Learn and share The hunt for a coronavirus vaccine

Learn and share The hunt for a coronavirus vaccine

The new coronavirus continues to run rampant around the world. The key to controlling the spread of infectious diseases like this is vaccinations that are safe and effective. With more than 200 vaccine candidates, some of which are in the final stages of clinical trials, pharmaceutical giant Pfizer beat its rivals in applying for an emergency use permit in the U.S. Fellow American startup Moderna also plans to file. Here we will explain the race to develop a vaccine that can be put to practical use with visual data.

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TOPIC 1

Who is at the forefront
of the development race?

Pfizer files for use
ahead of rivals

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On November 20, Pfizer applied to the U.S. Food and Drug Administration (FDA) for an emergency use permit for its coronavirus vaccine. If approved, Pfizer’s vaccine could be put to use in parts of the U.S. by the end of the year. Moderna is also planning to apply for an emergency use permit in the U.S. Both companies developed an RNA vaccine that artificially creates a substance called messenger RNA based on the coronavirus’ genetic material. The companies have been conducting clinical trials since the spring to confirm the safety and effect of the drugs.

Pfizer and Moderna each announced in November that initial data showed that their vaccines were at least 90% effective in preventing the spread of the virus. Later, Pfizer said that its vaccine reached 95% effectiveness in its final analysis. That figure is well over the 50% required by the FDA for emergency approval. Hopes for commercialization are rising now that a vaccine from a Western manufacturer had a promising result in final stage testing. If it obtains regulatory approval, Pfizer plans to produce up to 50 million doses of the vaccine globally by the end of 2020, and up to 1.3 billion doses by the end of 2021. Moderna expects to supply 20 million doses for the U.S. by the end of this year and hopes to produce 500 million to 1 billion doses in 2021.

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Clinical trial of a coronavirus vaccine being developed by Pfizer. (Photo courtesy of Cincinnati Children's Hospital Medical Center) = AP

■ Pfizer

Founded in 1849, Pfizer is a pharmaceutical giant based in the state of New York. The company developed Viagra, a drug that improves male sexual performance. The strategy of pursuing larger scale through mergers and acquisitions was known as the “Pfizer Model.” The company had previously planned to buy AstraZeneca in the U.K. and Allergan in Ireland, but those plans fell through.

■ Moderna

Founded in 2010, Moderna is a Massachusetts-based pharmaceutical start-up engaged in the research and development of mRNA-based drugs.

The 48 standouts
among 212 candidates

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There are many corona vaccine candidates in addition to those from Pfizer and Moderna. As of November 12, there are 212 candidate vaccinations for the coronavirus, of which 48 have started clinical trials, according to the World Health Organization (WHO). Eleven, including from British AstraZeneca and Chinese companies, are in the third and final stage. Vaccine development is mainly carried out by cultivating the virus, but new techniques using genetics to shorten the development period have also emerged. Here are the main candidates in clinical trials:

Prioritizing speed
in unprecedented development

A new type of vaccine and its developers

Vaccine type Developer (country or region)
RNA vaccine Pfizer (U.S.)/BioNTech (Germany)/Shanghai Fosun Pharmaceutical (China)
Moderna (U.S.)/National Institute of Allergy and Infectious Diseases
Imperial College London (U.K.)
CureVac (Germany)
People’s Liberation Army Academy of Military Sciences/Walvax Biotechnology (China)
DNA vaccine Inovio Pharmaceuticals (U.S.)
Genexine Consortium (South Korea)
AnGes/Osaka University/Takara Bio (Japan)
Cadila Healthcare (India)
Viral vector vaccine AstraZeneca/University of Oxford (U.K.)
CanSino Biological (China)
Gamaleya Research Institute (Russia)
Johnson & Johnson (U.S.) subsidiary Janssen Pharma
Merck (U.S.) and others
Source: WHO survey

Vaccines made using genetic material like RNA can be developed in a shorter period than those made through conventional processes. Researchers do not need to spend time cultivating the virus. However, there are no examples suitable for human use, and obstacles like verifying safety and efficacy are formidable. RNA and DNA vaccines use RNA or DNA fragments, which are the basis for the virus’ proteins, but there are also viral vector vaccines, which use another virus that incorporates the genetic information of the coronavirus.

What is an RNA vaccine?

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Artificial genetic material called “messenger RNA (mRNA)” is made based on genetic data from the coronavirus. That material is then incorporated into nanoparticles like lipids to make a vaccine. When administered to the body, the virus’ protein (antigen) is produced, and the immune system produces antibodies in response.

