Pfizer’s Clinical Trial For COVID-19 Pill For Children Aged 6 And Up

As the COVID-19 pandemic continues to impact millions of people around the world, finding treatment options for patients living with the long-term effects of the virus is a top priority.

The mission to find effective treatment options for COVID-19 becomes even more urgent when working with young children — as many treatments for adult patients with COVID-19 are not always viable options for children aged six and up.

According to the World Health Organization (WHO), as of mid-November 2022, over  630,000,000 cases of COVID-19 have been confirmed worldwide since the beginning of the pandemic.¹ Over 6.6 million people have died from the virus, with over 16,100 (or 0.4% of the total deaths) being children and adolescents under the age of 20.²

There are currently few COVID-19 treatment options available for children aged 12 and over, but this leaves a significant gap for younger children impacted by the disease.

Looking to expand the safe and effective treatment options available for the younger population, a new clinical trial from Pfizer called EPIC-PEDS (Evaluation of Protease Inhibition for COVID-19 in Pediatric Patients) has begun. Designed to test the efficacy and pharmacokinetics of medications commonly used in treating adults with COVID-19, Pfizer hopes to find a viable treatment option for the younger age groups impacted by symptoms of coronavirus infections.

But what is this clinical trial about, and will this medication be a safe option for your child?

Here is everything you need to know about this important and potentially life-saving clinical trial for oral COVID-19 treatment for children.

COVID-19 in children

Before we explore the Pfizer clinical trial, we first must understand how COVID-19 impacts children aged 12 and under.

COVID-19 is an infectious viral disease caused by the SARS-CoV-2 virus.³ From early 2020, cases swept across the globe, and the COVID-19 pandemic has now infected millions of adults and children worldwide.

According to the American Academy of Pediatrics, in October 2022, over 14.8 million children in the US tested positive for COVID-19 since the beginning of the pandemic.⁴ This number of infections represents 18.4% of all COVID-19 cases across the US.⁴

Thankfully, children tend to have strong, healthy immune systems, so the severity of most pediatric COVID-19 symptoms is less than those of adults or seniors with the same infection. Examples of some of the most common symptoms in children with COVID-19 during and after a COVID-19 infection include:⁵

• Cough

• Difficulty breathing (dyspnea) and shortness of breath

• Sore throat

• Conjunctivitis and eye infections

• Fatigue

• Nasal congestion and sneezing

• Fever

• Nausea, vomiting, and diarrhea

• Headaches

• Weight loss

• Poor focus and concentration

• Insomnia

• Muscle aches and pains

• Loss of taste and smell

Despite the reduced risk of fatality from the disease, it is important to note that children are incredibly vulnerable to COVID-19 infections. Due to close proximity to other students in schools and daycare centers, it is easy for the coronavirus to spread from child to child and from family to family.

Current treatment options are limited for young children

For adults and children who have tested positive for COVID-19 and develop significant symptoms, there are a few viable treatment options approved by the Food and Drug Administration (FDA):⁶

• Antiviral treatments: These treatment options target specific parts of the COVID-19 virus, preventing it from replicating and spreading throughout the body. Antiviral treatments can help to reduce the severity and risk of fatality from a COVID-19 infection.

• Monoclonal antibodies: Created to help strengthen a person’s immune response to a COVID-19 infection, this treatment option aims to assist immune cells in identifying the virus while also encouraging a better and more effective immune response. 

