Coronavirus vaccine approved in Japan Three challenges emerge in the race to a vaccine CORONAVIRUS-VACCINE
Coronavirus vaccine approved in Japan Three challenges emerge in the race to a vaccine CORONAVIRUS-VACCINE
Vaccinations are the key to controlling the spread of the new coronavirus. Following the U.S. and U.K., a vaccine made by U.S. pharmaceutical giant Pfizer was approved in Japan on February 14. Development usually takes nearly ten years, but it was greatly shortened in this case. As a result, there are many unknowns about the vaccine’s safety and efficacy. Will it prove effective against the mutated variant running rampant in the U.K. and elsewhere? When and how will inoculations become available in Japan? Here, Nikkei examines the vaccines under development, its efficacy at preventing infection, its safety and more.
From clinical trials to practical use
The production and sale of Pfizer’s vaccine was approved in Japan on February 14, 2021. The vaccine is already being administered in the U.K., U.S. and European Union. Vaccines from U.S.-based Moderna and pharmaceutical giant AstraZeneca have also been approved for emergency use in the U.S. and U.K. respectively, and inoculations have begun. The companies are also seeking approval for their vaccines in Japan. Vaccines from Sinovac and Sinopharm in China, as well as the Gamaleya Institute in Russia, are already in use domestically.
In addition to these, many other vaccines are under development elsewhere in the world. According to the World Health Organization (WHO), there were 63 vaccine candidates in clinical trials as of February 9, 2021. Of these, 16 have reached Phase 3 clinical trials -- the final stage of testing -- and there are five more cases in which Phase 2 and Phase 3 trials are being conducted together. These vaccines are diverse in their types, which include RNA, DNA, viral vectors and inactivated vaccines. As more vaccine success stories emerge, the global supply of inoculations will expand. That will make it easier for people everywhere to get a vaccination and make it easier for authorities to bring the pandemic under control.
The lead group entering the practical stage
PfizerCurrent production plan
Up to 50 million doses worldwide by the end of 2020, and up to 2 billion by the end of 2021. Assumes two doses per person.Development process
Co-developed mRNA vaccine with BioNTech, a German pharmaceutical company. Began clinical trials in May 2020. Applied for emergency use authorization in November, and received approval from U.K., U.S., EU, etc. in December. Approved in Japan on February 14.About Pfizer
Pfizer is a major pharmaceutical company founded in 1849 and based in New York in the U.S. It developed drugs to treat erectile dysfunction, such as Viagra.
ModernaCurrent production plan
Immediate production plan: 20 million doses for the U.S. by the end of 2020, and 500 million to 1 billion doses for the world by 2009.Development process
RNA vaccine to be developed, clinical trials to begin in spring 2020, application for emergency use approval filed with US authorities at the end of November, approval in December.About Moderna
Founded in 2010 and based in Massachusetts, the pharmaceutical startup is involved in the research and development of drugs made from mRNA.
AstraZenecaCurrent production plan
Produce 3 billion doses in 2021.Development process
Developed a viral vector vaccines with Oxford University in the U.K. Began clinical trials in April 2020, and received approval in the U.K. in December. Application for manufacturing and marketing approval also filed in Japan.About AstraZeneca
Based in Cambridge, U.K., the company was formed in a 1999 merger between Zeneca, the pharmaceutical spin-off of a British chemical giant, and Astra, a Swedish drug manufacturer.
SinovacCurrent production plan
Sinovac plans to make 600 million doses, and it is considering making more.Development process
The company developed an inactivated vaccine. Clinical trials began in April, and emergency inoculations began in China from summer.About Sinovac
Sinovac is a state-owned pharmaceutical maker in China.
SinopharmCurrent production plan
Sinopharm plans to make 300 million doses, which it will expand to 1 billion doses in 2021.Development process
The company developed an inactivated vaccine. Clinical trials began in April 2020. Emergency inoculations began from summer, and 1 million people have received the vaccination. Sinovac applied to Chinese authorities in November for permission to sell the drug.About Sinopharm
Sinopharm is a state-owned pharmaceutical maker in China.
Gamaleya InstituteCurrent production plan
The organization plans to make vaccinations for medical professionals and the general public.Development process
The Institute developed a viral vector vaccine with the Russian Defense Ministry. It was approved by the Putin administration in August 2020, the first such approval worldwide, despite still being in clinical trials.About the Gamaleya Institute
The Institute is a national research organization in Russia.
About RNA vaccines
A substance called mRNA is artificially created based on the coronavirus’ genetic material. When administered to the body, the virus’ protein is produced and serves as an antigen. The immune system reacts by producing antibodies. It has no proven use in humans.
About viral vector vaccines
Another virus that contains genetic information from the coronavirus acts as a “courier,” provoking an immune response after it is administered to the body.
About DNA vaccines
A component with some of the virus’ genetic information is placed in the body to create immunity. It has no proven use in humans.
About inactivated vaccines
These vaccines use pathogens that have been rendered inert through conventional techniques, such as chemical treatment. They produce only a weak level of immunity, so multiple inoculations are necessary to gain full immunity.
How effective are vaccines against mutated strains?
