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 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
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 benefited from real-world evidence showing that they have substantially cut asymptomatic transmission.
- 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 current and future 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. With the delta variant now the dominant strain globally (>90%), and accounting for 97–100% of new cases in the US and Europe, efficacy against this strain is paramount to long-term commercial potential. So far, Comirnaty and Spikevax (mRNA-1273) have shown the most robust efficacy data against the delta variant with overall vaccine efficacy >90%, just slightly lower than efficacy against the original 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 late 2021 and early 2022 as demand outstrips supply. Conversely, pricing will become a more prominent factor after the pandemic phase as supply constraints are resolved and companies seek to adopt more typical vaccine pricing to ensure longer-term profitability. Johnson & Johnson was the first not-for-profit vaccine manufacturer to detail plans of transitioning its COVID vaccine to a more typical commercial product. However, earlier pledges from Johnson & Johnson and AstraZeneca to market vaccines at non-profit prices during the pandemic phase could set a price ceiling 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 in the near term and possible market withdrawals post-2022 as more minor players reallocate resources to other, more profitable indications. Pipeline attrition was evidenced by Sanofi’s recent decision to abandon development of its mRNA vaccine, with the company stating that it was unable to compete with the dominance of Comirnaty and Spikevax.
- Demand is expected to 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 late 2021 which will substantially boost global supply. The COVAX initiative (coordinated by CEPI, GAVI, and the WHO) 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. Although supply to COVAX fell short throughout 2021, the easing of restrictions on vaccine exports in India, the scale-up of manufacture for AstraZeneca’s and Johnson & Johnson’s vaccines, and the approval of multiple additional vaccines by the WHO will substantially increase supply towards the end of 2021 through to 2022.
- Five Chinese vaccines, a Russian vaccine (Sputnik V), and three 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 seventh and eighth vaccines approved in the EU, respectively, acting to plug a supply gap for adult vaccination campaigns. Despite pressure from Russia, the EMA has been reluctant to give EUA to the Sputnik V, stating that the manufacturer had failed to provide the required data needed for approval.
- Comirnaty’s and Spikevax’s excellent efficacy and safety profiles and first-to-market statuses have positioned them for phenomenal sales potential in 2021, with Pfizer guiding $33.5bn in sales, BioNTech guiding $15.9bn, and Moderna guiding $20.0bn. 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 has allowed the company to secure more pre-purchase agreements, including deals with the EU totaling 2.4 billion doses.
- Comirnaty will benefit from having a cleaner safety profile compared to rival vaccines, especially since Spikevax has recently been associated with a higher risk of heart inflammation. The risk of heart inflammation in younger populations has led to delays in the approval of Spikevax for adolescents aged 12–17 years in the US. Additionally, Swedish and Danish healthcare agencies have paused the use of Spikevax in younger age groups, opting to use Comirnaty instead. A superior safety profile will allow Comirnaty access to younger age groups, with the FDA likely to grant a milestone approval for its use in young children (5–11 years) in November 2021.
- 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 that also present with thrombocytopenia, and Guillain-Barré syndrome. It is currently unclear if these adverse events are 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, in particular, 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. In the post-exposure prophylaxis setting, REGEN-COV and bamlanivimab + etesevimab are the current leaders in this space, having gained label expansions in the prevention setting in August and September 2021, respectively. Pipeline candidates in development for post-exposure prophylaxis include Xevudy (Phase III yet to be initiated), as well as antiviral therapies molnupiravir (Phase III), AT-527 (Phase III), PF-07321332 (Phase II/III), and favipiravir (Phase II). In the pre-exposure prophylaxis space, AstraZeneca’s Evusheld is the most promising candidate, having shown strong efficacy for up to six months in high-risk individuals, with regulatory filings in late 2021.
- Key upcoming catalysts include regulatory submissions for Novavax’s NVX-CoV2373 to the EU and UK (EUA), Spikevax’s approval in the US (full approval), and Ronapreve’s approval in the US (full approval) as well as its supplemental approval in Japan.
