Although three COVID vaccines now have EUA in the United States, we do not yet have a vaccine for younger kids. The Pfizer COVID vaccine did receive emergency use authorization for children who are at least 12 years old in May.
And soon, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will discuss whether COVID vaccines will require authorization and/or licensure in younger age groups.
EUA vs Licensure of COVID Vaccines
To begin with, what’s the difference between EUA and full licensure by the FDA?
“From a safety perspective, FDA expects an EUA submission will include all safety data accumulated from phase 1 and 2 studies conducted with the vaccine, with an expectation that phase 3 data will include a median follow-up of at least 2-months (meaning that at least half of vaccine recipients in phase 3 clinical trials have at least 2 months of follow-up) after completion of the full vaccination regimen.”
Emergency Use Authorization for Vaccines Explained
It’s that folks in the clinical trials are observed for a longer period of time – 6 months for full licensure vs 2 months for EUA.
So we would have to wait at least an additional 4 months if the FDA were to require COVID vaccines for younger kids to get full licensure instead of an EUA.
And that means it would be unlikely that those COVID vaccines would be approved by the back to school season this fall…
EUA vs Licensure of COVID Vaccines for Younger Kids
Now, if EUA was good enough for everyone else, why isn’t it good enough for these younger kids?
“Furthermore, in considering the balance of benefits and risks to support licensure or emergency use authorization of COVID-19 vaccines for use in pediatric populations, it could be argued that the lower burden of disease in pediatric populations might warrant more stringent success criteria than for adults, at least for placebo-controlled trials.”
Licensure and Emergency Use Authorization of Vaccines to Prevent COVID-19 for Use in Pediatric Populations
Many people would simply say that it is because they are younger kids!
“In considering the prospect of emergency use authorization of a COVID-19 vaccine for use in younger pediatric age groups, a central question is the circumstances under which the known and potential benefits of making an effective COVID-19 vaccine available to these age groups would outweigh the known and potential risks.”
Licensure and Emergency Use Authorization of Vaccines to Prevent COVID-19 for Use in Pediatric Populations
There is also the fact that younger kids aren’t getting sick with COVID as often as everyone else, although many kids have been hospitalized and many have died.
“FDA acknowledges that direct demonstration of effectiveness in field efficacy trials may not be feasible in pediatric populations and thus, following direct demonstration of protection in adults, effectiveness of the same vaccine could be inferred in pediatric populations by immunobridging.”
Licensure and Emergency Use Authorization of Vaccines to Prevent COVID-19 for Use in Pediatric Populations
The Vaccines and Related Biological Products Advisory Committee is having a meeting to discuss all of these issues on June 10.
“While COVID-19 may affect all pediatric age groups, several complexities impact vaccine development specifically for use in younger infants <6 months of age, including the potential for maternally transferred antibodies to confer protection, increased potential for severe reactogenicity with decreasing age, and the need to account for concomitant use of a COVID-19 vaccine with multiple, closely-spaced routine immunizations. Younger infants would likely be the last age group enrolled in pediatric trials of COVID-19 vaccines, dependent on prior rigorous evaluation of safety and effectiveness (and dose ranging) in older pediatric age groups, and emerging data may provide a basis to justify a waiver from PREA requirements for assessment of COVID-19 vaccines in younger infants.”
Licensure and Emergency Use Authorization of Vaccines to Prevent COVID-19 for Use in Pediatric Populations
They will decide how best to get younger children vaccinated and protected against COVID.
Understand that the committee isn’t actually voting on anything though.
Again, they are just going to discuss what data will be needed to support authorization and/or licensure of COVID-19 vaccines in younger kids.
And we will have to see if this changes Pfizer’s plans to seek EUA for its COVID vaccine for children between the ages of two and eleven years in September…
More on COVID Vaccines for Kids
- When Will New COVID-19 Vaccines Be Approved for Kids?
- Where Are the Pediatric COVID-19 Vaccine Trials?
- COVID Vaccines for Children Should Get Emergency Use Authorization
- Are You Getting an Experimental COVID-19 Vaccine?
- FDA – Vaccines and Related Biological Products Advisory Committee June 10, 2021 Meeting Announcement
- FDA Briefing Document Licensure and Emergency Use Authorization of Vaccines to Prevent COVID-19 for Use in Pediatric Populations
- FDA – Emergency Use Authorization for Vaccines Explained
- WHO – Guidelines on Clinical Evaluation of Vaccines: Regulatory Expectations
- Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Transcript
- Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Transcript
- Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Transcript
- Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Transcript
- Pfizer says it will seek clearance in September for its vaccine to be used in children aged 2 to 11
- IAC – Ask the Experts about COVID-19 Vaccines