FDA Approves First COVID Treatment for Young Children Despite Alarming Risks

A vial of the drug remdesivir is visually inspected at a Gilead manufacturing site in March 2020. Gilead Sciences via AP

The Food and Drug Administration (FDA) recently approved the first COVID-19 drug for children under the age of 12–remdesivir, which has always been a controversial drug. Now, with its use in infants and young children, is the controversy over remdesivir already gone?

Previously, the drug was only approved to treat adults and adolescents over the age of 12 years old and weighing at least 40 kilograms. On April 25, the FDA expanded remdesivir’s approval to treat newborns and infants over 28 days of age and weighing 7 pounds (3 kg). This is the first FDA-approved COVID-19 treatment for infants and children.

This FDA authorization is for two categories of children with confirmed COVID-19 infection:

1. Hospitalized
2. Children who are not hospitalized, but have mild to moderate symptoms and are at high risk of developing severe illness or death

In fact, prior to 2022, remdesivir was being used only for inpatients. The fact that it was so quickly approved for non-hospitalized infants and children with mild-to-moderate symptoms raises concerns.

In particular, children (especially newborns) have limited expression and cannot clearly express physical distress, so it is difficult for parents and pediatricians to determine whether an infant is mildly or moderately ill or at risk of becoming seriously ill.

In addition, since remdesivir brings certain side effects (which will be discussed later in the article), its administration needs to be monitored by a physician. So how can side effects be detected in a timely manner in infants and children, who are not hospitalized and cannot express themselves?

Timeline for Remdesivir’s Approval

In as early as October 22, 2020, remdesivir received emergency approval from the FDA for use in adults and adolescents aged 12 years and over 40 kilograms, who are hospitalized with the COVID-19 infection.

By January 21, 2022, remdesivir had received two expanded authorizations.

Expanded authorization: for use in patients aged 12 years and over 40 kilograms with mild to moderate symptoms, with or without hospitalization

Emergency use authorization: for use in children and toddlers under 12 years of age and over 3.5 kilograms.

On April 25, 2022, remdesivir received a full authorization allowing its use in infants, toddlers and adolescents over 28 days and 3 kilograms, both hospitalized and non-hospitalized with mild to moderate symptoms.

Remdesivir’s Pediatric Clinical Trial Data Are Astonishing

In order to obtain the FDA’s authorization, Gilead Sciences, Inc. published data from a clinical trial called CARAVAN, which was jointly conducted by research centers in different countries.

Unlike many trials with double-blind control groups, this clinical trial was very simple in design, as there was no control group. In addition, the total number of children participating in the trial was only 53.

The trial discovered that in this small population, 72 percent of the children experienced various adverse events, such as shortness of breath and rash; and nearly 21 percent experienced serious adverse events, including three deaths. The study emphasized that serious adverse events were not considered to be directly related to the drug, and that deaths were caused by other diseases.

Nevertheless, during the clinical trial, children were not allowed to receive any other drugs at the same time. What caused the serious adverse events in 21 percent of the children, besides remdesivir? If no reasonable explanation is given, and the possibility is simply denied, it is hard not to believe that these serious adverse events were not related to the drug.

In addition, since the number of participants in the trial was very small, it is impossible to separate the participants into groups of recipients of 5 mg/kg and recipients of 1 mg/kg for a controlled trial, in order to analyze whether reducing the dose of the drug would reduce the harm to children. And this should have been a fundamental consideration. The approved dose to weight ratio for remdesivir in infants and children is 5 mg per kilogram of body weight, the same ratio as for adults.

In summary, Gilead Sciences, Inc.’s clinical trial is too simple and appears to be perfunctory.

Questionable Trial Conclusions: Is Remdesivir Less Effective Than a Placebo?

Remdesivir has always been said to be effective in the treatment of early-stage patients.

A clinical trial published in The New England Journal of Medicine examined the efficacy of remdesivir in treating COVID-19 infections. The trial had a small number of participants; it did not include people under 18 years of age or have data from clinical trials in adolescents or young children.

This trial found that the effectiveness of remdesivir in treating severe illness was very limited.

In cases of respiratory distress requiring mechanical ventilation, that is, non-invasive respiratory assistance, the recovery rate of the treatment group, who received remdesivir was only marginally better compared to the control group, who received the placebo, with a ratio of 1.09:1.

In the case of patients who required mechanical ventilation, remdesivir was found to be even slightly less effective than the placebo.

