White House outlines plans to vaccinate youngest children, pending FDA approval

The White House said Thursday it will dispatch millions of doses to states once regulators approve a COVID-19 vaccine for kids younger than 5. That decision could come within two weeks. Once approved, it would mean every age group can benefit from the shots.

President Biden and his team say eager parents will be able to get their kids vaccinated at pediatricians’ offices across America once the campaign begins, though uptake might be slow at first.

Only one-third of children ages 5 to 11 — the youngest group now eligible — have received the shots. The administration said uptake among families tends to rise gradually.

“Vaccine confidence builds over time,” said White House COVID-19 Coordinator Ashish Jha. “I remain very optimistic we’re going to get more and more children vaccinated over time.”

Officials said they did not want to prejudge the regulatory process, but said shots could reach children’s arms on June 21, or the Tuesday after Juneteenth.

“It would mean that for the first time essentially every American from our oldest to our youngest would be eligible for the protection that vaccines provide,” said Dr. Jha. “We also know it is important to do this right.”

There are several steps that must occur before doctors and clinics start administering shots. Advisers to the Food and Drug Administration will meet on Tuesday and Wednesday to consider applications from drugmakers Pfizer and Moderna.

Pfizer is proposing a three-dose regimen for children ages 6 months to 4 years that uses one-tenth of the adult dose. It released data in May that showed a preliminary efficacy of 80% after the third dose, though it was based on a small sample of symptomatic cases in the trial. A final analysis is pending.

Moderna has proposed a two-dose regimen for children ages 6 months to 5 years that uses one-fourth of the adult dose. It released data in late April that said the shots were 37% to 51% effective against symptomatic infection — a low level that is still on par with what adults would expect against the omicron variant after two doses.

The differing data and dosing could be confusing for parents, who will have to decide between two vaccines if both are approved in their current forms.

Availability may guide some of their decisions, with parents consulting with doctors and taking whatever they can get — especially if their kids are at high-risk from COVID-19 because of underlying medical problems.

Experts said some might prefer Pfizer because it has released third-dose data.

“I don’t how these parents are going to jump but here’s my prediction: The parents who are most interested in getting their kids vaccinated — they are very well-informed and would anticipate they would go for the Pfizer vaccine at this point until Moderna comes in with better data,” said William Schaffner, an infectious disease expert at Vanderbilt University.

Moderna is studying third doses in children, which should boost efficacy.

“We don’t want to taint that vaccine — make it look like it’s not as good — when we anticipate with a third dose it will be quite comparable to Pfizer,” Dr. Schaffner said.

The administration said it is planning as if both vaccines will be authorized. It will make equal numbers of the vaccines available to states and territories in an initial tranche of 10 million doses.

FDA regulators in the coming days will consider safety and efficacy data from the companies before signing off on the shots for emergency use.

Advisers to the Centers for Disease Control and Prevention will meet on June 17-18 to discuss how the shots should be used, before CDC Director Rochelle Walensky provides the final sign-off.

Some parents aren’t convinced they need to get their kids vaccinated.

A Kaiser Family Foundation poll in April found that only 18% of parents with children under 5 planned to get their kids vaccinated right away, while 38% were in a “wait and see” mode.

Another 11% said they would get their children vaccinated if required, and 27% said they would definitely not seek out the pediatric shots.

Reluctance to vaccinating the youngest children is likely fueled by the fact that COVID-19 hospitalizations and deaths in children are rare in the context of the broader pandemic — although they do occur.

U.S. Surgeon General Vivek Murthy said the federal government has documented 30,000 hospitalizations and 500 deaths.

Over a dozen Republican members of Congress asked FDA Commissioner Robert M. Califf this week if clinical trials for children were large enough and whether the vaccine needs to be given to children on an emergency use authorization, given that COVID-19’s worst outcomes tend to impact older adults. The long-term impacts of vaccination also may not be known.

“The data show that the risks of serious adverse outcomes for COVID for children five and under is very low and as such the standard for evaluating EUA interventions must be very high,” wrote Sen. Ted Cruz of Texas, Sen. Ron Johnson of Wisconsin and 16 House lawmakers. “By its very definition, a one-size-fits-all approach assumes the following: the vaccine is safe and has no unknown long-term adverse effects; that small population studies are sufficient to detect near-term acute adverse reactions among young children; and even without answers to these questions the EUA vaccine is a necessary risk to approve a one-size-fits-all approach to children who have a 99.98% COVID-19 survival rate.”

The White House says it is forging ahead.

The shots will be packaged in groups of 100 doses to suit individual doctor’s offices and rural providers.

The kits will also include smaller needles to serve younger kids.

“Pediatricians continue to be one of the most trusted sources of information about COVID-19 for parents and will play a critical role in the nationwide effort to get our youngest children vaccinated — as they are the most common, trusted location for routine childhood vaccines,” a White House fact sheet said.

The administration said shots also will be available at more than 100 children’s hospitals and health systems nationwide, which serve the nation’s highest-risk kids.

Equity would continue to be at the forefront of the federal campaign. The administration plans to promote the vaccines through Black, Hispanic and Asian American groups.

The administration said the pediatric campaign will be funded by previously authorized COVID-19 funding from Congress, as it pleads for an additional $10 billion for treatments and a likely fall booster campaign.

The administration began to shift money away from testing and protective equipment to fund future orders.

Dr. Murthy said the American public will be perplexed if Congress, which is deadlocked over a pandemic-related immigration issue, doesn’t act.

“It doesn’t make sense to people and I think that’s because it doesn’t make sense,” Dr. Murthy said.

For more information, visit The Washington Times COVID-19 resource page.