CONTENTS
9 OVERVIEW
9 Latest key takeaways
11 DISEASE BACKGROUND
11 Definition
11 Transmission
11 Symptoms
12 Diagnosis
12 Patient segmentation
13 Risk factors
14 WHO vaccination allocation guidelines
15 EPIDEMIOLOGY
15 Vaccinations
15 Variants
15 High-risk group populations
16 High-risk group prevalent populations
19 MARKETED PREVENTIVE AGENTS
24 PIPELINE PREVENTIVE AGENTS
32 KEY REGULATORY EVENTS
32 FDA Advisors Leave Door Open To Mix and Match COVID-19 Vaccine Boosters
32 Janssen Gets US FDA Panel Nod For Additional COVID Vaccine Shot – But Is It A ‘Booster’?
32 Moderna’s COVID-19 Vaccine Booster US FDA Panel Nod Driven By Pragmatism
33 Strike Two: US FDA Vaccine Advisors Again Shoot Down Broad COVID-19 Vaccine Boosting
33 Pediatric COVID-19 Vaccine Face-Off Looms As Bharat Biotech Heads For Approval
33 CureVac Pulls Covid Vaccine From European Review Process
34 Coronavirus Notebook: Australia ‘Recognizes’ Unapproved Vaccines, Russia Bigs Up Sputnik’s Chances At WHO
34 EU Renews Moderna’s Spikevax Approval, Clarifies Stance On Comirnaty Booster
34 AstraZeneca COVID-19 Antibody Could Be Solution For Vulnerable But Not Vaccine Alternative
35 FDA Authorizes At-Home COVID-19/Influenza Testing Kits As World Braces For Tough Flu Season
35 EMA OKs Comirnaty Booster Dose
35 Pfizer COVID Booster Recommendations From CDC Panel Narrower Than FDA’s EUA
36 Pfizer Booster Dose Authorization From US FDA Has Age Caveat: At-Risk Populations 18 And Up
36 US FDA Panel Rejects Pfizer’s Broad COVID Booster Plan But Backs Narrower Authorization For Third Vaccine Shot
36 Overflow Issue With Abbott COVID Tests Could Result In False Positives
37 UK Chooses Pfizer And Moderna For COVID-19 Boosters, But Questions Remain On Unpublished Trial Data
37 Cuban COVID-19 Vaccines To Come Under WHO Scrutiny
38 COVID-19: EMA Says Guillain-Barré Syndrome Is A Side-Effect Of AZ’s Vaxzevria
40 PROBABILITY OF SUCCESS
41 LICENSING AND ASSET ACQUISITION DEALS
41 TriLink To Supply CleanCap mRNA Capping Technology To EyeGene
41 BARDA Expands US Domestic Production Of Single-Use Systems For Vaccine Manufacturing
41 Recbio and Rhegen Co-Found An mRNA Vaccine JV
42 Pentagon Forks Over Another $109M To Make OraSure’s COVID-19 Antigen Test
42 DOD Contracts OraSure Rapid COVID-19 Tests For $205M
42 Biocon Biologics And Serum Institute Join Forces
43 Chinese Biotechs’ Foray Into mRNA Enters New Chapter With $100m Everest Deal
43 South Korea Forms New mRNA Vaccine Development Consortium
43 UK Terminates COVID-19 Vaccine Deal, But Valneva Can Bounce Back
44 Takeda Contracts To Provide Novavax Vaccine In Japan
44 Coronavirus Notebook: New Deal To Boost Local Vaccine Manufacturing
45 Sorrento And Dyadic Team On Broad Coronavirus Initiative
45 Serum Institute Secures Vaccine Vial Supply With Stake In Schott Kaisha
45 HDT Bio, Quratis To Co-Develop Novel COVID-19 Vaccine In Asia
46 CEPI Vaccine Deal With China’s ZerunBio
46 Dyadic Licenses Technology To Rubic For African COVID Vaccine Efforts
46 Novavax Announces Advanced Purchase Agreement with European Commission
