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Rachel V Thomas

Paxlovid Safe for Children Aged 6 And Older, New Study Finds

Paxlovid, the oral antiviral used to treat COVID-19, appears to be safe and well-tolerated in children aged 6 years and older, according to a new study.

The study, published in the journal Pediatrics, Paxlovid is safe for children who weigh at least 44 pounds who have mild to moderate COVID-19 but are at risk of developing severe disease. The drug did not cause any serious safety concerns.

Paxlovid was approved by the US Food and Drug Administration (FDA) for adults in 2023 and is currently authorized for children 12 years and older who weigh at least 88 pounds (40 kg). The new findings suggest the treatment could also be appropriate for younger children, although the study does not represent a new FDA approval for children aged 6 to 11 years.

The Pfizer-led study enrolled 75 children aged 6 to 17 years, all of whom received at least one dose of Paxlovid. Participants were divided into two dosing groups based on body weight. 

Also read: <a href="https://www.healthandme.com/health-news/long-covid-rehab-program-may-help-improve-brain-fog-study-finds-article-154870121" data-type="tilCustomLink">Long COVID Rehab Program May Help Improve Brain Fog, Study Finds</a>

<ul><li>Both dosing regimens were safe and well tolerated. </li></ul><ul><li>No serious adverse events were reported. </li></ul><ul><li>About 90 per cent of participants achieved blood concentrations associated with antiviral activity in adults. </li></ul><ul><li>No child was hospitalized or died from COVID-19 during the study. </li></ul><ul><li>No participant discontinued treatment because of side effects. </li></ul>

The most commonly reported side effects were: 

<ul><li>Diarrhea (4 per cent) </li></ul><ul><li>Headache (4 per cent) </li></ul>Both occurred infrequently.

The researchers concluded that the pediatric dosing regimens produced drug exposures similar to adults while maintaining a favorable safety profile. 

"Given the continued burden of disease in pediatric patients, even in a post-pandemic era, a convenient outpatient oral treatment option for preventing severe disease in individuals with mild-to-moderate COVID-19 continues to be an unmet medical need," the authors wrote. 

Read More: <a href="https://www.healthandme.com/health-news/natural-origin-or-lab-leak-gabbard-reignites-covid-origins-debate-claims-fauci-funded-wuhan-lab-research-article-154683911" data-type="tilCustomLink">Natural Origin or Lab Leak? Gabbard Reignites COVID Origins Debate, Claims Fauci Funded Wuhan Lab Research</a>

Paxlovid is a combination of two medicines: 

<ul><li>Nirmatrelvir, which blocks a key viral enzyme needed for SARS-CoV-2 to replicate. </li></ul><ul><li>Ritonavir, which slows the breakdown of nirmatrelvir in the body, allowing it to remain effective for longer. </li></ul>For maximum benefit, treatment should begin within five days of symptom onset.

Clinical trials in adults have shown that Paxlovid remains one of the most effective outpatient treatments for people at high risk of severe COVID-19. 

<ul><li>9 of 977 people who received Paxlovid within five days of symptom onset were hospitalized, and none died. </li></ul><ul><li>In the placebo group, 64 of 989 people were hospitalized, and 12 died from any cause. </li></ul>

Overall, Paxlovid reduced the risk of COVID-19-related hospitalization or death by 86 per cent in high-risk adults.

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The FDA first granted Emergency Use Authorization (EUA) for Paxlovid in 2021. 

<ul><li>Altered or metallic taste (dysgeusia) </li></ul><ul><li>Diarrhea </li></ul><ul><li>High blood pressure (hypertension) </li></ul>

The medication can also interact with several commonly used medicines, including statins, making it important for patients to discuss all current medications with their healthcare provider before starting treatment, the FDA said.

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Paxlovid, the oral antiviral used to treat COVID-19, appears to be safe and well-tolerated in children aged 6 years and older, according to a new study. The study, published in the journal Pediatrics, Paxlovid is safe for children who weigh at least 44 pounds who have mild to moderate COVID-19 but are at risk of developing severe disease. The drug did not cause any serious safety concerns. Paxlovid was approved by the US Food and Drug Administration (FDA) for adults in 2023 and is currently authorized for children 12 years and older who weigh at least 88 pounds (40 kg). The new findings suggest the treatment could also be appropriate for younger children, although the study does not represent a new FDA approval for children aged 6 to 11 years. What Are The Key Findings The Pfizer-led study enrolled 75 children aged 6 to 17 years, all of whom received at least one dose of Paxlovid. Participants were divided into two dosing groups based on body weight. Also read: Long COVID Rehab Program May Help Improve Brain Fog, Study FindsResearchers found that: Both dosing regimens were safe and well tolerated. No serious adverse events were reported. About 90 per cent of participants achieved blood concentrations associated with antiviral activity in adults. No child was hospitalized or died from COVID-19 during the study. No participant discontinued treatment because of side effects. The most commonly reported side effects were: Diarrhea (4 per cent) Headache (4 per cent) Both occurred infrequently. The researchers concluded that the pediatric dosing regimens produced drug exposures similar to adults while maintaining a favorable safety profile. "Given the continued burden of disease in pediatric patients, even in a post-pandemic era, a convenient outpatient oral treatment option for preventing severe disease in individuals with mild-to-moderate COVID-19 continues to be an unmet medical need," the authors wrote. Read More: Natural Origin or Lab Leak? Gabbard Reignites COVID Origins Debate, Claims Fauci Funded Wuhan Lab Research How Paxlovid Works Paxlovid is a combination of two medicines: Nirmatrelvir, which blocks a key viral enzyme needed for SARS-CoV-2 to replicate. Ritonavir, which slows the breakdown of nirmatrelvir in the body, allowing it to remain effective for longer. For maximum benefit, treatment should begin within five days of symptom onset. Clinical trials in adults have shown that Paxlovid remains one of the most effective outpatient treatments for people at high risk of severe COVID-19. In a pivotal placebo-controlled trial: 9 of 977 people who received Paxlovid within five days of symptom onset were hospitalized, and none died. In the placebo group, 64 of 989 people were hospitalized, and 12 died from any cause. Overall, Paxlovid reduced the risk of COVID-19-related hospitalization or death by 86 per cent in high-risk adults.    Possible Side effects The FDA first granted Emergency Use Authorization (EUA) for Paxlovid in 2021. Known side effects include: Altered or metallic taste (dysgeusia) Diarrhea High blood pressure (hypertension) The medication can also interact with several commonly used medicines, including statins, making it important for patients to discuss all current medications with their healthcare provider before starting treatment, the FDA said.

paxlovid safe for children aged 6 and older, new study finds

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