The US could authorize COVID-19 vaccines for younger kids by Halloween, Pfizer's new timeline suggests


israel kid vaccine A boy receives the Pfizer COVID-19 vaccine in the Israeli city of Holon on June 21.

Jack Guez/AFP via Getty Images

  • Kids from 5 to 11 could start getting COVID-19 shots by Halloween, Pfizer's new timeline suggests.
  • The company expects to submit data to the FDA for this younger age group in early October.
  • Pfizer is testing a lower dose of its vaccine among young kids to avoid unnecessary side effects.
  • See more stories on Insider's business page.

Though daily vaccination rates are decreasing again in the US, Pfizer recently offered hopeful news: Its COVID-19 vaccine could get authorized for kids ages 5 to 11 by the end of next month.

Under the best-case scenario, children in this age group might be able to start receiving COVID-19 shots by Halloween, Scott Gottlieb, a former Food and Drug Administration Commissioner who serves on Pfizer's board, told CBS News on Monday.

During an investor conference on Tuesday, Pfizer's Chief Financial Officer, Frank D'Amelio, outlined a similar schedule. Here's how that timeline could look:

  • Late September: Pfizer's clinical trial will show whether the shots are safe and effective for kids ages 5 to 11
  • Early October: Pfizer will submit that trial data to the FDA
  • Late October: The FDA could authorize COVID-19 shots for emergency use among kids ages 5 to 11
  • Early November: Pfizer will submit trial data for kids between 6 months and 5 years old to the FDA
  • Late November: The FDA could authorize the shots among kids between 6 months and 5 years old

Moderna, meanwhile, expects to have data about its vaccine's efficacy among young kids later in the fall or early this winter.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN's Jake Tapper on Tuesday that we might even see the FDA authorize both the Moderna and Pfizer shots for kids before the winter.

"There will be enough data to apply for an emergency use authorization both by Pfizer, a little bit later by Moderna," Fauci said, adding, "I believe both of them - with Pfizer first - will very likely be able to have a situation where we'll be able to vaccinate children. If the FDA judges the data sufficient enough, we could do it by the fall."

Morgan Stanley analysts recently estimated that Moderna could produce data for kids ages 6 to 12 around one or two months after Pfizer. Moderna data for kids 6 months and older would then be available in late 2021 or early 2022, the analysts said.

Johnson & Johnson is on a slower timeline. The company won't start studying its vaccine among children ages 12 to 17 until this fall. If the shot is shown to be safe and effective among older kids, J&J could then start enrolling 2- to 11-year-olds in its trial, followed by children younger than 2. That means a single-dose shot likely won't be available to kids until sometime in 2022.

Vaccines can reduce severe disease among young kids coronavirus back to school kids A mother walks her child to school on the first day of in-person classes at Baldwin Park Elementary School in Orlando, Florida, on August 21, 2020.

Paul Hennessy/NurPhoto via Getty Images

A recent study from the Centers for Disease Control and Prevention found that unvaccinated adults in the US are 11 times more likely to die and 10 times more likely to be hospitalized from COVID-19 than those who are fully vaccinated. In addition to offering kids protection, vaccinating them will probably make it harder for the virus to spread in the general population - particularly now that in-person school has resumed.

"Our fundamental problem is we don't have enough adults immunized right now, and we don't have approval for the kids," Chris Beyrer, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, told Insider. "Until that changes, we're going to have ongoing transmission [at] unacceptably high rates."

Right now, just 54% of all Americans are fully vaccinated. If all 48 million children under 12 were vaccinated in the US, that figure would rise to around 68%.

Young children may receive a lower dose children covid-19 vaccine

Francine Orr /Los Angeles Times via Getty Images

Since the FDA has fully approved Pfizer's vaccine for people 16 and older, pediatricians can legally prescribe the shot for "off-label" use in young kids. But health officials have warned not to do so yet.

Children tend to develop more intense side effects after vaccines than adults, likely because their immune systems rev up quickly. So Pfizer and Moderna are each testing a lower dose of their vaccines among kids to avoid unnecessary side effects.

So far, Pfizer's phase-one trial has indicated that the lower dose - 10 micrograms, instead of the 30 given to adults - is safe among children ages 5 to 11. The trial administered an even smaller dosage, 3 micrograms, to children ages 6 months to 5 years, who seemed to tolerate it well.

Moderna is similarly comparing its standard dose (100 micrograms) with lower doses for all age groups. Children ages 2 to 12 in the trial are receiving either 50 or 100 micrograms, and kids between 6 months and 2 years are receiving either 25, 50, or 100.

Once vaccines are authorized for kids, parents might be able to talk to their doctors about options outside of the standard two-dose regimen on a case-by-case basis, Gottlieb told CBS News.

"There's different ways to approach vaccination," he said. "You could go with one dose for now. You could potentially wait for the lower dose vaccine to be available, and some pediatricians may make that judgment. If your child's already had COVID, one dose may be sufficient. You could space the doses out more. So there's a lot of discretion that pediatricians can exercise."

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[Author: [email protected] (Aria Bendix)]


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