Disease Analysis: COVID-19 Prevention
Author: Michael Haydock
Publisher: Datamonitor Healthcare
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Definition
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 12 May 2021, there have been 159,319,384 confirmed cases of COVID-19, and 3,311,780 confirmed 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. SARS-CoV-2 is believed to have originated from a horseshoe bat coronavirus, which either spread to humans directly or jumped via an intermediate host (possibly a pangolin), which may have facilitated transmission to humans.
Latest key takeaways
- Several vaccines have been approved for emergency use in adults across the world, and while estimates of efficacy against symptomatic COVID-19 have varied from 50% to 95%, efficacy estimates against severe infection/hospitalization have been consistently high across all vaccine approaches investigated thus far. The latter is an important finding as severe/hospitalized COVID-19 infections represent the greatest social and economic disease burden, and the primary aim of current vaccination campaigns is to reduce mortality and ease pressure on overwhelmed hospitals by reducing hospitalization rates.
- Efficacy against asymptomatic infection is an important factor that could serve to differentiate the various vaccine approaches in the long term, as asymptomatic carriers are believed to be responsible for approximately one quarter of transmissions, thus vaccines capable of inducing sterilizing immunity will also provide some measure of indirect protection to non-vaccinated individuals. Earlier-launched vaccines developed by Pfizer/BioNTech, Moderna, and AstraZeneca have an advantage in this regard as they are the subject of ongoing studies to measure the impact of vaccination on asymptomatic transmission, and it is more feasible to conduct such trials when transmission is still high.
- Given the constant threat of the emergence of new viral variants bearing mutations in the spike protein that allow them to partially or fully evade immune responses generated by first-generation vaccines, developers that can generate data showing efficacy against these variants could have a substantial advantage, though the extent of the advantage will depend on the prevalence and spread of the variants in each region. All the leading vaccine developers (Pfizer/BioNTech, Moderna, AstraZeneca, Johnson & Johnson, and Novavax) are currently exploring booster shots with existing vaccines and/or second-generation vaccines with optimized spike protein antigens to address the threat posed by new variants, but Pfizer/BioNTech and Johnson & Johnson currently have the most robust efficacy data against the concerning South African B1.351 strain.
- Vaccine supply and pricing will also be crucial determinants of uptake, with the former likely to be the dominant influencer of market share trends throughout 2021 and early 2022 as demand outstrips supply. Conversely, pricing will become a more prominent factor post the pandemic phase as supply constraints are resolved and companies seek to adopt more typical vaccine pricing to ensure longer-term profitability. However, pledges from Sanofi, Johnson & Johnson, and AstraZeneca to market vaccines at non-profit prices during the pandemic phase could set a price ceiling for other for-profit competitors that may be hard to escape from beyond 2022, particularly given that competition from additional manufacturers is expected by that point. Indeed, even if only the current late-phase vaccines successfully reach the market, there will be substantial oversupply of vaccines post-2022, thus Datamonitor Healthcare expects significant pipeline attrition throughout 2021 and possible market withdrawals post-2022 as more minor players reallocate resources to other, more profitable indications.
- Demand is expected to vastly outstrip supply until at least mid-2022, meaning additional market entrants are still required to increase vaccine availability. This is especially the case for lower-income markets, which have struggled to compete in securing priority access to vaccines compared to developed markets. Fortunately, several more vaccines are expected to launch in 2021 which will substantially boost global supply. The COVAX initiative (coordinated by CEPI, GAVI, and the WHO), which aims to secure at least 2 billion doses for participating countries by the end of 2021, will also play a pivotal role in ensuring lower-income markets are able to have access to vaccines, though this supply will only be sufficient to vaccinate the highest-risk groups rather than entire populations.
- Four Chinese vaccines, a Russian vaccine (Sputnik V), and two Indian vaccines (Covishield and Covaxin) have gained emergency approvals in China, India, Russia, and other emerging markets, and will play an important role in supplying lower-income countries during 2021. Sputnik V and CoronaVac are also under review by the EMA and are expected to be the fifth and sixth vaccines approved in the EU, respectively, acting to plug a supply gap for adult vaccination campaigns.
