COVID-19

Therapeutics and
Vaccines Landscape
Overview
August 27, 2020

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COVID-19 vaccines development effort overview

262 vaccines are currently in development; 12-18 month timeline expected
Pipeline overview Weekly developments - August 27, 2020 Key takeaways
Trials expected to start in 2020 No announced start There are 260 vaccine candidates
Novavax expects to file for US approval in December, and new players entering the space
after kicking off Phase II this week, Sanofi/GSK say the every week
Protein-subunit 75 18 93 earliest approval for their candidate could be June 202112  63 vaccine candidates planning
CureVac begins Phase II and two vaccines started trials – to enter into clinical trials in
Viral Vectors 33 13 46
Adimmune (Phase I in Taiwan) and Finlay Vaccine Institute 2020
(Phase I/II in Cuba)1  37 vaccine candidates have
Undisclosed 30 2 32
Pfizer/BioNTech publish interim Phase I/II results already begun clinical trials
RNA 19 8 27 demonstrating neutralising GMTs in younger adults (18-55 Most experts estimate a 12-18
years of age) that were 3.8 times the GMT of a panel of 38 month timeline5 to bring a vaccine
DNA 11 9 20 convalescent patients, and 1.6 times in older adults (65-85 to market (approved and available,
years of age) not necessarily scaled-up), others
VLPs 14 2 16 Moderna publishes promising follow-up data on older believe an 18-24 month timeline or
adults, with the middle dose triggering the production of even longer is more realistic6,7
Inactivated 8 5 13 neutralising antibodies13  The earliest immunogenicity
from Phase 2 will be available
Live attenuated virus 9 1 10 AstraZeneca/IVA supply deal expands to EU overall,
for 3-4 vaccine candidates this
including specific allocations to Spain, Slovakia; separately,
year which could bring an EUA
Repurposed 0 5 5 AstraZeneca confirms a deal for 34 million doses with the
for high risk population into
Australian Government3
consideration depending on the
Total 199 63 262 UK secures another 90M doses in deals with Novavax data8,9,10,11
and J&J, and plans to partner with each company in Phase III
1. CT.gov
trials4
2. BusinessWire 4. Novavax, UK Government, J&J 7. SVB analyst on Fierce Pharma 10. CNBC
3. FiercePharma, UPI, information 5. Fierce Pharma 8. Moderna press release 11. Innovio press release
updated 7th September 6. HBR 9. FiercePharma 12. Reuters, SEC filing 13. Moderna press release
Source: Milken Institute, BioCentury, WHO, Nature, CT.gov, ChiCTR
2
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8 vaccine candidates are currently in Phase III or Phase II/III or

have announced potential EUA timelines
Phase I start date Phase II start date Phase III start date Triangle indicates a
Start dates of respective clinical trial phases Phase I/II start date Phase II/III start date Stated EUA
results read-out or
anticipated read-out

Company 2020 2021

Asset Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 1H 2H
Soonest AstraZeneca / Announced for Sep/Oct 20202
announced Oxford NCT04324606 NCT04400838* ISRCTN89951424
EUA date
AZD1222 /
ChAdOx1 nCoV-19

BioNTech / Pfizer Announced for Oct. 20205

BNT162 NCT04380701 NCT04368728 NCT04368728

Moderna
mRNA-1273 NCT04283461 NCT04405076 NCT04470427 Announced for Fall 20207

Novavax
NVX-CoV2373 NCT04368988 Q4 2020 Dec 202011
Sinopharm ChiCTR2000032459
ChiCTR2000034780 By end of 20208
ChiCTR2000031809

Johnson & Johnson

Ad26.COV-2.S NCT04436276 NCT04505722 Early 20213

Sanofi/GSK
AS03 03-Sep-202012 Jun 202112
Latest
announced Sinovac Biotech
EUA date PiCoVacc NCT04352608, NCT04383574 NCT04456595
10. FiercePharma
1. Oxford News 4. Wall Street Journal 7. Moderna press release 11. Reuters
2. CNBC 5. Washington Post 8. Reuters 12. SEC filing, Sanofi Press Release, information
3. FiercePharma 6. Forbes 9. PBR updated 7th September * indicates an estimated start date as trial has not yet officially commenced

Source: Milken Institute COVID-19 Tracker, clinicaltrials.gov, BioCentury, press search 3

