- The White House announced that children under age 5 may have access to COVID-19 vaccines as early as June 21.
- Pfizer’s three-dose COVID-19 vaccine is effective at protecting against symptomatic infections in young children under the age of 5, the company’s new data suggests.
- A decision from the FDA and CDC regarding the authorization of pediatric COVID-19 vaccines is expected in June.
White House officials announced today that COVID-19 vaccines may be available for children aged 6 months to 5 years within weeks.
Dr. Ashish Jha, White House COVID-19 Response Coordinator, told reporters in a White House briefing that the administration is planning to make 10 million doses available for states to order. They will be shipped to states if the Food and Drug Administration (FDA) authorizes the vaccines for use for children under 5.
The FDA’s Vaccines and Related Biological Products Advisory Committee is expected to meet on June 14 and 15 to discuss authorizing the Pfizer and Moderna vaccines for children under age 5.
Even if they authorize the vaccines to be used by young children, the Centers for Disease Control and Prevention will also have to give a recommendation about the vaccines.
If the vaccines are authorized and recommended by both the FDA and CDC, Jha said that the administration is preparing to make vaccines available quickly to healthcare providers.
“We expect vaccinations will begin in earnest as soon as June 21,” Jha said. “It will take some time to ramp up the program.”
Jha said they expect most young children to get the vaccine from their healthcare provider.
Moderna submitted a request to the FDA for EUA of its two-dose pediatric vaccine last month.
Pfizer has also asked the FDA to allow children aged 6 months to age 5 to get their COVID-19 vaccine.
The news comes weeks after Pfizer announced that its three-dose vaccine is 80.3 percent effective at preventing symptomatic infections in children 6 months to 5 years of age.
The three-dose vaccine series was well tolerated in children and produced a strong immune response with no new safety concerns, according to a press release from Pfizer.
The third dose — which is one-tenth of the dosage used for adults — was tested during the Omicron wave.
In December 2021, Pfizer announced that its two-dose series did not produce a strong enough immune response in children, prompting the company to evaluate a third pediatric dose and initiate a rolling submission to the U.S. Food and Drug Administration (FDA).
A decision regarding the authorization of pediatric COVID-19 vaccines is expected in
“The study suggests that a low 3-ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains. We are preparing the relevant documents and expect completing the submission process to the FDA this week, with submissions to EMA and other regulatory agencies to follow within the coming weeks,” Prof. Ugur Sahin, M.D., CEO and co-founder of BioNTech, stated in the press release.
The phase 2/3 trial evaluated the efficacy and safety of a third dose in 1,678 children between 6 months and 5 years of age.
The third dose, which is 3 micrograms, was given at least two months after the second dose when Omicron was the dominant variant.
To evaluate the shot’s efficacy, scientists measured the children’s neutralizing antibody levels and clinical data on the prevention of infection.
They found that the safety, immunogenicity and efficacy data for three doses in children was consistent with what was observed in adults.
The results are preliminary and the final data is expected soon.
Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security and an infectious disease expert, says it was necessary to perform additional studies evaluating various dosing regimens in children.
“That takes time,” Adalja said. “It is also the case that Pfizer had to pivot to a 3-dose primary regimen because of poor immunogenicity in the 2- to 4-years age group.”
Dr. Onyema Ogbuagu, Yale Medicine infectious diseases doctor and principal investigator on the Pfizer vaccine trial for children under age 5 at Yale School of Medicine, says the trial results were in line with what his research team expected.
The two-dose series would have been insufficient due to the new, more contagious variants that emerged, according to Ogbuagu.
“Third dose for kids boosts antibody levels, which provide robust clinical protection against the contagious and immune evasive Omicron variants/subvariants,” Ogbuagu told Healthline.
The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on
COVID-19 is typically mild in young kids, however, a small percentage of kids who contract COVID-19 become severely ill.
Ogbuagu says as the adult vaccination campaign rolled out, there was a shift in infections to younger people who were unvaccinated.
“While kids have less severe disease risk compared to adults, they do get hospitalized and hundreds have died,” Ogbuagu said.
In rare cases, children may develop
Public health experts also say that vaccinating children will help protect those around them, such as teachers and family members who may be at risk.
“In the vast majority of children, COVID is a mild illness however if a safe and effective vaccine can minimize the disruption of even a mild illness why not take advantage of it (as we do for chickenpox and rotavirus in the US),” says Adalja.
The vaccine is also extremely valuable in
Parents have expressed frustration that it has taken so long for the COVID-19 vaccines to be authorized for young children.
But polls have shown that many parents are hesitant about getting their kids vaccinated. A survey published in May by Kaiser Family Foundation found that just 18 percent of parents of kids under 5 plan to get their child vaccinated once a shot is approved for the age group.
The poll also found that 64 percent of parents said the FDA’s delay in authorizing the pediatric shots hasn’t effected their confidence on the shots. Another 22 percent said the delay made them more confident in the shots and 13 percent said the delays have made them less confident.
Parents of older children have been slow to get their kids inoculated as well.
As of May 18, 35 percent of five to 11-year-olds have received at least one dose and 28 percent have received two doses.
Approximately 18.4 million children in the United States have yet to receive their first dose.
“I don’t expect uptake to be high — based on 5-11-year-old uptake — but the more people eligible for vaccination the better,” Adalja said.
Pfizer’s three-dose vaccine series for children is 80 percent effective at preventing symptomatic infections in children.
Although COVID-19 is typically mild in children, some develop severe disease and hundreds have died from the illness.
The FDA is expected to make a decision on the authorization of the pediatric COVID-19 vaccines by July.
