A federal advisory panel Saturday strongly recommended that young children receive COVID-19 vaccines.
The 12-member committee’s unanimous recommendation was the second-to-last hurdle before vaccines become available to children as young as 6 months old as soon as Tuesday. The last step, approval by the director of the Centers for Disease Control and Prevention, is expected to happen as soon as Saturday afternoon.
That will clear the way for 10 million vaccine doses, which have already been pre-ordered from the federal government, to begin delivery and distribution as soon as Tuesday (after the Monday Juneteenth federal holiday).
The vaccines are safe and trigger the same immune response that has protected older children and adults, the advisory panel decided Saturday.
“All children six months and older should be immunized against COVID,” said committee member Dr. Sarah Long, a pediatric infectious disease specialist at the Drexel University College of Medicine and St. Christopher’s Hospital for Children, both in Philadelphia. “If you’re not going to immunize your children, we think that’s misplaced concern and that you should immunize your child to save their lives.”
An advisory panel to the Food and Drug Administration came to the same conclusion earlier in the week and the FDA commissioner formally authorized the vaccines on Friday morning.
The shots will be available at no cost to parents in local pharmacies, pediatricians’ offices, clinics and other locations.
Vaccines from Moderna and Pfizer-BioNTech are delivered differently, though based on the same mRNA technology. The vaccines for small children are identical to those given to older children and adults, just at a lower dose.
Vaccines will not be available to babies younger than 6 months, because they are believed to get protection from vaccination during pregnancy.
The Moderna vaccine was authorized for children ages 6 months up to 6 years, at a dose of 25-micrograms, one-quarter of the dose given to adolescents and adults. It was approved as a two-dose vaccine, given 4- to 8-weeks apart, though the company and officials believe a third dose will be necessary to provide full protection, probably about 12 weeks after the second dose.
The Pfizer-BioNTech vaccine will be used in children ages 6 months up to 5 years old, at a 3-microgram dose, one-tenth the size of the adult and adolescent dose. Three doses were needed to provide the same level of immune response as seen in young adults after two doses, so it is considered a three-dose vaccine.
The second dose is to be given 3 to 8 weeks after the first, and a third will be given at least eight weeks later.
It’s unclear whether further booster shots will be needed as the pandemic continues and the virus evolves. Moderna plans to start testing a third dose of its vaccine in the youngest children next week.
Although children are less likely to be severely affected by COVID-19, they can get sick enough to miss school, or even require hospitalization.
During the pandemic, 2 million children under 5 have been infected with COVID-19, 20,000 have been hospitalized and 200 have died, about half of whom did not have any underlying medical conditions.
There are about 19 million American children in this age group.
“It’s a real tragedy when you have something that’s free and with so few side effects that prevents death and hospitalization,” FDA Commissioner Dr. Robert Califf said in a Friday news conference. “Each of those events, though the numbers as we stress, aren’t large in children – children shouldn’t have these outcomes. It’s just an unnecessary tragic event that could have been prevented.”
Both companies conducted trials during the omicron phase of the pandemic and showed their vaccines to be safe, with no new side effects than those seen among older children, adolescents or adults. The most common side effects in small children are fever, irritability and pain at the injection site, but most are mild and pass within a few days.
Trials by Moderna and Pfizer-BioNTech, in which about 5,000 young children were vaccinated, found neither of the two serious side effects seen in adults and adolescents after vaccination – severe allergic reactions and a swelling of the heart muscle known as myocarditis. These side effects are so rare, however, that such effects cannot be ruled out.
Parents will have a choice between the two vaccines, but there is little difference between them and parents should pick whichever shot is available, Dr. Peter Marks, who heads FDA’s vaccine review process, said in the Friday news conference.
“Parents should feel comfortable giving either one of these vaccines to their children,” Marks said. Moderna’s vaccine may provide protection sooner, though it may also be more likely to cause fevers in young children, company research shows.
Data collected once the vaccines are available should eventually answer the question of whether one company’s vaccine is better than the other, Dr. Jesse Goodman, a former FDA official and Georgetown University physician, said in a Monday call with media.
Parents will soon have a choice of which vaccine to give to older children. To date, only the Pfizer-BioNTech vaccine has been authorized for use in adolescents and children. But the FDA this week also authorized Moderna’s vaccine to be used in children and adolescents and the CDC and its advisory committee will make a final recommendation on this vaccine next week.
Vaccines, particularly two primary doses followed by a booster, have been effective at preventing disease in older children and adolescents, according to data shown to the CDC committee Friday.
While two doses were sufficient to protect against delta and earlier variants, three doses were needed to provide protection against omicron, the data showed. Protection also fades much faster with two doses than three.
The FDA’s advisory committee is meeting June 28 to discuss whether to reformulate vaccines to specifically target the omicron or later variants.
But Marks said parents shouldn’t wait to start vaccinating their children.
The primary series of shots provides “excellent foundational immunity,” he said. “If it turns out there is a very major change in strains that needs to occur in the fall, we will adjust for that.”
COVID-19 vaccines will be available in the same places where young children traditionally get their shots, typically pediatricians’ offices and community health clinics.
Licensed pharmacists are legally authorized to administer recommended vaccinations to children ages 3 and older.
Shots for 3- and 4-year-olds will be available at select Walgreens locations, most starting on June 25, the company said in a statement.
On Sunday, the pharmacy chain will allow parents to start scheduling vaccine appointments for 3- and 4-year-olds at Walgreens.com/ScheduleVaccine, on the Walgreens app or by calling 1-800-Walgreens. About half of Walgreens locations nationwide are expected to offer the shots.
Both vaccines will come in vials that are colored differently than COVID-19 vaccines for children of older ages, to help avoid delivery mistakes.
But vaccines for young children will add a layer of complication for vaccine providers.
Pfizer-BioNTech’s vaccine must be diluted before delivery, while Moderna’s doesn’t, for example, which might lead medical offices and pharmacies to choose one vaccine or another rather than both.
Also, COVID-19 doses for small children come 10 to a vial, all of which must be used within 12 hours or thrown out.
CDC officials said Saturday that it is more important to vaccinate even one child than to worry about wasting vaccine doses.
“We want to shift from ‘don’t waste a dose’ to ‘don’t waste an opportunity to vaccinate a child,'” Dr. Kevin Chatham-Stephens, a CDC medical officer, told the committee.
Contact Karen Weintraub at email@example.com
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