Will the vaccine reach you?

September 3, 11:45

"Vaccine" is expected to be the trump card of the new coronavirus convergence.

The government intends to secure all the people by the first half of next year.

In the world, there is still a development competition and a fierce competition for a vaccine that we have not seen.

Is it possible to secure Japan firmly?

And when will it reach us?

He directly hit Keyman, who was the top medical department of the Ministry of Health, Labor and Welfare.

(Kazuma Ando, ​​Tomoyo Koizumi)

For everyone in the first half of next year!

?

“Aiming to secure a quantity that can be provided to all citizens by the first half of next year”

The target of vaccine protection was specified for the first time in the “Countermeasure Package” of the new coronavirus decided on August 28.

By the first half of next year, it will secure all the people, that is, about 120 million people.

The following are the main means for procuring vaccines.

(1) Domestic development and production

(2) Purchasing from overseas pharmaceutical companies

(3) Procurement under international framework

Among these, the most advanced is purchasing from overseas pharmaceutical companies in (2).

The Japanese government has proceeded to negotiate with several overseas manufacturers, among which two major pharmaceutical companies in the United States and Britain have entered into a basic agreement on vaccine supply.

Furthermore, it seems that negotiations with another American pharmaceutical company are final.

The total of the three companies is 140 million.

It seems that Japan's population is almost covered.

Unknown Special Mission Team

By the time this basic agreement was reached, fierce negotiations were underway.

It was a special mission team established within the Ministry of Health, Labor and Welfare that was in negotiations.

The contents of the lineup and negotiations are considered to be confidential and little known within the province.

Therefore, I spoke to Yasuhiro Suzuki, who retired in August as a medical and technology supervisor of the Ministry of Health, Labor and Welfare and was mainly involved in measures against the new coronavirus.

Mr. Suzuki is the top post of a bureaucrat who is qualified as a doctor, and Mr. Suzuki has also attended meetings of the Prime Minister's official residence every day.

For the first time after retiring, he interviewed the media.

Tough overseas pharmaceutical companies

Q: How do you approach negotiations?

A: The staff in charge of the Health Bureau of the Ministry of Health, Labor and Welfare is not so familiar with overseas negotiations, so in addition to the legal counsel of the Ministry of Health, Labor and Welfare, we have put in a number of "external lawyers" who are good at negotiations and are negotiating. I will.

The negotiation partner may be a Japanese branch of an overseas manufacturer, or an interpreter may be included in the head office.

I can't do business trips abroad at this time, so I'm doing an online video conference.

Q: What is the focus of the negotiation?

A: I cannot tell you the details because of the confidentiality obligation, but there are three main points.

(1) Supply... At what time and how much is supplied?

(2) Price... Overall price.

How much will you be refunded if you cannot supply after contracting?

Payment method, such as paying the full amount first or a part as a deposit.

(3) Compensation: Compensation for any side effects.

Exemption or loss compensation?

Since overseas is a litigation society, I am very concerned about who will ultimately take responsibility for health damage.

Is the country taking over the loss?

Q: What was the biggest bottleneck in the negotiations?

A: The supply period and price are tough, but the most difficult thing is the complete exemption from side effects.

Some companies demanded that "a pharmaceutical company should not be sued in case of side effects."

In the case of the United States, this "immunity" is in the legal system, but in Japan the constitutional right to litigation is recognized, so the hurdle is high.

In Japan, it is difficult to grant a “disclaimer”, so the government has decided to cover the loss of pharmaceutical companies by the state in the event of adverse health effects such as side effects.

The law will be established before the vaccine is supplied.

"Not surprisingly high"

Q: Do the other people attach importance to whether or not they will become a business?

A: Because of this situation, there are companies that do non-profit = non-profit, and there are companies that try to make a profit with this opportunity because it is a big game to grow or warp.

It depends on the company.

Negotiations with overseas manufacturers are like chicken races.

We have the desire to "buy this much", but if you want to buy too much, the price will increase as you can see your feet.

You have to negotiate well there.

Q: What is the price of the two companies' vaccines that you basically agreed on?

A: I can't tell you, it wasn't a surprisingly high price.

