Recent data from the American Academy of Pediatrics suggests that the COVID-19 Delta variant has caused an increase in cases among children. And even though the Food and Drug Administration (FDA) authorized the COVID-19 vaccine for children ages 12 and up in May, children under 12 are still waiting. That means life continues to be in a holding pattern while you try to balance protecting your kids with providing some sense of normalcy.
Still, things are moving in the right direction. On Thursday, Pfizer-BioNTech submitted an official application asking the FDA to authorize their vaccine for children between 5 and 11 years old. The FDA says it will move quickly and the New York Times reports that a meeting to consider it is scheduled for October 26. If approved, this would be the first vaccine available for younger children.
Last month, Pfizer-BioNTech announced that its Phase 2/3 clinical trial data show a "favorable safety profile and robust neutralizing antibody responses" against COVID-19 in children aged 5 to 11. Over 2,200 participants between 5 to 11 years of age received a lower dose of the typical two-dose regimen (21 days apart). Preliminary data show that the vaccine offered protection similar to that of teenagers and young adults. In short: the company's early data suggests evidence that the vaccine is both safe and effective in younger kids. Still, you might be asking, "How long are we talking here?"
Below, we've outlined the regulatory steps that need to happen before you can get your child vaccinated. Right now, Pfizer-BioNTech has submitted an application to request an EUA. Still, all manufacturers currently testing vaccines for younger children and other populations will eventually go through the same process.
The data has to be submitted to the FDA
At the moment, Pfizer is seeking an EUA for its COVID-19 vaccine in children aged 5 and up, something it has received for its vaccine in older age groups. An EUA is a "special consideration" that the FDA can grant during public health emergencies, like a pandemic. But the FDA won't just grant an EUA to anyone who wants it—agency officials need to carefully review the data, which then go before its Vaccines and Related Biological Products Advisory Committee (VRBPAC).
That committee will then vote on whether or not to authorize the vaccine, explains William Schaffner, MD, an infectious disease specialist and professor at the Vanderbilt University School of Medicine.
The data is then sent to the Centers for Disease Control and Prevention (CDC)
Once the FDA authorizes or approves a vaccine, it's sent to the CDC's Advisory Committee on Immunization Practices (ACIP). The ACIP, which is an independent panel of medical and public health experts, will hold a public meeting to review all the available data about the vaccine. That review will examine factors like who received it, how different groups reacted to the vaccine, and what side effects people had in clinical trials.
Based on that, the ACIP will vote on whether it will recommend the vaccine. And, if supplies are limited, the ACIP will also vote on recommendations on who should be offered the vaccine first. Only after that has happened will the vaccine be available to the public.
"The FDA and CDC need to do this for each vaccine manufacturer, for each age group tested, each time," Dr. Schaffner says.
This sounds like an involved process, but the amount of time between when the FDA grants a vaccine an EUA and when it gets the green light from the CDC is usually short. So far, the CDC has issued recommendations for using the vaccines within a few days after they've received an EUA. The most extended waiting period happens as the vaccine manufacturer gathers data to submit to the FDA and for the FDA to review it.
So, when will kids be able to get the COVID-19 vaccine
There's no set date at the moment, but it's coming. Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said on MSNBC this week that there's a "reasonably good chance" the vaccine will be available to kids aged 5 to 11 by the end of October. "I think there's a really good chance it will be before Halloween," he added.
But Dr. Russo isn't so sure about that timeline. "I think that, best-case scenario, it will be sometime in November," he says. "Before Halloween seems like a long shot."
Schaffner says that the Pfizer vaccine should be authorized for kids 5 and up "sometimes this fall," noting that fellow COVID-19 vaccine makers Moderna and Johnson & Johnson "are not there yet."
And, if you have kids under age 5, you'll need to continue to wait a bit longer. Vaccine manufactures are testing vaccines in children as young as six months, but clinical trials are still ongoing, and the data is just not ready, Dr. Schaffner says. "For the little guys, I don't think the COVID-19 vaccine will be authorized until at least 2022," he says.
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