It’s hard to believe we are in month 20 of this global pandemic. At some point around the one-year anniversary of COVID-19 infecting our world, I wondered if there would ever be a time when we would refer to the pandemic in the past tense and read about it in history books. Cases were still soaring across the country with no decline in sight.
Then, hope was injected into our lives. The vaccine for adults was released and people across the country lined up in droves. Then in May, kids ages 12-17 were also approved for the Pfizer-BioNtech vaccine, and hope glimmered brighter. But we all wondered about our younger kids.
According to the American Academy of Pediatrics, “as of October 14, nearly 6.2 million children have tested positive for COVID-19 since the onset of the pandemic.” As parents, we have every right to be concerned, worried, and fearful for our little ones who are unvaccinated, still wearing masks, and back in school in person. We fear the worst happening to our children, even though severe cases of COVID among children appear to be not as common. We witnessed the increase of children getting COVID during the Delta Variant phase. Many parents worldwide are anxiously awaiting the opportunity for their younger kids to be vaccinated so they can return to some form of normalcy.
Now that the COVID vaccine is on the horizon for kids ages 5-11 years old, parents have a litany of questions they would like answered. Just yesterday, on October 26, the U.S. Food & Drug Administration met and the FDA’s advisory panel recommended the agency move forward with authorizing the COVID-19 vaccine for children ages 5-11.
The FDA’s advisory panel recommended the agency move forward with authorizing the COVID-19 vaccine for children ages 5-11.
In preparation of this FDA announcement, I interviewed two highly-respected pediatricians from UCLA, Dr. Tammy Peng and Dr. David Feazell, who are both experts when it comes to our children’s well-being and have witnessed first-hand the effects of the pandemic on children, both professionally and personally.
Below are Dr. Peng’s and Dr. Feazell’s informative, empathetic, and evidence-based responses to your most commonly asked questions about the release of the COVID vaccine for kids ages 5-11. Our goal is to provide parents with the necessary medical information so they can make scientifically informed decisions about the health of their children.
Q: When will the COVID-19 vaccine become available for children ages 5-11?
Peng: “The FDA (Food and Drug Administration) will be meeting on October 26th to discuss emergency use authorization for the Pfizer-BioNTech vaccine in children 5-11 years, If authorization is approved, vaccines can begin to be ordered. Vaccination cannot start until the CDC director makes recommendations on the use of the vaccine. The CDC is expected to meet on November 2-3.”
Feazell: “Following the [October 26] meeting, it is anticipated that a decision regarding the vaccine for school-age children will be made within 1-2 weeks.”
Q: When can parents expect the vaccine for children under 5 to become available?
Peng: “Pfizer has been studying use of the vaccine in children under age 5 (both groups of ages 2-5 years and 6 months to 2 years). Results of these trials have been previously reported to be anticipated in November.
For Moderna, there are ongoing studies of the use of the company’s vaccine in children under age 5, but it is unclear when these results will be available. The company has requested emergency use authorization for children aged 12-17 in early June and FDA evaluation remains pending. Moderna’s vaccine is currently authorized for people ages 18 years and older.”
Feazell: “There has not yet been any formal announcement of if/when the vaccine might be approved for younger children, but there has been some informal discussion that children older than 6 months may be able to get the vaccine 1-2 months following approval for 5-11-year-olds.”
Q: Why should children ages 5-11 be vaccinated when the vaccine becomes available, especially as data has shown that children tend to have milder cases of COVID?
Peng: “Data from reporting states is overall reassuring that for most children, COVID infection is mild. Many children have mild symptoms or no symptoms at all, but some have been hospitalized and even some have died.
Unfortunately, cases of COVID-19 infection have been increasing at an alarming rate in children. Current data from the AAP states that over six million children have tested positive for COVID-19 since the start of the pandemic. The number of new COVID cases in children has remained high with over 148,000 cases added in the first week of October and over 750,000 cases since September 2021.
From the start of the pandemic, children represented 16.3% of total cases and for the first week of October children were 24.8% of the total cases. This may be in part due to the lack of an authorized COVID-19 vaccine for children under 12 and also due to the circulation of the highly contagious delta variant.
Though infection with SARS-CoV-2 variants remains possible, COVID-19 vaccination helps to protect children from getting COVID-19 and will also help prevent spread of COVID-19. COVID-19 vaccination is effective at preventing serious illness, hospitalization, and death.
Unfortunately, all families and parents have been forced to deal with very difficult decisions to make during this pandemic. I believe parents and families all have their child’s well-being and safety in mind when facing these unprecedented challenges. My hope is that every family seizes the opportunity to learn about the vaccine and consider the risks and benefits of the vaccine for their child and their family. I encourage families to reach out to their primary care providers and discuss any concerns or questions they may have regarding the vaccine.”