I don't know if it works!

?

Most vaccines for other diseases inject the virus or protein.

However, this development will take time.

For this reason, vaccines that are currently being developed are often injected with genetic information.

While he can start development early, he says that he has a poor track record and often does not know.

Vaccines, unlike drugs, strike healthy people, so safety is more important.

Q: How effective are the two companies' vaccines?

Does it work for Japanese people?

A: I still don't know if it's Japanese or not.

Of the three-stage clinical trials, we are proceeding to the third stage trial that actually inoculates a large number of patients to examine the efficacy and safety, but it is unclear how much antibody is produced and how long immunity continues Is big.

Q: Is it okay if I hit it once?

A: Some vaccines, such as the measles and rubella vaccines, do not last a lifetime once they are struck, while others, such as the influenza vaccine, have to be struck every year.

There are also vaccines that do not prevent the disease, but rather prevent it from becoming more severe or prolonged.

I don't really know what it is.

Q: The two companies secured 120 million people, almost the population, but will you increase more?

A: We want the vaccines from the two companies to be successful, but we can't just bet on this with 100% confidence.

We cannot afford to secure vaccines at this stage so that all Japanese people can be covered even if there is some moss.

The number will change depending on whether you hit once or twice.

Our basic strategy is to prepare as many different types of vaccines as possible, and be prepared to accept which one will be the winner.

Fierce vaccine competition

In the world, many countries are now involved in development and negotiations.

The major companies in Europe and America are as follows.

*Clinical trials are finalized in three phases, Phases 1 to 3.

See the end of the sentence for details.

According to the World Health Organization (WHO), there are 176 types of vaccines under development worldwide, 33 of which are in the stage of clinical trials for humans.

(As of August 28)

Normally

, it

takes about 5 to 10 years to develop, but the new coronavirus is being researched at a speed that is many times faster than usual because of its large impact.

Overseas, full-scale vaccination of some vaccines may start before the end of the year.

It is Russia that has appealed for the completion of the vaccine at a time ahead of the West.

Putin officially approved on August 11 the vaccine that has been developed domestically.

My daughter also participated in the clinical trial.

In the future, in addition to large-scale vaccinations for its own citizens, it will also be provided to desired countries.

However, some of the three clinical trials have been completed up to the second stage, and there are many unclear points, and some have questioned the safety and efficacy.

China is in a hurry to develop as if to chase its back.

China, which had acquired the virus from an early stage, has promoted vaccine development nationwide.

It seems that it is in the process of clinical trials in the third stage, and has "approved for internal administration only within the PLA."

If it is put into practical use, it will actively provide it to developing countries such as Africa.

There may be speculation that it would be a diplomatic and economic advantage for countries to devote themselves to the development and supply of vaccines.

Japan is also following the "delayed feeling"

But what about Japan?

In Japan, about 10 vaccines are being developed mainly by pharmaceutical companies and research institutions.

(As of August 31).

However, none have been entered into the third-stage trial to examine the efficacy and safety by inoculating a large number of patients.

Q: How is the progress of domestic development compared to overseas?

A: I think there is a slight delay.

However, once started, because of the characteristics of the Japanese people, we can proceed quickly, so I think that there will be places where we can start supply from the first half to the middle of next year.

In Japan, there is also a movement to install production facilities in parallel with research and development so that production can be increased immediately after completion, and the government is giving back with a subsidy.

Subsidies for 6 companies have already been decided.

A: When you buy a vaccine, you buy it once and it ends.

But this vaccine may have to be given every year.

Then, if you have a manufacturing base in Japan, you can make it every year.

In that sense, it is very important to improve the domestic production system to secure a continuous vaccine.

The postponed Tokyo Olympics and Paralympics are scheduled for next summer.

Many say that vaccine development is needed to hold the event as scheduled.

Q: Wasn't there any pressure from the political side to "rush the vaccine supply"?

A: Nobody can deny that vaccines are very important in helping people feel safe and fear of disease.

We want to do whatever we can, such as simplifying and speeding up the procedure.

On the other hand, safety and effectiveness cannot be ignored.

How do you balance that?

