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FDA Meeting Highlights: Pfizer vaccine authorized for children 5 - 11

Sources are cited at the bottom of the page!

The FDA had a meeting (on YouTube, see SOURCE 1 ) to vote on allowing children over 5 to get vaccinated.

On October 26th, 2021, VRBPAC [ Vaccines and Related Biological Products Advisory Committee ] met to vote on authorizing Pfizer-BioNTech's COVID-19 Vaccine [ BNT162b2* ] for children 5 – 11 years old.

*BNT162b2 is the official name of the Pfizer Vaccine

The committee voted on the following question:

"Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine when administered as a 2-dose series (10 µg each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age?"

The question more or less asks:

“Do the benefits of vaccinating children 5 – 11 outweigh the risks?”

They had to vote yes or no.

To answer this question, it must first be known, what are the benefits?

What are the risks?

The main benefit of vaccinating children in this age group is to prevent serious COVID-19 illness. Other benefits include reducing COVID-19 hospitalizations, reducing COVID-19 deaths, and opening schools to in person learning again!

Notice I did not say reduce transmission of COVID-19, because there is no data to support that at this time.

( SOURCE 1; 2:58:52 )

Pfizer representative William Gruber said:

“We did not specifically look at the potential for asymptomatic disease, and therefore the potential for transmission.”

He adds:

“It’s worth remembering that prevention of symptomatic disease in its own right *might* reduce transmission.”

( SOURCE 1; 7:03:25 )

One of the voters, Dr. Michael Kurilla, said:

“The argument that this will lead to herd immunity and reduce transmission, that’s a theoretical possibility. I’ve seen very little data… If all we’re focused on is reducing cases in terms of a benefit, I don’t think that’s likely to be realized.”

( SOURCE 1; 7:11:39 )

Dr. Meisner adds:

“This vaccine is probably not going to prevent infection; it’s going to prevent severe disease.”

Seems one of the panelists gave up on reducing transmission entirely! Saying this:

( SOURCE 1; 7:00:00 )

Dr. Lee says:

“The reality is, at one point we thought if we vaccinate enough people the virus would go away; it’s not going away, and I think we’re going to have to find a way to live with it, and I think the vaccines give us a way to do that.”

Now that we know the benefits, what are the risks?

The risks are adverse reactions (or dangerous side effects) to the vaccine. The primary concern is myocarditis. However, myocarditis is not the only adverse event (AE) possible.

The following are adverse events currently being investigated:

( SOURCE 1; 3:40:13 )

Acute Myocardial Infarction

Anaphylaxis

Appendicitis

Disseminated Intravascular Coagulation

Deep Vein Thrombosis

Bell’s Palsy

Encephalomyelitis

Guillain – Barre Syndrome

Hemorrhagic Stroke

Non-Hemorrhagic Stroke

Pericarditis

Narcolepsy

Pulmonary Embolism

Transverse Myelitis

Immune Thrombocytopenia

Here is a slide from Pfizer's presentation ( see SOURCE 1 ) that shows the adverse events being investigated:

The voters focused on myocarditis because it’s the most prevalent reaction in adolescent groups.

I’ll note that there is NO data on myocarditis for children 5 – 11 years old at this time.

( SOURCE 2; page 11; paragraph 3 )

Pfizer's document states:

“The number of participants in the current … program is too small to detect … risks of myocarditis associated with vaccination.”

( SOURCE 3; page 33; paragraph 1; see image below )

The FDA's document states:

“For this analysis the estimate for ages 12-15 years is applied to ages 5-11 years because vaccine associated myocarditis/pericarditis data is NOT available for this age group.”

In other words, since 12 – 15 is the closest age group to 5 – 11 , it is assumed that the myocarditis rates for these two age groups are similar.*

*Note: this is strictly an assumption that’s not based off of any clinical data, as there is no data available at this time.

Pfizer, the sponsor of the meeting, adds that the assumption is likely an overestimate.

