AP – US regulators on Friday authorized the first COVID-19 shots for infants and preschoolers, paving the way for vaccinations to begin next week.
The Food and Drug Administration’s action follows the unanimous recommendation of its advisory panels for Moderna and Pfizer’s shots. That means American children under the age of 5 — about 18 million young people — are eligible for the shots. The nation’s vaccination campaign began about 1 1/2 years ago with older adults being the hardest hit during the coronavirus pandemic.
There’s one step left: The Centers for Disease Control and Prevention recommends how to use vaccines. Its independent advisers began a debate on Friday on the two-dose Moderna and three-dose Pfizer vaccines and will recommend them on Saturday. A final signing from CDC Director Dr. Rochelle Valensky is expected soon.
At a Senate hearing on Thursday, Wallensky said his staff was working the Juneteenth federal holiday weekend “because we understand the urgency of this for American parents.”
He added that pediatric deaths from COVID-19 are generally higher than the deaths seen from the flu every year.
“So I really think we need to protect young children, as well as protect everyone from vaccines and especially protect elders,” she said.
The FDA also authorized Moderna’s vaccines for school-age children and adolescents; CDC review is due next week. For those age groups, shots from Pfizer were the only option.
This May 2022 photo provided by Pfizer shows Pfizer’s production of a COVID-19 vaccine for children under the age of 5 in Purs, Belgium. US regulators authorized the first COVID-19 shots for infants and preschoolers on June 17, paving the way for vaccinations to begin next week. (Pfizer via AP)
For weeks, the Biden administration has been working with states, tribes, community health centers and pharmacies to prepare for millions of doses of vaccines for young children. With the FDA’s emergency use authorization, manufacturers can begin shipping vaccines nationwide. The shots are expected to debut early next week but it is unclear how popular they will be.
Without the safety of their children, some families put off birthday parties, vacations, and visits with grandparents.
“Today is a day of great relief for parents and families across America,” President Joe Biden said in a statement.
While younger children generally do not get as ill from COVID-19 as older children and adults, their hospitalizations increased during the micron wave and FDA advisors determined that the benefits from vaccination outweigh the minimal risks. The Moderna and Pfizer studies showed that side effects were mostly minor, including fever and fatigue.
FDA Commissioner Robert Califf said in a statement, “As we have seen with older age groups, we expect that vaccines for young children will provide protection against the most severe consequences of COVID-19, such as: hospitalization and death.”
In the trial, young children developed higher levels of virus-fighting antibodies than those seen in young adults, the FDA said. The agency said Moderna’s vaccine was about 40% to 50% effective at preventing infection, but there were too few cases during Pfizer’s study to give a reliable, accurate estimate of effectiveness.
“Both of these vaccines have been authorized with science and safety at the forefront of our minds,” FDA vaccine chief Dr. Peter Marks said at a news briefing.
This May 2022 photo provided by Pfizer shows Pfizer’s production of a COVID-19 vaccine for children under the age of 5 in Purs, Belgium. US regulators authorized the first COVID-19 shots for infants and preschoolers on June 17, paving the way for vaccinations to begin next week. (Pfizer via AP)
Marx said parents should feel comfortable with either vaccine, and get their children vaccinated as soon as possible, rather than waiting until fall, when a different virus variant could be circulating. He said that adjustments will be made in the vaccines for this.
“Whatever vaccine your health care provider, or pediatrician has, I would give to my child,” Marks said.
The two brands use the same technology but there are differences.
The Pfizer vaccine for children under 5 years old is one-tenth of the adult dose. Three shots are needed: the first two three weeks apart and the last at least two months apart.
Moderna has two shots, each one-fourth of the adult dose, given about four weeks apart for children younger than 6 years old. The FDA has also authorized a third dose at least one month after the second shot for those who have immune conditions that make them more vulnerable to serious illness.
Both vaccines are for children under 6 months of age. Moderna plans to study their shots for the next 3-month-olds. Pfizer hasn’t finalized plans for shots in young babies. A dozen countries, including China, are already vaccinating children under 5, along with other brands.
Soon after hearing the FDA’s ruling, Houston radiologist Dr. Toma Omofoy made appointments for her 4-year-old daughter and 3-year-old son. Without shots, her family would have missed out on family gatherings, indoor concerts, even trips to the grocery store, she said. During a recent pharmacy stop, Omofoye said that her daughter kept staring and walking around like Disneyland, and thanked her.
“My heart broke in that moment, which is why my heart is so excited now,” Omofoy said.
Example – A child arrives with their parents to receive the Pfizer COVID-19 Vaccine for Children aged 5 to 11 at London Middle School in Wheeling, Illinois on November 17, 2021. (AP Photo/Name Y. huh, FILE)
But would other parents be just as eager to get their youngest child vaccinated? By some estimates, three-quarters of all American children have already been infected. And about 30% of children aged 5 to 11 have been vaccinated since Pfizer opened its shots last November.
FDA officials acknowledged those low rates and said the government was committed to vaccinating more older children and having better success with younger children.
“It’s a real tragedy when you have something free with so few side effects that it prevents deaths and hospitalizations,” Calif said.
About 440 children under the age of 5 have died from COVID-19, federal data shows.
University of Washington School of Medicine in Seattle, Dr. Beth Abel said total-sized vaccines would be particularly welcome by parents with children in daycare, where outbreaks could throw parents off jobs, adding to the financial strain.
“A lot of people are going to be happy and a lot of grandparents are going to be happy too, because we’ve missed kids who grew up when you weren’t able to see them,” Abel said.