Using existing methods, a reliable route

Vaccine types using existing methods and developers

Vaccine type Developer (country or region)
Inactivated vaccine Institute of Medical Biology, Chinese Academy of Medical Sciences (China)
Sinopharm/Wuhan Institute of Biological Products (China)
Sinopharm/Beijing Institute of Biological Products (China)
Sinovac Biotech (China)
Bharat Biotech (India)
Subunit Novavax (U.S.)
Clover Biopharmaceuticals (China)/GlaxoSmithKline (U.K.)
Anhui Zhifei Longcom Biopharmaceutical/Institute of Microbiology, Chinese Academy of Sciences (China)
Vaxine Pty (Australia)/Medytox (South Korea)
Kentucky Bioprocessing (U.S.)
University of Queensland/CSL (Australia)/Seqirus (U.K.)
Sanofi (France)/GlaxoSmithKline (UK)
Virus-like particle Medicago (Canadian subsidiary of Mitsubishi Tanabe Pharma)
Source: WHO survey

Conventional vaccines are made by cultivating the virus in cells and eliminating its ability to infect, or removing part of the virus. Inoculating humans with it then triggers the immune response and prevents future infection. Progress is reliable, because these vaccines use existing methods of development. There are inactivated vaccines, which use a virus that has lost the ability to infect, subunits that use part of the virus and virus-like particles, which use particles with a structure similar to the virus’ own.

What is an inactivated vaccine?

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This type of vaccine uses a virus that has lost its pathogenicity through chemical treatment. Multiple immunizations are often required to obtain immunity because the immunity produced by the body is weak.

TOPIC 2

Countries fight for
leadership in vaccines

Vaccines are on the front line in the U.S.-China confrontation

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The majority of vaccines in clinical trials are from China or the U.S. The U.S. is prioritizing its own supply, and China wants to expand its diplomatic influence by supplying a vaccine to developing countries as well. The race to develop a vaccine reflects a part of the competition between the U.S. and China for leadership.

Major spending to support development

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All countries have provided large-scale financial support for vaccine development. The U.S. and China surpass all others. The U.S. will promote “Operation Warp Speed,” a public-private partnership that will support the development and provision of vaccines. An extra budget in late March allocated $10 billion (1.7 trillion yen) to the project. In 2020, China issued special government bonds worth 15 trillion yen (1 trillion yuan) to leverage research and development of vaccines and therapeutic drugs. Japan included more than 200 billion yen for vaccine development and system maintenance in its second supplemental budget.

100 times the SARS papers, sharpening academia

There are 100 times more papers related to the coronavirus than there were for SARS

The U.S.-China competition is also reflected in the number of academic papers. This is a comparison with the severe acute respiratory syndrome (SARS) that happened in 2002. There were about 100 papers on SARS worldwide seven months after the outbreak started, according to a survey by Japan’s Ministry of Health, Labour and Welfare. Four months after the outbreak of the new coronavirus, there were about 10,000 papers on it, about 100 times more than for SARS.

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*As of April 2020, according to a survey by the National Institute of Science and Technology Policy

Academic papers by country

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*As of April 2020, according to a survey by the National Institute of Science and Technology Policy and WHO data

Comparing data on papers by country published by the WHO, the U.S. and China overwhelmed other countries in terms of output with more than 1,000 papers each as of April 2020. Japan produced just 56.

TOPIC 3

Vaccines are
a huge business

Boosted by the coronavirus, the market is forecast to grow to 6.9 trillion yen in 2027

Vaccine market size

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*Note: Exchange rate of one dollar = 107 yen
*Source: Pharmaceutical Processing World

Company shares of the vaccine market

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*Source: Company earnings documents and Nikkei estimates

The global vaccine market is growing. Pharmaceutical giants that are flush with capital, like the U.K.’s GlaxoSmithKline, dominate the market. Four European and American companies hold command about an 80% share of the market. By 2027 the market is forecast to grow to 64.5 billion dollars (about 6.9 trillion yen), 1.7 times larger than in 2018. Unlike regular medicines, vaccines require not only patents, but also a stable supply capacity. If a vaccine for the rampant coronavirus becomes widespread, the market will grow even more.

The development period is about ten years, and total costs exceed $1 billion

Development process

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Vaccine development is not a straightforward process. Generally it takes five to ten years from drug discovery to clinical trials, and then approval and application. In some cases the process costs more than $1 billion. There are many hurdles to verifying efficacy and safety, and in some cases vaccines are not approved even after making it to clinical trials. Nonetheless, British pharmaceutical giant AstraZeneca, eyeing early approval, will set up a mass production system. The goal is to provide supplies by the end of 2020. Drugs used overseas can receive “special approval” from Japan’s health ministry if there is an urgent need, and they do not need to go through clinical trials. If the process moves quickly, there could be a coronavirus vaccine in Japan as early as spring 2021.

A new view of development using advanced technology

Using artificial intelligence (AI) in vaccine development

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The field of developing vaccines and therapeutic drugs has changed. Using AI and other cutting-edge technologies, researchers can shorten the enormous amount of time required to obtain the necessary genetic information. NEC uses its own AI system to analyze thousands of types of genetic information of the new coronavirus, supporting vaccine development.

Selecting therapeutic drug candidates using supercomputers

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Research is moving forward at “Fugaku,” RIKEN and Fujitsu’s domestically produced supercomputer that was named the world’s fastest. Researchers use its advanced simulation capabilities to efficiently search for therapeutic drugs.

The deciding factor in overcoming the coronavirus

A vaccine will be the deciding factor in the fight against the coronavirus. If a certain percentage of the population gains immunity to the virus through a vaccine, it will stop infections from spreading. But some experts have pointed out that it would be dangerous to rush to put a vaccine into use if its effectiveness has not been fully verified. The confirmation of efficacy and safety is essential in vaccine development.