Corona Vaccines Approved and Administered Before Clinical Trials End WHO Concerned

Corona Vaccines Approved and Administered Before Clinical Trials End WHO Concerned September 2 at 10:47 PM

An exceptional movement to emergencyly administer, formally approve and inoculate vaccines for the new coronavirus at the end of clinical trials to confirm its safety and effectiveness is likely to be allowed in China and Russia, as well as emergency use in the United States, regulators said. The World Health Organization has expressed concern that “too much intensing inoculation of large numbers of people can miss harmful events.”
Last month, the Russian government officially approved a vaccine under development in the country at the end of only the second phase of a three-stage clinical trial, and has indicated that it will begin mass vaccinations for healthcare professionals and other personnel starting in November.

The Chinese government also announced late last month that it had begun an exceptional emergency administration of vaccines under development in the country for healthcare professionals and quarantine personnel in July.

In addition, this week, The United States also revealed in an interview with the media that Hahn, director of the FDA’s Food and Drug Administration, which is responsible for approving medicines, could allow emergency use even after clinical trials are over.

Vaccines are usually a three-stage clinical trial that are officially approved after verifying their safety and effectiveness, but experts say it would be unusual if they were to be widely vaccinated by the public before they were completed.

Mike Ryan, WHO’s head of crisis response, said in a press conference that it is the country’s right to decide on the use of vaccines, but said: “If you are too hastened to vaccinate too many people, you may miss harmful events that can’t be obtained with a small number of people. Safety and efficacy must come from a number of research results,” he said, pointing to the idea that clinical trials with a certain number of people are essential for vaccine approval.

With the prolonged global epidemic of the new coronavirus, expectations for vaccines are growing, but many experts have expressed concern that hastened use with insufficient safety and effectiveness verification.

Russia’s president stresses safety, calls for safety questions

Russia last month formally approved a vaccine under development that has only finished up to the second phase of a three-stage clinical trial as a vaccine for the new coronavirus.

President Putin stressed the safety of his daughter, who also participated in clinical trials, said she had been vaccinated and did not cause any major problems.

The vaccine was named “Sputnik V” after the name of the world’s first satellite launched by the former Soviet Union in 1957, more than half a century ago, and Domitriev, president of the Russian Direct Investment Fund, a government fund involved in the development, said “the United States will be as surprised as it was then” and showed that it had succeeded in developing it over the United States.

And President Dmitriev has already received requests from about 20 countries around the world, including Saudi Arabia and the Philippines, to provide vaccines.

Russian foreign affairs critic Lukyanov told NHK in an interview that “the country that first developed the vaccine will have an important political and economic advantage”, pointing out that it is most important than anything else to be the first in the world to succeed in development in order to increase its presence in the international community.

The Russian government said it will begin a final clinical trial of 40,000 people this week, as well as mass vaccinations for doctors, teachers and others starting in November.

On the other hand, it is not expected that there are many people in Japan who question the safety of vaccines, such as 54 percent of the public who say they are not prepared to be vaccinated in some polls.

China’s President Xi, if successful, becomes the “public good of the world”

The Chinese government says it has begun an exceptional emergency administration of a new coronavirus vaccine under development in the country for healthcare professionals and other professionals on July 22.

This is a measure based on the provisions of Chinese law that, in a serious public health case, can be used urgently to a certain extent, and is limited to healthcare professionals, quarantine personnel, immigration officials, etc.

As for the purpose, Tadahide Tsuji, chief of the Science and Technology Development Center of the National Health and Health Commission, said on state-run China Central Television, “First of all, we will create an ‘immune barrier’ for certain people and stably operate the entire city.”

According to Chinese media, four vaccines are currently in the final third phase of clinical trials in China, and it is believed that one of them is being administered urgently.

President Xi Jinping has said that if the vaccine is successfully developed, it will be a “public good in the world” and is trying to increase its influence in developing countries, including Africa, by providing vaccines.

In the background of emergency administration, it is also expected that the goal is to confirm the safety and effectiveness of the emergency by inoculating many people.

American experts are allowed an unusual situation if widely inoculated

U.S. experts point out that vaccines that have not yet completed clinical trials would be unusual if they were allowed for emergency use in the country and widely vaccinated.

According to Dr. Rene Nahera, who is familiar with the history of vaccines, in the early 1950s, more than 60 years ago in the United States, vaccines were officially approved for humanitarian reasons, including large-scale vaccinations under development as part of clinical trials to fight polio, which was prevalent at the time, and when a high-lethal Ebola outbreak occurred in 2018. It is that it has been inoculated in the person with a high risk of infection.

However, it is said that it is an unusual situation if emergency use in the United States is permitted and it is widely inoculated this time because the emergency use of the vaccine is permitted before the clinical trial ends, and it has been widely inoculated in the United States.