Depending on a patient’s age, medical history, and severity of symptoms, the medication and treatment they receive can vary greatly. According to the National Institute of Health (NIH), the following medications can be used for the treatment of COVID-19 for the specific age groups mentioned:⁶

• Nirmatrelvir with Ritonavir (Paxlovid): This antiviral medication is approved for adults and children aged 12 and over with active COVID-19 symptoms. It must be started within five days of symptom development for the best results. It is taken as an oral tablet.⁷

• Remdesivir (Veklury): This antiviral medication is approved for adults and children older than 28 days who weigh more than 3kg. It must be started within seven days of symptom development to be effective. It is given as an intravenous (IV) infusion by a trained medical professional for three consecutive days.⁸

• Bebtelovimab: This monoclonal antibody medication is approved for adults and children over the age of 12 infected with COVID-19. Treatment must begin within seven days of symptom development to be effective. It is given as a single-dose intravenous injection by a trained medical professional.⁹

• Molnupiravir (Lagevrio): This antiviral medication is approved for the treatment of COVID-19 in adults only. It is not currently approved for children. Treatment must be started within five days of symptom development for the best results. It is taken as an oral medication.¹⁰

As we can see, there are significant gaps in what is currently available for treating active COVID-19 infections. Additional research and clinical trials are needed to find safe and effective treatment options for children younger than 12 to provide better care — which is where Pfizer’s EPIC-PEDS clinical trial comes into play.

Clinical trial of oral COVID-19 treatment in children

Officially announced by Pfizer in March 2022, the EPIC-PEDS (Evaluation of Protease Inhibition for COVID-19 in Pediatric Patients) clinical trial has entered into phase 2/3. Through this clinical trial, the goal is to test the safety, efficacy, and pharmacokinetics of Nirmatrelvir 300mg tablets and 100mg Ritonavir tablets on pediatric patients in the hospital setting.¹¹

This is the first clinical trial to test oral medications for COVID-19 in children. The goal of the trial is to prevent children with active COVID-19 infections from progressing to a more severe form of infection.

Conducted as a multi-label, single-arm study on 140 children below the age of 18, the study participants were divided into two primary groups:¹¹

• The first group (children aged 6–17 who weighed over 88lbs) received the medications as oral tablets twice a day. They took them for five consecutive days.

• The second group (children aged 6–17 who weighed 44 lbs or more) followed the same routine of oral medications given twice a day for five days.

While the data from this pediatric clinical trial is yet to be released, the results from a similar adult trial showed positive results. A study published in April 2022 found that 89% of adults with active COVID-19 infections who received the oral Pfizer treatment had a reduced risk of developing more serious complications.¹²

The results of this successful adult clinical trial lead the NIH to prioritize this oral treatment over other potential options. Additionally, while this oral medication is not currently approved for young children, the FDA has approved its use in emergency situations for children over the age of 12.¹³ Pfizer, and clinical researchers are hopeful that this clinical trial will help to expand the demographic allowed to receive this treatment, offering more safe and effective treatment options for young children.

Children as young as 6 months old can get vaccinated

While we wait for the results of this hopefully successful trial, what can you do to better protect your children from COVID-19?

The Centers for Disease Control and Prevention (CDC) currently recommends that all children over six months should receive the COVID-19 vaccine to reduce their risk of experiencing severe side effects from a potential infection.¹⁴

Both the Moderna and BioTech/Pfizer COVID-19 vaccines are approved for children over the age of six months. Young children receive the same vaccine as adolescents and adults, just in a smaller dose. The number of doses and the timeline between each dose depends on which vaccine is recommended for your child.

According to the WHO, 12,885,748,541 doses of COVID-19 vaccines have been administered worldwide.¹ As a result of this global initiative to combat COVID-19, the number of people who experience severe reactions or require hospitalization from infection has dramatically declined.

In a study conducted by the Yale School of Public Health, it was estimated that increased vaccination rates in US children and adults have helped to save up to 296,000 since they became widely available.¹⁵

COVID-19 booster shots are available too

Additionally, beyond the base-level COVID-19 vaccinations available, the FDA has approved COVID-19 vaccine boosters for young children.

In October 2022, the FDA approved the use of the bivalent COVID-19 booster vaccine for children aged 5–11 years old as an additional protective measure for the vulnerable population.¹⁶ This news was released at a similar time to the announcement for omicron-specific boosters being offered to children aged 12 and older. This decision to make COVID-19 boosters available to younger children was also supported and approved by the CDC.

