COVID-19 is an infectious disease caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus that emerged in late 2019 in Wuhan, China. As of October 2021, there have been 245,373,039 confirmed cases of COVID-19, and 4,979,421 deaths globally. SARS-CoV-2 belongs to the coronavirus family, which collectively cause respiratory and intestinal disease in humans and animals, with other prominent members of the family including Middle East respiratory syndrome (MERS) virus and severe acute respiratory syndrome (SARS) virus
CONTENTS
9 OVERVIEW
9 Latest key takeaways
12 DISEASE BACKGROUND
12 Definition
12 Transmission
12 Symptoms
13 Diagnosis
13 Patient segmentation
14 Risk factors
15 WHO vaccination allocation guidelines
16 EPIDEMIOLOGY
16 Vaccinations
16 Variants
16 High-risk group populations
17 High-risk group prevalent populations
19 MARKETED PREVENTIVE AGENTS
26 PIPELINE PREVENTIVE AGENTS
33 KEY REGULATORY EVENTS
33 New Breathalyzer Test Authorized By FDA Detects Virus, Not The Inebriated
33 Valneva’s COVID-19 Vaccine Approved In UK While Talks Continue Over Scrapped Supply Deal
34 US FDA Bypasses Adcomm In Authorizing Second COVID Booster Because Decision ‘Straight-Forward’
34 Moderna’s Bid For Second COVID Vaccine Booster Spans Broader Age Group Than Pfizer/BioNTech
35 AstraZeneca’s Evusheld Wins EU Marketing Nod For Preventing COVID-19
35 AZ’s Evusheld Gains UK & Australian Approval
35 China Approves Chongqing Zhifei’s Recombinant Protein Vaccine For Emergency Use
36 China OKs Heterologous Booster Shots Amid Heated COVID Vaccine Race
36 Canada Approves Nuvaxovid
36 Australia OKs Spikevax In Younger People
37 US IND Hold For Bharat’s Vaccine Lifted: Ocugen
37 Biological E/Baylor College’s Vaccine Gets Indian EUA For Use In Adolescents
37 ‘Don’t Make Promises Until You Have The Data’: FDA Gamble On Speeding Up COVID Vax In Kids Flops
38 mRNA COVID Vaccine Dosing Intervals May Be Extended To Mitigate Myocarditis Risk
39 Coronavirus Notebook: UK Approves Novavax Vaccine
39 Sputnik Fully Approved In Russia
39 ‘Show Us The Data’: Plan To Speed Pfizer COVID Vaccine OK In Kids Under Five Draws Questions
40 Moderna’s COVID Vaccine Had Longer FDA Review Than Pfizer’s; Similar Post-Market Requirements
40 Novavax Requests FDA EUA For Its Vaccine
40 Technology Transfer Deal Allows Brazil To Produce Vaxzevria Domestically
41 Australia OKs Nuvaxovid
41 Japan Approves Comirnaty For Kids
41 EMA: Multiple COVID-19 Booster Programs ‘Not Sustainable’ In Long Term
42 Novavax’s Nuvaxovid Approved In Korea
42 Janssen COVID-19 Vaccine Adds Another Thrombotic Warning
43 No Need For Second Booster, Says UK
43 Novavax Readies COVID-19 Vaccine Request For EUA, But How Much Longer Will The Door Be Open?
43 ACIP Upgrades Child Vaccine Booster Recommendation To ‘Should’
44 COVID Vaccine Authorization Changes Without Advisory Committee Becoming More Common
45 PROBABILITY OF SUCCESS
46 LICENSING AND ASSET ACQUISITION DEALS
46 Valneva Receives £20M Research And Development Funding In Scotland
46 Covaxin UN Supply Suspended
46 SK Bioscience To Supply 10 Million Doses of GBP510 In South Korea
46 UK Boosts mRNA Lipid Manufacturing
47 DoD Contracts For OTC COVID-19 Tests Go To Abbott, iHealth, Roche Diagnostics, Siemens
47 Iconovo Expands Collaboration With ISR
48 Wockhardt Expands UK Vaccines Unit With Serum Institute Deal
48 CR Biopharma In-Licenses COVID-19 Antibody From AB Studio
48 AstraZeneca Inks Canadian Supply Contract For Evusheld
49 ConserV Wins UK Funding For Vaccine Candidate
49 Wockhardt To Export 100 Million Sputnik Vaccines
49 CEPI Partners Panacea, THSTI For Pan Beta Coronavirus Vaccines
50 Detect Inc. Nabs $22.9M Gov’t Award To Develop 30-Minute Flu/COVID-19 Combo Test
50 Biocon Finalizes Merger Between Covidshield And Biologics Business
51 BravoVax Teams With Fulgent And Fudan University To Develop Beta-Coronavirus Lineage B Vaccine
51 Japan Contracts For 18 Million Moderna Booster Shots
51 Novavax, SK Bio Expand Vaccine License Agreement
52 CEPI, SK Bio Look At ‘Variant-Proof’ Vaccines
52 UK Pfizer/BioNTech & Moderna Deal
53 J&J Nears Deal Close With South African Manufacturer
53 Serum Institute Resumes COVAX Supplies, Exports Novavax Vaccine
53 Wockhardt Partners With RDIF To Produce Sputnik V And Sputnik Light Vaccines
54 CLINICAL TRIAL LANDSCAPE
55 Sponsors by status
56 Sponsors by phase
57 Recent events
66 VACCINES ASSESSMENT MODEL
66 Overview
70 MRNA-BASED VACCINES
73 ADENOVIRAL VECTOR VACCINES
79 PROTEIN SUBUNIT VACCINES
83 INACTIVATED VACCINES
87 DNA SUBUNIT VACCINES
