[Washington Insights] "Is it okay for children to get the corona vaccine?"... What is the FDA Advisory Board's answer?

'Booster expanded inoculation'...

White House ahead, FDA advisory committee opposing

Paradoxically, since Independence Day (July 4), when President Biden declared independence from Corona, the United States has become a playground for delta mutations.

The White House was shocked as the worst delta mutation exploded as vaccination hit its limits.

I had to vaccinate a person who had never been vaccinated, but there was no other way because I endured that I would not get it even if I died.

It was so difficult for Americans to enforce social distancing and wearing a mask, there was no other means of response than vaccination.

The United States, who was in a hurry, turned to booster vaccination.

Vaccine companies persuaded the White House by diligently providing data that boosters boost neutralizing antibody levels again.

In August, President Biden officially declared a booster vaccine for all adults, which the FDA has not yet discussed. It was suggested from September 20 to the point of inoculation, but the FDA was in a lot of shock. Vaccines Director Martin Gruber and Deputy Director Philip Kraus both resign at the same time. It was taken as a strong protest against Biden's pursuit of science for going ahead of his own promises. However, on September 17, the Vaccine and Biologics Advisory Committee (VRBPAC), which plays a very important role in FDA decision-making, rejected the overall adult booster vaccination by an overwhelming vote of 16-2. The committee re-established the target of booster vaccination by limiting it to the elderly 65 years of age or older and the vulnerable with underlying diseases such as obesity and diabetes. 

The FDA Advisory Committee is an organization that guarantees a high degree of independence as a gathering of the best and recognized experts in the field of vaccines in the United States. Although FDA did not have to accept the Advisory Committee's comments, it was extremely rare that this decision would not be followed. Although the president's plan was in turmoil, after twists and turns, CDC Director Michel Wallensky made a compromise on the line of adding people with jobs that were in close contact with people infected with the coronavirus ex officio, and first started the booster vaccination. 

White House Chief Medical Adviser Fauci has been an avid booster advocate from the start.

Preferring Israeli data, he explained several times during the coronavirus briefing how effective booster vaccination is, and in media interviews, he predicted that all adults would eventually be vaccinated with booster.

Yesterday, citing data from South Africa and the UK, both Pfizer and Moderna promoted that booster vaccination would have a great effect on Omicron.

Vaccine companies submitted data again saying that they should expand the booster vaccination to all adults right after the FDA advisory committee rejected the expansion of booster vaccination, and the FDA approved it on November 19, two days after receiving the data.

At this time, the FDA advisory committee was skipped altogether.

As overwhelming opposition was confirmed, it seems that it was decided that there was no real profit to hold an advisory committee even after a short time has passed.

As the White House intended, once all adults in America are starting to get boosted. 

One thing to be clear about is that the FDA advisory committee did not disagree about vaccination itself.

Experts agree that vaccines can save lives and have a huge impact on the coronavirus response.

However, there was a controversy about how far and how to extend the vaccine to ensure the maximum safety of the corona vaccine, which is very rare but has side effects.

In the FDA advisory committee on this issue, there has been a fierce internal debate about how far to expand booster vaccination and to what extent to lower the vaccination age. 

The general idea is the same, but the opinions are different...

I asked an FDA advisor.

The controversy over the youth quarantine pass in Korea raises the question of how far the vaccination target should be expanded in Korea.

Adults who have experienced difficult side effects from receiving the corona vaccine are reluctant to vaccinate their children, and some deaths suspected of side effects have occurred, leaving great fear in the public.

In addition, it is a factor that makes us more concerned about vaccines because children and adolescents think that they do not suffer much even if they contract the corona virus.

▲ Professor El Salle Baylor (left) and Professor Cody Meissner, Tufts School of Medicine 

I wanted to personally check the problems raised in Korea, so I started asking FDA advisors.

This is because, although it plays an important role in FDA decisions, it is an organization that has objectivity that the White House cannot do anything about.

Most of the advisory members are university professors who treat patients in hospitals, so it was not easy to find time.

