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Where Are the Pediatric COVID-19 Vaccine Trials?

By / / Anthony Fauci, clinical trials, COVID-19 vaccine, KidCOVE, Operation Warp Speed, phase III trials, SARS-CoV-2, TeenCOVE, vaccine development, vaccine manufacturers

Breaking News – the FDA is expected to authorize the Pfizer COVID-19 vaccine for 12-15 year olds by next week. (see below)

Most people understand that we are well on our way to getting a COVID-19 vaccine, as several vaccines have completed stage III clinical trials and are up for approval.

"You have to strike a balance of making sure you get a vaccine — if it’s safe and effective — to children in a timely manner while you’re also very attentive to the extra potential risk you’d see in a child given the vulnerability of children." - Anthony Fauci
“You have to strike a balance of making sure you get a vaccine — if it’s safe and effective — to children in a timely manner while you’re also very attentive to the extra potential risk you’d see in a child given the vulnerability of children.” – Anthony Fauci

Unfortunately, so far, none of those trials have included younger children.

Where Are the Pediatric COVID-19 Vaccine Trials?

Why is that a problem?

It means that it is going to take all that much longer for us to get a COVID-19 vaccine for younger kids.

“…it is counter to the ethical principle of distributive justice to allow children to take on great burdens during this pandemic but not have the opportunity to benefit from a vaccine, or to delay that benefit for an extended period of time, because they have not been included in vaccine trials. Children must be included in vaccine trials to best understand any potential unique immune responses and/or unique safety concerns.”

AAP President Sara “Sally” H. Goza, M.D., FAAP

Still, doesn’t it make sense to make sure that the COVID-19 vaccines being developed are safe and effective in those who are most at risk for severe disease, and then begin to test those approved vaccines in the pediatric population?

After all, there are over 100 vaccine candidates being developed for COVID-19.

Does anyone think it would be a good idea to test all of them in kids?

Or do we only start the pediatric trials once some of these vaccine candidates finish their phase III trials and gain approval because they are found to be safe and effective?

Of course, there is a middle road.

Which Covid-19 Vaccines Should Enter Pediatric Trials?

Start testing COVID-19 vaccine candidates that have entered phase III clinical trials.

“At the time that Phase III adult clinical trials are initiated, data support the initiation of careful pediatric Phase II clinical trials to evaluate safety and immunogenicity of advanced COVID-19 vaccine candidates. These initial pediatric studies should be conducted in parallel with adult efficacy trials, rather than delaying until adult efficacy is established. Additionally, it is incumbent upon us to begin these studies to address the economic, educational, and equity impact of COVID-19.”

Warp Speed for COVID-19 Vaccines: Why are Children Stuck in Neutral?

And actually, that’s what’s being done now!

Oxford's ChAdOx1 COVID-19 vaccine clinical trial now includes children in at least one group.
Oxford’s ChAdOx1 COVID-19 vaccine clinical trial now includes children in at least one group.

Well, kind of.

The COVID-19 vaccine from the Oxford Vaccine Group in the UK will be studied in kids who are at least 5 years old. New vaccinations are on pause though as they await “the outcome of a review by the Medicines and Healthcare products Regulatory Agency (MHRA) of very rare and unusual blood clots in adults.”

And although other vaccine manufacturers have announced plans to start pediatric trials soon, no new pediatric trials have been announced from Johnson & Johnson, Moderna or Pfizer.

Until now, as Pfizer and Moderna have already started enrolling younger children.

In fact, both the Pfizer teen trial and Moderna TeenCOVE tials are fully enrolled and should be done by the end of the summer.

When Will Pediatric COVID-19 Vaccines Be Available?

What’s next?

With reports that the Pfizer and Moderna vaccines have an efficacy rate of about 95%, over 20 million people have already been vaccinated in the United States, and that now includes some high risk teens who are at least 16 years old.

Anthony Fauci says that “Within a period of a few months we will be doing a number of studies, including what we call bridging studies, showing that you can induce the same kind of response in kids. And it’s safe in kids. And then you can wind up giving it to them within a few months thereafter.”

We are getting closer and closer to having COVID-19 vaccines for younger kids!

Johnson and Johnson trials in teens haven't started yet.
Johnson and Johnson COV2001 trials in teens have started already. The COV2004 will follow infants whose pregnant mother received a COVID-19 vaccine.

In addition to waiting for the teen trials to finish, we still need trials to start for younger children and infants.

The Moderna KidCOVE trial began enrolling kids between the ages of 6 months and 12 years in mid-March, with study sites in Arizona, California, Kentucky, Louisiana, New York, South Carolina, Texas, and Utah.

As has the Pfizer pediatric study, enrolling children who are 6 months to 11 years old.

“Pfizer expects to file for full US Food and Drug Administration approval for its Covid-19 vaccine for people ages 16 to 85 this month, and will seek emergency use authorization for its vaccine for children ages 2 to 11 in September, the company said during an earnings call on Tuesday.”

Pfizer to seek authorization for Covid-19 vaccine for children ages 2 to 11 in September

So, while COVID-19 vaccines for young children this spring/summer is not looking very realistic, it looks like we might have them by fall.

More on COVID-19 Vaccines for Kids

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