WHO “Emergency Use Should Be Considered”

Mr. Swaminasan, chief scientist at the World Health Organization, stressed at a press conference that vaccine approval is a sovereign process by each country, but he was cautious, noting that “permission and approval of emergency use should be done seriously and with careful thought.”

Vaccine Approval Japan’s Response

In order to confirm the safety of overseas vaccines in Japan, clinical trials are conducted to be given to healthy people and patients in advance.

Based on this data, it is reviewed by the Pharmaceuticals and Medical Devices Agency, an independent administrative agency, and if safety and efficacy are recognized, it will be approved as a drug and insurance will be applied.

On the other hand, for vaccines and therapeutic drugs that are highly urgent, there is also a system called “special approval” that simplifies the screening process only in overseas countries where there is a similar approval system as in Japan, only if they have already been sold.

With regard to the new coronavirus, the system was applied to the drug “Remdesivir” in May, and it was approved three days after the application.

As for the flow of approval when a new coronavirus vaccine is developed overseas, the Ministry of Health, Labour and Welfare said that “the judgment of the necessity of special approval will be on a case-by-case” and that “the vaccine strikes healthy people, so it is necessary to check the safety more rigorously. In any case, we want to aim to provide the public with therapeutic drugs and vaccines that have been confirmed to be safe and effective as soon as possible.”

Some cases were used in an emergency.

Vaccines must be approved by the government to confirm their effectiveness and safety, but in some cases vaccines have been used urgently to simplify this process.

In general, for a vaccine to be approved, it is necessary to actually administer it to a person to see if there are any safety issues or whether it is effective in preventing infection or severity in a three-stage clinical trial.

In clinical trials, basic data such as the effective amount is collected by administering to a small group in the first stage, and then the number of people administered in the second stage is increased to determine whether it is safe or effective.

Promising results so far will advance to the final third phase and conduct large-scale clinical trials administered to hundreds to tens of thousands of people to finally confirm their safety and efficacy.

Because vaccines are vaccinated against healthy people, the benefits of preventing the spread of infection and reducing the number of people who become severe are expected to be inoculated when they exceed the disadvantages of side reactions, which can take time to evaluate and usually take about five to ten years from the start of development to approval.

However, there have been cases where urgent action has been needed due to a large-scale epidemic of infectious diseases, and in 1961, when polio, which had aftereffects such as paralyzes, became prevalent in Japan, the then Minister of Health and Welfare urgently imported vaccines from the former Soviet Union and took measures to inoculate approximately 13 million children without reviewing them for approval.

In addition, when the outbreak of the new influenza at the time in 2009, in response to the approval of vaccines in the United States and Europe, the country applied “special approval” to greatly simplify the examination in the country, and allowed the import of vaccines from overseas.

At that time, imported vaccines were manufactured by the method of culturing the virus using cells, that the domestic vaccine and the production method using chicken eggs were different, contained substances that activate the function of immunity called adjuvant, and the method of administration was also injected into the muscle, since the side reaction was different from the conventional subcutaneous injection, as there is a risk that the side reaction is different from the conventional vaccine, Medical institutions reported directly to the country so that side reaction information could be collected quickly.

At this time, however, the outbreak of the infection had passed its peak at the time of the vaccine’s available, and the amount of specially approved imported vaccines was small, and the Ministry of Health, Labour and Welfare issued a summary of 7,550 times the following year.only inoculation, and there were five reports of side reactions.

In addition, for Ebola, which has a high mortality rate overseas, there have been cases where vaccines were used urgently against healthcare professionals and residents in Guinea, West Africa, and other countries before the final clinical trials confirmed their safety and efficacy, and the World Health Organization later recognized that the vaccine met safety and efficacy standards.

It has been pointed out that many of the new coronavirus vaccines currently under development are called “gene vaccines,” which use some genes of artificially synthesized viruses to cause immune responses, which have never been used anywhere in the world and cannot be expected to cause side reactions when inoculated by many people.

Many experts are calling for careful attention because using these vaccines in Japan without sufficient review can have unexpected effects due to differences in lifestyle and genetic background.

Expert: “The original way vaccines should be may be distorted”

Regarding the urgent approval of vaccines for the new coronavirus in countries at the end of clinical trials to confirm safety and efficacy, Professor Jiro Yasuda of Nagasaki University’s Institute of Tropical Medicine, who is familiar with infectious diseases, said, “As infections spread around the world, preparations for vaccine development and vaccination should proceed promptly. It is necessary to take enough time to check the safety of the vaccine in practice. Neglecting this point could also distort the vaccine’s original way of being safely inoculated to prevent infection and severity. With excessive expectations, it is a quick impression to proceed with rapid approval.”

Regarding vaccinations in Japan, he said, “It is usually thought that it is necessary for at least one year just to confirm safety, and it may be difficult to inoculate all citizens in the first half of next year. In recent years, the number of treatments has been increasing, and citizens’ awareness of prevention, such as hand washing, wearing masks, and avoiding three secrets, should focus not only on vaccines but also on various measures to prevent infection.”