United States health authorities on Saturday cleared the Pfizer and Moderna COVID-19 vaccines for children aged five and younger, in a move President Joe Biden greeted as a “monumental step” in the fight against the virus.
The US thus became the first country to approve the use of the so-called mRNA vaccines for children as young as six months.
The US Food and Drug Administration had on Friday authorised their emergency use for young children – who previously had to be at least five to receive the vaccine.
But the vaccines required further clearance from the US Centers for Disease Control and Prevention, the country’s leading public health agency – and they received that on Saturday.
“We know millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision, they can,” CDC Director Rochelle Walensky said in a statement Saturday.
Once the green light was received from the FDA, the US government began distributing millions of doses of the vaccine across the country.
Biden promised that parents could begin scheduling appointments as early as next week to have their young children vaccinated at hospitals, clinics, pharmacies, and doctor’s offices.
In a statement Saturday, he touted the vaccines as “safe (and) highly effective,” and said that “for parents all over the country, this is a day of relief and celebration.”
In the coming weeks, with more and more doses shipped out, “every parent who wants a vaccine will be able to get one,” he said.
The Moderna vaccine, administered in two doses a month apart, will be available to children aged six months to five years in reduced doses of 25 micrograms (half the amount given to children aged six to 11, and a quarter the dose for those 12 and older). The Pfizer-BioNTech vaccine is now authorized for children aged six months to four years and will be given in doses of three micrograms per injection – one-tenth the adult dosage.
The difference, however, is that children will receive three shots – the first two to three weeks apart, followed by a third eight weeks later.
So, children receiving it will not have full protection for the first few months.
Its side effects, however, have appeared less serious in drug trials than those of the Moderna vaccine.
About a quarter of young children receiving Moderna have developed fevers, particularly after the second dose – but they generally lasted no more than a day.
About 20 million US children are now eligible, by age, for the new vaccines.
While children have generally proved less vulnerable to COVID-19, some 480 in the US in this age group have died of the virus.
So-called long Covid is also a concern, as is a multisystem inflammatory syndrome, a rare but serious post-viral condition.
Pfizer has said it hopes to apply in early July to the European Medicines Agency for authorisation to provide its vaccines to children in this youngest age group.
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.
