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From enlisting doctor's offices to school clinics to drive-through vaccination sites, public health officials are tasked with using their creativity to ensure as many adolescents can receive the Pfizer COVID-19 vaccine as desired.

Indeed, the FDA's decision to expand the vaccine's emergency use authorization (EUA) to include children ages 12 to 15 raised a host of logistical questions for the public health officials responsible for making it happen.

At a media briefing Monday, FDA officials noted how state licensing boards, and local rules and regulations, may affect who is allowed to administer vaccines to adolescents, as "terms of agreement may vary from state to state."

"Our authorization is for across all of the United States, so it applies everywhere," said Peter Marks, MD, PhD, director of FDA Center for Biologics, Evaluation and Research at the briefing.

"It's just who can administer a vaccine may vary from jurisdiction to jurisdiction," he said. "It may be [that] the local pharmacy is not able to."

Marks stressed that parents should be asking healthcare providers about the vaccine. At a media briefing by the Association of State and Territorial Health Officials (ASTHO) on Tuesday, officials reiterated that message.

Because pediatricians and family practitioners offices are well-known stakeholders due to the Vaccines for Children program, officials said there is a "great relationship with the pediatrics community" and primary care physicians are "ready to help and ready to have this conversation with their patients."

ASTHO President Nirav Shah, MD, noted that while states have been planning and preparing for how to vaccinate adolescents, they also need to address parents and guardians, especially with recent research revealing a low percentage of parents would consent to getting their kids a COVID-19 vaccine.

He broke parents up into four groups: ones motivated to get the vaccine, ones who would get it only if it was convenient for their children, ones with lots of questions about the vaccine, and ones who are not in favor of vaccinating.

In all these groups, the role of primary care providers is "critical," Shah added, saying states are "grappling with things like consent."

And it's not necessarily just the consent of the parent. ASTHO said vaccination also requires the "assent" of the child, meaning the child should agree to get vaccinated.

Shah suggested conversations with providers, educators, and parents to get them ready to go through the consent process so kids can get vaccinated. While consent is more extensive in a pediatrician's office, Shah pointed out that in Maine, a parent is not required to be onsite and present during vaccination, which helps facilitate vaccination in school-based clinics.

"We can get a parent on the line, and [they] can give verbal consent over the phone," he said.

Tackling Logistical Challenges

In addition to issues with consent, the "unique properties of the Pfizer vaccine introduce logistical challenges," Shah said. Public health officials are faced with the challenge of "breaking up" the lots of vaccine, so smaller providers can administer it and not waste vaccine. For sites who lack deep-freezing capability, using dry ice is an alternative so vaccination can take place in the community.

"One of the things our colleagues across states have been discussing ... is a need for smaller packaging to accommodate smaller venues of administration," he said, noting breaking up the lots and redistributing them "takes a fair amount of effort."

Shah said as the vaccine begins to become available, they will be utilizing existing vaccination sites, and working with larger pediatric sites. He added there may even be some sites that have vaccinated all the adults who want to be vaccinated, and can now switch their focus to adolescents.

The CDC Advisory Committee on Immunization Practices (ACIP) will meet on Wednesday to vote on recommending the Pfizer vaccine for adolescents ages 12 to 15. If recommended, FDA officials said on Monday that they could expect "shots in arms" for this population by Thursday.

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