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Overview of candidates with publicly announced target Emergency
Use Authorisation dates (1/2) CURRENT AS OF AUGUST 27, 2020
NONEXHAUSTIVE
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Developer Current Dosing used Total supply

and clinical in trial & Trial commitments Announced
Vaccine manufacturer trial phase pathway Countries Most recent published or pre-released trial results (m doses)2 EUA3
AZD1222 / Phase 2-3 1-2 doses UK, Brazil, Interim Phase I/II readout July 20th : 2020: 800 Sept-Oct 2020
ChAdOx1 South Africa,  Neutralising antibodies were generated in more than 90% of participants across different
Viral vector 2021: 2,000
nCoV-19 India, US assays. Responses were sustained up to 56 days of observation.”1
 “No serious adverse events1

BNT 162 Phase 2-3 2 doses Germany, Interim Germany Phase I/II readout July 20th : 2020: 100 Oct 2020
USA and
RNA  BNT162b1 elicited strong CD4+ and CD8+ T cell responses against SARS-CoV-2- 2021: 1,300
Argentina
receptor binding domain (RBD), compared to baseline4
 The RBD-specific, interferon-γ+, IL-2+, CD8+ T cells elicited by BNT162b1 in immunised
participants indicate a strong potential for cell mediated anti-viral activity4
 T cell cytokine profile shows vaccine elicited T cells exhibit a Th1 phenotype, which is
associated with antiviral propertie4
Interim US Phase I/II readout August 20th :
 BNT162b2 elicited SARS-CoV-2–neutralising GMTs in younger adults (18-55 years of
age) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent
patients, and in older adults (65-85 years of age) the vaccine candidate elicited a
neutralising GMT 1.6 times5
 Well tolerated with mild to moderate fever in fewer than 20% of participants 5

mRNA-1273 Phase 3 2 doses USA Interim Phase I readout August 26th : 2020: Sept-Nov 2020
RNA  Follow-up results showed promising data for older adults – with the middle dose 2021: 1,000
triggering the production of antibodies in patients over 56 (2-3x higher than patients
recovered from COVID-19)5
 Titer levels were not disclosed in the preliminary results; FDA suggests levels of 160 and
above 6

1. The Lancet 4. Pfizer press release

2. Based on public announcements about manufacturing capacity 5. Businesswire
3. EUA date is an estimate and subject to change 6. Moderna press release

4
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Overview of candidates with publicly announced target Emergency
Use Authorisation dates (2/2) CURRENT AS OF AUGUST 27, 2020
NONEXHAUSTIVE
Outside-in view based on media coverage and published research results if available EXAMPLES FOR ILLUSTRATION PURPOSES ONLY
DOES NOT CONSTITUTE A MEDICAL OR SCIENTIFIC PERSPECTIVE

Developer Current Dosing used Total supply

and clinical in trial & Trial commitments Announced
Vaccine manufacturer trial phase pathway Countries Most recent published or pre-released trial results (m doses)2 EUA3
NVX- Phase 1 2 doses Australia Interim Phase 1 readout August 4th : 2020: 100 Dec 2020
CoV2373
Protein-subunit  All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of 2021: “Billions”
them also developing wild-type virus neutralising antibody responses, and after Dose 2,
100% of participants developed wild-type virus neutralising antibody responses1
Nonclinical animal trials August 19th
 SARS-CoV-2 GMT antibody titers in immunised macaques were 7.9-10.1-fold higher
than in convalescent sera4
 Vaccine offered protection against SARS-CoV-2 replication in the nose and lungs; and
the absence of pulmonary pathology in vaccinated macaques4
N/A5 Phase 3 2 doses UAE, Bahrain Interim Phase I/II readout August 14th : 2020: 100 End of 2020
Inactivated  The trial linked the vaccine to increases in antibody titers. However, unlike other COVID- 2021:
19 vaccine trials, the study lacked a comparison arm featuring serum samples from
patients previously infected with the coronavirus, complicating the task of interpreting
whether the response is likely to confer immunity5
Ad26 Phase 1-2 Viral vector USA, Japan, Nonclinical animal trials July 30th : 2020: Early 2021
SARS-CoV- Belgium  Demonstrated immunogenicity and protective efficacy of a single dose of adenovirus 2021: 1,000
2 serotype 26 (Ad26) vector-based vaccines expressing the SARS-CoV-2 spike (S) protein
in nonhuman primates6
As03 Phase 1-2 2 doses USA Pre-clinical results 3rd September: 2020: Jun 2021
Recombinant • Preclinical data showed an acceptable reactogenicity profile and data based on two 2021: 1,000
protein injections of the adjuvanted recombinant vaccine showed high levels of neutralizing
antibodies that are comparable to levels in humans who recovered from the COVID-19
infection7
PiCoVacc Phase 2-3 2 doses Brazil, Interim Phase II readout August 10th : 2020:
Indonesia  Reported that the vaccine candidate appeared to be safe and induced detectable
Inactivated 2021: 100
antibody-based immune responses8
1. Novavax press release 5. Unclear which vaccine candidate the EUA date applies to so results for ‘BBIBP-
2. Based on public announcements about manufacturing capacity CorV’ candidate have been used; FiercePharma
3. EUA date is an estimate and subject to change 6. Nature
4. BioRxiv 7. Sanofi Press Release, information updated 7th September
8. Reuters
5
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Governments & organisations are creating supply NONEXHAUSTIVE

