Pfizer Now Testing Vaccines on Children Under 12

Pfizer has started clinical trials of its COVID-19 vaccine on children, the pharmaceutical giant announced last week.

The global Phase 1/2/3 study involves healthy children ages 6 months to 11 years, in order to establish whether the vaccine, developed in partnership with BioNTech, is safe and effective for kids.

What's Involved in the Trials?

The first phase of the Pfizer trials includes 144 children (some of which have already received their shots) and involves identifying the preferred dosing level for three age groups: 6 months to 2 years, 2 to 5 years, and 5 to 11 years.

Initially, each child will get a 10-microgram dose of the vaccine, then move on to higher doses. The adult dose of the Pfizer/BioNTech COVID-19 vaccine is two shots, 30 micrograms each.

Phase 2 of the trial is an evaluation of safety and effectiveness of the chosen dose levels. Participants will be chosen at random to get the vaccine or a placebo; after a six-month follow-up, the children who got the placebo will be offered the vaccine.

“Pfizer has deep experience in advancing clinical trials of vaccines in children and infants and is committed to improving the health and well-being of children through thoughtfully designed clinical trials,” the company said in a statement, as reported byCNBC.

According toThe New York Times, the trial’s first participants were a pair of 9-year-old twin girls, who were immunized at Duke University in North Carolina on March 25.

A Key Step in the Fight Against COVID-19

Kelly Fradin, MD, pediatrician and author of育儿in a Pandemic: How to Help Your Family Through COVID-19, is happy to hear that Pfizer studies have started to include children as young as 6 months.

"Though children are at lower risk for serious complications of COVID-19 than adults, in the past year with all the precautions and school closures more children died of COVID-19 than nearly every flu season on recent record (with the exception of the H1N1 virus in 2009)," Dr. Fradin says.

Although we think of most children as healthy and low risk, Dr. Fradin points out that many children do have comorbidities and underlying conditions like preterm birth, cardiac disease, type 2 diabetes, and obesity, which may put them at higher risk.

"A vaccine will be particularly helpful for these children and help their families feel confident and safe resuming pre-pandemic activities," Dr. Fradin explains. "Children can get and spread COVID-19 and once we have a tested vaccine, children can help their communities to reach herd immunity and stop the spread of the coronavirus."

If current COVID-19 restrictions are lifted before children are protected andcommunity spreadis controlled, there would be many more cases and, unfortunately, more deaths, Dr. Fradin warns.

For parents who have concerns about their kids getting the vaccine, Dr. Fradin’s advice is not to worry just yet, because it will be a while before you have to make a decision.

"Every day we gain so much information, and if you keep an open mind you may be reassured by data from studies," she says. Plus, you aren’t alone in this decision. Your pediatrician can help you think through the individual considerations before you make your decision.

Ultimately, a child who doesn’t get vaccinated remains a risk to others. "If kids resume normal activities unvaccinated while we still have significant viral spread, many children will get and transmit the coronavirus," Dr. Fradin says. "More cases means more severe cases, more new variants, and more spread to members of the community who are incompletely protected by the vaccine or unable to be vaccinated."

When a safe, effective COVID-19 vaccine for kids is available, life really can go back to "normal." Children can be free to resume all the things they've missed out on, like indoor play dates, birthday parties, and school without distancing or masks.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit ourcoronavirus news page.