Pediatric vaccine program likely to be up and running by Nov. 8

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend the Pfizer-BioNTech Covid-19 vaccine, BNT162b2, for all children ages 5-11 years of age.

ACIP’s recommendation reads as follows: “The Pfizer-BioNTech Covid-19 vaccine is recommended for children 5-11 years of age in the U.S. population under the FDA’s Emergency Use Authorization.”

ACIP’s decision comes four days after the FDA granted an emergency use authorization (EUA) for a two-dose regimen of the BNT162b2 vaccine for all kids ages 5-11. Those shots are authorized to be given on the same dosing schedule as for adults—with the second shot following 21 days after the first and a recommended 15-minute observation period after each shot in case of adverse reactions to the vaccine—but at a dose of 10 μg, or one third the dose approved for ages 12 and older. The CDC noted that the vaccine’s manufacturers have taken steps to differentiate the age 5-11 vaccines from those for older patients, with the children’s doses coming in an orange-capped vial and the doses for ages 12 and up coming in vials with purple caps.

The American Medical Association reacted quickly to the ACIP decision, issuing a statement praising the action.

In the prepared statement, AMA President Gerald E. Harmon, MD, called ACIP’s vote “a critical step toward protecting this population from Covid-19 infections and ensuring widespread vaccination in the United States. We look forward to the final recommendation of the CDC director on use of the vaccine, which is the final step in a comprehensive, evidence-based, transparent process to ensure vaccines are safe and effective for children in this age group. We urge all parents to get their children vaccinated as soon as they are eligible. While there is overwhelming scientific evidence showing the Covid-19 vaccines are safe and effective, we know many parents and families still have questions. We encourage parents to speak with their child’s physician and review trusted resources, such as getvaccineanswers.org, to get the information they need to make an informed decision.”

The FDA’s authorization was based on findings from the manufacturers’ phase II/III study of the BNT162b2 vaccine for kids ages 5-11 years, which found that kids in this age group achieved vaccine efficacy of over 90% against confirmed Covid-19 infection, with similar side effects to those seen in adolescents and adults—pain, swelling, and erythema at the injection site, as well as fever, fatigue, headache, chills, myalgia, arthralgia, and lymphadenopathy.

Now, with ACIP’s vote, a final decision from Covid-19 Response Team member and CDC director Rochelle Walensky, MD, MPH, is all the administration needs to begin immunizations for kids ages 5-11.

The CDC anticipates that vaccinating kids ages 5-11 years of age would accelerate the current decline in Covid-19 cases, reducing cumulative incidence nationally by about 8%, or roughly 600,000 cases, from November 2021 through March 2022. And, while vaccinating in this age group is not expected to eliminate the emergence of new SARS-CoV-2 variants, it would dampen the spread of a new strain.

ACIP member Sarah S. Long, MD, of Drexel University College of Medicine and St. Christopher’s Hospital for Children in Philadelphia—who raised several concerns over Covid-19 booster dosing in previous ACIP meetings—threw her full support behind the pediatric recommendation.

“I, believe it or not, have no questions,” Long joked, “I have just a comment: I am very supportive of this recommendation in its fullest extent, as a ’should,’ not a ’may,’ for all children in this age group. And I think we reflect that we are very grateful that Pfizer has studied this and made a dose that is tailored to do what we know works in other age groups… and I think the data support that we have one more vaccine that saves lives of children, and that we should be very confident to employ it to the maximum to do what it is meant to do, without significant concerns of serious adverse events. So, I couldn’t be more supportive.”

Immediately after the FDA’s authorization on Friday, the Biden Administration began to kick it’s child Covid-19 vaccination program into gear, getting 15 million doses of BNT162b2 rolled out to distribution centers, Jeff Zients, the White House Coronavirus Response Coordinator, explained in a press briefing Monday.

“While vaccinations may start later this week, the program will still be ramping up to its full strength, with millions more doses packed, shipped, and delivered, and thousands of additional sites coming online each day,” he said. “So, starting the week of November 8th, the kids’ vaccination program will be fully up and running. Parents will be able to schedule appointments at convenient sites they know and trust to get their kids vaccinated. And the number of sites will continue to increase throughout the month as more vaccine sites open their doors and administer vaccine. “Bottom line: We have been planning and preparing for this moment,” he added. “We are ready to execute… And starting the week of November 8th, our vaccination program for kids ages 5 through 11 will be running at full strength.”

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According to a CDC presentation given at the ACIP meeting, most jurisdictions anticipate that the majority of children will be vaccinated by their pediatricians, a projection that jibes with survey data suggesting nearly 63% of 1,028 parents surveyed noted a preference to have their child vaccinated at their regular doctor’s office.

In addition to setting up pediatric offices to administer shots, the CDC plans to provide guidance to school districts to facilitate partnerships with health departments, pharmacies, and other pediatric providers to hold school-located vaccine clinics. Over 100 children’s hospitals across the country are also lined up to set up vaccination sites in an effort to increase vaccine access for kids with underlying medical conditions.

When it comes to administering the BNT162b2 vaccine in this age group, some questions remain—notably, while previous safety monitoring efforts identified a small risk for myocarditis and pericarditis in male adolescents and young adults post-vaccination, that trend was not observed in the 5-11 age group, and baseline risk for myocarditis is generally much smaller in kids ages 5-11 compared to ages 12-17. However, the manufacturer also acknowledged that their vaccine trial in this group was not powered to assess myocarditis risk. As a result, the CDC was not able to conduct a full benefit-risk analysis for myocarditis post-vaccination in this age group.

And, the CDC noted, it remains to be seen whether parents will get their children vaccinated—results from a CDC survey of 1,000 parents of kids in this age group found that only 57% stated they would “definitely” (35%) or “probably” (22%) get their child vaccinated, and 37% cited fear of side effects as the reason they did not want their kid to receive the shot.

As the White House Covid-19 Response Team emphasized in their Monday press briefing, primary vaccinations remain the most effective method for protecting both kids and adults from Covid-19.

“As I’ve said before, vaccinating our children is one way that we can protect them from Covid-19… [but] we must continue to do all that we can to protect them today in our homes, schools, and communities. This means surrounding children with adults who are vaccinated to protect them against Covid-19 hospitalization and death,” Walensky said. “Currently, over 60 million Americans who are eligible for vaccination remain unvaccinated. If you have not yet been vaccinated, I encourage you to do so.”

In the meantime, she added, it is important for the public to keep wearing masks in public spaces, staying home when sick, and washing hands frequently.

“For many families, the possibility of vaccines for our children will provide a great deal of comfort with every dose administered,” she noted. “Parents should feel comforted not just that their children will be protected but that this vaccine has gone through the necessary and rigorous evaluation that ensures the vaccine is safe and highly effective.”

The AMA’s Harmon added that ensuring equitable access to the vaccine among all children will be “critical” for dismantling disparities in Covid-19 outcomes in this age group. He also urged any physicians that have not yet signed up as Covid-19 vaccine providers to do so as soon as possible, calling on them to “reach out to their state or local immunization program to help ensure a smooth and quick rollout of the vaccine to all children.”

John McKenna, Associate Editor, BreakingMED™

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