46 Canadian Biotech Takes COVID-19 Nasal Spray To Asia Via Glenmark
47 UNICEF Signs Delivery Deal For Janssen COVID-19 Vaccine
47 Clover To Supply 414m Doses To GAVI
47 Korea Kick-Starts Major Consortium For Next-Gen mRNA Vaccines
48 Dyadic Collaborates With Syngene To Develop COVID-19 Vaccine
48 Brazil Permits Imports Of Bharat Biotech’s Covaxin, Sputnik V
48 Serum Institute To Make Sputnik Vaccine
49 UNICEF Strikes Deal To Buy Russia’s Sputnik V Vaccine
49 EU Orders 1.8 Billion Comirnaty Doses
49 Moderna Announces Agreement with Gavi Vaccines Alliance
51 CLINICAL TRIAL LANDSCAPE
52 Sponsors by status
53 Sponsors by phase
54 Recent events
59 VACCINES ASSESSMENT MODEL
59 Overview
63 MRNA-BASED VACCINES
66 ADENOVIRAL VECTOR VACCINES
72 PROTEIN SUBUNIT VACCINES
75 INACTIVATED VACCINES
78 DNA SUBUNIT VACCINES
79 MONOCLONAL ANTIBODIES
80 Other monoclonal antibodies to watch
81 ANTIVIRALS
82 MARKET DYNAMICS
89 FUTURE TRENDS
90 RECENT EVENTS AND ANALYST OPINION
90 Comirnaty for COVID-19 Prevention (October 26, 2021)
91 mRNA-1273 for COVID-19 Prevention (October 25, 2021)
92 Comirnaty for COVID-19 Prevention (October 22, 2021)
93 VLA2001 for COVID-19 Prevention (October 18, 2021)
95 JNJ-78436735 for COVID-19 Prevention (October 15, 2021)
98 JNJ-78436735 for COVID-19 Prevention (October 13, 2021)
99 mRNA-1273 for COVID-19 Prevention (October 13, 2021)
101 SCB-2019 for COVID-19 Prevention (September 22, 2021)
103 JNJ-78436735 for COVID-19 Prevention (September 21, 2021)
105 Comirnaty for COVID-19 Prevention (September 20, 2021)
106 Comirnaty for COVID-19 Prevention (September 17, 2021)
110 Comirnaty for COVID-19 Prevention (September 15, 2021)
114 Evusheld for COVID-19 Prevention (August 20, 2021)
115 mRNA-1273 for COVID-19 Prevention (August 5, 2021)
117 CVnCoV Vaccine for COVID-19 Prevention (June 30, 2021)
119 Evusheld for COVID-19 Prevention (June 15, 2021)
120 NVX-CoV2373 for COVID-19 Prevention (June 14, 2021)
121 mRNA-1273 for COVID-19 Prevention (May 25, 2021)
123 Coronavirus Vaccine (Sanofi/GSK) for COVID-19 Prevention (May 17, 2021)
124 mRNA-1273 for COVID-19 Prevention (May 5, 2021)
126 KEY UPCOMING EVENTS
127 UNMET NEEDS
127 Increased vaccine supply, particularly in lower-income countries
128 Alternative options for individuals not eligible for vaccination
129 Additional data and approvals in pediatric patients
130 BIBLIOGRAPHY
135 APPENDIX
LIST OF FIGURES
24 Figure 1: Overview of pipeline COVID-19 preventive agents in the US
24 Figure 2: Pipeline COVID-19 preventive agents, by company
25 Figure 3: Pipeline COVID-19 preventive agents, by drug type
25 Figure 4: Pipeline COVID-19 preventive agents, by classification
40 Figure 5: Probability of success in the antiviral pipeline
51 Figure 6: Clinical trials in COVID-19 treatment and prevention
51 Figure 7: Top 10 drugs for clinical trials in COVID-19 treatment and prevention
52 Figure 8: Top 10 companies for clinical trials in COVID-19 treatment and prevention
52 Figure 9: Trial locations in COVID-19 treatment and prevention