Feazell: “The decision to vaccinate a child is a personal decision. As with any medical decision, I encourage my patients/families to weigh risks/benefits when deciding what is best for them. It is correct (although not always widely acknowledged) that the risk of complicated illness from COVID in otherwise healthy pediatric patients is extraordinarily low. It is a reasonable observation to note that the medical benefits of vaccination are not nearly as high for a healthy child as they are for an elderly person or someone with a high-risk medical condition.
However, the non-medical benefits of being vaccinated will likely be significant even for young people. It is my expectation and hope that vaccinating kids will allow us to look forward to a happier and more fulfilling quality of life with less reason for concern in regards to masking/testing/quarantining/etc (not to mention less anxiety and worry for many parents and children as well).
With all of that being said, if the vaccine is safe and effective (as we anticipate), I expect that for the vast majority of families, choosing to be vaccinated will allow their families to move forward with their best health (in a holistic sense of the word).”
Q: There are parents who may be hesitant with giving their children the vaccine when it initially becomes available, can you explain the authorization process?
Peng: “The COVID-19 vaccines were developed quickly but without sacrificing any steps in ensuring safety or efficacy. While SARS-CoV-2 was a new virus, it belongs to a family of coronaviruses with similar traits that have been studied. As a result, scientists already knew that the spike protein could be a target for vaccines. mRNA vaccines, in particular, have been researched for decades and scientists were able to tailor the use of this technology to the spike protein for SARS-CoV-2. Vaccine clinical trials were organized quickly and participants were enrolled rapidly given public interest. Since the virus was also spreading quickly, regulators were able to see if the vaccine candidates made a difference in a shorter time frame.
Manufacturing facilities were built in anticipation prior to approval though this is something that is not typically done until licensure is already expected. The FDA compressed the review timeline from an estimated six to nine months to weeks thanks to people working on parallel teams that were working nights, days, and weekends.
The authorization and approval process for vaccines in the U.S. involves clinical trials where laboratories independent from vaccine companies or the government study the safety and efficacy of a vaccine. The FDA then assesses the risks and benefits of a vaccine and approval of a vaccine occurs only if the benefits of a vaccine are greater than the risks for those being vaccinated. Even after authorization and approval occur, monitoring continues for adverse effects. If problems are linked to a vaccine, the administration of the vaccine may be paused. The FDA has strict guidelines for vaccine manufacturers so that vaccine doses are tested to ensure consistency and reliability in the quality and effectiveness.
There are 72.8 million children under the age of 18 representing 22% of the US population. Children under 12 represent 14.5% of the population. Currently, 13.4 million (57% 12-17-year-olds) have received one dose of the vaccine and 11.1 million (47%) have received two doses and are considered fully vaccinated.”
Feazell: “It is completely understandable and reasonable for parents to have questions about any medical treatment for their children. The process for authorization of vaccines for children is nearly identical to that which was undertaken for adults. The vaccine manufacturer completes rigorous trials for a certain population and provides government regulators with the results of those studies. The expert panels (at the FDA and CDC) review the data to ensure strong evidence of both safety and efficacy and subsequently approve treatments/vaccines that they believe meet the standards which they have set.”
Q: What, if any, side effects can there be with either vaccine for children? What warning signs should parents be aware of if they choose to vaccinate their children?
Peng: “Side effects have been reported to be similar to other vaccines and to side effects reported in prior age groups receiving the vaccine. Side effects may include arm soreness, fatigue, redness at the site of injection, fever, chills, headache, muscle soreness, or aches. These symptoms are usually mild to moderate in severity and are temporary. Side effects may be worse after the second dose in some. Severe allergic reactions or anaphylaxis to the vaccine has been reported, but has been rare.
A small number of adolescents and young adults have experienced mild inflammation of the heart (myocarditis) after getting the COVID-19 vaccine. However, research shows greater risk of this condition with COVID-19 infection than those who receive the vaccine. There is no evidence that COVID-19 vaccination affects puberty, reproductive development, or fertility side effects.”
Feazell: “We do not anticipate any serious vaccine reactions for young children. The experts at the CDC/FDA will certainly review all available data prior to potentially approving the vaccine, but at this time I would not expect any issues for the vast majority of patients beyond the routine side effects like low-grade fever or soreness at the injection site.”
Q: Are there any circumstances as to when a child ages 5-11 should NOT be vaccinated?