But, as important as vaccination is to ending our fight with COVID-19, it is important to note that vaccination does not inherently reduce your risk of catching the virus. While getting vaccinated does reduce your risk of experiencing severe symptoms should you come in contact with the virus, it is important to stay vigilant with other protective and preventive measures to reduce your risk of catching COVID-19 in the first place.

How to protect yourself and your children from COVID-19

Like any infectious disease, the best treatment option for COVID-19 is avoiding infection in the first place. As a respiratory virus that spreads through contact-droplet methods (meaning it spreads from sneezing, coughing, or direct contact from touching the virus and then touching your face), there are precautions you can take to protect your family from catching COVID-19. Examples of protective measures you can take to reduce your risk include:

• Getting yourself and your children vaccinated, including boosters as available 

• Wearing face masks in crowded, indoor public spaces

• Regularly washing our hands with soap and water

• Taking extra precautions to clean and disinfect commonly touched surfaces

• Keeping a minimum of 6 feet of distance between yourself and others

• Whenever possible, avoid large gatherings and opt for safer activities for yourself and your children

Unfortunately, because of the highly contagious nature of COVID-19, it is still possible to catch the virus even when following the above precautions. If your child has become infected with COVID-19, here are a few suggestions to reduce the risk of spreading the virus further:

• Keep your child home, away from other family members and fellow students.

• If possible, allow your child to use their own bedroom and bathroom to reduce the number of shared surfaces within the home.

• While isolating, focus on symptom relief. Keep your child as comfortable as possible, encourage fluid consumption, and allow plenty of rest to speed up recovery.

• Contact your primary care provider if you notice that your child’s symptoms are worsening over time. If your child is experiencing shortness of breath, chest pain, confusion, or is becoming difficult to rouse, seek emergency medical attention immediately.

The lowdown

While there are available treatment options for children with active COVID-19 infections, there are significant gaps in medications available for the younger age groups.

With exciting clinical trials being conducted to learn more about the safety and efficacy of pediatric medications for COVID-19, research like the EPIC-PEDS trial is leading the way to a future with more effective treatments for this highly contagious virus.

While we wait to learn more about the results of this important trial, it is important to remember that there are things you and your family can do in the meantime to reduce your risk of exposure to COVID-19. Following the recommended precautions while getting yourself and your children vaccinated are great first steps to keeping your loved ones safe!

Sources:

1. WHO coronavirus (COVID-19) dashboard | World Health Organization

2. Child mortality and COVID-19 | Unicef

3. Coronavirus disease (COVID-19) | World Health Organization

4. Children and COVID-19: State-level data report | American Academy of Pediatrics

5. Post COVID-19 condition in children and adolescents: An emerging problem (2022)

6. COVID-19 treatments and medications | Centers for Disease Control and Prevention (CDC)

7. Emergency use authorization (EUA) of paxlovid for coronavirus disease 2019 (COVID-19) | U.S. Food & Drug Administration

8. Remdesivir | NIH: COVID-19 Treatment Guidelines

9. Therapeutic management of nonhospitalized adults with COVID-19 | National Institute of Health | NIH: COVID-19 Treatment Guidelines

10. Emergency use authorization (EUA) of LAGEVRIOTM (molnupiravir) capsules For coronavirus disease 2019 (COVID-19) | U.S. Food & Drug Administration

11. Pfizer initiates phase 2/3 study of novel COVID-19 oral treatment in pediatric participants | Pfizer

12. Oral Nirmatrelvir for high-risk, nonhospitalized adults with Covid-19 (2022)

13. Coronavirus (COVID-19) update: FDA authorizes first oral antiviral for treatment of COVID-19 | U.S. Food & Drug Administration

14. COVID-19 vaccination for children | Centers for Disease Control and Prevention

15. U.S. vaccination campaign prevented up to 279,000 COVID-19 deaths | YaleNews

16. Coronavirus (COVID-19) update: FDA authorizes Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose in younger age groups | U.S. Food & Drug Administration

Claire Bonneau is a medical writer and certified trauma operating room nurse.