This shows that remdesivir doesn’t have a visible effect on severely ill patients. Therefore, even if remdesivir receives full FDA approval, the main emphasis should still be on the efficacy of the drug in treating early-stage patients.

Another clinical trial of remdesivir’s efficacy, PINETREE, was also published in The New England Journal of Medicine. This trial’s participants included adolescents under the age of 18. However, there were only eight of them, and the trial still didn’t appear to have included children under the age of 12.

The PINETREE trial concluded that remdesivir “resulted in an 87% lower risk of hospitalization or death than placebo.” How did this figure come about? This figure was obtained only from the treatment of elderly people over 60 years of age. And the report’s conclusion didn’t emphasize that the drug is more effective in treating people from this age group.

Moreover, no one in the experimental group or the control group died, so how can we conclude that remdesivir can protect patients against death?

Although the report’s conclusion is eye-catching, from a scientific point of view, it is not rigorous and may be misleading to the public.

The two aforementioned clinical trials were the primary basis for remdesivir to obtain the FDA approval, and they did not include any data on children under the age of 12.

In fact, Omicron’s damage to children is minimal, and the probability of death in infants due to Omicron infection is very low.

Remdesivir’s Side Effects Include Severe Kidney Failure

The controversy over remdesivir has been focused on the issue of side effects.

Remdesivir is currently sold under the brand name VEKLURY. In April 2022, the month when the drug received full FDA approval, Gilead Sciences, Inc. released a Patient Information document, which stated that before using remdesivir, it is important for the patient to inform his or her doctor if he or she has liver or kidney problems. And it listed the top two serious side effects of remdesivir to be:

• Allergic reactions:
  • Changes in heart rate
  • Rash, fever, nausea, and shortness of breath
  • Swelling of the lips, face, and throat, as well as shivering
• Increased liver enzymes, which is a sign of liver function impairment

Gilead Sciences, Inc. stated in a released report that increased liver enzymes after drug use might be a sign of liver function impairment, and that this is a common occurrence. In November 2020, the World Health Organization (WHO) stated that it did not recommend the use of remdesivir for the COVID-19 treatment, due to the relatively high probability (nearly 10 percent) of serious side effects, such as liver function impairment.

This large percentage of risk of serious side effects is very difficult for the medical community to accept, which is why many countries question the widespread promotion and use of remdesivir.

In addition to the side effects of hepatic (liver) function impairment, there have been many reports of acute renal failure and kidney injury associated with remdesivir.

A study published in the journal Clinical Pharmacology & Therapeutics performed a comprehensive analysis of adverse event data from the WHO’s international pharmacovigilance postmarketing databases (VigiBase). The study analyzed 138 reports of acute renal failure and found that a number of other adverse effects were observed in patients with acute renal failure, including hypoglycemia, hypoxia, respiratory distress, and multiple organ dysfunction syndrome.

A comparison of remdesivir with other commonly used COVID-19 drugs, including antivirals, monoclonal antibodies, and hydroxychloroquine, showed that the risk of renal failure was 20 times higher with remdesivir than with other drugs.

Among the adverse events related to renal injury, there are other more serious long-term conditions besides acute renal failure, such as renal injury and chronic renal failure. Although the probability of developing these conditions is not very high, these are serious conditions.

In addition, there is a risk of cardiac damage associated with remdesivir, including cardiac arrest, hypotension, and bradycardia.

In a study published in the journal Clinical and Translational Science, researchers also conducted an in vitro trial, in which different doses of remdesivir were added to cardiac myocytes grown in vitro, and they found a linear relationship between the damage to cardiac myocytes and the dose of remdesivir.

This suggests that the dosage is very important and that simply administering the drug to children in the same dose-to-weight ratio as adults may put the children’s hearts at great risk.

Furthermore, the public is concerned about the toxicological analysis and studies of remdesivir in fetuses, newborns, infants, as well as in breast milk. Gilead Sciences, Inc. also mentioned in the Patient Information that it was not certain whether or not remdesivir would harm fetuses or whether or not the drug would enter breast milk. In general, before a drug can be tested in vivo, animal testing must be completed, to see if the drug causes any harm to the animals’ development. However, remdesivir has not undergone such tests.

The current controversy over the side effects of remdesivir seems to be ignored, and the FDA has authorized the use of this drug in infants and young children over 28 days of age, which I believe poses a significant risk.

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