Peng: “The CDC has identified the following contraindications for vaccination to the Pfizer-BioNTech COVID-19 vaccines: severe allergic reactions after a dose of mRNA COVID-19 vaccine or its components, an immediate allergic reaction to a dose of the mRNA COVID-19 vaccine or its components (including polyethylene glycol and a potentially cross-reactive compound polysorbate).
Patients who have a history of anaphylaxis or severe allergic reactions to any vaccines may want to discuss considerations and risks further with their doctor. Referral and evaluation with an allergist-immunologist may be helpful in these scenarios. If you have questions about whether or not it is safe for your child to be vaccinated, I encourage discussion with your primary care provider.”
Feazell: “I would encourage each family to consider their own unique circumstances when considering the COVID vaccine for kids. With that being said, the only established medical reasons not to be vaccinated would be a personal history of an allergy to a component of the vaccine or individuals who are currently in quarantine due to active COVID-19 infection. Many times, a person and their doctor will opt to defer vaccination at a time when they have moderate/severe illness or if they have a history of being immunocompromised or having another underlying medical condition, and it is always a good decision to discuss those types of considerations/scenarios with your personal pediatrician.”
Q: What are the risks involved if parents want to delay vaccinating their children?
Peng: “The risks for delaying vaccination would include the risks for COVID-19 infection and possible post-COVID conditions. Children most at risk for COVID-19 infection include those who have weakened immune systems, cancer, obesity, heart conditions or heart disease, lung disease, diabetes, neurodevelopmental disorders, chronic kidney disease, and other complex medical conditions.”
Feazell: “The primary risk of delayed vaccination will be continued risk for COVID-19 infection. Children continue to test positive and while significant clinical illness is extremely rare, 10-day quarantines for children and unvaccinated contacts remain and aren’t any fun for anyone involved. Furthermore, any number of local rules relating to masking and/or restrictions on access to things like indoor venues will likely remain in place and will negatively impact families who opt to delay vaccination for any extended amount of time.”
Q: Do you anticipate there to be vaccine mandates as a requirement for children to attend schools once the vaccine is made available?
Peng: “In addition to academic learning, the pandemic highlighted the role of schools in providing children access to healthy meals, internet, exercise, support services including mental health as well as the opportunity for learning social and emotional skills. In the beginning of October, California became the first state to mandate COVID-19 vaccination (once approved) for children to attend public and private schools in the state. I expect that similar mandates in other states, cities, or counties will follow as this would allow for ongoing safe attendance in school for both students and teachers.”
Feazell: “The discussion of vaccine mandates is more of a political question as opposed to a medically related matter, and I do not have professional expertise in politics. Speaking solely based on my personal observations, I anticipate that there will be mandates in many communities (that is the case in my community as LAUSD—the Los Angeles Unified School District—has already announced plans for a vaccine mandate), while in other communities/schools around the country the local decision-makers will opt not to pursue mandates. Regardless, I think it is highly likely that for children in the United States, being vaccinated will make it easier for a child to live their best/happiest life going forward.”
Q: Please answer this question only if you feel comfortable: do you plan on vaccinating your own child(ren) when they become eligible to receive it? Why or why not?
Peng: “I am the proud parent of a young child and my husband and I fully intend to vaccinate our child once they are eligible for the vaccine. I strongly believe in the safety and efficacy of vaccines, including the COVID-19 vaccine. Though severe COVID-19 infection and complications from infection are uncommon, we want our child to be protected against these threats.
I feel that this pandemic has stolen some precious moments from children and their families. We all yearn for the normalcy of life prior to the pandemic. I believe that widespread vaccination will allow for a safer “return” to normalcy and allow children to resume school and daily life routines and to reunite with their friends and families. Additionally, I consider vaccination, in part ‘doing our share’ as a family to protect others from infection, especially those individuals at higher risk for severe infection or those who may not be able to safely receive the vaccines themselves.”
Feazell: “I do have children under the age of 11, and I do plan to have them vaccinated. I believe the vaccine will be both safe and effective. While I do not necessarily believe the medical benefits will be of great significance for children who have an extraordinarily low risk of complicated illness from COVID, I do think my kids will be most likely to live their best lives as we move forward if they are vaccinated. After such a long and difficult time for young people over the past year and a half, I am enthusiastic about doing whatever I can to set my family up for health AND happiness as kids only get to be kids one time and I want it to be as joyful a time as possible for my children.
As the world finally seems to be coming to an understanding that the pandemic (in which we have lived FOR COVID in many regards) is now transitioning to an endemic (in which we learn to live WITH COVID), it is my sincere wish that each of you finds both health and happiness (which you all certainly deserve) moving forward after this difficult time in our lives.”