As the COVID-19 outbreak advances worldwide, companies are stepping up to the challenge to develop a potential vaccine. There are over 75 confirmed COVID-19 vaccine candidates, five of which have already entered clinical trials. In its recent report on vaccine development, Kalorama Information, part of Science and Medicine Group, has tracked companies that are developing vaccines for COVID-19. The firm says that a vaccine for COVID-19 would create a market worth billions in revenue, perhaps even as much as ten billion, but that companies would also incur large R&D spends and production challenges which have always keep profit margins in the industry on the low side. Kalorama has covered vaccines in market research studies for two decades.

Vaccination protects not only individuals, but also entire communities from diseases spread by person-to-person transmission. When immunization programs achieve high levels of “community” immunity, the likelihood that an infected person will transmit the disease to a susceptible individual is greatly reduced. Vaccination can prevent about 50% of deaths from pneumococcal disease and 80% of deaths from influenza-related complications in the elderly. Pharmacoeconomic studies have demonstrated the value of influenza and pneumococcal vaccines; however, despite various vaccination campaigns and promotional efforts, immunization rates for these diseases continue to be low in the elderly population.

In the U.S., for example, the Centers for Disease Control (CDC) has found that Influenza is responsible for 20,000 to 40,000 deaths annually, and up to 50,000 deaths and an estimated 200,000 excess hospitalizations at a cost of $750 million to $1 billion during epidemic years. Also mortality from all pneumococcal disease, also vaccine-mitigatable, results in about 40,000 deaths annually, with morbidity estimated at 500,000 cases of pneumonia.

“Only 45% of US adults tend to get the flu shot, depending on the severity of the flu season,” said Bruce Carlson, Publisher of Kalorama Information. “Presumably, many more will rush to get the COVID-19 vaccine, and we expect more attention on flu as well because of the attention on respiratory disease transmission.”

Influenza vaccines generated $5.1 billion in revenues. Sales fluctuate from year to year with a variety of factors including new influenza strains and outbreaks, government contracts and stockpiling, new production formats and rising demand in developing countries affecting demand.

Roughly estimated market demand based on comparison to flu vaccine alone, Kalorama believes the market for COVID-19 could be 8-10 billion dollars in its first full year of implementation. It would represent a quarter of the vaccine market in that year.

“But there will likely be many factors that would move that number up or down,” said Carlson. “Price, supply, government intervention, stockpiling effects all could temporarily create a very large or smaller than expected market.”

Carlson also noted that such a vaccine could start out at a high market figure and then in the future settle down to a more stable number as it becomes standard and as competition is introduced, which has been the case with cervical cancer, travel and flu vaccines.

Many vaccine trials are underway, some for diseases such as breast cancer, HIV, and malaria. But because of the nature of the severity of the COVID-19 pandemic, vaccine manufacturers are prioritizing the development of COVID-19 vaccines. As of April 20, 2020, several candidates for a COVID-19 vaccine are showing promise:

  • CanSino Biologics is developing a vaccine for the prevention of COVID-19, Ad5-nCoV, a recombinant vaccine incorporating the adenovirus type 5 vector. On March 8, 2020, CanSino received approval from the Chinese authorities to begin human trials. This is the first coronavirus vaccine to advance to phase II trials.
  • Moderna offers its mRNA-1273, a novel lipid nanoparticle-encapsulated mRNA vaccine encoding for a perfusion-stabilized form of the SARS-CoV-2 spike protein. On March 16, 2020, the company began its phase I open-label, dose-ranging trial, occurring at Kaiser Permanente Washington Health Research Institute in Seattle. The company says it has applied for Phase II.
  • Inovio Pharmaceuticals announced that CEPI provided a grant to develop a vaccine against COVID-19 called INO-4800. The company is collaborating with Beijing Advaccine Biotechnology to advance the product. Preclinical testing has begun, with human clinical trials to commence in April 2020 in the U.S., China, and South Korea. It is anticipated that with positive results, some 1 million doses of the INO-4800 DNA vaccine can be produced by the end of 2020. On April 6, 2020, the company received approval to begin phase I trials. The Bill and Melinda Gates Foundation, along with other nonprofits, is supporting Inovio’s COVID-19 vaccine project.
  • Shenzhen Geno-Immune Medical Institute offers the LV-SMENP-DC vaccine. The LV-SMENP-DC vaccine is made by modifying dendritic cells (DC) with lentivirus vectors expressing COVID-19 minigene SMENP and immune-modulatory genes. CTLs will be activated by LV-DC presenting COVID-19 specific antigens. The project is in phase I.
  • Shenzhen Geno-Immune Medical Institute has a second product — the COVID-19/aAPC vaccine. The COVID-19/aAPC vaccine is prepared by applying lentivirus modifications, including immune-modulatory genes and the viral minigenes, to the artificial antigen-presenting cells (aAPCs). It is also in phase I.

Many vaccine trials are underway, some for diseases such as breast cancer, HIV, and malaria. But because of the nature of the severity of the COVID-19 pandemic, vaccine manufacturers are prioritizing the development of COVID-19 vaccines. As of April 20, 2020, several candidates for a COVID-19 vaccine are showing promise including CanSino, Moderna, Inovio and others. Kalorama Information’s vaccine production report is available at: https://kaloramainformation.com/product/vaccine-development-and-production-trends-covid-19-and-other-vaccines-pipeline/.