( SOURCE 1; 6:06:59 )

FDA representative Forshee says:

“The estimates that we’re using are likely to be significant overestimates … There were very limited options for what we were going to use to ground our analysis … We can revisit this as more data are accumulated.”

So the benefits are about preventing serious COVID-19 illness.

The risks are about dangerous side effects, mainly myocarditis.

How did the vote go? Do the benefits outweigh the risks?

17 members voted yes, no one voted no, and one person chose not to vote (abstained).

Here are some reasons the overwhelming majority vote was YES:

( SOURCE 1; 8:01:53 )

Dr. Hildreth:

“I voted yes primarily because I want to make sure that the children who really need this vaccine, primarily the black and brown children in our country get the vaccine.”

( SOURCE 1; 7:01:56 )

Dr. Pergam:

“I’m trying to put myself in the position of a parent who has a child at particular risk that currently does not have the option to give their children this vaccine.”

( SOURCE 1; 6:52:31 )

Dr. Rubin:

“We’re never going to learn about how safe this vaccine is unless we start giving it.”

( SOURCE 1; 6:55:03 )

Dr. Sawyer:

“I’ll paraphrase Dr. Fauci, who said “models are what you rely on until you get the data, and then you throw out the model. The models are the best we have at the moment; as was just mentioned, we’re not going to get the data unless we start to use this vaccine. Remember, EUA is not permanent, can change as we get more data.”

The decision, however, wasn’t easy.

( SOURCE 1; 6:56:09 )

Dr. Offit:

“It’s nerve-racking when you’re asked to make a decision for millions of children based on studies of only a few thousand children.”

Specifically, less than 5k children were in Pfizer's study.

( SOURCE 1; 7:10:03 )

Dr. Meisner said:

“I’m torn.”

The biggest concern across the board was adverse reactions [meaning: undesired harmful side effects] to the vaccine.

( SOURCE 1; 6:51:01 )

Panelist Rubin said:

“This is a much tougher (question) than we expected. data shows that the vaccine works and is safe. Yet we’re worried about an adverse event that can’t (be) measured yet and/but is probably real.”

( SOURCE 1; 6:54:00)

Dr. Hildreth had this to say:

“This is a really tough one for me. I do believe that children at high risk need to be vaccinated, but vaccinating all of the children to achieve that just seems a bit much for me so I’m having some challenges with this one.”

( SOURCE 1; 7:43:35 )

Dr. Michael Nelson said:

"I understand why the question was asked the way it was, but I certainly don’t like it."

Panelist Levy, who voted yes, asked to rephrase the voting question because many members were uncomfortable with authorizing the vaccine to ALL children. Some members thought the vaccine should only be accessible to children that REALLY need it. These are children with underlying health issues that may make them more susceptible to severe COVID-19 disease.

( SOURCE 1; 7:07:27 )

Dr. Levy said:

“maybe it’s good to make this available to certain children at higher risk, comorbidities … Is that an option? Is there the possibility also of considering rephrasing? We’ve certainly done that as a committee recently.”

His request was denied.

Here are some other concerns that were brought up:

( SOURCE 1; 7:42:03 )

Dr. Michael Kurilla said:

“for children who have undergone a delta infection, does now vaccinating them with a strain that goes back almost two years from the time they’re getting the vaccine, does that actually help or hurt their current immune system with regard to ongoing variants? I don’t think we know that, we have no idea.”

( SOURCE 1; 6:53:38 )

Dr. James Hildreth:

“it seems to me we’re vaccinating children to protect the adults, and it should be the other way around. If 30 million children already have some form of immunity, they’ve made their contribution to herd immunity already.”

( SOURCE 1; 7:04:01)

Dr. Michael Kurilla:

“I have a lot of issues with the immuno-bridging”.

Note: Immuno-bridging is the method Pfizer used to test vaccine efficacy by comparing antibody levels to different age groups. Dr. Kurilla doesn’t think it’s reliable.

Voting members had many questions for Pfizer regarding safety and efficacy that were left unanswered.

The following is a list of these questions and responses from Pfizer’s representatives.

