FDA panel recommends COVID-19 vaccine for 5 to 11 year olds (Updated)
Update, 11/3/21, 9:20 a.m. ET: On November 2, the CDC officially recommended Pfizer’s COVID-19 vaccine for 5 to 11 year olds.
Update, 10/29/21, 5:15 p.m. ET: The FDA has followed the panel’s recommendation and issued an EUA for Pfizer’s vaccine in 5 to 11 year old children. It’ll now be up to the CDC to decide whether or not to recommend the shot in that age group.
On October 26, an FDA panel voted 17-0 to recommend Pfizer’s COVID-19 vaccine for kids ages 5 to 11.
Here’s what comes next in the authorization process, the shots’ potential impact, and when they could be available for young children.
Do younger kids need COVID-19 vaccines?
While children are often among those most vulnerable to viruses, that hasn’t been the case with COVID-19 — kids have been much less likely than adults to develop symptoms, require hospitalization, or die from the disease.
“One of the few silver linings of this pandemic is that children are relatively spared,” infectious-disease physician Kawsar Talaat told Nature in September.
Nearly 100 children between the ages of 5 and 11 have died of COVID-19.
Kids aren’t immune to COVID-19, though.
According to Peter Marks, interim director of the FDA’s Office of Vaccines Research and Review, at least 1.9 million children ages 5 to 11 have contracted COVID-19, so far. Of those, more than 8,300 have been hospitalized and nearly 100 have died.
That’s 1 death per every 10,000 or 20,000 cases, compared to 1 death in 10 cases among people over age 65.
However, even if a child only has a milder case, they could still suffer from long COVID — lingering symptoms like fatigue, cough, and brain fog — so vaccination could save them from extended health problems.
“We have the prospect of … getting all of those activities back that are so important to our children.”
Vivek Murthy
Not to mention, there is the simple desire for kids not to get sick or miss time in school.
“COVID has … disrupted our kids’ lives,” U.S. Surgeon General Vivek Murthy told NBC. “It’s made school harder. It’s disrupted their ability to see friends and family. It’s made youth sports more challenging.”
“Getting our kids vaccinated, we have the prospect of protecting them, but also getting all of those activities back that are so important to our children,” he continued.
Do we need younger kids to get vaccinated?
Short answer: yes.
Even if a child is asymptomatic, they can still infect other people, so protecting them with vaccines will help hasten the end of the pandemic.
With the coronavirus evolving to become more infectious, we will need younger people to get vaccinated in order to boost population immunity and prevent the virus from surging out of control again and again.
Is Pfizer’s COVID-19 vaccine safe and effective in young kids?
According to the data we have: yes and yes.
In late September, Pfizer announced the results of a trial of its COVID-19 vaccine in kids between the ages of 5 and 11.
The trial involved about 2,200 children, and about two-thirds of them received two shots delivered three weeks apart; the rest received placebos. While the doses authorized for people 12 and older contain 30 micrograms of the vaccine, these doses only contained 10 micrograms.
One month after receiving their second dose, children displayed antibody levels on par with those of 16-25 year olds, which suggests a similar level of immunity.
The shots were also well-tolerated, with the kids reporting side effects similar to those experienced by teens and young adults (arm pain and fatigue, most commonly).
On October 22, the FDA released a more detailed review of the trial — it showed that the vaccines were 90.7% effective at preventing symptomatic COVID-19 through four months.
What about myocarditis?
Some people, usually younger men, have experienced heart inflammation (myocarditis or pericarditis) after receiving Pfizer’s and Moderna’s mRNA-based vaccines. This side effect is rare — a number of studies put it around 2 cases per 100,000 — and usually treatable.
While none of the 1,500 children in the trial who received the Pfizer’s COVID-19 vaccine experienced myocarditis, it is possible that some kids would be affected if the vaccine is distributed more widely.
The benefits of the vaccine in 5 to 11 year olds outweigh the known or potential risks.
Pfizer
However, if the shot’s 90% efficacy holds up in the “real world” — based on current rates of infection — vaccinating one million children would prevent about 33,600 COVID-19 cases and 170 hospitalizations in the four months post-vaccination, according to Pfizer.
In that same time period, 21 kids would be expected to experience myocarditis if the rate is the same in the 5 to 11 age group as it is in 12 to 15 year olds — however, Pfizer expects it to be lower, given that the dose is one-third the size.
“Given all the above, the benefits of the Pfizer-BioNTech COVID-19 Vaccine … in children 5 to <12 years of age outweigh the known or potential risks,” the company concludes.
What’s next?
On October 26, the FDA’s Vaccines and Related Biological Products Advisory Committee — an independent committee of experts that advises the FDA on new vaccines — voted 17-0 to authorize Pfizer’s vaccine for kids ages 5 to 11 (one panel member abstained).
The FDA can now choose to follow that recommendation or not. If it issues an EUA for the lower dose vaccine in that age group, the shots will be authorized for kids, but the question of whether to officially recommend them will then move to the CDC — that would most likely happen next week.
The U.S. has purchased enough shots to fully vaccinate all 28 million Americans between the ages of 5 and 11.
If the CDC decided to recommend Pfizer’s COVID-19 vaccine for kids, the U.S. can then begin distributing the shots.
On October 20, the White House announced that it had already purchased enough shots to fully vaccinate all 28 million Americans in that age group. The doses have even been divided into smaller packages along with smaller, kid-sized needles.
If everything goes as the White House hopes, shots will be going into arms by the beginning of November, with some kids fully vaccinated in time for Christmas.
Will the vaccines be mandated for young kids?
Maybe. Every state requires some shots for school (such as the measles vaccine), and a handful also require flu shots. Some school districts have mandated COVID-19 vaccine for children 12 and older, so it’s possible guardians will need to decide between vaccinating their younger kids or keeping them home from school.
But some states have introduced bills or otherwise prohibited schools from requiring COVID-19 vaccines, so it will probably depend on where you live.
The nation’s top health officials aren’t ready to share their opinion on the matter yet.
“Right now we are at authorization,” CDC Director Rochelle Walensky told Fox News. “We’re having discussions about authorization. I think we need to get children vaccinated through this authorization and get to approval before we can make a judgment there.”
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