- Comirnaty’s and mRNA-1273’s excellent efficacy and safety profiles and first-to-market statuses have positioned them for phenomenal sales potential in 2021, with Pfizer guiding $26bn in sales, BioNTech guiding $15.1bn, and Moderna guiding $19.2bn. Comirnaty’s greater success thus far likely reflects Pfizer’s extensive commercial resources and marketing experience, as well as its higher manufacturing capacity (3 billion annual capacity in 2021 vs 800 million to 1 billion for Moderna), which have allowed the company to secure more pre-purchase agreements, including deals with the EU totaling 2.4 billion doses.
- The longer-term role of adenoviral vector-based COVID-19 vaccines is in doubt following the association of AstraZeneca’s and Johnson & Johnson’s vaccines with an increased risk of very rare blood clots, including cerebral venous sinus thromboses (CVSTs) that also present with thrombocytopenia. It is currently unclear if this association is a class-wide effect, as similar adverse events have not yet been reported with Sputnik V (Ad26 and Ad5) or Convidecia (Ad5), but widespread media coverage of blood clots with Vaxzevria and JNJ-78436735 has led to significant hesitancy among younger adults, particularly younger women.
- Vaccines will ultimately be able to cater for the vast majority of individuals, but there remains a smaller market opportunity for monoclonal antibodies and antivirals in the prevention setting for those who are not eligible for vaccination or who require immediate protection in outbreak control settings. A handful of monoclonal antibodies are in development for the prevention of COVID-19, though they are expensive to produce and manufacturing capacities are limited. Antivirals could also play an important role in these scenarios and have the advantage of oral dosing and lower cost compared to monoclonal antibodies, though there is still room for improvement in dosing schedules as the most advanced candidates require twice-daily dosing.
- Key upcoming catalysts include pivotal trial readouts for Novavax’s NVX-CoV2373, CureVac’s CVnCoV, and Medicago’s CoVLP, as well as possible approvals for these vaccines in Q3 2021. These vaccines will play a crucial role in boosting supply, particularly in the EU and Canada, where vaccine rollout has been slow.
CONTENTS
10 OVERVIEW
10 Latest key takeaways
12 DISEASE BACKGROUND
12 Definition
12 Transmission
12 Symptoms
13 Diagnosis
13 Patient segmentation
14 Risk factors
14 WHO vaccination allocation guidelines
16 EPIDEMIOLOGY
16 High-risk population prevalence methodology
16 High-risk group prevalent populations
18 High-risk group prevalent cases
18 Infection fatality rate
19 Hospitalization
19 Hospitalized patient characteristics
21 MARKETED PREVENTIVE AGENTS
24 PIPELINE PREVENTIVE AGENTS
32 KEY REGULATORY EVENTS
32 Coronavirus Notebook: EMA Begins Rolling Review of Sinovac Vaccine
32 EMA Reviews Comirnaty In Younger Age Groups
32 COVAX To Get Moderna Vaccine
32 Brazil Regulator Rejects Sputnik V Vaccine Citing Serious Quality & Safety Concerns
33 With J&J’s COVID Vaccine Pause Now Lifted, The Question Is How Well The System Worked
33 Coronavirus Notebook: New EMA Review To Contextualize Blood Clot Risk From AZ Jab, EU Gets Earlier Access To More Pfizer Vaccines
34 Sputnik V Cleared in India, Trajectory Against Variants May Be Key