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contracts with rights to an allocation of doses (non-exhaustive)

Value ($) / Doses
Unk for unknown
Total

$1.95B / 100M $1.525B / 100M $1B+ / 100M

USA $1.2B / 300M $1.6B / 100M ~$1B / 100M1 $8.3B+ / 800M+
(+500M) (+$6.6B /400M) (+200M)
UK Unk / 100M Unk / 60M Unk / 30M Unk / 60M9 Unk / 60M Unk / 30M Unk / 340M
$843M / 300M
EU $843 / 400M
(+100M)
Brazil $356M / 100M $356M / 100M
Israel Unk / Unk $66M / Unk $66M / Unk
Unk / 250M
Japan Unk / 120M Unk / 120M Unk / 490M
(via Takeda)
Canada Unk / Unk Unk / Unk Unk / Unk
Unk/ 100M+200M
China Unk / 100M
YoY15
Argentina &
Unk / 150M-250M Unk/150M
Mexico (LatAm)
Switzerland Unk / 4.5M Unk / 4.5M
Australia Unk / 34M Unk/ 34M
CEPI, Gavi
$750M / 300M $750M / 300M
(LMIC)
Serum Inst. of
Unk / 1B Unk / 1B Unk / 2B
India (LMIC)
Total $3.1B+ / 2.8B+ $1.6B / 1.4B $1.95B+ / 250M+ Unk / 60M $1B / 160M Unk / Unk $1.6B+ / 105M+ $1B+ / 130M+ $10.3B+ / 4.9B+
1. Sanofi press release – “over half of $2.1B for dev., other for doses”
Source: Economist, Reuters, FiercePharma, BBC, The Marker, Pharmaceutical Technology, GlobalNews, Bloomberg, FOPH Switzerland, UPI, Company press releases 6
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Public announcements indicate global vaccine manufacturing

capacity of ~8 – 9 billion doses by end of 2021
Manufacturing YE 2020 YE 2021 In- Out-
type Asset Asset category Company Collaborators (M) (M) source source Partner Comment
Specific-assets mRNA-1273 RNA Moderna NIAID, Lonza 1,000 1 1 1 Lonza, Catalent,
ROVI
BNT162 RNA BioNTech Pfizer and Fosun Pharma 100 2 1,3002 2 2 Pfizer

INO-4800 DNA Inovio Beijing Advaccine Biotechnology, 1 4 1 1 Richter-Helm

Ology Bioservices
Viral vectors Themis Merck, Institut Pasteur and Uni. 1,000 5 1 1
of Pittsburgh
AAVCOVID Viral vectors Mass. Eye and Ear and Novartis Millions 6 1 Novartis
Mass. General Hospital
Ad26.COV-2.S Viral vectors J&J Beth Israel, HHS 1,000 7 1 1 Catalent, Emergent Biosolutions,
Biological E
AZD1222 / ChAdOx1 Viral vectors University of Oxford AstraZeneca, Advent SRL 800 8,3 2,000 9 SII, Oxford Biomedica, Emergent
nCoV-19 (Jenner Institute) MilliporeSigma, Cobra Biologics 1 Biosolutions, Catalent, Scotland
Symbiosis, Wockhardt, BioKangtai
AS03 Protein-subunit Sanofi Pasteur GSK 1,000 10 1

