Global COVID-19 Prevention Disease Analysis Report 2020: MHRA Begins Rolling Review Of Moderna Vaccine, Sanofi/GSK Hook Up To COVAX

Dublin, March 23, 2021 (GLOBE NEWSWIRE) -- The "Disease Analysis: COVID-19 Prevention" report has been added to ResearchAndMarkets.com's offering.

Moderna's mRNA-1273 and Pfizer/BioNTech/Shanghai Fosun Pharmaceutical's BNT162b2 are the most advanced vaccines in development and could gain emergency use authorizations (EUAs) in the US as early as December 2020.

Both are novel mRNA vaccines encoding the full-length spike protein and hold the distinguished statuses of being the first vaccines to show efficacy against symptomatic COVID-19 infection, with Pfizer reporting that BNT162b2 was 95.1% effective and Moderna reporting that mRNA-1273 was 94.5% effective.

Both vaccines were also effective against severe COVID-19 disease, which is crucial as severe infections are associated with greater costs (both social and economic), and vaccines that are not capable of preventing severe infections will not facilitate the easing of lockdown/social distancing restrictions for vulnerable individuals. However, both vaccines require storage at very cold temperatures (-20C for mRNA-1273 and -70C for BNT162b2), meaning there is still ample room in the market for vaccines with less stringent storage requirements, including adenoviral vector vaccines, recombinant protein subunit vaccines, and inactivated vaccines.

AstraZeneca's AZD1222 is expected to gain emergency approvals from the MHRA and EMA in December 2020 following mixed interim results from a pooled analysis of Phase III studies in Brazil and the UK. In patients who received a 5x10^10 viral particle (vp) formulation for two doses, vaccine effectiveness was only 62%, which is still above the >50% threshold for approval, but disappointing compared to mRNA-based vaccines.

AstraZeneca is seeking approval based on this high dose schedule and will therefore launch with an inferior efficacy claim, though the company intends to investigate the lower dose (which showed 90% effectiveness) in a post-approval efficacy study. Unfortunately for AstraZeneca, the ongoing US pivotal trial expected to yield data in early 2021 is currently investigating a prime-boost schedule with the higher dose 5x10^10 vp formulation, thus we expect that effectiveness from that trial will be around the 60% mark, which would severely hamper competitiveness in that market.

JNJ-78436735 is the only vaccine in late-phase development in the US currently being investigated in a single-dose schedule (in the US ENSEMBLE study of 60,000 participants), which could be an important differentiator in the longer term as it would be cheaper, more convenient, allow more patients to be vaccinated with the limited dose supply, and ensure greater adherence than two-dose schedules.

In addition to clinical and logistical factors, vaccine supply and pricing will be crucial determinants of uptake, with the former likely to be the dominant influencer of market share trends throughout at least the first half of 2021. 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.

Topline safety and efficacy data for a range of vaccines are expected throughout the next six months, including pivotal trial readouts for Novavax's NVX-CoV2373 and Johnson & Johnson's JNJ-78436735, which will play a crucial role in boosting vaccine supply if results are comparable to the impressive effectiveness shown by BNT162b2 and mRNA-1273.

Lower-income markets have struggled to compete in securing priority access to vaccines compared to developed markets such as the US, Canada, Japan, EU, and UK, which have collectively secured ~3.2 billion doses despite having a combined population of only approximately 1.01 billion (ie ~1.2 billion more doses than may be required based on two-dose schedules). Fortunately, several more vaccines could launch in 2021, including Novavax's NVX-CoV2373 and Johnson & Johnson's JNJ-78436735, 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 in 2021, though this supply will only be sufficient to vaccinate the highest-risk groups rather than entire populations.

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 (eg immunocompromised individuals) or who require immediate protection in outbreak control settings (eg in care homes).

A handful of monoclonal antibodies are in development for the prevention of COVID-19, though they are expensive to produce and most candidates require IV administration, which is inconvenient in the outpatient setting. AstraZeneca's AZD7442 seems the most promising candidate because of its once-every-six-months dosing, its intramuscular administration, and its inclusion of two antibodies targeting different sites on the spike protein to reduce the likelihood of resistance generation. Antivirals could also play an important role in these scenarios, and have the advantage of oral dosing and likely lower cost compared to monoclonal antibodies.