34 COVID-19 Vaccine Authorization In Adolescents Would Raise Questions Around Routine Immunizations
35 AZ And Capillary Leak Syndrome
35 Regulators Reassure On AZ Vaccine Safety After Rare Side Effect Deemed Plausible
35 Coronavirus Notebook: Moderna Vaccine First To Get GB Conditional MA, EMA To Update On AstraZeneca Blood Clot Issue
35 Brazil OKs Fourth COVID-19 Vaccine, But Knocks Back Bharat Biotech
36 First EU Nation OKs CanSino’s One-Shot COVID Jab
36 Dr Reddy’s Submits Sputnik V To DCGI
36 J&J’s Single Shot Is EU’s Fourth COVID-19 Vaccine – But Supplies Lag
37 Takeda Files For Japan Approval Of Moderna Vaccine
37 Russia’s Sputnik V COVID-19 Vaccine Starts EU Rolling Review
37 Canada Approves Two Versions Of AZ Vaccine
38 Slovakia Becomes Second EU Country To OK Use Of Russian Vaccine
39 PROBABILITY OF SUCCESS
40 LICENSING AND ASSET ACQUISITION DEALS
40 Moderna Announces Agreement with Gavi Vaccines Alliance
40 Pfizer Commits To Supporting Indian Government’s Immunization Program
40 Strides Pharma’s Stelis And Dr Reddy’s Partner With RDIF For Sputnik V Vaccine
40 Sputnik V In Turkish Production Deal
41 Korea’s Genexine To Supply Vaccine To Kalbe In Indonesia
41 RDIF Links With Korean Consortia For Local Production
41 EU Extends Pfizer Deal
42 RDIF Ties Up Nearly 750 Million Doses Of Sputnik V From India
42 AstraZeneca Partners With Insud Pharma For Vaccine In Spain
42 UK Government Extends Vaccination Contract With Wockhardt
43 Beximco Orders Vaccine Doses For Bangladesh’s Private Healthcare
43 Daiichi Starts Japan Contract Production Of AZ Vaccine
43 Partnership To Boost Vaccine Production In India
43 EU Buys More Comirnaty Doses
44 GC To Distribute Moderna Vaccine In Korea
44 CEPI, SK Expand Vaccine Partnership To Variants
45 Russians Negotiating EU Manufacturing Deals
45 Novartis Teams Up With CureVac To Make COVID-19 Vaccine
45 Merck & Co. Will Manufacture J&J Vaccine, Other COVID-19 Medicines Under BARDA Deal
45 Start-Up Scanwell Adds Another Collaboration, Targets Home COVID-19 Testing With BD
46 Pfizer And Moderna Reap Rewards Of Expanded US And EU Deals
46 CureVac Enlists Bayer To Secure Place Among COVID-19 Vaccines ‘Second Wave’
46 COVAX Secures New Vaccine Deals
47 BioNTech Agrees China Supply Deal With Fosun
47 Singapore Adds Moderna To List Of Suppliers
47 Coronavirus Notebook: Regulators To Work Together On Vaccine Evaluation, AstraZeneca In Russia Link-Up
48 Operation Warp Speed Angles For Greater Role In Pfizer COVID-19 Vaccine Manufacturing
48 CEPI Allies With Korea’s SK bioscience For Vaccine
48 RDIF-Hetero Collaborate To Produce Sputnik V
49 AuraVax Takes Option To Novel Intranasal Vaccine Technology
49 TScan Teams Up With Qiagen On T Cell COVID-19 Test
49 Destiny And SporeGen Back Nasal Spray Over Vaccine To Tackle COVID-19
50 CLINICAL TRIAL LANDSCAPE
51 Sponsors by status
52 Sponsors by phase
53 Recent events
58 VACCINES ASSESSMENT MODEL
58 Overview
61 MRNA-BASED VACCINES
64 ADENOVIRAL VECTOR VACCINES
69 PROTEIN SUBUNIT VACCINES
72 INACTIVATED VACCINES
75 OTHER VACCINES
76 MONOCLONAL ANTIBODIES
76 Other monoclonal antibodies to watch
78 ANTIVIRALS
79 MARKET DYNAMICS
84 FUTURE TRENDS
85 RECENT EVENTS AND ANALYST OPINION
85 mRNA-1273 for COVID-19 Prevention (May 5, 2021)
86 VLA2001 for COVID-19 Prevention (April 6, 2021)
