The Federal Food and Drug Administration on Friday authorized both Moderna’s and Pfizer-BioNTech’s vaccines for children as young as 6 months old — meaning COVID shots for the last age group of Americans without access may be just days away.

The vaccines now await sign-off from the Centers for Disease Control and Prevention, the final step before children under 5 can begin rolling up their sleeves. The White House expects providers to begin administering doses on Tuesday, immediately after the federal Juneteenth holiday.

On Wednesday, an FDA panel of experts — made up of pediatricians, infectious disease experts and vaccine researchers — voted 21-0 in favor of both vaccine options.

“There are so many parents who are absolutely desperate to get this vaccine, and I think we owe it to them to give them the choice,” said committee member Jay Portnoy, a professor of pediatrics at Children’s Mercy Hospital in Kansas City, Missouri.

Philip Chan, medical director for the Rhode Island Department of Health, called the panel’s unanimous vote a “major milestone in COVID prevention.” His state is ready to distribute the shots as soon as they receive the all clear, he said.

“We’ve pre-ordered thousands of [doses], and we expect them to ship within 24 or 48 hours after the FDA issues the EUA” (emergency use authorization), he told ����Ӱ�� Wednesday. With EUA now granted, the COVID shots should soon be on their way.

Parents who are eager to finally vaccinate their young children took advantage of the public comment period at the FDA’s Wednesday committee meeting to urge advisors to recommend authorization. Michael Baker, the father of a 1 and a 3 year old, described the tough choices he has had to make to protect his children from the virus. He shared a slide of all the events they have missed out on during the pandemic, including weddings, holidays and funerals.

“All I am asking is now that … I have the choice to vaccinate my children, [that] I have the choice to do it in the most timely fashion possible,” he said to the committee.

Parents like Baker awaiting vaccines for their little ones have been on a months-long rollercoaster that has repeatedly raised their hopes only to later send them crashing down. In late February, Pfizer-BioNTech first submitted a request asking the FDA to grant emergency authorization for a two-dose regimen of their vaccine for children 6 months to 4 years old, only to then withdraw the application just five days later. Then in April, when Moderna was on the verge of submitting its EUA application for the age group, the FDA postponed the committee review process until Pfizer’s shots were also ready.

Just 29% of children 5 to 11 years old and 59% of youth 12 to 17 years old have so far received two vaccine doses, according to data from the American Academy of Pediatrics. 

However, Katelyn Jetelina, creator of Your Local Epidemiologist, wrote in her hyper-popular newsletter that parents of young kids should still take COVID seriously and vaccinate their children.

“The rate of severe disease is lower compared to adults, but this is an inherently flawed comparison because kids don’t die as often as adults. Since the beginning of the pandemic, 442 children aged 0-4 years old have died from COVID-19. If we compare to other vaccine preventable diseases among children, deaths due to COVID19 are highest. We cannot become numb to these deaths,” she explained.

COVID cases across the U.S. are finally leveling off after a springtime surge fueled by an Omicron subvariant spurred bumps in pediatric infections and hospitalizations through the final weeks of the school year.

You can view the FDA’s and watch the full recording of its June 15 vaccine advisory committee’s virtual meeting:

It’s a major boost in efficacy compared to data from Moderna, which announced in March that its two-dose regimen is 51% protective in toddlers 6 months to 2 years old and 37% protective in youngsters 3 to 6 years old.��

Researchers believe both vaccines offer a strong defense against severe illness and hospitalization in the age group.

The U.S. Food and Drug Administration on Monday its vaccine advisory committee will meet June 15 to review Moderna’s and Pfizer-BioNTech’s emergency use authorization requests for kids ages 6 months to 5 years old and 6 months to 4 years old, respectively. Pfizer and BioNTech have not yet submitted an EUA request, but plan to do so by the end of the week, BioNTech CEO Ugur Sahin said in a .

The agency’s advisory committee will make a recommendation on whether to approve the shots at the end of the meeting, which the FDA typically follows. Many experts hope the agency will greenlight shots soon after the mid-June meeting.

“I have some optimism that this will go well at [the] FDA advisory meeting and we might begin immunizing under 5 beginning next month,” Peter Hotez, co-director of Texas Children’s Hospital’s Center for Vaccine Development, wrote on .

Children under 5 years old remain the last Americans without access to COVID vaccines, and parents are eager to protect their children, especially as cases once again rise, said Atlanta-based pediatrician Jennifer Shu.��

On Monday, as the Pfizer news was announced, multiple parents of young children asked whether they could get their kids on a waiting list for the forthcoming vaccines.

