June 9, 2022 -- Parents anxiously awaiting official word that they can vaccinate their children under 5 years of age against COVID-19 could find relief as early as the week of June 20, U.S. officials announced today.
It all depends on whether the FDA decides to grant emergency use authorization (EUA) at a meeting scheduled for June 14 and 15, followed by CDC recommendations for use expected on June 17 or 18.
"We have waited a long time for this moment -- more than 2 years into the COVID-19 pandemic and after nearly 18 months since the first set of vaccines became available for adults," Ashish Jha, MD, White House COVID-19 Response Coordinator, said during a June 9 White House COVID-19 Response Team press briefing.
Although not willing to speculate on how both agencies might act, the White House already pre-ordered 10 million doses of the Pfizer-BioNTech and Moderna mRNA vaccines for this age group. White House officials are also ramping up partnerships with community organizations; alerting pediatricians, family physicians, and pharmacists to be ready; and preparing an educational campaign to fight vaccine misinformation and to help educate parents about the safety and efficacy data behind these vaccines.
Unlike the authorization in 5- to-11-year-old children, this time the FDA and CDC are considering two vaccines at once.
"While we are going to make [vaccines] widely available across a variety of different locations and channels, my suspicion is a lot more parents are going to get their kids vaccinated in physician offices," Jha said.
Successful vaccination in this age group will rely in part on community partnerships and on education by "trusted messengers," which include pediatricians, family physicians, nurses, and other health care professionals, said U.S. Surgeon General Vivek Murthy, MD. "Our nation needs your help ... to keep our youngest ones safe. Your role could not be more vital right now."
Parents Want to be 'Absolutely Sure'
Parents are "understandably cautious" about vaccinating children in this youngest age group, Murthy said. "I say this as a parent myself of a 4-year-old. They want to be absolutely sure that they've got the right information."
"Us parents want to ensure that anything we are giving our children has gone through a rigorous scientific assessment, and that it is both safe and effective," Murthy said.
It may take more than one conversation with a trusted messenger to reassure some parents, Murthy said, and the planned national public education campaign could help answer many questions parents might have. But at the same time, more than 30,000 children under age 5 in the U.S. have been hospitalized with COVID-19 and almost 500 deaths have been reported in this group.
Regarding reassurance, "The data on kids over 5 and vaccines is clear. Kids are better protected, and they are better off, if they're vaccinated,” Jha said.
Wide Availability, Equitable Access
Dawn O'Connell, U.S. Health and Human Services Assistant Secretary for Preparedness and Response, joined Jha and Murthy at the briefing. Pre-ordering the 10 million vaccine doses, she said, "allows us to [provide] communities with enough vaccine so that it is readily accessible and equitably distributed across the country."
"We also have states and other partners to ensure equity, giving priority to sites that will vaccinate children at highest risk for severe COVID-19 disease," O'Connell said.
Murthy agreed about the importance of this approach. "As before, we will ensure that equity is at the center of our approach as we work hard to get vaccines to our hardest hit communities."
Anticipation -- for Now
Again, everything at the moment is riding on the FDA and CDC decisions.
"We are not in the predicting business, we're in the planning business," O'Connell said. "Our teams are hard at work planning for the possibility that the FDA and CDC will give the green light in the near future. Our objective is clear: to be ready to swiftly and efficiently deliver vaccines for kids under the age of 5 to communities nationwide."
Jha said we could soon be witnessing a milestone.
"Let's actually take a moment to understand what a historic moment it is if the FDA and CDC recommend these vaccines. 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."
Frustrated Over Future Finances
Federal funding to support vaccinating the youngest Americans is available. But Jha said the White House can no longer wait for Congress to act and approve additional funding for next-generation vaccines and other COVID-19 resources that could be needed as early as fall.
Instead, the White House decided to take money allocated for domestic testing manufacturing and stockpiling personal protective equipment (PPE) and move the funding toward vaccines and therapeutics, as The Washington Post reported on June 8.
"What you heard yesterday was us making a series of very painful decisions, taking resources away from what we think are vital programs to make sure that we're at the table when it comes to purchasing the next generation of vaccines, to make sure that we have enough therapeutics for Americans as we get into the fall and winter,” Jha said.
"These are very, very difficult choices," he said.
"We learned in prior public health emergencies that when we fail to sustain our attention and funding to public health interventions, the cost of that failure can be measured in illness incurred and lives lost."
Jha noted that there is a misperception "some people have that because we're in a better place, we don't have to fund this anymore." Instead, he said the opposite is true. "We've demonstrated that we can get the country to a better place, he added, and "it's particularly important that we keep and sustain that effort to get us through the rest of this pandemic."
"The bottom line here is these are not the tradeoffs that we should be having to make at this point in the pandemic," Jha said. "We shouldn't have to choose between testing and vaccines. We should be able to do both. We can do both, but we do need Congress to step up and be a partner in this effort."