87 BNT162 for COVID-19 Prevention (March 31, 2021)
88 C19VAZ for COVID-19 Prevention (March 22, 2021)
89 COVAXIN for COVID-19 Prevention (March 3, 2021)
90 JNJ-78436735 for COVID-19 Prevention (February 26, 2021)
91 JNJ-78436735 for COVID-19 Prevention (February 24, 2021)
92 Coronavirus Vaccine (Vaxart) for COVID-19 Prevention (February 3, 2021)
93 JNJ-78436735 for COVID-19 Prevention (January 29, 2021)
95 NVX-CoV2373 for COVID-19 Prevention (January 28, 2021)
96 REGEN-COV for COVID-19 Prevention (January 26, 2021)
98 Bamlanivimab for COVID-19 Prevention (January 21, 2021)
99 mRNA-1273 for COVID-19 Prevention (December 17, 2020)
100 mRNA-1273 for COVID-19 Prevention (December 15, 2020)
102 BNT162 for COVID-19 Prevention (December 10, 2020)
103 BNT162 for COVID-19 Prevention (December 8, 2020)
104 mRNA-1273 (Moderna) for COVID-19 Prevention (November 30, 2020)
105 C19VAZ for COVID-19 Prevention (November 23, 2020)
107 BNT162 for COVID-19 Prevention (November 18, 2020)
108 C19VAZ for COVID-19 Prevention (November 18, 2020)
109 mRNA-1273 for COVID-19 Prevention (November 16, 2020)
110 Coronavirus VLP Vaccine (Medicago) for COVID-19 Prevention (November 10, 2020)
112 BNT162 for COVID-19 Prevention (November 9, 2020)
113 mRNA-1273 for COVID-19 Prevention (November 9, 2020)
114 JNJ-78436735 for COVID-19 Prevention (September 25, 2020)
116 C19VAZ for COVID-19 Prevention (September 9, 2020)
118 mRNA-1273 for COVID-19 Prevention (August 26, 2020)
119 BNT162 for COVID-19 Prevention (August 20, 2020)
120 NVX-CoV2373 for COVID-19 Prevention (August 4, 2020)
122 BNT162 for COVID-19 Prevention (July 20, 2020)
124 C19VAZ for COVID-19 Prevention (July 20, 2020)
125 Convidecia for COVID-19 Prevention (July 20, 2020)
127 mRNA-1273 for COVID-19 Prevention (July 14, 2020)
128 BNT162 for COVID-19 Prevention (July 1, 2020)
129 mRNA-1273 for COVID-19 Prevention (May 18, 2020)
132 KEY UPCOMING EVENTS
133 UNMET NEEDS
133 Increased vaccine supply, particularly in lower-income countries
133 Alternative options for individuals not eligible for vaccination
134 Additional data and approvals in pediatric patients
135 BIBLIOGRAPHY
139 APPENDIX
LIST OF FIGURES
18 Figure 1: COVID-19 infection fatality rates, by age group
19 Figure 2: COVID-19 hospitalization rates, by age group
24 Figure 3: Overview of pipeline COVID-19 preventive agents in the US
24 Figure 4: Pipeline COVID-19 preventive agents, by company
25 Figure 5: Pipeline COVID-19 preventive agents, by drug type
25 Figure 6: Pipeline COVID-19 preventive agents, by classification
39 Figure 7: Probability of success in the antiviral pipeline
50 Figure 8: Clinical trials in COVID-19 treatment and prevention
50 Figure 9: Top 10 drugs for clinical trials in COVID-19 treatment and prevention
51 Figure 10: Top 10 companies for clinical trials in COVID-19 treatment and prevention
51 Figure 11: Trial locations in COVID-19 treatment and prevention
52 Figure 12: COVID-19 treatment and prevention trials status
53 Figure 13: COVID-19 treatment and prevention trials sponsors, by phase
58 Figure 14: Datamonitor Healthcare’s vaccine assessment summary for COVID-19 prevention
79 Figure 15: Market dynamics in COVID-19 prevention
84 Figure 16: Future trends in COVID-19 prevention
95 Figure 17: JNJ-78436735 for COVID-19 Prevention (January 29, 2021): Phase III – ENSEMBLE
