021, manufactured in the US, Czech Republic, Spain, Sweden, Denmark and South Korea. Global Distribution: Worldwide. Storage requirements: Transported and stored at 2C to 8C. Expected to last at least six months at those temperatures, though work on this area is ongoing.
Global Health Governance Programme 9 Dec 2020 Jay Patel Status of Covid-19 vaccine clinical trials: Phase 3 Trials: *Novavax should read UK, Mexico, USA. Note: Though the data in the table above are largely accurate, they may not necessarily reflect a truly contemporaneous picture, as the paper was first published on October 13th [Ref 8] Poland GA, Ovsyannikova IG, Kennedy RB. SARS-CoV-2 immunity: review and applications to phase 3 vaccine candidates. Lancet 2020; 396: 1595-1606. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32137-1/fulltext
Global Health Governance Programme 9 Dec 2020 Jay Patel Data up to August 21st [Ref 9] Callaway E. The unequal scramble for coronavirus vaccines - by the numbers. Nature 2020; 584: 506-507.
Global Health Governance Programme 9 Dec 2020 Jay Patel Data up to August 21st [Ref 9] Callaway E. The unequal scramble for coronavirus vaccines - by the numbers. Nature 2020; 584: 506-507.
Global Health Governance Programme 9 Dec 2020 Jay Patel
References:
1. Gov.UK. Government welcomes the MHRA review into Pfizer and BioNTech vaccine.
November 23, 2020. https://www.gov.uk/government/news/government-welcomes-
the-mhra-review-into-pfizer-and-biontech-vaccine
2. Guardian. UK scrambles to buy 5m doses of Covid breakthrough vaccine. November
16, 2020. https://www.theguardian.com/world/2020/nov/16/uk-in-advanced-
discussions-to-buy-moderna-covid-vaccine
3. Financial Times. Covid vaccine tracker: How do the leading jabs compare?
December 4, 2020. https://www.ft.com/content/ac5e5ef8-bccb-482b-9f8d-
0dab5cac6f9a?shareType=nongift
4. US Food and Drug Administration. Pfizer-BioNTech Covid-19 vaccine (BNT162, PF-
07302048) Vaccines and Related Biological Products Advisory Committee Briefing
Document. December 10, 2020. https://www.fda.gov/media/144246/download
5. New York Times. Moderna Applies for Emergency F.D.A. Approval for Its
Coronavirus Vaccine. November 30, 2020.
https://www.nytimes.com/2020/11/30/health/covid-vaccine-moderna.html
6. US Food and Drug Administration. Coronavirus (COVID-19) Update: FDA
Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine
Candidate. November 30, 2020. https://www.fda.gov/news-events/press-
announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-
meeting-discuss-second-covid-19-vaccine
7. European Medicines Agency. EMA receives application for conditional marketing
authorisation of Moderna COVID-19 vaccine. December 1, 2020.
https://www.ema.europa.eu/en/news/ema-receives-application-conditional-
marketing-authorisation-moderna-covid-19-vaccine
8. Poland GA, Ovsyannikova IG, Kennedy RB. SARS-CoV-2 immunity: review and
applications to phase 3 vaccine candidates. Lancet 2020; 396: 1595-1606.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32137-1/fulltext
9. Callaway E. The unequal scramble for coronavirus vaccines - by the numbers. Nature
2020; 584: 506-507.You can also read
