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Northeast Ohio kids continue to play prominent role in COVID-19 vaccine trials

More trials underway, seeking participants 12-17 years old
Senders Pediatrics COVID Trial
Posted at 4:54 PM, May 10, 2021
and last updated 2021-05-10 18:42:45-04

SOUTH EUCLID, Ohio — Pfizer received clearance from the FDA to begin administering their vaccine to those ages 12-15 years old on Monday.

Back in February, News 5 highlighted how Senders Pediatrics in South Euclid was one of the only locations in Ohio to participate in that study.

“We’re very excited that about 8% of the people who participated in the adolescent trial for Pfizer came from this practice, really Northeast Ohio,” Dr. Shelly Senders said. “They’re not all from our practice. They’re from friends and relatives of people in our practice. We’re very excited we played that kind of pivotal role.”

That study involved 173 adolescents who either initially received the Pfizer vaccine or a placebo.

Novavax Adolescent Vaccine Trial Underway

While that trial concluded, this pediatric office is already underway on several new trials.

Ongoing right now is their vaccine trial with the Maryland-based biotechnical company, Novavax.

“Novavax is the COVID vaccine that no one has heard of,” Senders said. “It’s actually the fourth vaccine to go through Phase 3 trials in the United States. It’s a more traditional vaccine, similar to the vaccine we used for Hepatitis B or the vaccine we use in Africa for Ebola.”

Novavax is a two-dose vaccine with doses about a month apart.

If you’re looking for the super-scientific details behind the “more traditional” Novavax vaccine, here’s what Senders had to say:

“When we say a more traditional vaccine, it’s called a protein subunit vaccine. They take just the COVID spike protein and they take the gene for part of that spike protein and put it into a virus that affects moths. It’s not a human virus and it makes billions of particles and then they attach them together into what's called a nanoparticle and that’s what’s ingested into your body. Essentially it’s like every other vaccine we have where you’re not just telling the body to make antibodies, you’re actually injecting a small piece of foreign protein, in this case the spike protein, into the body.”

According to the U.S. National Library of Medicine clinical trials database, Senders Pediatrics is one of six locations in Ohio taking part in the Novavax trial. Other locations in Northeast Ohio include Synexus Clinical Research in Akron and Rapid Medical Research, Inc. in Cleveland.

“Nationwide there will be around 3,000 [participants,]” Senders said. “We hope to enroll about 100 in our study and we have a little over 50 that have agreed to participate.”

Gregan Burge, 12, was one of the first to enroll, receiving her first dose this past Friday.

“I want to go back into school and if this vaccine is going to let me go back into school and I’m going to go back and be a normal person, I’m going to do it,” she said.

The sixth-grader at Harding Middle School in Lakewood continues to do virtual learning as a precaution for her family. In fact, she’s never set foot in Harding Middle School since she began virtual learning in 2020.

“I was really proud of her to take the risk,” her father James Burge said. “We talked about it and read those pages of the study and we felt confident this was the right decision to make. It was a very strong thing for a little girl to decide to do.”

Gregan Burge
12-year-old Gregan Burge receives her first dose in the Novavax trial

Gregan Burge should learn after her second dose whether or not she received the vaccine or the placebo. After that, she hopes she’ll finally be able to see some of her friends outside in public.

“I’m waiting for the second one,” she said “I’m super anxious. It’s crazy to think about.”

“I know a lot of people are afraid of what can happen [with the vaccine], but I’m more afraid if you don’t, what’s going to happen [without it],” her father said.

According to the Ohio Department of Health COVID-19 vaccination dashboard, only 5.91% of those 0-19 years old have received at least one dose of the COVID-19 vaccine.

As of May 10, only those 16 and older are eligible for the Pfizer vaccines, with those 18 and older eligible for Moderna or Johnson & Johnson’s vaccines.

In Ohio, people under 18 make up more than 22% of the population based on the last census report, which makes it difficult to hit herd immunity because experts say the U.S. needs anywhere from 70-85% of the population to be vaccinated for it to occur.

If you’re interested in enrolling your child in the COVID-19 Novavax vaccine study, you’re asked to contact their office or email study@senderspediatrics.com.

New Pfizer Trials involving kids 6 months through 11-years-old getting underway

It’s not just the Novavax trial occupying experts' time inside Senders Pediatrics; another round of Pfizer trials is set to begin in just a couple of weeks.

These three trials will involve children ages 6 months to 2 years old, 2 years old to 5 years old, and 5 to 11 years old.

Enrollment for any of the age groups in the Pfizer vaccine trial is already closed.

“We will probably end up enrolling 25-40 [kids] in each one of those groups, as opposed to the 170 we enrolled in the last [trial,]” Dr. Senders said.

According to the U.S. National Library of Medicine clinical trials database, Senders Pediatrics is one of two locations in Ohio participating in the latest Pfizer trials involving children ages six months up through 11 years old.

What’s next for children and the vaccines?

“I think we can hope the youngest children can get vaccinated by the end of this year or early next year,” Senders said.

Moving forward, Dr. Senders explained how hopefully middle school students will be vaccinated before the upcoming school year.

“The next set of trials will be do we need boosters or do we not,” Senders said. “I don’t think anyone knows that information yet.”

While pointing to Novavax’s early results signaling 91% effectiveness against the South African variant, Dr. Senders explained how mixing vaccines and boosters will likely be the focus of research in the near future.

“The hope is with these newer vaccines, we will be able to capture the variants and we may get to the point where you get the Pfizer vaccine and a Novavax booster or a Johnson and Johnson vaccine and a Moderna booster,” Senders said. “Combinations of vaccines are going to be I think the next step of where this whole research process goes.”