‘This Is Politics, Not Science’: White House, CDC Prepare to Vaccinate 5- to 11-Year-Olds Prior to FDA Authorization

Via Children’s Health Defense

The White House today unveiled plans to roll out COVID vaccines for children ages 5 to 11, even though vaccine safety experts — who advise U.S. drug regulators and review safety and efficacy data — have not met to discuss whether Pfizer’s COVID vaccine should be authorized for use in the pediatric age group.

The Biden administration said it will secure enough vaccine doses to vaccinate the 28 million children ages 5 to 11 who would become eligible if the vaccine is authorized for that age group, CNN reported.

The White House will also help equip more than 25,000 pediatric and primary care offices, hundreds of community health centers and rural health clinics as well as tens of thousands of pharmacies to administer the shot.

Jeff Zients, White House COVID-19 response director, said 15 million doses will be ready to ship within a week after the vaccine is authorized, with millions of additional shots coming each week thereafter.

“We know millions of parents have been waiting for [a] COVID-19 vaccine for kids in this age group,” Zients told reporters during a COVID briefing. “And should the FDA and (U.S. Centers for Disease Control and Prevention) authorize the vaccine, we will be ready to get shots in arms.”

Zients said kids have different needs than adults and “our operational planning is geared to meet those specific needs, including by offering vaccinations in settings that parents and kids are familiar with and trust.”

The administration said it is launching a partnership with the Children’s Hospital Association “to work with over 100 children’s hospital systems across the country to set up vaccination sites in November and through the end of the calendar year.”

The administration plans to make vaccination available at school and other “community-based sites” with help from Federal Emergency Management Agency funding.

The U.S. Department of Health and Human Services (HHS) will also carry out a national public education campaign “to reach parents and guardians with accurate and culturally responsive information about the vaccine and the risks that COVID-19 poses to children.”

As has been the case for adult vaccinations, the administration believes trusted messengers — educators, doctors and community leaders — will be vital to encouraging vaccinations, according to U.S. News & World Report.

The White House began laying the groundwork with states earlier this month, asking governors to enroll pediatricians and other providers in vaccination programs so they could start administering shots as soon as they were ready.

“In the era of Delta, children get infected as readily as adults do, and they transmit the infection as readily as the adults do,” Dr. Anthony Fauci, White House chief medical advisor, told reporters Wednesday. “We may not appreciate that, because about 50% of the infections in children are asymptomatic.”

According to the American Academy of Pediatrics, less than 2% of children known to be infected by the coronavirus are hospitalized, and less than 0.03% of those infected die.

As The Defender reported in June, experts testifying before the FDA, when it was considering authorizing Pfizer’s vaccine for 12- to 15-year-olds, argued the risks did not outweigh the benefits, even for that older age group.

Vaccinating children for the benefit of adults is an “unproven hypothetical benefit,” Peter Doshi, Ph.D., associate professor University of Maryland School of Pharmacy and senior editor of The BMJ, told the FDA.

Doshi reminded FDA officials they cannot authorize or approve a medical product in a population unless the benefits outweigh the risks in that same population.

“If the FDA does not have a high bar for EUAs [Emergency Use Authorization] and licensing, the point of regulation is lost,” Doshi said.

Vaccine advisers to the FDA aren’t scheduled to meet until Oct. 26 to consider Pfizer’s request to authorize its vaccine for children ages 5 to 11. In the meeting, the advisers will review the companies’ data and FDA’s own assessment, then vote on whether the FDA should grant EUA.

The CDC will convene its committee of independent vaccine experts on Nov. 2 and 3 to set official recommendations for the vaccine’s use.

If authorized, this would be the first COVID vaccine for younger children. The Pfizer-BioNTech vaccine is currently approved for people age 16 and older and has emergency authorization for children ages 12 to 15.

CDC issues guidance on administering Pfizer-BioNTech vaccine to kids ahead of meeting

The White House isn’t alone in making plans to vaccinate 5- to 11-year-olds official in advance of the vaccine being authorized for that age group. The CDC last week issued guidance outlining key aspects of a COVID vaccination program for children younger than 12 years old “designed to inform jurisdictional planning under the assumption of FDA authorization and CDC recommendations of at least one COVID-19 vaccine product for children of this age.”

The CDC’s “Pediatric COVID-19 Vaccination Operational Planning Guide” includes details about the anticipated Pfizer-BioNTech vaccine — though it may be updated as other manufacturers submit applications for FDA review — and is based on “current facts and planning assumptions.”

In the document, the CDC lays out the differences between the pediatric vaccine and adult vaccine, gives detailed product configuration and provides a distribution strategy.

In addition, the CDC informed providers the Public Readiness and Emergency Preparedness (PREP) Act and PREP Act Declaration issued by the HHS Secretary “authorize and provide liability protections to licensed providers and others identified in the declaration to administer COVID-19 vaccines authorized by FDA, including COVID-19 vaccines authorized for administration to children.”

Beginning Oct. 20, states and other jurisdictions will be able to preorder doses of the Pfizer-BioNTech COVID vaccine formulated for children ages 5 to 11, according to the CDC’s federal planning document. The orders are in anticipation of a rollout that could begin as early as Nov. 3.

The CDC said jurisdictions should be ready to vaccinate children 5–11 years old shortly thereafter pending FDA authorization and CDC recommendation.

“By the White House already purchasing 65 million pediatric doses of the Pfizer-BioNTech vaccine, and the CDC putting out guidelines ahead of FDA authorization — let alone, a recommendation by its own Advisory Committee on Immunization and Practices — these actors are revealing the whole vaccine regulatory process to be a complete sham,” said Mary Holland, president of Children’s Health Defense in an email to The Defender.

“There could be no better way to undermine public confidence than to make it clear that this is politics, not science.”

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