The Centers for Disease Control and Prevention recommended COVID-19 shots for children as young as six months old, clearing the way for the youngest Americans to begin getting vaccinated next week.
Director Rochelle Walensky quickly signed off on the vaccines for children under five just hours after a panel of advisers to the CDC unanimously voted to recommend them.
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against COVID-19. We know millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision, they can," Walensky said in a statement. "I encourage parents and caregivers with questions to talk to their doctor, nurse, or local pharmacist to learn more about the benefits of vaccinations and the importance of protecting their children by getting them vaccinated.”
President Joe Biden hailed the decision in a statement, calling Saturday "a monumental step forward in our nation’s fight against the virus."
"After a rigorous and independent scientific review, the Food and Drug Administration and the Centers for Disease Control and Prevention have now authorized and recommended the first COVID-19 vaccines for kids under the age of five," Biden said. "For parents all over the country, this is a day of relief and celebration."
"As the first country to protect our youngest children with COVID-19 vaccines, my Administration has been planning and preparing for this moment for months, effectively securing doses and offering safe and highly effective mRNA vaccines for all children as young as six months old," he continued. "We are ready to build on the progress of our historic vaccination program that has resulted in over 220 million Americans fully vaccinated, more than 100 million Americans boosted, and over 2 million American lives saved."
The move from the CDC's advisers came one day after the Food and Drug Administration authorized the first COVID-19 vaccines for children under five.
The FDA updated its emergency use authorizations for the vaccines from Moderna and Pfizer-BioNTech on Friday to allow shots for children as young as six months old, the last remaining group in the U.S. not yet eligible for vaccination.
"Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age," FDA Commissioner Robert Califf said in a statement. "As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death."
"Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data," Dr. Califf added.
In a statement Friday, President Biden called FDA's decision a "huge relief for parents and families across America."
"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," Biden said, adding that Friday's ruling "will help build on this progress, giving parents much-needed relief and peace of mind and helping our nation continue to move forward safely. We look forward to hearing from the CDC on its recommendations."
Earlier this week, a panel of advisers to the FDA unanimously voted to recommend the shots for the youngest Americans, ruling that the benefits of the vaccines greatly outweigh the risks.
“This is a long-awaited vaccine,” Dr. Jay Portnoy, a member of the panel who works at Children’s Hospital in Kansas City, Missouri, said at Wednesday's meeting. “There are so many parents who are absolutely desperate to get this vaccine and I think we owe it to them to give them a choice to have the vaccine if they want to.”
The matter now heads to the the Centers for Disease Control and Prevention before shots can begin for the roughly 18 million children in the age group.
Dr. Walensky said at a Senate hearing that her staff will be working through the weekend – a federal holiday weekend commemorating Juneteenth – "because we understand the urgency of this for American parents."
"We need to protect young children, as well as protect everyone with the vaccine and especially protect elders," Dr. Walensky said, citing pediatric deaths from COVID-19 trending higher than what they typically see from annual flu deaths.
Pfizer’s vaccine is for children 6 months through 4 years; Moderna’s vaccine is for 6 months through 5 years.
Moderna’s shots are one-quarter the dose of the company’s adult shots. Two doses appeared strong enough to prevent severe illness but only about 40% to 50% effective at preventing milder infections. Moderna has added a booster to its study and expects to eventually offer one.
Pfizer’s shots are just one-tenth its adult dose. Pfizer and partner BioNTech found that two shots didn’t provide enough protection in testing, so a third was added during the omicron wave.
Pfizer’s submitted data found no safety concerns and suggested that three shots were 80% effective in preventing symptomatic coronavirus infections. But that was based on just 10 COVID-19 cases; the calculation could change as more cases occur in the company’s ongoing studies.
Dr. Peter Marks, FDA’s vaccine chief, opened the meeting with data showing a “quite troubling surge” in young children’s hospitalizations during the omicron wave, and noted 442 children under 4 have died during the pandemic. That’s far fewer than adult deaths, but should not be dismissed in considering the need for vaccinating the youngest kids, he said.
“Each child that’s lost essentially fractures a family,” Marks said.
FDA reviewers said both brands appear to be safe and effective for children as young as 6 months old in analyses posted ahead of the all-day meeting. Side effects, including fever and fatigue, were generally minor in both, and less common than seen in adults.