“I assure them that we will make availability for everyone who wants [the shots],” said Shu, explaining that her practice has received ample pediatric vaccine supply every time they have placed an order. “I don’t think that access is going to be an issue.”

The news from Pfizer and BioNTech comes on the heels of a months-long saga that has repeatedly raised the hopes of parents anxious to vaccinate their toddlers against COVID only to later send them crashing down. In late February, Pfizer-BioNTech first submitted a request asking the FDA to grant emergency authorization for a two-dose regimen of their vaccine for children 6 months to 4 years old, only to then withdraw the application just five days later.��

Then in April, when Moderna was on the verge of submitting its EUA application for the age group, that the FDA might postpone the review process until Pfizer’s shots were also ready, a reveal that angered many parents and spurred a congressional letter asking the agency to explain the reported delay. The announcement of the June 15 committee meeting appears to confirm those speculations of a simultaneous review.

The trial results released Monday clarified what experts have hinted at since February — that Pfizer’s two-dose regimen never offered the full intended protectiveness for young children.

“It was always a three-dose vaccine,” said Hotez.

The news comes as reported U.S. coronavirus cases are up 53% since two weeks ago and youth infections are also rising, though less steeply. With the increased prevalence of at-home testing, those numbers may fail to capture the full scope of new case totals, said Shu.

During the winter’s massive Omicron surge, children under 5 were hospitalized with the virus at five times the rate they were during the Delta surge, a from the Centers for Disease Control and Prevention recently found. And in February, the agency’s data revealed that kids under 18 had been infected by the virus.

Still, repeat infections remain a threat, and can happen of each other. Children who have not yet been vaccinated are more likely to get sick and, in turn, more likely to experience severe outcomes than immunized peers, said Shu.

“The kids who are ending up in the hospital are more likely not to be vaccinated,” she told ����Ӱ��.

Just 28% of children 5 to 11 years old and 58% of youth 12 to 17 years old have received two vaccine doses, rates that have remained nearly stagnant for months.

Aside from recommending that kids roll up their sleeves as soon as they’re eligible, the pediatrician believes schools should consider reinstating universal face-covering rules while infections multiply. While a few schools and districts have made that jump, the vast majority continue to keep masks optional, though some have upped their language recommending masks.��

Shu, however, knows of some children who have chosen to mask up at school as they’ve watched their peers get sick. It’s prom and graduation season, the pediatrician noted, and young people don’t want to miss out.

“If you miss some of these things, you can’t make them up,” said Shu.

The Food and Drug Administration April 29 that it will reserve the dates June 8, 21 and 22 for its vaccine advisory committee to review the emergency use authorization requests of Moderna’s and Pfizer-BioNTech’s coronavirus shots for toddlers. While the dates remain subject to change, they provide an indication of when doses may be available to those under 5, as the FDA typically follows the recommendation of the committee in the weeks following its meeting.

Members of Congress sent a to the U.S. Food and Drug Administration Monday asking whether the agency intended to delay reviewing Moderna’s coronavirus vaccine for children 5 years old and younger and for “the scientific basis and any other rationale” for such an action.

The move comes after White House officials told last week that young kids, the last age group not yet eligible for coronavirus vaccines, will likely have to wait until the summer for immunizations — a longer timeline than previously expected.

Although Moderna completed the trial for its toddler vaccine in late March and submitted a on Thursday, Anthony Fauci said that the FDA is considering reviewing the pharmaceutical company’s application at the same time as Pfizer-BioNTech’s, which has not yet been submitted.

“[The] two products … are similar but not identical, particularly with regard to the dose. And what the FDA wants to do is to get it so that we don’t confuse people to say, ‘this is the dose. This is the dose regimen for children within that age group of 6 months to 5 years,'” President Biden’s chief medical advisor on Thursday.

“Such a decision could delay the potential authorization and administration of the Moderna vaccine by several weeks,” points out Rep. James Clyburn, chair of the House Subcommittee on the Coronavirus Crisis, in its letter to the FDA. The committee asked for a staff briefing on the subject by May 9.

In early February, Pfizer-BioNTech submitted data on a two-dose vaccine series for children under 5 to the FDA, but in a highly unusual move withdrew their application just 10 days later. The two shots, which are 10 times less potent than the companies’ adult doses, were safe for all age groups, but did not provide enough protection against the Omicron variant for 3- and 4-year-olds. Pfizer-BioNTech now plans to request that the FDA authorize a three-dose regimen for children under 5, the companies have said.