88 MONOCLONAL ANTIBODIES
90 ANTIVIRALS
91 MARKET DYNAMICS
95 FUTURE TRENDS
96 CONSENSUS FORECASTS
97 RECENT EVENTS AND ANALYST OPINION
97 Spikevax for COVID-19 Prevention (April 15, 2022)
98 ADG20 for COVID-19 Prevention (March 30, 2022)
99 Spikevax for COVID-19 Prevention (March 23, 2022)
100 Coronavirus Vaccine (Sanofi/GSK) for COVID-19 Prevention (February 23, 2022)
101 AZD2816 for COVID-19 Prevention (January 13, 2022)
102 AKS-452 for COVID-19 Prevention (December 22, 2021)
103 ABNCoV2 for COVID-19 Prevention (December 5, 2021)
104 JNJ-78436735 for COVID-19 Prevention (December 5, 2021)
105 Evusheld for COVID-19 Prevention (November 18, 2021)
106 Comirnaty for COVID-19 Prevention (October 26, 2021)
107 mRNA-1273 for COVID-19 Prevention (October 25, 2021)
109 Comirnaty for COVID-19 Prevention (October 22, 2021)
110 VLA2001 for COVID-19 Prevention (October 18, 2021)
112 JNJ-78436735 for COVID-19 Prevention (October 15, 2021)
115 JNJ-78436735 for COVID-19 Prevention (October 13, 2021)
116 mRNA-1273 for COVID-19 Prevention (October 13, 2021)
119 KEY UPCOMING EVENTS
120 UNMET NEEDS
120 Multivalent booster vaccines for broad protection
120 Pan-respiratory seasonal vaccines
120 Increased vaccine supply, particularly in lower-income countries
121 Alternative options for individuals not eligible for vaccination
121 Additional data and approvals in pediatric patients
122 BIBLIOGRAPHY
127 APPENDIX
LIST OF FIGURES
26 Figure 1: Overview of pipeline COVID-19 preventive agents in the US
26 Figure 2: Pipeline COVID-19 preventive agents, by company
27 Figure 3: Pipeline COVID-19 preventive agents, by drug type
27 Figure 4: Pipeline COVID-19 preventive agents, by classification
45 Figure 5: Probability of success in the antiviral pipeline
54 Figure 6: Clinical trials in COVID-19 treatment and prevention
54 Figure 7: Top 10 drugs for clinical trials in COVID-19 treatment and prevention
55 Figure 8: Top 10 companies for clinical trials in COVID-19 treatment and prevention
55 Figure 9: Trial locations in COVID-19 treatment and prevention
56 Figure 10: COVID-19 treatment and prevention trials status
57 Figure 11: COVID-19 treatment and prevention trials sponsors, by phase
66 Figure 12: Datamonitor Healthcare’s vaccine assessment summary for COVID-19 prevention
91 Figure 13: Market dynamics in COVID-19 prevention
95 Figure 14: Future trends in COVID-19 prevention
109 Figure 15: mRNA-1273 for COVID-19 Prevention (October 25, 2021): Phase II/III – KidCOVE
112 Figure 16: VLA2001 for COVID-19 Prevention (October 18, 2021): Phase III – Cov-Compare (UK)
119 Figure 17: Key upcoming events in COVID-19 prevention (one of two)
119 Figure 18: Key upcoming events in COVID-19 prevention (two of two)
LIST OF TABLES
14 Table 1: Clinical status scores and interpretations
15 Table 2: WHO recommendations for prioritization of vaccination in settings where there is widespread community transmission
17 Table 3: High-risk populations and prevalence sources
18 Table 4: Estimated prevalent population in each COVID-19 high-risk group, by region
20 Table 5: Marketed preventive agents for COVID-19
28 Table 6: Pipeline preventive agents for COVID-19 in the US
92 Table 7: Summary of available efficacy data and estimates of manufacturing capacity for vaccines with emergency/conditional approvals or in late-phase development
96 Table 8: Historical global sales, by drug ($m), 2020–21
97 Table 9: Spikevax for COVID-19 Prevention (April 15, 2022)
98 Table 10: ADG20 for COVID-19 Prevention (March 30, 2022)
99 Table 11: Spikevax for COVID-19 Prevention (March 23, 2022)
100 Table 12: Coronavirus Vaccine (Sanofi/GSK) for COVID-19 Prevention (February 23, 2022)
101 Table 13: AZD2816 for COVID-19 Prevention (January 13, 2022)
102 Table 14: AKS-452 for COVID-19 Prevention (December 22, 2021)
103 Table 15: ABNCoV2 for COVID-19 Prevention (December 5, 2021)
104 Table 16: JNJ-78436735 for COVID-19 Prevention (December 5, 2021)
106 Table 17: Evusheld for COVID-19 Prevention (November 18, 2021)
107 Table 18: Comirnaty for COVID-19 Prevention (October 26, 2021)
108 Table 19: mRNA-1273 for COVID-19 Prevention (October 25, 2021)
110 Table 20: Comirnaty for COVID-19 Prevention (October 22, 2021)
111 Table 21: VLA2001 for COVID-19 Prevention (October 18, 2021)
113 Table 22: JNJ-78436735 for COVID-19 Prevention (October 15, 2021)
115 Table 23: JNJ-78436735 for COVID-19 Prevention (October 13, 2021)
117 Table 24: mRNA-1273 for COVID-19 Prevention (October 13, 2021)
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