The Covid-19 Vaccine For Children Is Closer Than Ever

Pfizer has announced that their clinical trial data found their Covid vaccine was safe and effective at creating a strong immune response in kids ages 5 through 11, and was comparable to the results in adults and adolescents. Moderna has not yet released results addressing children specifically.

When testing happened for adolescents, data found that the Pfizer-BioNTech Covid-19 vaccine demonstrated 100% efficacy in a phase 3 clinical trial involving 2,260 adolescents aged 12 to 15 years old. Not a single child in the vaccinated group became infected with the virus, and the vaccine apparently produced “robust antibody responses” in the children.

Dr. Bita Nasseri, a Los Angeles physician, says that there really isn't extensive research on how Covid affects children, except for the rare MIS-C, which occurs in less than one in 10,000 to one in 100,000 children and appears weeks after a Covid-19 infection. "It is therefore difficult to demonstrate that children will have adequate and lasting immunity from any of the vaccines yet," she explains. "Once the trials are completed and a good number of children have received the vaccine and been followed closely for any of the potential side effects, the medical and scientific community can weigh in properly."

The most commonly reported side effects of the Pfizer vaccine for kids ages 12 to 15, according to the Mayo Clinic, include pain at the injection site, fatigue, headache, chills, muscle pain, fever, and joint pain. “Similar to adults, children have side effects that typically last one to three days,” the Mayo Clinic website stated. “More adolescents reported these side effects, except for injection site pain, after the second dose of the vaccine.”

"Just like any vaccine, it is expected to cause minor symptoms of a viral infection, including low-grade fever, fatigue, body aches, and muscle soreness," Nasseri explains. Not because you're being injected with any kind of virus, but because there is a shot site where muscle soreness can occur, and because there is also some research that suggests your immune system is reacting to the vaccine and may have some of these side effects.

The CDC has reported that “relatively few” adolescents have experienced heart inflammation called myocarditis following vaccination, but still recommends that kids ages 12 and up receive the vaccine. More information should be available as the vaccine trials continue and FDA approval is sought. "Most vaccines that have been FDA-approved do not have very commonly occurring serious or life threatening side effects at anything more that one per 100,000 or one per million doses," Nasseri tells Romper.

"Since the vaccines are very new, it is possible that there are either rare reactions or also undiscovered long-term effects," Nasseri tells Romper. "Without proper long-term studies, it's hard to say what those may be and how often they occur."

With the vaccine (and even the virus itself) still in its infancy, it may be some time before any answers to this question are available. "It’s such a new virus that the vaccine has not been studied long term in anyone," Lipton says. "No one can know for sure right now."

The FDA will meet on October 26 to discuss EUA for the Pfizer vaccine for the 5 to 11 age group, but Pfizer’s clinical trials for kids did find the vaccine to be well-tolerated and effective. “We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults,” said acting FDA Commissioner Janet Woodcock, M.D. in an Oct. 1 press release.

Despite many American adults and teens receiving the vaccine already, some parents are still waiting on more information about whether the vaccine is safe for their children, too. Mobeen Rathore, M.D., board-certified pediatric infectious disease specialist and chief of Pediatric Infectious Disease and Immunology for Wolfson Children’s Hospital, told Romper in early 2021 that we should have answers by March 2021. And now we do.

“I think it will be very similar to how they did it with adults, where after the second shot we could see that data in as little as three months,” Rathore said. “It all depends on what they find and what the FDA board says, but it could be approved for children 12 and over as early as March.”

Now, the Pfizer vaccine has been approved for children over the age of 12, and Moderna has been approved for people over the age of 18. As time marches on, the safety and efficacy data will continue to accumulate for younger children as well.

The currently-approved vaccines from Pfizer and Moderna requires two doses to fully protect an adult from Covid, per the CDC, with some adults requiring booster shots as well. Will this be the same for children? And will they need to get their doses once, or annually, like a flu shot?