(see SOURCE 1; Questions are BLUE; Responses are RED):

( 3 : 06 : 36 ) Kurilla: “Do you have any idea if the lower dose you’re giving to children provides an equivalent stimulation to the memory as opposed to just antibody levels?”

( 3 : 06 : 45 ) Gruber: “We don’t have that specific data.”

( 6 : 34 : 11 ) Meisner: “As a fellow pediatrician, you understand the concern that people have about the issue of myocarditis… did you or is it possible to look for troponin levels in those samples that you got from participants after the vaccine, thinking about the possibility of subclinical myocarditis?”

( 6 : 35 : 47 ) Gruber: “as of today we don’t have that data.”

( 6 : 37 : 06 ) Hans: “Were any of the new variants of concern tested?”

( 6 : 37 : 25 ) Gruber: : “We’ve not tested in the pediatric population the responses to new variants… ”

( 2 : 53 : 24 ) Monto: “What would happen if you gave a lower dose to a 12 year old? In terms of antibodies and in terms of side effects?”

( 2 : 54: 24 ) Gruber: “There is the potential, although we don’t have the data to show it, for a 10 mg dose ( for 12 – 15 age group ) … we have some possibility of looking at that in the future, but we don’t have that data today.”

( 6 : 42 : 20 ) Kurilla: Are you looking at different dosing intervals, because the 3 week dosing interval, quite frankly, seems to be suboptimal, at least in terms of durability of the antibody response.

( 6 : 43 : 03 ) Gruber: Obviously, as we think farther ahead to a post-pandemic period and particularly as we get into very younger populations it may be advisable, and probably will as we get particularly in that first year of life to look at longer intervals as part of a routine immunization series, but we don’t have that data now.

One last thing,

( SOURCE 1; 2:32:16 )

Pfizer representative William Gruber said:

“You can see there was good representation in terms of gender, race, and ethnicity (in the study)”

But Hildreth does not feel this way.

( SOURCE 1; 6:53:24 )

Dr. Hildreth said:

“I was disappointed that the number of minorities in the Pfizer study is such a small percent of the total because they bear the brunt of disease and hospitalizations…”

The following is a slide from Pfizer's presentation ( see SOURCE 1 ) that breaks down the demographics of Pfizer's pediatric study:

What are your thoughts? Do you think this is good representation of race and ethnicity?

As difficult as it was for the members to vote on this question, a decision had to be made, because any request to change the question was denied.

To understand the context of the decision-making process, I will explain the scientific evidence from Pfizer's pediatric study in favor of vaccinating children age 5 – 11.

Pfizer's pediatric study is a clinical trial labeled “C4591007”. From here on out I will refer to this trial as “1007”, and that’s because this is how it’s referenced in the FDA meeting video ( SOURCE 1 );

“1007” is an ongoing study with 3 phases. The study is randomized, observer-blinded, and placebo-controlled. As the study is ongoing, it isn’t over yet and we’ll get to that in a moment.

Phase 1 of the study is complete, and 48 children 5-11 years old participated. The goal was to see which dosage of the mRNA vaccine would achieve the best balance between vaccine efficacy and safety.

As shown in the appendix of the FDA briefing document ( see SOURCE 3 ), vaccine

[ BNT162b2 ] dosages of 10 µg, 20 µg, then 30 µg were evaluated. 16 children participated in each of the 3 dosing studies (10 µg, 20 µg, 30 µg).

Critical Findings from Phase 1:

( SOURCE 2; page 21 )

In Section 3.4.1, Local Reactions:

“Local reactions at the 30-µg dose level were deemed unacceptable, leading to the discontinuation of this dose level.”

( SOURCE 2; page 21; see image below )

In Section 3.4.1, Systemic Reactions:

“Systemic events at the 30-µg dose level were deemed unacceptable, leading to the discontinuation of this dose level”

It is important to know that a 30-µg dose is unacceptable for children 5 – 11.

