Charlie Crist urges swift FDA approval of COVID-19 vaccines for kids under 12

charlie crist
'Issuing an emergency authorization for school-aged children under 12 would be prudent.'

U.S. Rep. Charlie Crist is calling on the Food and Drug Administration to authorize a COVID-19 vaccine for children under 12.

In a letter sent Monday to FDA Acting Commissioner Janet Woodcock, Crist noted rising impacts of the COVID-19 virus on school-aged children, many of whom remain ineligible for vaccines.

“As of Sept. 2, over five million cases were reported in children, representing 15.1 percent of total nationwide cases. This alarming increase in child cases is in large part driven by the lack of an approved vaccine for children, combined with the return of in-person learning,” Crist wrote. “Social isolation, missed school, difficulties finding affordable childcare, and the added stress of the pandemic have profoundly affected families over the past 18 months.”

Woodcock released a statement Friday answering questions about the approval process, noting clinical trials are underway but cautioning there is still work to be done.

“Some have stated that they are still enrolling, and some are still administering doses or following participants. This process is expected to include a follow-up period of at least about two months to allow for proper safety monitoring following the administration of vaccine doses for at least half of the clinical trial vaccine recipients,” Woodcock wrote.

Still, Crist, , who represents parts of Pinellas County, urges expedience.

“I understand that the Food and Drug Administration (FDA) has been working hard to approve a COVID-19 vaccine that is safe and effective for children under 12. As you can imagine, parents are eager for the FDA to reach a favorable conclusion as soon as possible, consistent with FDA’s gold standard scientific process,” Crist wrote. “At the same time, many are worried that a vaccine may not be available before the end of the calendar year, given reports that the FDA is requesting manufacturers extend and expand their trials.”

“I would urge the FDA to carefully consider the costs and benefits of expanding the trials, rather than using existing data from the initial cohort,” he continued.

Currently, vaccines are available to children 12 and older, leaving most middle school students and all elementary and pre-K students unable to obtain vaccinations.

There is a demonstrated desire to change that. Parents across the nation have been scrambling to find ways to vaccinate their young children despite the lack of approved vaccines for kids under 12, The New York Times reported Saturday.

Most seek clinical trials, but some are pleading with pediatricians to use off-label vaccines meant for adults. The FDA discouraged that trend on Friday.

But Crist notes parents are increasingly desperate for additional protection for their children, especially as case counts rise among young children, including an infant death reported just Monday.

“Community leaders, health officials, parents, teachers, and school administrators have been working to create safe, in-person learning environments for our children. While there are things we can do right now to keep children safe, including requiring vaccinations for adults who work with children and wearing masks indoors at schools, nothing compares to a safe, effective COVID-19 vaccine,” Crist wrote.

He also reminded children could spread the virus to more vulnerable adults.

“With my home State of Florida struggling with its worst COVID surge to date, and our Governor recklessly playing politics with masks in schools and downplaying the importance of vaccines, there is a devastating cost to delay,” Crist continued in his letter. “In Florida, we have seen pediatric ICUs near capacity, with more than 13,000 additional deaths over the last four months. The downside risk to the rest of the country enduring a wave like Florida is frightening. In short, the delta variant has changed the stakes.”

While Crist acknowledged a COVID-19 vaccine for younger children should only be approved “should the FDA find that existing safety and efficacy data among COVID-19 vaccines in children meets FDA’s rigorous standards,” he said, “issuing an emergency authorization for school-aged children under 12 would be prudent.”

Children need to be in school and learning in a safe environment. Thank you for your consideration, and I am grateful for all of your work to help us achieve this critical goal.

It’s unlikely Crist’s letter will move the needle much, however.

“Just like you, we are eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible,” Woodcock wrote. But she added, “We have to let the science and data guide us.”

Woodcock said she “cannot offer a specific date or timeline” for when a vaccine might be approved for kids under 12. But she said, “the FDA is working around the clock to support the process for making COVID-19 vaccines available for children.”

“This process is complex and relies on robust manufacturer trials and data,” she said. “We can assure the public we are working as expeditiously as possible to meet this critical public health need, and we very much hope to have pediatric COVID-19 vaccines available in the coming months.”

Janelle Irwin Taylor

Janelle Irwin Taylor has been a professional journalist covering local news and politics in Tampa Bay since 2003. Most recently, Janelle reported for the Tampa Bay Business Journal. She formerly served as senior reporter for WMNF News. Janelle has a lust for politics and policy. When she’s not bringing you the day’s news, you might find Janelle enjoying nature with her husband, children and two dogs. You can reach Janelle at [email protected]


7 comments

  • Alex

    September 13, 2021 at 3:20 pm

    I bet Charlie wakes up every day knowing he did the right thing by leaving the GOP as it was going insane.

    Reply

    • Impeach Biden

      September 13, 2021 at 4:10 pm

      Charlie blows with the wind. Maybe he will rejoin the Republican Party one day. If he is the nominee for the Governor race I sure hope he will have Sleepy and Giggles come campaign for him. That would be a laugh a minute. Then again, I doubt any Democrat would want those two around as they would be harmful to their election chances.

      Reply

      • Alex

        September 13, 2021 at 5:58 pm

        From Google Answers;

        What does this quote from Eleanor Roosevelt mean “Great minds discuss ideas, Average minds discuss events, Small minds discuss people”?

        When the quote says “Small minds discuss people,” it means that those who discuss people as an end to itself are shallow.

        Reply

  • Aimee Hall

    September 13, 2021 at 6:12 pm

    Here are 7 at-home jobs that pay at least $100/day. And there’s quite the variety too! Some of these work-at-home jobs are more specialized, others are jobs that anyone can do. They all pay at least $3000/month, but some pay as much as $10,000.
    GO HOME PAGE HERE FOR MORE DETAILS… http://amazingjobs.tk/

    Reply

  • Tom

    September 14, 2021 at 5:35 am

    This POTUS # 46, has delayed now for 10 months the appointment of a full time and new FDA commissioner. We only have a 100 yr pandemic raging and he cannot identify a qualified doctor and scientist.

    Furthermore, two scientists resigned last month related to the booster being approved by WH.

    Yes Alex, you are anything but a great mind. Just a socialist. Charlie needs to ask better questions.

    Reply

  • Eve Wright

    September 14, 2021 at 4:54 pm

    Here are 7 at-home jobs that pay at least $100/day. And there’s quite the variety too! Some of these work-at-home jobs are more specialized, others are jobs that anyone can do.KJH They all pay at least $3000/month, but some pay as much as $10,000.
    GO HOME PAGE HERE FOR MORE DETAILS… http://amazingjobs.tk/

    Reply

  • Edward Lyle

    September 15, 2021 at 11:13 am

    Those DemoKKKrats sure to hate them some children. If they can’t kill them on the birthing table, they’ll shoot ‘em up with poison. If they get past that, they’ll tax them to death or kill them in the ALF’s.

    Reply

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