Antiviral assets, on average, take 8.5 years from Phase I to approval, slightly shorter than the average of 8.9 years for all infectious disease assets. However, in the case of COVID-19, development periods have been shortened substantially to as little as 6-9 months as repurposed agents have been rushed through clinical trials and granted rapid reviews by regulators.

Key Topics Covered:

OVERVIEW

• Latest key takeaways

DISEASE BACKGROUND

• Definition

• Transmission

• Symptoms

• Diagnosis

• Patient segmentation

• Risk factors

EPIDEMIOLOGY

• High-risk population prevalence methodology

• High-risk group prevalent populations

• High-risk group prevalent cases

• Infection fatality rate

• Hospitalization

• Hospitalized patient characteristics

MARKETED PREVENTIVE AGENTS

PIPELINE PREVENTIVE AGENTS

KEY REGULATORY EVENTS

• Coronavirus Notebook: An Accidental Oxford Half Dose, And EU Finally Seals Moderna Vaccine Deal

• US FDA's COVID Whirlwind: Pfizer Vaccine Adcom Set; Monoclonal EUAs Cleared; Trump Aggrieved

• Coronavirus Notebook: Leading Vaccines Near Approval, EU Signs More Advance Purchase Deals

• COVID-19 Vaccines: Placebo Crossover May Depend Upon Number Of Doses, Allocation Strategy

• COVID Vaccines Getting Parallel Review: ACIP To Begin Process Before FDA Decisions

• COVID-19 Vaccines: Can US FDA Complete Assessment In Less Than Six Weeks?

• EU Mandates Monthly Safety Summaries For Approved COVID-19 Vaccines

• The Next COVID Vaccine Race: Comparative Efficacy In Post-Market

• Coronavirus Notebook: MHRA Begins Rolling Review Of Moderna Vaccine, Sanofi/GSK Hook Up To COVAX

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

• AuraVax Takes Option To Novel Intranasal Vaccine Technology

• TScan Teams Up With Qiagen On T Cell COVID-19 Test

• Destiny And SporeGen Back Nasal Spray Over Vaccine To Tackle COVID-19

CLINICAL TRIAL LANDSCAPE

• Sponsors by status

• Sponsors by phase

• Recent events

VACCINES ASSESSMENT

• mRNA-based vaccines

• Adenoviral vector vaccines

• Protein subunit vaccines

• Inactivated vaccines

• Other vaccines to watch (no or limited trial data)

• Monoclonal antibodies

• Antivirals

MARKET DYNAMICS

FUTURE TRENDS

RECENT EVENTS AND ANALYST OPINION

• mRNA-1273 (Moderna) for COVID-19 Prevention (November 30, 2020)

• AZD1222 for COVID-19 Prevention (November 23, 2020)

• AZD1222 for COVID-19 Prevention (November 18, 2020)

• BNT162 for COVID-19 Prevention (November 18, 2020)

• mRNA-1273 for COVID-19 Prevention (November 16, 2020)

• Coronavirus VLP Vaccine (Medicago) for COVID-19 Prevention (November 10, 2020)

• mRNA-1273 for COVID-19 Prevention (November 9, 2020)

• BNT162 for COVID-19 Prevention (November 9, 2020)

• JNJ-78436735 for COVID-19 Prevention (September 25, 2020)

• AZD1222 for COVID-19 Prevention (September 9, 2020)

• mRNA-1273 for COVID-19 Prevention (August 26, 2020)

• BNT162 for COVID-19 Prevention (August 20, 2020)

• NVX-CoV2373 for COVID-19 Prevention (August 4, 2020)

• Ad5-nCoV for COVID-19 Prevention (July 20, 2020)

• AZD1222 for COVID-19 Prevention (July 20, 2020)

• BNT162 for COVID-19 Prevention (July 20, 2020)

• mRNA-1273 for COVID-19 Prevention (July 14, 2020)

• BNT162 for COVID-19 Prevention (July 1, 2020)

• mRNA-1273 for COVID-19 Prevention (May 18, 2020)

KEY UPCOMING EVENTS

UNMET NEEDS

• Increased vaccine supply, particularly in lower-income countries

• Alternative options for individuals not eligible for vaccination

• Vaccine trials in pediatric patients

BIBLIOGRAPHY

APPENDIX

For more information about this report visit https://www.researchandmarkets.com/r/ph95u7

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