Home country priority or international cooperation

As countries rush to secure vaccines for themselves, one international framework is about to move.

That is the "COVAX Facility".

It is a mechanism for joint purchase of vaccines launched by WHO and others, and developed countries will contribute funds to purchase vaccines for their own countries, and will also supply them to developing countries with poor development and financial resources.

It is expected to reach all countries fairly.

However, it is unlikely that the United States, which is in the process of making its own production, and the EU countries such as Germany and France, which are making group purchases, will not participate.

Under these circumstances, the Japanese government announced its intention to join the framework on August 31st.

Q: How does Japan think of this framework?

A: In addition to Japan, the UK is very interested and is actively considering participation in the framework.

If Japan and the UK enter, vaccines can be provided to developing countries while showing their presence as a diplomatic means.

In a country where you can make and buy a vaccine in your own country, your garden may be clean, but if you open the border, people who have not hit from outside will come in.

Considering the world as a whole, it is absolutely necessary to have a mechanism to spread the vaccine to developing countries.

When a considerable number of people can be distributed to Africa, Asia, South America, etc., the countries that they receive will feel a benefit.

Vaccines can be used as diplomatic tools beyond the protection of their own people.

The framework aims to produce 2 billion doses of vaccine by the end of 2021.

It is expected that the whole picture will be solidified by mid-September, which countries other than Japan will participate, and what kind of country will become the whole.

Who was the first one?

Who will be the first vaccination in Japan?

The government subcommittee decided the priority of vaccination.

▽Medical workers at high risk of infection, ▽Elderly people at high risk of becoming severe and those with underlying diseases were given priority for vaccination.

In addition, pregnant women, paramedics, and staff of facilities for the elderly will be further examined while checking the effectiveness.

Q: When will you actually be able to inoculate?

A: I think we probably want to hit it early next year.

However, even if a manufacturer contracts for 60 million people, it does not mean that 60 million people will come in at once.

For example, millions of people come in in small groups every three weeks.

That's why it's important to decide in what order.

Q: How do you do it?

A: The executing agency is likely to be a local government.

Rather than gathering people at public halls, it is more natural to hit at a medical institution like an influenza.

You have to make sure there is no confusion.

Unless you're convinced that a young, healthy person will be put off, you'll end up as "Why can't I strike?"

Will the new corona become a "normal illness"?

There is also a "vaccination myth" in which one could get back to normal life by getting a vaccine.

Will Vaccines Be the Trump of Overcoming Corona?

Finally, I asked Mr. Suzuki.

Q: What happens with the vaccine?

A: There is a vaccine for influenza, and there are "Tamiflu" and "Relenza" as therapeutic agents.

With these two tools, people can feel safe and not panic.

The new coronaviruses now use the drugs "dexamethasone" and "lemdecibir."

After that, if the vaccine can be used quantitatively in the world, this disease will shift from a special one to a “normal one” little by little.

Q: When will I be afraid of corona?

A: I don't know if this virus is 3 years, 5 years, or 7 years, but there is no doubt that it will be attenuated eventually.

In the meantime, it is important to control infections and prevent confusion with vaccines, remedies and various social policies.

Vaccines are a very important pillar of that.

When will you visit the days when you can balance your socio-economic activities without fear of corona more than necessary?

There is no doubt that the vaccine holds the promise of a post-corona society.

I look forward to future progress.

*Note: A "clinical study" (clinical trial) in humans is divided into three stages:

Phase 1 study...

Phase 2 study

examining side effects in healthy people

... Effective for a small number of patients

Phase 3 trial (final stage) to

check if there is any ... Examining

safety and efficacy in a large number of patients

Kazuma Ando,

Reporter of the Ministry of Political Affairs,

joined the company in 2004.

Also worked at Yamaguchi and Sendai stations.

Club cap from Ministry of Health, Labor and Welfare since last August.

Continue coverage of the new coronavirus.

Tomoyo Koizumi,

Reporter of the Ministry of Political Affairs,

joined the company in 2011.

In charge of the Ministry of Health, Labor and Welfare and the Japan Medical Association.

Continue coverage of the new coronavirus.