However, I asked him to take time to explain the chaotic situation in Korea, and Hana El Salley Baylor, a medical professor who specializes in the field of viruses, and Cody Meissner, a professor of medicine at Tufts Medical School, who specializes in pediatrics, gladly agreed to an interview.

After the interview was over, the two professors had the same opinion in general, but they had different opinions in each discussion.

It is also a sign of internal discussions on the FDA Advisory Committee, but I think we need to take note of their views as well.

Similar questions were posed to two professors, and their opinions were summarized in a question-and-answer format. 

Are adolescent vaccinations really safe?

A Different Perspective Around Myocarditis Side Effects

El Salari) The United States has had millions of vaccines given to young people in the community since last spring. The stability of the mRNA vaccine was found to be very high. There was some fatigue and fever that occurred during the inoculation, but it usually disappeared within a day or two. Of course, there was myocarditis as a new side effect. It causes inflammation of the heart, and the incidence is very low. Most side effects occur within 6 weeks of inoculation. So far it seems safe. Although closely followed, there are no signs of long-term harm. 

Meissner) is a very complex and controversial question. If you ask if this is a safe vaccine to vaccinate, I think yes. Enough youth have been vaccinated, and we know it's safe. But we also know that myocarditis cases occur in young men. It mainly occurs in men under the age of 30, which is triggered by mRNA vaccines, which increases the risk of developing inflammation. It has to do with myocarditis. Maybe it has something to do with testosterone. This is very rare. However, in this age group, it can be said that the risk of hospitalization due to Corona is slightly higher. You cannot eliminate all dangers in life. Even taking aspirin can cause death from bleeding. Balancing these risks and benefits is difficult. Pediatricians say that myocarditis caused by a side effect of the vaccine is very mild and is discharged in two or three days. However, we do not know of long-term complications. Usually, if you are hospitalized for myocarditis caused by a side effect of a vaccine and then are discharged, cardiologists tell you not to exercise for 3 to 6 months. This is a big deal for teenagers. 

El Sali) In terms of age, the proportion of young people who are seriously ill with the coronavirus is lower than that of older people, but when considering the total number of millions of young people, it is very high.

In terms of the safety of the vaccine and the probability of contracting a serious corona disease, getting a vaccine is much more effective.

Meissner) because the corona is getting more and more serious.

I think everyone over the age of 18 should be vaccinated and have immunity.

Even young people get sick and die from Corona.

Of course, completely healthy adolescents and children are very unlikely to be admitted to the hospital.

I want to clarify what the side effects of the vaccine are. 

What is compulsory vaccination for adolescents?

Why Corona Explosions Even With High Vaccination Rate?

El Sali) We need to reconsider what our purpose is. Our goal is not to get seriously ill or die from Corona. We already have a vaccine that has vaccinated millions of adolescents and has a record of being very safe. When hospitalized for Corona, the community pays for the sick. You will receive the best treatment and provide intensive care. So it is not unreasonable to ask the community to participate in vaccination. That way, there will be room left to take care of patients who have not received the vaccine or who have been hospitalized for a disease other than Corona. 

Meissner) Has the corona vaccine given to adolescents been officially approved in Korea? In the United States, it is still under emergency use approval for those under the age of 16. It is still a trial vaccine. In my opinion, getting people to participate in an investigational vaccine is difficult. (Explain that it has been officially approved in Korea) Of course, the measles vaccine requires vaccination at school. As for measles, I know it's safe after 70 years of use. However, the mRNA vaccine has not been used for less than a year. To force something, you need to know the full range of benefits you will get. 

El Sali) vaccine will prevent you from becoming seriously ill, but may not protect you from all infections.

Once vaccinated, the patient is usually mild and rarely hospitalized.

Older people can be hospitalized, but they keep them from entering the intensive care unit or contracting terrible pneumonia.

What we learn as we go through Delta and Omicron is that vaccines remain effective and prevent serious consequences.

Still, what we can see as hopeful and blessing so far is that if you get two mRNA vaccines, you won't get seriously ill.

The idea that infection can be zeroed is the opposite of what viruses have taught us.

The current goal is to protect people while controlling the serious consequences of the corona virus. 

