Tuesday Pfizer announced it's expanding its clinical trials for younger children ages 5 to 11-years-old. Medical doctors are calling this the final frontier.
This is a 2-year study, where a subset of the children enrolled in the trial will receive the COVID-19 vaccine, and a second group will receive a placebo or salt water as part of the Phase 2/3 trials. The Pfizer vaccine injected in children is the same as the one injected in adults, but the dosage will be less.
Eight-year-old Max and his 6-year-old sister Zoe Perales were vaccinated at Stanford.
All they could think about afterwards, "Going back to baseball and soccer maybe. How about jiu-jitsu and martial arts? I have a couple suits that probably don't fit me anymore," said Max Peralez. Sitting next to him, Zoe said, "I'm looking forward to going back to my teacher."
Pfizer's trial is focused on detecting the antibody response to the COVID-19 vaccine, and verifying if a lower dosage produces enough immunity for this group. Children 5 to 11-years-old will be injected with 10 micro grams in each dose, as opposed to 30 micro grams those 12 and older received.
"We are hoping to enroll enough children to get safety data and antibody response data in the next couple weeks, so that we can then get second doses in and submit this information to the FDA by the fall. We would love to see a vaccine for 5 - 12-year-olds as safe and effective by fall, so kids can go back to school with vaccine coverage," said Dr. Yvonne Maldonado, Stanford's Professor of Global Health and infectious diseases.
Dr. Yvone Maldonado is the principal investigator at Stanford University School of Medicine for the Pfizer trial. Dr. Maldonado said they've received an influx of interested families.
"These are families that are coming forward. We are not advertising. They are coming forward and volunteering. We would love to enroll more, but in order to get these vaccines trials done we are limited, and we certainly have hundreds of people more than we can accommodate, if not thousands," said Dr. Maldonado.
Luz Pena: "Are there any concerns when it comes to vaccinating children as young as 5-years-old?"
Dr. Yvonne Maldonado: "We are just not seeing any major safety concerns. We know these vaccines do not cause cellular or DNA damage, which is one of the areas that people have been talking about. That is not happening."
Dr. Maldonado said children will be monitored for two years during this process.
"Watch them in the clinic for several hours, and then everyday they would be sending us information about how they are doing and they will come back for visits as well," said Dr. Maldonado.
Kaiser Permanente enrolled about 75 children 5 to 11-years-old for this trial. 11-year-old Luci Guardino got the first shot yesterday.
"Starting yesterday and this morning my arm did feel a little bit heavy but I don't feel sick or anything," said Guardino.
Pfizer is anticipating initial results of the 5 to 11-year-old trials in September. Ahead of those results, Dr. Nicola Klein, principal investigator for the Northern California trials, is getting ready for the next age group. That group would be children as young as 2 years old, followed by children as young as 6-month-old infants.
"We are still arranging logistics for a younger age group. Younger than 5, but that is still a little bit of a work in progress still for the next several weeks," said Dr. Klein.
As the trial continues, families won't know for six months if their children were vaccinated with Pfizer COVID-19 vaccine or a placebo. Those who received the placebo will have a chance to get the vaccine after the six-month period.
As the trial expands, medical doctors believe Pfizer will submit an emergency authorization for children in this age group soon.
"At least by what Pfizer Biotech has publicly stated is that they were planning to make this available in the fall. Submit authorization to the FDA," said Dr. Klein.
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