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
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 the publisher 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.
Table of Contents
OVERVIEW
DISEASE BACKGROUND
EPIDEMIOLOGY
KEY REGULATORY EVENTS
LICENSING AND ASSET ACQUISITION DEALS
CLINICAL TRIAL LANDSCAPE
VACCINES ASSESSMENT MODEL
MONOCLONAL ANTIBODIES
RECENT EVENTS AND ANALYST OPINION
UNMET NEEDS
LIST OF FIGURES
LIST OF TABLES
