What are the benefits of vaccines for children? What are the risks?

Vaccination with the new coronavirus is about to spread to elementary school age.

The new coronavirus vaccine from Pfizer, a major American pharmaceutical company, is currently targeted for vaccinations over 12 years old, but the FDA = Food and Drug Administration expert committee said on October 26, 2021, 5 to 11 years old. The majority of the children passed the conclusion that "the benefits of vaccination outweigh the risks".

The FDA is expected to soon issue permission to expand coverage.

What should we think about vaccination of children in elementary school age?

We summarized the current situation and asked experts familiar with pediatric medicine and vaccines.

Vaccine 5 to 11 years old

Pfizer's new coronavirus vaccine is currently targeted for people over the age of 12.

On October 26, a committee of FDA experts discussed a plan to extend vaccination coverage from 5 to 11 years old and passed the conclusion that "the benefits of vaccination outweigh the risks."

Reported here are the results of a clinical trial of the new corona vaccine in children aged 5 to 11 years, conducted by Pfizer and others.

According to FDA data, more than 2,200 children are divided into a group that receives one-third of the vaccine used for people over the age of 12 and a group that receives a fake vaccine-like drug, placebo. It means that we have confirmed the effectiveness and safety.

As a result, the effect of preventing the onset was 90.7%, and there were no cases of serious illness.

On the other hand, the side reaction of the vaccine was

▽ fever of 38 degrees or higher

in 2.5% of children

after the first inoculation and 6.5% after the second inoculation,

▽ malaise

after the first inoculation.

It was seen in

33.6% and

39.4% after the second inoculation.

Pfizer explained that there were no safety concerns.

For future discussions in Japan

Initially, Pfizer's vaccine was intended for people over the age of 16, but in May 2021 it was expanded in the United States to over the age of 12 and then in Japan.

At this time, Pfizer announced on March 31 that it had confirmed the safety and efficacy of clinical trials for 12 to 15 years old.

On April 9, I applied to the FDA to increase the age of vaccination.

Then, on May 10, the FDA expanded the scope of emergency use permits, and on May 13, vaccinations of this age began in the United States.

Pfizer also submitted data from overseas clinical trials to the Ministry of Health, Labor and Welfare in Japan.

On May 28, the Ministry of Health, Labor and Welfare decided to add 12 to 15 years old to the age at which vaccination is possible.

Then, on May 31, it became the target of public inoculation and the inoculation started.

At this time, about three weeks after the target of inoculation was expanded in the United States, inoculation in Japan began in this age group.

The FDA is expected to issue an emergency use permit to expand the scope of inoculation for children aged 5 to 11 in the near future, and discussions will begin in Japan as to whether this age group will be the target of inoculation in the future. It is a prospect.

What is the meaning of inoculation in elementary school age?

In response to the conclusion of the FDA committee this time, Tetsuo Nakayama, a pediatrician who is familiar with vaccines, said, "Since there was no vaccine that could be inoculated so far in this age group, we relied on measures other than vaccines. Being able to inoculate is significant in that it provides a new means of infection control. "

When considering vaccination, it is important to consider the balance between the “benefits and benefits of vaccination” and the “risk of side reactions”.

What is happening to children's infections in Japan now?

"Children are also infected, but few children become seriously ill."

Children are also infected with the new corona, but it is known that most of them are mild and rarely become severe.

The Ministry of Health, Labor and Welfare regularly publishes data such as the number of infected people and the number of people who have become severely ill, compiled by age group.

According to the data on October 26, 2021, the total number of infected people in Japan is 1,712,947, the number of people who died is 18,213, and the mortality rate is 1.06%.

Of the infected people, more than 92,000 are under the age of 10 and more than 172,000 are teenagers.

Few people have died, and local governments have reported that a man in his late teens who had an underlying illness in Osaka Prefecture and a woman in his teens died in Yokohama.

According to another source from the Ministry of Health, Labor and Welfare, 0.09% of people under the age of 10 and 0% of those diagnosed became severely ill.

Although there are cases in which children with the underlying disorder become severely ill, the current situation is that few children have become severely ill.

"Infection is" adult → child "rather than" child → adult ""

According to an analysis by an expert meeting of the Ministry of Health, Labor and Welfare, most domestic infections are "adult-to-child transmission" and relatively few "child-to-adult transmission".

Takaji Wakita said that the infection of children at school and other places has not become like the flu that spreads to families at home. After the family meeting, he was asked about the infection of children. For now, I don't expect to be in a flu-like situation where the infection is growing among children. "

The benefits of vaccination for children

While most children are mildly infected, the significance of vaccination by children may be less than that of adults, given that there are some side reactions.

What are the benefits of inoculation?

..

▽ Preventing the onset and aggravation The

vaccine currently being inoculated is known to be highly effective in preventing the onset and aggravation of Delta strains.

▽ Reducing clusters in schools and lessons In

the fifth wave of infection spread

, clusters

centered on children occurred through lessons such as schools and cram schools, and it is thought that the occurrence of such clusters can be reduced.

▽ Reducing the risk of infection

in the home It is thought that vaccination by children can reduce the risk of spreading the infection to people who have not been vaccinated at home or who cannot be vaccinated.

Expert Opinion “Benefits ＞ Risks”

Professor Nakayama said, "Even if you are 5 to 11 years old, the effect of suppressing the onset is 90%, so you can think that it is highly effective. There are certain side reactions, but most of them are mild, so much I think it's more effective than a high-risk vaccine, "he said, saying that the benefits outweigh the risks.

He added, "A cluster is actually occurring in schools and cram schools, and if infected, it may spread not only to your own risk but also to the children around you. Vaccines protect individuals and at the same time they live their lives. It also has the effect of protecting the population that is infected. In the current situation, it is necessary to consider that isolation may be necessary in the case of infection, which can be a burden on the mind. "

Discussion based on the difference in circumstances with the United States

On the other hand, it has been pointed out that the situation is different from that in the United States, where discussions on inoculation of children are progressing.

Data from the American Academy of Pediatrics show that by October 21, 6.3 million children had been infected with the new coronavirus, and 118,000 new infections were confirmed in the last week.

In addition, the CDC = Centers for Disease Control and Prevention has reported data that the number of children hospitalized has increased with the expansion of Delta strains.

On the other hand, in Japan, the number of infected people, including children, is decreasing rapidly.

Professor Nakayama said, "In the United States, the infection of children is quite widespread, but in Japan, the number of infected people is gradually decreasing, and the number of infected children is also decreasing." He pointed out that different things should also be considered.

On top of that, "For children with underlying diseases, there is a high risk of becoming severe when infected, so I think it is better to proceed with vaccination. However, in the current infection situation in Japan, all children should be vaccinated. You have to think carefully. Instead of rushing to inoculate children, the inoculation gradually expands while watching the situation, and the inoculation progresses around you, so that the person who receives the new inoculation I hope there will be more. "

Thinking about the balance

We don't know when the next wave of spread will come, but vaccines will continue to be a great weapon.

Increasing the target age for vaccination is of great interest as a countermeasure against infection in children.

It is important to carefully assess the benefits such as effectiveness and the risks such as side reactions and consider the balance, and it is necessary to make a judgment including whether the child or the guardian desires it.