The Centers for Disease Control has greenlit the Pfizer and Moderna COVID-19 vaccines for kids as young as 6 months old, finding them both safe and effective.
CDC Director Rochelle Walensky issued a recommendation for how doctors, nurses and pharmacists should administer the shots on Saturday.
The CDC panel’s reviewed and unanimously supported the vaccines after the FDA's committee of independent experts also voted to recommend the Moderna and Pfizer vaccine on Wednesday, and the FDA authorized the vaccines on Friday.
Vaccines will start shipping out over the weekend and are on track to arrive as soon as Monday, a spokesperson with the Department of Health and Human Services said.
Kids could begin to get their shots Monday, but given the federal holiday in honor of Juneteenth, some offices may be closed and it's more likely that shots ramp up starting on Tuesday.
"As doses are delivered, parents will be able to start scheduling vaccinations for their youngest kids as early as next week, with appointments ramping up over the coming days and weeks," President Joe Biden said in a statement applauding the news on Friday.
Ten million doses were made available by the federal government to states for pre-ordering over the last few weeks. Of those, 3.8 million doses have been ordered so far, according to HHS, including 2.5 million Pfizer doses, about half of the doses available, and 1.3 million Moderna doses, about a quarter of the doses made available.
Officials cautioned that preordering is generally slow when a new age group becomes eligible for shots as doctors and clinics get their vaccine programs up and running, but they expected orders to ramp up in the coming weeks.
Both Pfizer and Moderna's CEOs said in statements they're proud to finally be able to offer a vaccine option for parents of the youngest kids.
"Children need to live highly social lives to develop and flourish. With this authorization, caregivers for young children ages 6 months through 5 years of age finally have a way to safeguard against COVID risks in classroom and daycare settings," said Stéphane Bancel, CEO of Moderna.
Albert Bourla, CEO of Pfizer, said they are "grateful" to those who enrolled children in the clinical trial to make the authorization possible.
And while the vaccines are both valuable options for COVID protection, some parents have struggled to decide which vaccine would be best for their child.
The nation's leading health officials said Friday they'd give their kids whichever shot was available first. Dr. Robert Califf, the FDA commissioner, said he has two grandchildren under 5: "They'll get the first one that's available," he said.
"The differences between the two are so much less than the fundamental benefit to risk balance," he said in a press conference.
Dr. Peter Marks, the FDA's vaccine chief, said the same but acknowledged the nuances that particularly attentive parents might consider.
"It may be that the Moderna vaccine brings an immune response slightly more rapidly. On the other hand, the three-dose Pfizer regiment may also bring a greater immune response after the third dose, and there are some subtle differences in the safety profile," Marks said.
"But again, these are relatively subtle, and unless you really want to dive into the subtlety, to a first approximation the correct answer here is whatever vaccine your health care provider pediatrician has, that's what I would give my child," Marks said.
Data from Moderna, which is a two-shot series, showed its vaccine was about 40% to 50% effective at preventing mild infections after both shots.
But representatives for Moderna said they expected a third shot, or booster, would be available to kids in the coming months -- either the current vaccine, or the omicron-specific vaccine the company is developing for the fall -- which could increase efficacy.
Pfizer's vaccine is one-tenth the size of the adult dose, given as a three-shot series.
The company's early data showed it was 80% effective in preventing symptomatic COVID-19. But that protection largely didn't kick in until the third shot -- the data showed very minimal protection after doses one and two.
Marks also cautioned that the data from Pfizer was based on a much smaller group of children and that the FDA was waiting to see more follow-up data to know for sure what the efficacy rate was -- though they remained confident there would be no concerns based on other data.
He urged parents to get their kids vaccinated regardless of past COVID infections, detailing new studies that showed the omicron variant in particular didn't offer the same lasting immunity after infection as the vaccine does, and said parents should not wait for the fall, when there could be a new-and-improved vaccine, because getting vaccinated now would build up "foundational immunity."
"I would strongly recommend that with the availability of this primary series, which provides excellent foundational immunity against a broad range of COVID-19 variants, that I would have children start this right now. And if it turns out that there is a very major change in strains that needs to occur in the fall, we will adjust and make sure that there is an option available for the youngest children and throughout the pediatric age range as appropriate," Marks said.
"But for right now, this is something where we would recommend that people start this now because it will provide that foundational level of immunity."