It's not clear when babies as young as 6 months old could become eligible for the COVID-19 vaccine after federal regulators delayed their decision.

The Food and Drug Administration (FDA) announced Friday that it will wait for data on whether three doses of Pfizer's vaccine are effective in children under 5 – the only U.S. age group that isn’t eligible for one – before deciding whether to authorize two doses of the companies' vaccine.

Pfizer said in a new release that its three-dose trial in younger children should be finished in early spring, adding that the FDA's delay will give regulators more information to review. Both the FDA and Centers for Disease Control and Prevention (CDC) will need to sign off.

“Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” the companies said.

An estimated 18 million children in the U.S. are between 6 months and 5 years old, so it will be an important step forward in stopping virus spread. More than 3.5 million children tested positive in January alone, data shows, which is about 30% of all pediatric cases since the pandemic began.

And, doctors agree, vaccination remains the best way to protect individuals and people most at-risk of severe illness. Parents are encouraged to speak with their pediatrician and ask questions as they weigh the decision.

COVID vaccines for children 5+

Novant Health is already administering Pfizer's vaccine to children ages 5 to 11. Data from Pfizer's clinical trial showed its vaccine is safe and effective in children 5 to 11 – producing “mostly minor side effects” and the “same type of strong immune response,” similar to that in older populations, the company said.

Dr. David Priest
Dr. David Priest

The data is "very promising" in terms of its safety profile for children, said Dr. David Priest, Novant Health chief safety, quality and epidemiology officer.

“I think we’ll also see the COVID vaccine get incorporated into the childhood vaccination schedule, and it will be a routine part of care going forward. So, we're excited for that," Priest said.

Pfizer’s study included more than 2,000 children and “if you look back at the history of clinical trials, that’s a pretty big number. I think it’s adequate,” he added.

Keep in mind, a parent or legal guardian must provide written consent for anyone under 18 to receive a vaccine that only carries emergency use authorization from the FDA, according to North Carolina state law. Since Pfizer's vaccine has full FDA approval for those 16 and older, parental consent is only currently required for youngsters under age 16.

What side effects might children have?

Side effects (also referred to as expected effects) in children are similar to what adults experience after vaccination, including:

  • Tiredness.
  • Headache.
  • Muscle pain.
  • Fever or chills.
  • Soreness at the injection site.

These may affect children’s daily activities but will go away within a few days. Please contact your child’s pediatrician if expected effects linger.

How do I schedule an appointment?

You do not have to be a Novant Health patient to schedule an appointment. However, established patients can make an appointment at their primary care clinic, if it is available there.

The best ways to schedule an appointment include:

  1. MyChart: Anyone can create a MyChart account by visiting MyNovant.org. Legal guardians have primary access to a child’s MyChart account through age 11. To schedule a vaccination, a legal guardian can log in to their own MyChart account and select the child’s user profile. Appointment availability can be accessed under Schedule an Appointment. For children 12 and over, legal guardians may request to have proxy access to a child’s MyChart account, which includes the ability to schedule or modify appointments on behalf of their child.
  2. GetVaccinated.org: Anyone can schedule an appointment online.
  3. Pediatric clinics: Established patients are encouraged to check their pediatric clinic’s website or Facebook page to find out if their clinic is offering the vaccine and find out how to schedule a vaccine.

Is it the same COVID vaccine that adults and adolescents receive?

Yes, the only difference in Pfizer’s vaccine for ages 5 to 11 is a smaller, 10-microgram dose. That’s one-third the 30-microgram dose that adults and adolescents receive.

As in adults, the vaccine is given to younger children in two shots, administered at least three weeks apart. Both doses are necessary to get full immunity.

Additionally, an even smaller dose would be administered to children under 5, Pfizer confirmed.

How will the second dose be scheduled?

The second dose appointment will be scheduled on-site during the first dose appointment.

Will legal guardians need to provide proof of age to verify eligibility?

No. Parents will be asked to attest their child’s age.

Will children need a parent or guardian with them?

Yes. North Carolina state law requires written consent from a parent/guardian for a minor to receive a vaccine that has been granted an emergency use authorization and is not fully approved by the FDA. This includes the Pfizer COVID-vaccine.

Minors who are 16 or 17 can give their own consent for the vaccine, and written parental consent is not required because the Pfizer vaccine is fully FDA approved for those age 16 and older.

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If most children don’t get seriously ill from COVID, why should my child get vaccinated?

Aliza Hekman, PA-C
Aliza Hekman, PA-C

While COVID does not typically result in serious illness in children, Aliza Hekman, a Novant Health physician assistant who specializes in infectious diseases, noted an increase in pediatric hospitalizations during the latest surge.

Another reason to vaccinate is to slow the spread of COVID in the community. This helps protect those too young to receive the vaccine and vulnerable populations who are more likely to have serious complications.

Bottom line: The more people we can vaccinate, the more lives we're able to save.

What about parents who are still hesitant?

People age 65 and above, and those with comprised immune systems, are especially vulnerable to COVID complications, Priest said. He encourages families to focus on that.

"I tell people to consider their home situations. Who lives in the home? Immunosuppressed people? Grandparents? Someone going through chemotherapy? Getting children vaccinated is a way to protect the child and ultimately, their household," Priest said.

Hekman, also confident the vaccine is safe, vaccinated her children. "I have 3 children in the 5-11 age range who got vaccinated when they became eligible," she said.

Any there any safety concerns about administering the vaccine to children?

In rare cases, myocarditis (inflammation of the heart) has occurred after mRNA vaccines – especially in male adolescents and young adults. "But most cases have been mild and responded well to medicine and rest," Hekman said.

Myocarditis can also occur after many viral infections, including COVID. Benefits of the vaccine have been shown to outweigh the potential risks of having a rare adverse reaction to vaccination, including the possible risk of myocarditis.

Should I be concerned about future fertility for my child?

No. The mRNA technology shows cells how to make a protein – think of it as a blueprint – that triggers an immune response. And then it disappears. There is no plausible mechanism by which an mRNA vaccine could affect future fertility of children, doctors confirm.