Parents and healthcare providers MUST be diligent in making sure a vaccinated child gets the correct dose ( 10-µg ). To be clear, a 30-µg (adult) dose has a very high likelihood of causing serious harm or injury to a child.

To spare confusion:

Adult vials of the vaccine have purple caps.

Vials for children have orange caps.

Please bare this in mind.

Phase 1 concluded that 10-µg is the appropriate dosage for children 5-11; this dosage advanced to Phase2/3 of the clinical trial.

Phase 2/3, which is NOT complete, tests for vaccine efficacy and safety with 2 cohorts (or groups of participants).

The first group, Cohort 1, tested the vaccine in about 1500 children in the experimental group, while about 750 children were given a placebo in the control group.

There was a safety follow up of at least 2 months for 95% of the participants.

Conclusions from the current data have not been verified.

( SOURCE 3; page 17; paragraph 1 )

“FDA has not fully verified the underlying data or Pfizer-BioNTech’s conclusions from this analysis.”

The second group, Cohort 2, also tested the vaccine in about 1500 children in the experimental group, while 750 were given a placebo in the control group. So this cohort has about the same number of children in the study as the first cohort.

The follow up for this study, instead of 2 months, is 2.4 weeks on average (less than 20 days).

The data from this study hasn't been verified yet either.

( SOURCE 3; page 17; paragraph 2 )

"Data verification is in process, but not yet finished at the time this briefing book was completed."

Thus, none of the data or conclusions from phase 2/3 has been verified.

Pfizer stated that Phase 2/3 concludes that the vaccine is safe and effective for this age group by using immunobridging, and because 16 unvaccinated children contracted COVID-19 while 3 vaccinated children got infected.

Phase 2/3 is not yet complete, and conclusions drawn from the current data have not been verified. The underlying data hasn't been verified yet either.

Some FDA members are eager to vaccinate children that have comorbidities [ meaning: underlying conditions ] that increase their risk of severe COVID-19 illness.

( SOURCE 1; 6:54:03 )

Dr. Hildreth:

“I do believe children at high risk need to be vaccinated.”

( SOURCE 1; 7:05:29 )

Dr. Kurilla:

“There are high risk individuals, and I think they do need to be attended to, we do need to provide a vaccine for them…”

Children at high – risk of severe COVID-19 have underlying health conditions, also called comorbidities, such as obesity, diabetes, lung cancer, etc.

562 children have been hospitalized with COVID-19 (from March 2020 - August 2021), and nearly 70% of them had underlying conditions.

Note: About 20% of children hospitalized were not hospitalized due to COVID-19, and just happened to be COVID positive. Thus, saying "562 children have been hospitalized due to COVID-19" is not accurate. It is likely less than that, closer to 450.

Here’s a breakdown of the hospitalized COVID-19 cases for children with comorbidities in this age group: ( Refer to image below; SOURCE 1 )

29% | Chronic Lung Disease

25% | Obesity

23% | Neurologic Disorders

11% | Cardiovascular Disorders

9 % | Blood Disorders

9 % | Immunosuppressed conditions

6 % | Chronic Metabolic Disorder

6 % | Feeding Tube Dependence

9 % | other

While vaccinating children that are high – risk for COVID-19 is encouraged, it’s also recommended to not vaccinate healthy children because there is no emergency for them and the safety data is lacking.

( SOURCE 1; 8:02:03 )

Dr. Hildreth:

“To be honest, the best way to protect the health of some kids would be to do nothing at all because they’re going to be just fine.”

( SOURCE 1; 7:52: 13 )

Dr. Meisner:

“the rate of ( COVID-19 ) hospitalizations in this age group of 5-11 is … less than 10 per million, and the rates for myocarditis … were as high as 100 to 150 cases per million…”

Note, if these rates are consistent, it implies that vaccine related myocarditis occurs 10 to 15 times more than COVID hospitalizations for this age group. More data is needed to confirm.

( SOURCE 1; 6:14:44 )

Dr. Hildreth:

“The emergency for children is not what we might think it would be, and that’s just my main concern.”