NVX-CoV2373 Protein-subunit Novavax Emergent BioSolutions, Praha 100 15 “”Billions” 11 1 Praha Vaccines, Takeda (250M
Vaccines, Serum Inst. of India doses), Fujifilm
Other PiCoVacc Inactivated Sinovac Biotech Dynavax 100 12 N/A

Inactivated Sinopharm Beijing Institute of Biological 100 13 N/A

Products
Inactivated Sinopharm Wuhan Institute of Biological 100 13 N/A
Products
Government- N/A N/A HSS / Operation Warp To be determined N/A N/A Text Emergent $628M
funded Speed Biosolutions reservation 14

1. Moderna press release 4. Inovio press release 7. J&J press release 10. FiercePharma 13. Chinadaily.com.cn
2. Pfizer press release 5. FierceBiotech 8. AZ press release 11. FiercePharma 14. HHS press release
3. FiercePharma 6. Masseyeandear.com 9. AZ press release 12. BusinessWire 15. FiercePharma
Source: Milken Institute, BioCentury, WHO, Nature, clinicaltrials.gov, press searches as noted above 7
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COVID-19 Therapeutics landscape update

Pipeline snapshot Key takeaways Weekly developments as of August 27
Number of candidates
Preclinical Over 380 candidates are being considered across a range of ▪ The US approved convalescent plasma for emergency
modalities and use cases. Remdesivir and Dexamethasone use authorisation (EUA). A recent study of 35,000 patients
Clinical
are the two drugs with clinically proven benefits. sponsored by Mayo Clinic and NIH demonstrated that
Virus-directed Approved or EUA patients receiving convalescent plasma at 3 vs. 4+ days
None have been approved globally for COVID-19, but
Small 27 41 69 in the US post-diagnosis had reduced mortality at day 7 (8.7% vs.
some countries approved specific drugs (not
Molecule comprehensive): remdesivir received EUA by FDA2 and is 11.9%, respectively) and day 30 (21.6% vs. 26.7%,
approved in EU, Japan, Taiwan, India, UAE, Australia, and respectively). However, this study is limited by the lack of a
1
Singapore, UK, and Canada3,; Favipiravir is approved in placebo group. During the press conference to announce the
Virus China, India, and Russia4; Dexamethasone is approved in approval, FDA commissioner Stephen Hahn incorrectly
neutralising 45 22 67 Japan and the UK and provisionally approved in Taiwan 6; remarked that the treatment is responsible for a “35%
antibodies Coronavir is approved in Russia7; Itolizumab is approved for improvement in survival.” In subsequent statements, Hahn
emergency use in India8; convalescent plasma from COVID- corrected the language, noting “What I should have said
19 patients is approved under emergency use authorisation in better is that the data show a relative risk reduction not an
Immune the US9 absolute risk reduction.”10
20 88 108
modulators  Virus-directed small molecules: Mostly repurposed drugs;
▪ Roche signs deal to manufacture and distribute
early results for many drugs are not yet robust, however.
Regeneron’s COVID-19 antibody cocktail outside the US.
 Monoclonal & polyclonal antibodies (virus neutralising): The deal triples the manufacturing capacity of the therapy,
Mostly in pre-clinical stage, but showing some early positive which is currently in Phase III trials.11
Cell, gene, 22 20 42 382 assets in signals. Several companies have entered late-stage clinical
and RNA total1 trials and expect to receive first EUA as early as late 2020.5 ▪ Takeda and Johnson & Johnson lead a new collaborative
 Immune modulators: Various immune modulators are initiate aimed at addressing the current and potential
being tried, mostly for severe/critical cases with acute future coronavirus pandemics. The group, called CARE,
respiratory distress syndrome and/or cytokine storm, but no will focus on repurposing existing drugs and developing
Other 29 67 96 drug with clear benefits yet. novel antibodies and small molecules.12
 Cell, gene, and RNA: Multiple therapies in development,
many in pre-clinical stage.
1. Clinical trial information may not have been captured if not registered at CT.gov or published otherwise
2. FDA 3. Gilead, Reuters, Reuters, Reuters, Press, Department of Health , Reuters, gov.uk 4. RDIF, HospiMedica, PMlive 5. Reuters 6. Fiercepharma; Reuters
7. CGTN 8. Indiatvnews 9. FDA, STATNews 10. MedRxiv, Fiercepharma 11. Roche, Fiercepharma 12. Pharmaphorum, Fiercepharma
Source: Milken Institute, BioCentury, WHO, Nature, CT.gov, ChiCTR, press as of July 14, 2020 8
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