Toddlers aged 5-11 are one step closer to the COVID-19 vaccineExBulletin

Ali Shapiro, Host:

For younger children, this year’s Halloween could mean chocolate bars, lollipops, and perhaps the COVID-19 vaccine. Today, Pfizer-BioNTech has requested the FDA to authorize a vaccine for emergency use in children aged 5 to 11 years. This is a step-by-step step in the process. The FDA Advisory Board should continue to consider the requirements. There is a meeting scheduled for October 26th. Every step of the journey to vaccine approval prompts new questions from parents who had to navigate school and other parts of their child’s daily life without vaccine protection. Dr. Grace Lee is a pediatrician at Stanford University’s Lucille Packard Children’s Hospital and chairs the CDC’s Immunization Implementation Advisory Board. Thank you for your participation.

Grace Lee: I’m glad I came here. Thank you very much.

Shapiro: What are your most frequently asked questions and concerns from your parents right now?

LEE: I think it’s a mixture of what people have been asking for. I have many parents, families and community members who are really eager to provide vaccines to school-aged children, children aged 5 to 11 years. Of course, I think you are always asked about the safety of vaccines, but that is a very important and important point. But in general, most parents will be really excited to have another tool in their toolbox to protect their children, families and communities. It goes beyond the masking, distance and other interventions that are happening.

Shapiro: Looking at the impact of delta variants on children, what’s the problem here?

LEE: Well, we’ve clearly seen an increase in the number of infectious diseases occurring in children, which reflects the number of infectious diseases we see in the community. I think that there. As you know, it’s actually related to community communication, as is the previous increase we’ve seen in the past. The more we can do to help our community increase immunization rates, the more it will help everyone, especially those who are not yet vaccinated.

Shapiro: When it comes to the impact of delta variants on children, is it correct that more children are hospitalized, but the child-to-adult ratio is still much lower? Is that correct?

LEE: As you know, the elderly, in particular, are clearly at increased risk of serious illness. And, as we know, many people currently hospitalized for severe infections are not vaccinated. However, it is very important to remember that some children can actually get a very serious illness due to COVID-19 infection. Also, it is not always possible to predict who will have serious consequences for infection. Therefore, although the overall proportion tends to be lower than in adults, it is still a concern and a preventable infection.

Shapiro: Dr. Forch states that these vaccines could probably be approved by Halloween. This hearing is October 26th. When do you think the children will actually go to the pediatrician and be shot?

LEE: That’s a great question. I will give you a longer answer. It means that there is a very clear process we are implementing for vaccine approval. Therefore, you must first wait for the company to test and submit the data. The FDA should review the data, including its own primary analysis, to make sure that the data makes sense. In this case, there is also an FDA Advisory Board called VRBPAC for these vaccines, which meets to discuss and advise the FDA Commissioner. The FDA then decides whether approval or approval will be granted. After that process, our advisory board, ACIP, reviews these recommendations for vaccine use in the US population-balance between benefits and risks, value of fairness, acceptability, and feasibility. , And the director of the CDC, reviewing information about resource usage. Basically, all these steps need to be done before the vaccine is available in the pediatrician’s office. And a really important part of the process is public deliberation. So that was the basis of ACIP’s work.

Shapiro: So, in summary, does the process usually take a week, a month, or several times? For example, what are you talking about?

LEE: The process usually takes several months. And obviously, the COVID-19 and public health emergencies accelerated the process. But I would like to emphasize that the process only considers all the data as carefully as possible and makes the best possible decision at the moment, even considering the uncertainty. I think it’s a very important process. It’s really fundamental to public confidence in vaccines and vaccination programs. So the process is very important to me and we want to accelerate it, but we don’t want to rush it.

Shapiro: Please tell me about the dosage. Is it different from older children?

LEE: We know that the dose will be lower than the currently approved Pfizer products. It makes sense and is fairly common with most vaccines and drugs in general. Again, it is very important to make sure that the low dose maintains the same level of immune response and the same safety profile.

Shapiro: How big a concern are the reports of myocarditis (heart inflammation) received after receiving the mRNA vaccine? I understand that it is more common in young men and teenage boys. I see?

LEE: Yes, several studies have been published that show high risk. I think it’s very important to put these data in context. It is also known that the COVID-19 infection itself causes serious inflammation of the heart and myocarditis. It also occurs like other types of severe systemic syndromes such as MIS-C. And those risks are actually higher after infection than after vaccination. Unless we maintain a complete bubble, I think it is inevitable that at some point we will all be exposed to COVID. Therefore, there is always a risk of infection. It is important to know that this can occur over time and accumulates over time. On the other hand, the risk after vaccination is low and is known at some point. And you achieve that protection from the serious consequences of COVID.

Shapiro: We’ve been talking about ages 5-11. Finally, I would like to ask about children under the age of 5, when can I get the vaccine?

LEE: So I’m looking forward to that data too. I haven’t seen it yet, so I couldn’t comment on it.

Shapiro: Dr. Grace Lee is a pediatrician at Stanford Children’s Health. Thank you very much.

LEE: Thank you.

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