On Tuesday, an FDA advisory panel approved Pfizer’s COVID-19 vaccine for children ages 5-11.
“Today our message is simple. Get your child and teen vaccinated against both COVID-19 and the flu as soon as possible,” said Dr. Frank Belmonte, the chief physician of Advocate Children’s Hospital.
At a press conference, along with his colleagues from the Chicagoland Children’s Health Alliance, Dr. Belmonte said his hospital and others had been preparing for weeks to administer vaccines to children.
“We were all notified of the formulation several weeks ago. We have all placed orders across all networks. We have it available in all pediatric offices. We are just waiting for the approval to actually give it,” said Dr. Belmonte.
“Giving vaccinations, that’s our hobby. That’s what we do in pediatric offices,” said Dr. Sharon Robinson.
“We’re more than ready,” said Robinson, a pediatrician with the NorthShore University Health System. “All we need are those vials, and we’re ready to get shots in the arms of these younger kids.”
The Centers for Disease Control will meet early next week to make a recommendation on the vaccine for children.
If the vaccine is fully approved, pediatricians will encourage parents to vaccinate children against both the flu and COVID. As quarantine, masking and social distancing reduced the spread of flu last year, experts say it’s hard to predict what will happen this winter.
“As a result, this flu season could potentially be very severe as last year reduced the population’s chances of building immunity,” said Dr. Robinson.
“Ninety percent of those who have severe cases and die are not vaccinated. That’s why the vaccines in both cases, COVID and the flu, are so important to reduce the severity and save lives.”
The pediatric dose of the Pfizer vaccine is the same formula, but one-third the dose given to adults and teens. Two shots are still needed, three weeks apart.
“Because the dose for children is smaller, there is another, separate vial to differentiate it, so we give the children a lower dose,” says Dr. Allison Bartlett, a pediatric infectious disease specialist at Comer Children’s Hospital.
The FDA panel voted unanimously on Tuesday, with one abstention, that the vaccine’s benefits in preventing COVID-19 in that age group outweigh its possible risks — including a heart-related side effect that is very rare in teens and young adults despite their using a much higher dose.
Although children are at a lower risk of severe COVID-19 than older people, many panelists ultimately decided it is important to give parents the choice to protect their children, especially those at high risk of disease or who live in places where other precautions, such as masks in schools, are not used.
“According to the CDC, there has been a dramatic increase in childhood COVID-19 as a result of the Delta variant. More than five million children have been diagnosed in the US,” said Dr. Belmonte.
“Thousands are now hospitalized and more than 600 children across the country have died from what is now a preventable disease.”
The Pfizer study followed 2,268 children ages 5 to 11 who received two injections three weeks apart, either a placebo or the infant dose. Vaccinated children developed levels of virus-fighting antibodies that were as strong as teens and young adults who received the full-strength injections.
The pediatric dosage was also found to be safe, with similar or less temporary side effects — such as sore arms, fever or pain — that teens experience. At the request of the FDA, Pfizer recently enrolled an additional 2,300 young people in the study, and preliminary safety data has shown no red flags.
“Clinical studies in children and intensive research have shown that the science is clear. The benefits of vaccine far outweigh the risks of not getting it,” said Dr. Bartlett.
In Chicago, there are 210,448 children living in the city between the ages of 5-11, according to the Chicago Department of Public Health.
dr. CDPH Commissioner Allison Arwady says the city will receive 100,000 pediatric doses next week, which will be distributed to 125 locations across the city.
“We expect more availability than we had in the beginning for adults,” said Dr. Arwady. “This won’t be the Hunger Games.”