UK COVID-19 VACCINE PROCUREMENT - Briefing Document Jay Patel COVID-19 POLICY SERIES GLOBAL HEALTH GOVERNANCE PROGRAMME 11 DECEMBER 2020 - GLOBAL ...
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UK COVID-19 VACCINE PROCUREMENT Briefing Document Jay Patel COVID-19 POLICY SERIES GLOBAL HEALTH GOVERNANCE PROGRAMME 11 DECEMBER 2020
11 December 2020 Jay Patel
Overview of UK COVID-19 Vaccine Procurement
UK Government Press Release
Government welcomes the MHRA review into Pfizer and BioNTech vaccine.1
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. Moderna for 5 million doses
3. Oxford/AstraZeneca for 100 million doses
4. Janssen/Johnson & Johnson for 30 million doses
5. Novavax for 60 million doses
6. GlaxoSmithKline & Sanofi Pasteur for 60 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-vaccine
211 December 2020 Jay Patel
Overview of Vaccine Candidates
Information below primarily derived from the FT reference below, but other sources have been included:
[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 began administering their supply of 800,000 Pfizer vaccines on 8th December (in
accordance with JCVI guidance) and have advance orders for 40m doses. The primary
completion date was expected by 13 June 2021 but positive interim results were announced
on 9th November. On 16th 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 the UK, Bahrain, and Canada.
95% efficacy according to press release on phase 3 trial data. Full details were first published
(though not necessarily peer-reviewed) in the FDA briefing document.* Interim trial data
published on 10th December in the New England Journal of Medicine.4
Regulatory approval confirmed in the UK (by MHRA on 2nd December), Bahrain (by Bahrain
NHRA on 4th December), and Canada (by Health Canada on 9th December), and the US (by
FDA on 10th December)
Pending approval in the EU (expected on 29th December)
*The FDA published the briefing document on the Pfizer/BioNTech vaccine on 9th December,
guiding the Vaccines and Related Biological Products Committee meeting held on 10th
December 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 -75°C. Has a lifespan of five days when
refrigerated at between 2°C and 8°C.
311 December 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 27th October 2022, but positive interim results were announced on 16th
November.
At a glance: expected dates of vaccine approval:
USA: 17th December
EU: 12th January
Moderna applied on 30th November to the US FDA for emergency authorisation of their
vaccine. The FDA meeting, which will conclude its assessment, is to be held on 17th
December.6,7 If approved, a vaccination programme could begin on 21st December.6
For a sense of timescale, Pfizer submitted their application to FDA on 20th November, and US
approved vaccine on 10th December.
Moderna also applied to EU EMA for “conditional marketing” of their vaccine on 1st December
(meeting, which will conclude its assessment, to be held on 12th January).8
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 -20°C. Has a lifespan of 30 days when
refrigerated at between 2°C and 8°C.
411 December 2020 Jay Patel
Oxford University/AstraZeneca
UK
UK has advance orders for 100m doses. The primary completion date is expected for 22nd
December 2020, but AstraZeneca announced a press release on interim results for Phase 3 on
23rd November, with peer-reviewed data published on 8th December 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 2°C and 8°C but does not expire.
511 December 2020 Jay Patel
Johnson & Johnson/Janssen
US
UK has advance orders for 30m doses. The earliest primary completion date is expected for
10th 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 1st December 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: 1bn doses in 2021, manufactured in the US, Europe, Asia and Africa.
Global Distribution: expected to be worldwide once approved.
Storage requirements: Can be transported and stored at between 2°C and 8°C for three
months. Will last for two years if kept at -20°C.
611 December 2020 Jay Patel
Novavax
US
UK has advance orders for 60m doses. 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 2°C to 8°C. Expected to last at least six
months at those temperatures, though work on this area is ongoing.
711 December 2020 Jay Patel
Status of Covid-19 vaccine phase 3 trials
Note: These data may not necessarily reflect a truly contemporaneous picture, as the paper
was first published in the Lancet on 13th October.
[Ref 9] 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
811 December 2020 Jay Patel
Overview of Global COVID-19 Vaccine Procurement
[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
911 December 2020 Jay Patel
Data up to August 21st
[Ref 10] Callaway E. The unequal scramble for coronavirus vaccines - by the numbers. Nature
2020; 584: 506-507.
1011 December 2020 Jay Patel
Data up to August 21st
[Ref 10] Callaway E. The unequal scramble for coronavirus vaccines - by the numbers. Nature
2020; 584: 506-507.
1111 December 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. Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA
Covid-19 Vaccine. New England Journal of Medicine 2020 (online ahead of print).
5. 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
6. 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
7. 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
8. 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
9. 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
10. Callaway E. The unequal scramble for coronavirus vaccines - by the numbers. Nature
2020; 584: 506-507.
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