We have begun age de-escalation trials. Age de-escalation means that phase I and II trials are conducted first in adults, then in older children, and finally, if relevant, in small children. Vaccines need to show safety in each stage in order to move down in age.
Vaccine sponsors have already started trials for 12+ and are drafting trial plans for younger kids. Given that kids are usually asymptomatic, the trials will probably involve regular, frequent testing. First and foremost, scientists will be looking at safety. And, unlike adult studies, the plan is for the trial endpoint to be immunity (instead of disease).
Here is the status for the age groups:
12+ years: Pfizer started in October and has now finished enrollment. 2000 kids (aged 12-15) are enrolled. Moderna started in December and are still enrolling. They are aiming for 3000 kids (aged 12-17) to enroll. Moderna is starting to open more sites (see link below to find the cities). AstraZeneca is starting next month (but not in the US). Kids in all three of these trials will receive the same dose as adults. Many are hopeful that, with a bit of luck, we can have vaccines for this group by Fall 2021.
5/6-11 years: Starting late Spring. Pfizer starting Phase I in April.
<5 years: Don’t expect data until 2022
Kids have fared much better than adults during this pandemic, mostly comprising of asymptomatic infection. So, why do kids need vaccines?
1. Herd immunity. Children are part of the transmission chain, so eventually, if we want to get to the stage of herd immunity, they have to be included. Especially, if this virus is mutating to be more transmissible. The more transmissible, the higher herd immunity we need. We are hopeful that the vaccines reduces asymptomatic spread, we just don’t know by how much. We are still waiting on studies.
2. Disease. There are kids that get very serious disease, like MIS-C, from this virus. The vaccine will provide protection among the few that will get the disease.
3. Morbidity. Long term morbidity is something we still know very little about. Especially among kids.
CDC’s Advisory Committee on Immunization Practices (ACIP) is meeting on January 27 (10a-5p EST) to discuss this very topic.
Here is the meeting agenda: https://www.cdc.gov/…/agen…/Agenda-2021-01-27-508.pdf…
Here is the webcast link: https://www.ustream.tv/channel/VWBXKBR8af4
It is open to the public. Should be a very interesting discussion. Like always, I’ll be happy to provide you with cliff notes. Stay tuned.
Ethics on child vaccine trials: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3601712/
Moderna Trial Info: https://clinicaltrials.gov/ct2/show/NCT04649151
Pfizer Trial Info: https://clinicaltrials.gov/ct2/show/NCT04368728
Kids and Herd Immunity: https://www.theatlantic.com/…/should-kids-get…/617762/
TeenCove study (if you want to enroll): https://connect.trialscope.com/…/a6dd51e8-c0a0-4ad5…/