Analysis Reveals Most COVID-19 Treatments Have Minimal Serious Side Effects

Recent research from the Keck School of Medicine at USC provides reassuring insights into the safety of COVID-19 treatments, revealing that the majority of therapies approved by the U.S. Food and Drug Administration (FDA) exhibit few serious side effects. This evaluation draws from a comprehensive analysis of available U.S. biomedical studies over the past four years, focusing on antiviral medications and monoclonal antibodies designed to manage excessive immune responses.

The findings indicate that oral antiviral treatments, such as Paxlovid, show no significant links to severe adverse events. Additionally, monoclonal antibodies like Evusheld, which previously required intravenous administration in hospitals, and are no longer authorized for use against certain COVID-19 variants, also demonstrated no serious side effects. However, the intravenous monoclonal antibody Actemra (tocilizumab) was associated with some adverse outcomes, including infections and low white blood cell counts in select studies.

Transfusions of convalescent plasma, which is sourced from individuals who have recovered from COVID-19, were linked to a heightened risk of internal bleeding, infections, and blood clots, consistent with existing product labeling. While many individuals with COVID-19 can recover without medical intervention, healthcare professionals may recommend treatments for those at higher risk, including older adults, individuals with obesity, cardiovascular conditions, diabetes, or weakened immune systems. The recent findings should offer encouragement to these patients.

The study emphasizes that patients prescribed Paxlovid can proceed without concern regarding severe side effects. The review, published in the journal Open Forum Infectious Diseases, examined 54 studies that included both inpatient and outpatient treatment scenarios, clinical trials, and observational research. Only studies comparing COVID-19 therapies against standard care, placebo, or no treatment were included to ensure that the effects of the disease itself were not conflated with treatment outcomes.

The Southern California Evidence Review Center, which is part of the Keck School of Medicine, often provides rigorous analyses to inform public health policy. This particular study was aimed at contributing to a countermeasure injury compensation table that helps determine eligibility for public benefits for patients reporting adverse events. The results are particularly reassuring given the rapid development of COVID-19 treatments during the pandemic.

In public health emergencies like the COVID-19 pandemic, having an effective compensation program for treatment-related injuries based on solid scientific evidence is essential. The current study strengthens the understanding that available treatments are safe and do not frequently lead to severe side effects.

The research focused specifically on severe side effects as classified by a standard scale from the National Institutes of Health. A rating of three or above indicates serious conditions requiring hospitalization, while the highest rating signifies a fatal outcome. The FDA mandates that manufacturers submit detailed records for emergency authorization, ensuring that all adverse events are documented. Notably, the review found no serious adverse events that were not already mentioned in product labeling.

The study's co-authors included a team of researchers from USC, reflecting a collaborative effort in advancing knowledge regarding the safety of COVID-19 treatments.