WASHINGTON — The Biden administration said it’s getting ahead of the game in anticipation of the FDA’s likely authorization next week of COVID-19 vaccines for children ages 4 and under.
“We’ve waited a long time for this moment, more than 2 years into the COVID-19 pandemic,” Ashish Jha, MD, MPH, White House COVID-19 response coordinator, said during a Thursday morning press briefing. “And after nearly 18 months since the first set of vaccines became available for adults, we are on the cusp of having safe, highly effective vaccines for kids under 5.”
“If the FDA and CDC recommend these vaccines, this would mark an important moment in the pandemic. 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,” he added.
The FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to meet next Tuesday and Wednesday to discuss whether to recommend emergency use authorization (EUA) for the Moderna vaccine for children ages 6 months to 5 years, and for the Pfizer vaccine for children ages 6 months to 4 years. The committee could recommend authorization for one of the vaccines, for both, or for neither, with the FDA expected to act on the matter a few days after its advisory committee meets. The committee will also consider recommending the use of the Moderna vaccine for children ages 6 to 17 years.
The CDC’s Advisory Committee on Immunization Practices is scheduled to meet next Friday and Saturday to discuss any FDA action that may have occurred, and then CDC Director Rochelle Walensky, MD, MPH, will make her recommendations shortly after those meetings.
“So what does this mean for you if you’re a parent or a pediatrician?” Jha said. “Realistically, it means we could see shots in arms of kids under 5 as early as the week of June 20,” although with that Monday being the federal Juneteenth holiday, many pediatricians’ offices may be closed, “so we think that vaccinations would really start in earnest on Tuesday, June 21.”
In the event that both vaccines are authorized — which is considered likely — the White House has taken several steps to prepare, including allowing states, tribes, territories, community health centers, federal pharmacy partners, and physician practices to pre-order the vaccines. The administration is making 10 million doses available, split evenly between Pfizer and Moderna; the Moderna vaccine requires two doses, while Pfizer requires three. In the first round of pre-ordering — for which 5 million doses were available — 58% of the Pfizer allotment was pre-ordered, as was 34% of Moderna, a senior administration official said on a call with reporters Wednesday night.
“We saw some states and jurisdictions only order Moderna; we saw some states and jurisdictions only order Pfizer,” the official said. “And, of course, this is just in those first early days — the second wave of ordering is going to allow these states and jurisdictions to come back and balance out.” The second wave of vaccines will become available next week. A White House fact sheet noted that “to ensure that we are able to reach a broad range of pediatric providers — including those in smaller practices and in rural settings — vaccines will be available in package sizes of 100 doses and will come with all of the supplies that health care providers need to serve younger kids, including small needles.”
“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,” the fact sheet said. “More than three in four children under the age of 5 receive their flu vaccine in a doctor’s office. Well-patient visits are also an opportunity for pediatric providers to conduct recommended screenings and provide counseling.”
“We are also ready to leverage federal programs that serve parents and families,” a senior administration official said on the Wednesday call. “We’re going to be reaching out to millions of children and their parents and guardians nationwide through WIC [the Women, Infants, and Children program] and SNAP [the Supplemental Nutrition Assistance Program], through Head Start and childcare programs, through [federally] supported housing, and Medicaid, and CHIP [the Children’s Health Insurance Program].”
The fact sheet noted that the administration “will also work with state and local public health departments and others to ensure that every child — including those who may not have a pediatrician or primary care provider — has access to the vaccine. And, the administration will work with states and other entities to make vaccinations available at convenient hours … including after school and evenings, and on weekends.”
Although administration officials have been warning Congress that vaccine funding may run dry unless more money is authorized, that won’t be an issue with this round of vaccines, Jha told MedPage Today during Thursday’s press briefing. “The good news is, because of prior funding from Congress, we have secured enough vaccines and we have the resources to get these vaccines out to the American people,” he said. “We’ve been very clear that because of those resources, we can get every child who wants to be vaccinated, every parent who wants to vaccinate their kid, vaccinated now.”
“The challenge … is really about what’s going to happen in the fall,” he continued. “We do not have enough … vaccines for every American for the next generation of vaccines.” The White House has asked Congress for $22.5 billion “because what that will do is allow us to get enough vaccines for every American, to make sure that we have enough therapeutics, to make sure that we actually can continue the domestic manufacturing, [and] just make sure we have enough testing supply. So, those resources are still what are essential.”