CBS4 digs deeper into Pfizer’s clinical trial data among children

Coronavirus

INDIANAPOLIS – CBS4 Investigates is digging deeper into Pfizer’s clinical trial data among children 5-11 years old.

The pharmaceutical company is waiting to hear whether its pediatric doses will be granted emergency use authorization. The FDA unanimously recommended the drug for school-aged children and then authorized it October 29th.

“These are external advisors. These are not FDA employees. They are pediatricians, infectious disease experts and epidemiologists that were part of this 18-member panel. They voted 17 to zero to approve the vaccine. One member did abstain,” Dr. Veronica Vernon, an assistant professor of pharmacy at Butler University, explained.

On November 2nd and 3rd, the CDC advisory committee will meet to discuss who is eligible for the shots.

“Then, the CDC director will make a recommendation by November 3rd or 4th,” Dr. Vernon explained. “So, it could be Friday – Thursday or Friday – we get the vaccine out.”

Dr. Vernon advised parents to be patient if they are wanting to be first in line to get their children vaccinated. She said it could take some time to ship the vaccine, being that the doses are in smaller vials and require smaller needles.

Indiana is set to receive 200,000 doses in its initial shipment. It will receive more afterward. The Department of Health suggested parents keep an eye on its website. The department plans to update its list of locations where the shots are being administered. A spokesperson said families will be able to go to local pharmacies, clinics, pediatrician’s offices and in some rural areas, churches and schools.

CVS and Walgreens both told CBS4 they are prepared to start administering the pediatric shots as soon as they are given the go ahead.

“CVS Health has administered more than 34 million COVID-19 vaccines and 32 million COVID-19 tests across the country to date. The company has played a prominent role in administering third doses to the immunocompromised and previously authorized booster shots from other manufacturers and is prepared to expand vaccine eligibility to ages 5-11 as soon as authorized to do so by public health agencies,” a media spokesperson emailed.

We look forward to receiving additional information from the FDA, CDC and Advisory Committee on Immunization Practices’ (ACIP) regarding official guidance and timing for the potential approval of COVID-19 vaccinations for children aged 5-11 and will share more information once that is available. Until ACIP provides guidance, COVID-19 vaccinations are not available in our stores for children under the age of 12.

Following previous FDA Emergency Use Authorization and CDC guidance, we continue to provide Pfizer COVID-19 vaccines for children aged 12 and older. We encourage eligible patients to make an appointment through Walgreens.com/ScheduleVaccine or 1-800-WALGREENS to reduce wait times and assure the right dose is available for you at the time of your shot,” Walgreens wrote.

CBS4 reviewed some of the documents Pfizer submitted for emergency use authorization. In them, Pfizer claimed its vaccine was 91 percent effective in preventing symptomatic coronavirus in children. 

How many children participated in the trial?

The initial part of Pfizer’s trial in children 5-11 years old included more than 2,200 individuals. About 1,500 children received the vaccine. About 700 children received the placebo. This pediatric trial was a little different from the adult’s trial in that this was not a one-to-one ratio. More kids received the vaccine than the placebo because Pfizer needed to test dosage. According to the company, its 10-microgram dosage worked best compared to its 20 and 30-microgram amounts. For perspective, adults received 30 micrograms in each of their shots.

How did the trial work?

Each of the children received two shots about three weeks apart. Clinicians followed most of the participants for two months after they received their second dose; some were followed longer.

“We don’t follow children for years after, but this was a good amount of time because from what we know from adults and adolescents 12-17 receiving the Pfizer vaccine, most adverse events are going to happen – usually – within the first week or within the first couple of months,” Dr. Vernon explained.

According to her, the FDA requested additional data from Pfizer. The company tested its vaccine on another 2,200 patients. Of that, about 1,600 children received the vaccine. They were followed for two weeks after their second dose.

Did anyone experience adverse side effects after receiving the vaccine?

CBS4 spoke with a Pfizer representative and confirmed there were few instances of side effects after children received the vaccine. The most common adverse reactions included fatigue, injection site reactions (swelling), and pain at the injection site. Another common side effect included headache.

“These resolved within a couple of days. Interestingly, fever was actually less in the adolescent group than what we see among adolescents and adults that received the Pfizer vaccine,” Dr. Vernon pointed out. “I always say, fever is not a bad thing. It means your immune system is working.”

According to the paperwork, there were 13 instances where children reported lymph node swelling. Each of the cases lasted less than two weeks. There was one case of elbow pain that resolved the next day. There was one case of tingling that lasted three days.