The Moderna series currently submitted for review includes two shots that are each one-quarter the dose adults received. Trial data showed shots to be 44% and 38% effective in preventing illness among children 6 months to 2 years old and 2 years to under 6 years old, respectively.

But despite the relatively low efficacy, many parents of young children are anxious for a base level of protection for their kids, especially as mask mandates and social distancing requirements continue to fall across the country. 

For some, the idea that the FDA would delay the Moderna shots on parents’ behalf — ostensibly to avoid confusion — struck the wrong chord.

“If I sign a waiver saying ‘I don’t find this confusing at all,” can I go ahead and get the vaccine for my four-year-old?” parent and New York Times writer Whet Moser .

Meanwhile, a Tuesday report from the Centers for Disease Control and Prevention revealed that more than half of Americans have been infected by the coronavirus, including . Rates of prior infection nearly doubled over the course of the Omicron surge, the agency found.

Jennifer Shu, an Atlanta-based pediatrician, agrees that if doses are ready for emergency use authorization, Washington should not delay the rollout. After all, vaccines from separate companies were approved at different times for other age groups, she pointed out.

“If it’s ready to go, if the science has proven that the vaccine is safe and effective, then why not let the parents educate themselves on it?” she told ����Ӱ��, adding that health professionals like herself can help families make an informed choice.

Parents of kids under 5 may feel they’re being “thrown under the bus” as pandemic precautions dwindle and the BA.2 Omicron subvariant threatens, said Shu.

But despite thousands of families eager to vaccinate their toddlers, still more are likely to pass on the opportunity when it becomes available. 

Immunization rates remain relatively low for older kids and teens with 28% of 5- to 11-year-olds and 58% of 12- to 17-years-old fully vaccinated as of April 20, according to the . New immunizations have slowed nearly to a halt, with vaccine coverage having increased only 1 percentage point in each age group since mid-March.

Even as vaccination rates are flatlining, Pfizer-BioNTech is planning to seek authorization for a third booster shot for kids 5- to 11-years old after trials found that it offers added protection against the Omicron variant.

The protection provided by the shots, the companies say, supports authorization of the vaccine for the 28 million U.S. children in that age group. The Food and Drug Administration has a hearing scheduled Tuesday with expert advisors to review the case for authorization. 

Two weeks ago, Pfizer and BioNTech submitted their formal request to the FDA for the green light to deliver doses to 5- to 11-year olds. 

If the review timeline spans a similar length as that of vaccines for 12- to 15-year olds, the agency could grant authorization ahead of the Thanksgiving holiday — meaning that the vast majority of K-12 students may soon be eligible for immunizations.

The vaccine efficacy numbers come from a Pfizer and BioNTech provided to the FDA, released Friday morning by the federal agency. In their trial, the companies tested a 10 microgram dose of the vaccine, one-third the size of the shot for teenagers and adults, and found that it produced a “robust” antibody response. Immunity and side effects, they said, were comparable to those produced by the larger dose in 16- to 25-year-old patients. 

No new safety problems or cases of heart inflammation were observed in the trial, which tested 2,268 participants. Israeli studies have found myocarditis to occur in , so it’s possible the condition would have been too rare to have been detected in the main study. 

The news comes as children make up over , amounting to about a quarter of all reported infections per week nationwide, according to mid-October data published by the American Academy of Pediatrics. Over have closed so far this year due to outbreaks of the virus, according to Burbio, an organization that has tracked schools through the pandemic, though COVID-related school closures have slowed considerably in recent weeks as and schools hone their protocols to curb spread.

The White House has made it clear that immunizing children will be a priority once shots are authorized for 5- to 11-year olds. The Biden administration will match schools with COVID-19 vaccine providers, the White House Wednesday. The Department of Health and Human Services will also enlist community-based clinics, doctor’s offices, hospitals and faith-based organizations in rapidly distributing vaccines.

Two-thirds of parents of children aged 5 to 11 years say they will immunize their children against COVID-19 once shots are authorized for the age group, according to by the COVID-19 Vaccine Education and Equity Project.

“While we’re encouraged to see that a majority of parents intend to vaccinate their children against COVID-19 once they are eligible, there is clearly more work to be done to help address parents’ questions and ease concerns about the vaccines,” Beth Battaglino, CEO of the nonprofit HealthyWomen, one of the partner organizations behind the polling, said in a .

Pfizer-BioNTech vaccinations have been fully approved by the FDA for individuals ages 16 and above, and have emergency use authorization for teenagers ages 12 to 15. Shots for kids younger than five may arrive .