The Food and Drug Administration’s (FDA’s) Drug Safety Surveillance During the COVID-19 Pandemic

Abstract

Introduction On 4 February, 2020, the Secretary of the Department of Health and Human Services declared a public health emergency related to coronavirus disease 2019 (COVID-19), and on 27 March, 2020 declared circumstances existed to justify the authorization of the emergency use of drug and biological products (hereafter, “drugs”) for COVID-19. At the outset of the pandemic with uncertainty relating to the virus, many drugs were being used to treat or prevent COVID-19, resulting in the US Food and Drug Administration’s (FDA’s) need to initiate heightened surveillance across these drugs. Objective We aimed to describe the FDA’s approach to monitoring the safety of drugs to treat or prevent COVID-19 across multiple data sources and the subsequent actions taken by the FDA to protect public health. Methods The FDA conducted surveillance of adverse event and medication error data using the FDA Adverse Event Reporting System, biomedical literature, FDA-American College of Medical Toxicology COVID-19 Toxicology Investigators Consortium Pharmacovigilance Project Sub-registry, and the American Association of Poison Control Centers National Poison Data System. Results From 4 February, 2020, through 31 January, 2022, we identified 22,944 unique adverse event cases worldwide and 1052 unique medication error cases domestically with drugs to treat or prevent COVID-19. These were from the FDA Adverse Event Reporting System (22,219), biomedical literature (1107), FDA-American College of Medical Toxicology COVID-19 Toxicology Investigator’s Consortium Sub-registry (638), and the National Poison Data System (32), resulting in the detection of several important safety issues. Conclusions Safety surveillance using near real-time data was critical during the COVID-19 pandemic because the FDA monitored an unprecedented number of drugs to treat or prevent COVID-19. Additionally, the pandemic prompted the FDA to accelerate innovation, forging new collaborations and leveraging data sources to conduct safety surveillance to respond to the pandemic.

Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study

“…Further, AE reporting probabilities may differ by medicine and severity; for instance, serious acute events are more likely to be reported than mild events with a prolonged onset. Thirdly, the data evaluated were not from recent years and thus avoided any impact COVID-19 may have had on reporting patterns [ 54 ] as well as the other datasets utilized in this study. To address concerns about generalizability, we subsequently evaluated the characteristics of reports received by FAERS in 2019 and found patterns to be largely consistent with earlier years (OSM Table 3).…”

Nanobodies against SARS-CoV-2 reduced virus load in the brain of challenged mice and neutralized Wuhan, Delta and Omicron Variants

“…However, it has been reported that the efficacy of some mAbs against specific variants and subvariants can be variable [15]. The Food and Drug Administration (FDA) has granted emergency use authorization to a number of antibody therapies, generally in the form of a mixed cocktail of antibodies, to better target a broad spectrum of SARS-CoV-2 variants [16]. One concern about employing mAbs therapies is that the emergence of new variants, such as the Omicron, are often unaffected by their use [17–19].…”

Impact of the COVID-19 pandemic on the spontaneous reporting and signal detection of adverse drug events

“…Reference 8 until 6/Oct/2023, over 771 million cases and more than 6.9 million deaths worldwide have been confirmed by the WHO and over 13 billion vaccine doses have been administered 9 , 10 . This global health issue has had an impact on the utilisation of healthcare systems with a significant reduction of minor ailment consultations 11 and massive vaccination campaigns against COVID-19 12 , which may have affected the number and type of adverse events (AEs) deposited in spontaneous reporting systems (SRSs) during the pandemic period 13 , 14 .…”