According to Pfizer and BioNTech, the two 10-microgram doses of their vaccine given 21 days apart administered to children ages 5 to 11 was found to be well-tolerated and “elicited robust neutralizing antibody responses” in clinical trials.

Schneider says only time will tell whether or not additional doses will be needed.

“With the currently approved Pfizer and Moderna vaccines, we still don't yet know how long immunity will last. And there are other vaccines currently still in the clinical trial phase that we have yet to determine the safety, efficacy, and therefore the duration of the immunity. That information will likely determine whether or not an annual shot will be required. It is quite possible that we will need an annual COVID shot as we currently get an annual flu shot.”

Although there is no data available to answer this particular question yet, it is worth discussing with your child's physician prior to vaccine administration. "The most important question will be how long does this vaccine confer immunity, and if it will require a repeat booster or yearly injection for new strains," Sonpal explains. As Romper previously reported, research about booster requirements for the Covid-19 vaccine is ongoing.

"Kids should absolutely get their routine vaccinations whether or not they receive the Covid-19 vaccine," Dr. Susan V. Lipton, MD, MPH, Chief of Pediatric Infectious Diseases at Sinai Hospital of Baltimore tells Romper.

Since the currently authorized vaccines have mostly been administered to adults, these subjects have likely had their adult and childhood vaccinations. "There is limited to no data currently on the interactions with other vaccinations, and the Covid-19 vaccine will come with its own safety protocols," Dr. Niket Sonpal, a New York-based internist and gastroenterologist, tells Romper.

Instrumental in protecting children from illness, it's imperative to continue vaccinations as recommended by your child's pediatrician. Nasseri calls the resurgence of infections such as measles and whooping cough "a realistic concern," to stress the importance of continuing with routine vaccinations.

During your child's next visit with their doctor, it's likely the topic of vaccines will come up. When it comes to a Covid-19 vaccine, Nasseri says, "Just like any vaccine, it is important to ask their physician if they know the data about the specific vaccine being offered."

Because the information about this specific vaccine is continuously evolving, inquiring about potential side effects and efficacy rate at the time of your visit is a good idea. Your doctor may have access to new information that you have not yet seen.

"I think the best question to always ask when you are concerned about anything recommended by your doctor is, 'Are you doing this for your own children or grandchildren?'" Lipton tells Romper. Your child's pediatrician is the best direct resource you have for specific questions about a Covid-19 vaccine and your kids.

You can also ask your child’s pediatrician about the best way to prep your child for the vaccine. Make sure they’re hydrated, relaxed, and that they aren’t feeling unwell before they go in for their shot.

Parents may be wondering whether the Covid vaccine will be available by request at their pediatrician’s office, like the flu shot, or if they’ll need to go to a special site for their shot, like a local hospital or health department. Rathore says how the vaccines will be distributed to the public depends on a lot of logistical factors, especially the vaccine’s special storage requirements.

“I think it makes the most sense to have it at the pediatrician’s office of course, but it requires a -73-degree freezer to store it in, so I don’t think many pediatricians will have that. The freezer will be the big thing,” he says.

Currently, anyone 12 and older is eligible to get a Covid-19 vaccine in the U.S.. The CDC recommends that parents search for a vaccine provider in their area by using the Vaccine.gov search portal and your zip code.

Currently, both Pfizer and Moderna have active vaccine trials for kids. Moderna’s trials are ongoing for kids under age 12 and Pfizer for kids under age 5. While each manufacturer’s requirements for trial participation varies, the process typically involves receiving the vaccine through a research facility or participating practitioner and then following up for up to a year afterward to study impacts related to efficacy and safety.

Moderna’s vaccine trial for children, which they call KidCove, has a dedicated website that allows parents to check whether or not their child is eligible for the trial through an online survey. The site details the 14-month study, which includes two injections given 28 days apart, and follow-ups via monthly telehealth appointments and six in-person visits.

Information on Pfizer’s website directs parents to search a directory of available vaccine trials (for Covid-19 and other vaccine trials in progress) to learn about what enrollment entails, view eligibility requirements, and find a designated study facility.