“Adverse events were very minimal,” Dr. Vernon explained. “That’s likely because we’re using a much smaller dose, which is pretty standard for pediatric populations. We use smaller doses than what we would give to our adults in our adolescents.”

Pfizer said there were no cases of anaphylaxis, severe allergic reaction, myocarditis or blood clots.

“When you open this up to everyone, we could start to see that, but I am very optimistic after reviewing the data and listening to the discussion,” Dr. Vernon said.

Why do doctors believe children get the vaccine?

In the beginning of the pandemic, doctors had pointed out that the coronavirus was not impacting children as much as it was affecting adults.

“The delta variant really changed the game for children. Prior to the delta variant, children were not having as many hospitalizations in ICU admissions. Unfortunately, this summer, we saw a very steep increase. It was the first time that we’ve seen pediatric ICU’s filled to the brink and really stressed for resources all due to COVID admissions,” Dr. Vernon said.

CBS4 has reported that the “benefits outweigh the risks.” According to Dr. Vernon, experts are using that line because COVID has had a long-lasting impact on some children.

“As many as seven to 15 percent of children who contract COVID-19 will have what we call long-haul symptoms. They will have these symptoms that lasts for months and potentially years. We have some children that had COVID at the beginning of the pandemic back in March of 2020 that are still having symptoms today,” she said. “So, 18, 19 months later!”

Records show about 30 percent of COVID hospital admissions nationwide, of those who were 5-11 years old, were children that did not have preexisting conditions.

“So, they didn’t have asthma. They didn’t have obesity. they didn’t have diabetes. That’s concerning,” Dr. Vernon told CBS4.

Are there fertility concerns?

Those that have researched the vaccine during its trials and after it rolled out to the public have noted the vaccine has not had any effect on people’s fertility.

“There is no evidence,” Dr. Vernon said. “There is no evidence to show there are any fertility concerns. And what we’ve seen from adults getting vaccinated is that many of those adults who were vaccinated did get pregnant, who were trying to conceive, did so very easily.

What is a mRNA vaccine?

Records indicate doctors have been studying the mRNA technology since the 1960s.

Some vaccines will inject a weak or inactivated germ into the recipient’s body. That is not the case with a mRNA vaccine. Instead, they are created in a laboratory. Once injected, the drug teaches a person’s cells how to make a protein that will trigger the immune response inside their body. All mRNA vaccines are administered in the upper arm.

This is what the CDC website says:

“The mRNA will enter the muscle cells and instruct the cells’ machinery to produce a harmless piece of what is called the spike protein. The spike protein is found on the surface of the virus that causes COVID-19. After the protein piece is made, our cells break down the mRNA and remove it.

Next, our cells display the spike protein piece on their surface. Our immune system recognizes that the protein doesn’t belong there. This triggers our immune system to produce antibodies and activate other immune cells to fight off what it thinks is an infection. This is what your body might do to fight off the infection if you got sick with COVID-19.

At the end of the process, our bodies have learned how to protect against future infection from the virus that causes COVID-19.”

“A lot of parents think, well, this was very rushed,” Dr. Vernon said. “There’s a difference between rushed and speed. We have seen great speed because of the resources that we’ve pulled together from across the globe. So, this isn’t just scientists in the US creating this. It’s scientists across the world. And we have seen resources in the form of money. You need money to get things approved and get drug trials off the ground and vaccine trials off the ground. We have also had a huge surge of people wanting to participate in clinical trials. Often, that can be your rate limiting step, or the step that can take the longest amount of time.”

Is it possible Indiana’s public schools will require the COVID vaccine for students in the future?

An individual who participated in the FDA discussion in October shared concern about this topic. Dr. Vernon said it’s too early to discuss any COVID mandates among children.

CBS4 reached out to the Department of Education and Governor Eric Holcomb’s office. Both of their agencies referred us to the Department of Health, which said:

“The COVID-19 vaccines are not mandated by the state. Decisions about school protocols rest with school boards and local leaders, including local health departments and elected officials. Things not required by the state are handled locally.”

A spokesperson did not respond when we asked whether there had been any unofficial discussion about school-related mandates.

When will the vaccine be available for babies and toddlers?

Pfizer’s most recent clinical trial included patients six months and up. Experts believe the company is reviewing and finalizing its data, preparing to submit that to the FDA for emergency use authorization.

“My guess will probably be, maybe, by the end of this year or maybe beginning of 2022,” Dr. Vernon suggested. “I think it’s coming very soon.”

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