53 Figure 10: COVID-19 treatment and prevention trials status
54 Figure 11: COVID-19 treatment and prevention trials sponsors, by phase
59 Figure 12: Datamonitor Healthcare’s vaccine assessment summary for COVID-19 prevention
82 Figure 13: Market dynamics in COVID-19 prevention
89 Figure 14: Future trends in COVID-19 prevention
92 Figure 15: mRNA-1273 for COVID-19 Prevention (October 25, 2021): Phase II/III – KidCOVE
95 Figure 16: VLA2001 for COVID-19 Prevention (October 18, 2021): Phase III – Cov-Compare (UK)
103 Figure 17: SCB-2019 for COVID-19 Prevention (September 22, 2021): Phase II/III – SPECTRA
115 Figure 18: Evusheld for COVID-19 Prevention (August 20, 2021): Phase III – PROVENT
120 Figure 19: Evusheld for COVID-19 Prevention (June 15, 2021): Phase III – STORM CHASER
123 Figure 20: mRNA-1273 for COVID-19 Prevention (May 25, 2021): Phase II/III – TeenCove
126 Figure 21: Key upcoming events in COVID-19 prevention
LIST OF TABLES
13 Table 1: Clinical status scores and interpretations
14 Table 2: WHO recommendations for prioritization of vaccination in settings where there is widespread community transmission
16 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
26 Table 6: Pipeline preventive agents for COVID-19 in the US
84 Table 7: Summary of available efficacy data and estimates of manufacturing capacity for vaccines with emergency/conditional approvals or in late-phase development
88 Table 8: Summary of the progress of vaccination campaigns in the US, Japan, and five major European markets
90 Table 9: Comirnaty for COVID-19 Prevention (October 26, 2021)
91 Table 10: mRNA-1273 for COVID-19 Prevention (October 25, 2021)
93 Table 11: Comirnaty for COVID-19 Prevention (October 22, 2021)
94 Table 12: VLA2001 for COVID-19 Prevention (October 18, 2021)
96 Table 13: JNJ-78436735 for COVID-19 Prevention (October 15, 2021)
98 Table 14: JNJ-78436735 for COVID-19 Prevention (October 13, 2021)
100 Table 15: mRNA-1273 for COVID-19 Prevention (October 13, 2021)
101 Table 16: SCB-2019 for COVID-19 Prevention (September 22, 2021)
104 Table 17: JNJ-78436735 for COVID-19 Prevention (September 21, 2021)
105 Table 18: Comirnaty for COVID-19 Prevention (September 20, 2021)
107 Table 19: Comirnaty for COVID-19 Prevention (September 17, 2021)
111 Table 20: Comirnaty for COVID-19 Prevention (September 15, 2021)
114 Table 21: Evusheld for COVID-19 Prevention (August 20, 2021)
116 Table 22: mRNA-1273 for COVID-19 Prevention (August 5, 2021)
118 Table 23: CVnCoV Vaccine for COVID-19 Prevention (June 30, 2021)
119 Table 24: Evusheld for COVID-19 Prevention (June 15, 2021)
120 Table 25: NVX-CoV2373 for COVID-19 Prevention (June 14, 2021)
122 Table 26: mRNA-1273 for COVID-19 Prevention (May 25, 2021)
123 Table 27: Coronavirus Vaccine (Sanofi/GSK) for COVID-19 Prevention (May 17, 2021)
124 Table 28: mRNA-1273 for COVID-19 Prevention (May 5, 2021)
128 Table 29: Doses secured by the US, Canada, Japan, EU, UK, India, and COVAX, by vaccine
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