Covid-19

Despite new reports of potential efficacy, parents still have questions about a COVID-19 vaccine and...
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The Covid-19 Vaccine For Children Is Closer Than Ever

We get to the bottom of every question you have about kids and teens getting the Covid-19 vaccine.

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We’re officially in year two of the Covid-19 pandemic, and despite early warnings that vaccines could take years to develop, there are now three approved by the U.S. Food and Drug Administration (FDA) for emergency use in adults. The CDC reports that more than 488 million doses have already been administered.

So when will it be approved for kids? Older teens are already eligible in some areas. The Pfizer vaccine has been authorized for use in people ages 12 and older, and the Moderna vaccine is approved to vaccinate those ages 18 and up. Administration of the single-dose Johnson and Johnson vaccine was paused by the FDA and CDC on April 13 to review side effects concerning blood clots, but the pause was then lifted on April 23, resuming J&J shots.

And now, doses for children under the age of 12 could be available as early as Halloween, per NBC News.

Latest News & Clinical Trial Results

On September 28, Pfizer submitted data from its clinical trials to the FDA to begin reviewing for emergency use authorization (EUA) for kids ages 5 through 12. Pfizer filed their formal submission for EUA to the FDA on October 7, according to a tweet from the manufacturer. The FDA’s advisory committee will meet October 26 to review this request. In a news release, Pfizer said, “In participants 5 to 11 years of age, the vaccine was safe, well-tolerated, and showed robust neutralizing antibody responses.”

Pfizer recently announced that children ages 6 months to 5 years old were part of the 2,268 participants in the Phase 2 and 3 trials of the vaccine. Trials are done in three phases, the first to determine the ideal dosage for children in this age group, and the following two to study the vaccine’s efficacy and safety. Results for kids in this age group should be shared with the FDA as soon as the end of 2021.

Following their phase three clinical trial of 2,260 participants ages 12 to 15, Pfizer reported 100% efficacy in this teenage age group when administered the same two-shot vaccine approved for adults. On May 10, The New York Times reported the vaccine was officially approved for 12 to 15-year-olds.

When it comes to vaccinations, safety is a top concern for parents. Romper previously reported that “a vaccine safety group from the CDC is looking into reports of heart conditions developing in vaccinated teens.” Though the CDC report detailed presentations of myocarditis, or heart inflammation, in adolescents following vaccination, stating that “relatively few” experienced the side effect, that most cases are mild, and it is more common in males than females.

As Romper previously reported, Moderna announced in late May that their vaccine trials show a 100% efficacy in children ages 12 to 18. Moderna submitted data to the FDA in June for an EUA approval for kids 12 to 17, and Johnson & Johnson is still conducting trials in children of all ages, according to NBC News.

When Can Kids Under 12 Get Vaccinated?

If Pfizer’s formal EUA submission is approved, children ages 5 through 11 could begin receiving the Covid vaccine at the end of October, reports NBC News. For little ones younger than 5, the wait continues. Pfizer has not yet submitted clinical trial data on children from 6 months through 5 years old, but intends to do so at the end of the year or in early 2022.

Moderna has begun a children’s vaccine trial study through the National Institute of Allergy and Infectious Diseases that includes kids ages 6 months to 12 years old, NPR reported. The trial will include 6,750 children in the U.S. and Canada to measure the impact and efficacy of the vaccine’s two-dose shots, as well as monitor the effects of the vaccine on this age group.

Experts Weigh In On Vaccines & Kids

The high efficacy rates shown in trial phases for adults by the currently available vaccines and the beginning of vaccine trials for children mark a promising turn in the fight against Covid-19. However, the speed at which these vaccines have been developed and tested means that there is still much that researchers and physicians alike do not know about the long-term impacts of a vaccine.

To help address some of the concerns parents may have about Covid-19 vaccines and kids, Romper asked experts to weigh in on some of the biggest questions we have about the vaccine and kids.

1

How Effective Is The Covid-19 Vaccine For Kids?

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."

2

What Are The Potential Immediate Side Effects Of A Covid-19 Vaccine For Kids?

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.

3

Are There Any Known Long-Term Effects Of A Covid-19 Vaccine?

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"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."

4

How Do We Know The Vaccine Is Safe For Kids?

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.

5

How Many Doses Of The Covid-19 Vaccine Will Kids Receive?

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.”

6

Will Kids Eventually Need Booster Shots?

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.

7

Can Kids Continue Getting Their Routine Vaccinations Whether Or Not They Receive The Covid-19 Vaccine?

"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.

8

How Can Parents Approach Their Pediatricians With Questions About A Covid-19 Vaccine?

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.

9

Where Can Parents Take Their Children To Get Vaccinated?

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.

10

Are Vaccine Trials Still Ongoing For Kids Under 5?

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.

Experts:

Dr. Susan V. Lipton, MPH, Chief, Pediatric Infectious Diseases at Samuelson Children’s Hospital at Sinai Hospital of Baltimore and Chief, Section on Infectious Diseases, Maryland American Academy of Pediatrics

Dr. Bita Nasseri, Los Angeles-based physician

Dr. Niket Sonpal, New York-based internist, gastroenterologist, and adjunct professor at Touro College

Mobeen Rathore, M.D., board-certified pediatric infectious disease specialist and chief of Pediatric Infectious Disease and Immunology for Wolfson Children’s Hospital

James Schneider, M.D., board-certified pediatric critical care specialist at Northwell Health