Dr. Kurilla, the one that chose not to vote, had this to say.

( SOURCE 1; 7:03:01)

Dr. Kurilla:

“I resented the binary presentation that’s sort of like “take it or leave it”, everything the way the sponsor presented it and nothing else can be considered.”

( SOURCE 1; 7:04:56)

Dr. Kurilla:

“I think the possibility that they [ the children] likely need only one dose at best is going to be very optimal … So, I think the idea of doing it under an emergency use authorization, 2 doses for everybody, without any flexibility around this, … (will) not go over very well and I don’t think it’s going to give the healthcare community the options and parents the option to choose what’s best for their children.”

( SOURCE 1; 7:11:07 )

Dr. Meisner:

“we’re getting down to a very small percent of otherwise healthy 5-11 year old children who might derive some benefits. And we simply don’t know what the side effects are going to be.”

Phase 2/3 data presented by Pfizer is not verified at this time, which adds to the doubts some voting members had about safety.

Refer to image below ( SOURCE 3; page 17 ):

There is data in Pfizer’s study that suggest natural immunity may be as good as vaccine immunity for this age group.

( SOURCE 1; 6:10:56 )

Dr. Kurilla:

“They [ Pfizer ] saw no cases of infection in any of that subset that had demonstrated prior infection. One could say that prior infection was 100% efficacious, at the very least it’s probably as good as vaccination.”

To clarify, Kurilla is saying that in Pfizer's pediatric study, none of the children with natural immunity got re-infected with COVID-19, regardless of vaccine status. So the data shows that natural immunity is either 100% effective, or it’s at least as good as immunity from the vaccine.

( SOURCE 2; page 60; see image below )

From Pfizer’s Results:

“No cases of COVID-19 were observed in either the vaccine group or the placebo group in participants with evidence of prior SARS-CoV-2 infection.”

Perhaps the 2nd biggest concern was vaccine mandates for children:

( SOURCE 1; 7:12:12 )

Dr. Meissner:

“I’m just worried that if we say yes, that the states are going to mandate administration of this vaccine to children in order to go to school, and I do not agree with that; I think that would be an error at this time until we get more information about the safety.”

( SOURCE 1; 7:43:48)

Dr. Nelson:

“I see this as a personal choice and equity question and not a mandate for all in this age group…”

( SOURCE 1; 7:06:55 )

Dr. Levy:

“our purpose today … is not to discuss or consider mandates. … Technically that’s not our job right now, but nevertheless, … we have in the back of our minds that after our vote, how this is used … and how its implemented across states and counties can vary…"

Voters expressed so much concern about mandates that FDA representative Marks said this to put them at ease:

( SOURCE 1; 8:06:32 )

Peter Marks, FDA representative:

“Just to reassure the committee, because we are taking an emergency use authorization (EUA) rather than an approval, in general, people have not done mandates with emergency use authorization, and there are certain governors who have already announced that they would not do a mandate until there was an approval.”

The FDA says this, yet NBC news just announced that San Francisco is already planning on enforcing mandates for this age group. ( SOURCE 4 )

Why is this decision leading to mandates when it was clearly stated by multiple voting members that was NOT their intention from this decision, and an FDA representative said it wouldn’t be likely?

Which parts of the FDA meeting do you consider the most interesting?

Is Pfizer's pediatric study reliable?

What would you have voted?

Share your thoughts in the comment section below!

I encourage you all to discuss and debate, respectfully.

SOURCES:

SOURCE 1:

FDA meeting on YouTube about authorizing vaccine for kids.

https://www.youtube.com/watch?v=laaL0_xKmmA&t=25647s

SOURCE 2:

Pfizer briefing document for this meeting.

https://www.fda.gov/media/153409/download

SOURCE 3:

FDA briefing document for this meeting.

https://www.fda.gov/media/153447/download

SOURCE 4:

San Francisco announces mandate for children coming soon.

https://www.nbcnews.com/news/us-news/san-francisco-will-require-children-5-11-show-proof-covid-n1283212

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