Mutated variants of the novel coronavirus are spreading around the world. The number of infections is rapidly increasing, especially in the U.K., and cases have also been reporting in Japan, South Africa, the U.S. and elsewhere. The new strain may have mutated some of the virus’ genes that function when it infects human cells, making it more infectious. A study in the U.K. found that the new strain is up to 70% more infectious that the existing virus.
Experts say that the risk of developing a serious illness through the mutated variant is the same as the existing strain of the virus. Additionally, there are no issues with the effectiveness of the vaccines that have entered use. However, the virus mutates once every two weeks, and there is a risk that a new, even more infectious variant could emerge, meaning continued caution is necessary.
China and Russia lead in vaccinations
In contrast to the West, China and Russia have already moved forward in vaccine development.
China’s Sinovac and Sinopharm administered emergency inoculations from summer 2020 of their vaccines even though they that were still in clinical trials. In November, Sinopharm applied to Chinese authorities for permission to sell its vaccination. Russia approved the Gamaleya Institute’s vaccine, currently in the clinical trial phase, in August, the first such approval in the world, and it approved a second one in October. The Russian vaccine has been approved in countries like Belarus and Argentina. Sinovac and others are conducting trials in more than ten countries, including Indonesia and Brazil. If development is successful, it aims to supply these countries with vaccines and expand its influence.
When will vaccines
Contracts with the Japanese government
The approved Pfizer vaccine will first be administered to healthcare workers from mid-February. When will the vaccine arrive in Japan? The Japanese government has completed contracts with major overseas producers.
The government assumes each person will require two doses of the vaccine. Pfizer, which was approved in Japan, will supply vaccines for 72 million people (144 million doses) by the end of 2021. Japan also has a plan with Moderna to provide vaccines for 20 million people (40 doses) by June 2021. To maintain its effectiveness for a long time, the RNA vaccines need to be stored at minus 20 to 70 degrees centigrade, and are set to be transported to Japan by cold transport. The vaccine is expected to arrive in Japan by the agreed date, and then actual inoculations will begin. To make the vaccine available in Japan, Pfizer and Moderna must submit data from the clinical trials that show their efficacy and safety to the Ministry of Health, Labor and Welfare (MHLW). The companies will then receive approval to manufacture and sell the vaccine. Takeda Pharmaceutical is contracted for clinical trials and to distribute the Moderna vaccine in Japan.
The government also has a contract with AstraZeneca, which has developed a viral vector vaccine in the U.K., for vaccines for 60 million people (120 doses) from the start of 2021. Out of that, vaccines for 15 million people will be procured by March. AstraZeneca’s vaccine can be stored in normal refrigerators, making it easier to supply and distribute. The company has partnered with mid-sized businesses, like JCR Pharma in the Kansai area, to produce the stock solution for the vaccine.
While Japan and the U.S. are on track to procure vaccines more than enough vaccines for their entire populations, emerging countries such as India and Brazil can supply only less than 30% of their populations, which could create more inequality among countries, according to some analysts.
What is the process of inoculation?
Let us take a look at the process of inoculating the population in Japan after the vaccine arrives.
The government aims to have enough vaccines for all residents by the end of 2021. Along with that from Pfizer, vaccines from Moderna and AstraZeneca are being put to practical use. If the supply Japan goes as planned, there will be enough for the entire nation.
Process of inoculation
The thinking is that everyone who wants to be inoculated can do so free of charge. Priority will be given to the elderly and healthcare workers, who are at greater risk of becoming seriously ill. It is envisioned that the municipalities will deliver vaccination tickets to individual residents and guide them through the process.
Low-temperature storage and distribution
One challenge to widespread vaccination is storage and distribution. Pfizer’s vaccine must be stored at minus 70 degrees centigrade, and Moderna’s at minus 20 degrees centigrade if it is to be stored for up to maximum limit of six month. Many deep-freeze boxes and facilities will be required. The Ministry of Health, Labor and Welfare is preparing for the task, in part by securing 3,000 cold storage units. Developing a distribution networks is also a challenge, and some have noted that not all hospitals and clinics have the capacity to store the vaccines at low temperatures.
Duration of the preventative effect
95% effective in final trials, but…
The duration of the vaccine’s effect poses another challenge to putting it to practical use. Pfizer announced that its vaccine was 95% effective in preventing infection in final trials, but it could only confirm the duration lasted for one to two weeks after inoculation. It is not clear if the effect is long-lasting. If the effect is short, it may be necessary to administer the vaccine multiple times per year.
careful response are essential
The main concern about vaccines is that they can result in negative side-effects that impact health. Pfizer and Moderna said that some people experienced headaches, fevers, muscle pains and fatigue during previous trials. However, no serious cases that would threaten people’s safety were reported. In an online poll conducted by a French research company, 40% of the American public said they would not get inoculated, citing concerns about side effects. The Japanese government has also put measures in place in case health problems emerge. It is expected that public funds will be used to pay for out-of-pocket medical costs and expenses for hospitalization and visits. As the number of people who receive inoculations increases with time, new side-effects may emerge. Safety needs to watched and handled carefully.