98 Figure 18: REGEN-COV for COVID-19 Prevention (January 26, 2021): Phase III – Prevention (Close Exposure)
132 Figure 19: Key upcoming events in COVID-19 prevention
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
16 Table 3: Priority populations for COVID-19 vaccination, and prevalence sources
17 Table 4: Total prevalent population in each COVID-19 high-risk group, by global region, 2020
20 Table 5: Proportion of hospitalized COVID-19 cases, by patient characteristic
22 Table 6: Marketed preventive agents for COVID-19
26 Table 7: Pipeline preventive agents for COVID-19 in the US
80 Table 8: Summary of available efficacy data and estimates of manufacturing capacity for vaccines with emergency/conditional approvals or in late-phase development
83 Table 9: Summary of the progress of vaccination campaigns in the US, Japan, and five major European markets
85 Table 10: mRNA-1273 for COVID-19 Prevention (May 5, 2021)
86 Table 11: VLA2001 for COVID-19 Prevention (April 6, 2021)
87 Table 12: BNT162 for COVID-19 Prevention (March 31, 2021)
88 Table 13: C19VAZ for COVID-19 Prevention (March 22, 2021)
89 Table 14: COVAXIN for COVID-19 Prevention (March 3, 2021)
90 Table 15: JNJ-78436735 for COVID-19 Prevention (February 26, 2021)
91 Table 16: JNJ-78436735 for COVID-19 Prevention (February 24, 2021)
93 Table 17: Coronavirus Vaccine (Vaxart) for COVID-19 Prevention (February 3, 2021)
94 Table 18: JNJ-78436735 for COVID-19 Prevention (January 29, 2021)
95 Table 19: NVX-CoV2373 for COVID-19 Prevention (January 28, 2021)
97 Table 20: REGEN-COV for COVID-19 Prevention (January 26, 2021)
99 Table 21: Bamlanivimab for COVID-19 Prevention (January 21, 2021)
100 Table 22: mRNA-1273 for COVID-19 Prevention (December 17, 2020)
101 Table 23: mRNA-1273 for COVID-19 Prevention (December 15, 2020)
102 Table 24: BNT162 for COVID-19 Prevention (December 10, 2020)
103 Table 25: BNT162 for COVID-19 Prevention (December 8, 2020)
105 Table 26: mRNA-1273 (Moderna) for COVID-19 Prevention (November 30, 2020)
106 Table 27: C19VAZ for COVID-19 Prevention (November 23, 2020)
107 Table 28: BNT162 for COVID-19 Prevention (November 18, 2020)
108 Table 29: C19VAZ for COVID-19 Prevention (November 18, 2020)
109 Table 30: mRNA-1273 for COVID-19 Prevention (November 16, 2020)
111 Table 31: Coronavirus VLP Vaccine (Medicago) for COVID-19 Prevention (November 10, 2020)
112 Table 32: BNT162 for COVID-19 Prevention (November 9, 2020)
114 Table 33: mRNA-1273 for COVID-19 Prevention (November 9, 2020)
115 Table 34: JNJ-78436735 for COVID-19 Prevention (September 25, 2020)
117 Table 35: C19VAZ for COVID-19 Prevention (September 9, 2020)
118 Table 36: mRNA-1273 for COVID-19 Prevention (August 26, 2020)
119 Table 37: BNT162 for COVID-19 Prevention (August 20, 2020)
121 Table 38: NVX-CoV2373 for COVID-19 Prevention (August 4, 2020)
123 Table 39: BNT162 for COVID-19 Prevention (July 20, 2020)
124 Table 40: C19VAZ for COVID-19 Prevention (July 20, 2020)
126 Table 41: Convidecia for COVID-19 Prevention (July 20, 2020)
127 Table 42: mRNA-1273 for COVID-19 Prevention (July 14, 2020)
128 Table 43: BNT162 for COVID-19 Prevention (July 1, 2020)
130 Table 44: mRNA-1273 for COVID-19 Prevention (May 18, 2020)
133 Table 45: Doses secured by the US, Canada, Japan, EU, and UK
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