Meissner) Even if you get the vaccine, you will still be infected.

But it will be much less painful.

We initially thought that the vaccine was so good that it would prevent the infection itself.

In fact, it was an unrealistic expectation.

People who have been vaccinated should know that if they become infected, they will almost certainly not show any symptoms.

The idea that the virus can be eradicated is not realistic.

Viruses will continue to mutate and roam communities and planet Earth.

A realistic goal is to get everyone vaccinated by the age of 18.

But in the United States, tens of millions of people are still unvaccinated.

There is a compulsory vaccination measure, but I'm not sure if it will work. 

Two doses of the vaccine are necessary, but...

FDA advisory committee with reservations on booster vaccination expansion

El Sali), a double dose, also seems to protect against serious illness. Booster inoculation remains to be seen. It is not possible to make a decision based on neutralizing antibody-based data alone. A variety of infectious disease data from local communities and other countries are needed. We are investigating the benefits of how often to vaccinate. Going back to the previous answer, everyone should get the first two doses of the vaccine to protect against the serious COVID-19 disease. 

Meissner) The FDA or CDC has not said anything about the fourth dose. Of course, Pfizer will be happy with the booster dose, and even happier with the fourth dose. I don't think Pfizer or Moderne or Johnson & Johnson should recommend getting a vaccine. It is subject to serious conflicts of interest. I don't want to blame the pharmaceutical companies, but the decision about booster doses should be left to health professionals.  

El Sali) is true according to laboratory results. The third inoculation increased the neutralizing antibody level against Omicron. However, actual clinical results are important. And community outcomes matter. And we have to look at it holistically. Data from South Africa and the UK show that people who have been vaccinated or have been infected have mild symptoms. So, if you haven't been vaccinated, get vaccinated. People with weakened immunity should receive booster vaccinations as an exception. However, it remains to be seen whether all of them will receive a third vaccination. Actual clinical results and neutralizing antibody data should be integrated and viewed. 

Meissner) That's true.

Booster inoculation allows the formation of higher levels of antibodies.

However, the immune response also includes neutralizing antibodies and T cells.

T cells seem to outlive neutralizing antibodies.

We don't know how far this will go.

Omicron causes less serious disease than delta mutations.

In South Africa, inpatients are less likely to need coral respirators.

As this virus mutates repeatedly, the symptoms are going in the direction of milder symptoms.

But it's only been a few weeks, so there's a lot we don't know. 

Vaccination: Where to balance benefits and risks?

Professor Meissner has repeatedly complained of mental conflicts about having to make a decision at the FDA advisory committee during the unprecedented pandemic. He abstained last year when the Pfizer vaccine was first reviewed. He said he knew better than anyone that a vaccine was more urgent than ever since there were 4,000 deaths a day at the time, but he could not understand it at all when he saw the data Pfizer brought in asking for 16- and 17-year-olds to be included in the vaccination list. At that time, I brought a clinical record of one myocarditis side effect in under 18 years old, but it was too difficult to determine this as a vaccine side effect. As a pediatrician, he frankly told the situation at the time that he wanted to give the Pfizer vaccine to those over the age of 18. 

Professor Meissner also explained that Pfizer knew that myocarditis had a high risk of side effects, and that the pediatric vaccine had reduced the dose by one-third. Reducing the dose significantly reduced myocarditis side effects, but there was no significant difference in immunity formation. Professor Meissner also added that he doubts that Pfizer's lower adult vaccine dose setting would have been an optimal outcome. 

It's hard to argue broadly that the coronavirus vaccine is safe.

Children, too, can experience less emotional burden when going to school or going out with their parents if they get vaccinated.

As the vaccination of children and adolescents started in the United States, I knew that data for millions of people was being accumulated, and I decided that it was difficult to see it as a big problem, so I also vaccinated both elementary and middle school children.

However, it is also an undeniable fact that side effects do exist even though they are extremely rare.

No matter how much scientific data is presented, if parents do not mentally agree that vaccination is safe, the expansion of youth vaccination will inevitably lead to a big backlash.

Governments also face the challenge of figuring out the optimal balance between the benefits and risks of vaccination.