Safety Risk Lead Worldwide Medical and Safety, Worldwide Research and Development, Pfizer Inc, USA Staten Island , United States
Background: Upon the World Health Organization designating COVID-19 as a global pandemic (and declaration of a national emergency in the U.S.) in 2020, a COVID-19 surveillance program was initiated by Pfizer on 16 March 2020, using data from the Pfizer global safety database (SDB) and routine pharmacovigilance.
Objectives: To characterize cases that report (1) COVID-19 during treatment with Pfizer products and (2) use of products for treatment of COVID-19
Methods: The SDB, which includes worldwide adverse event (AE) data from various sources, was searched retrospectively between 01 October 2019 and 01 February 2023. Selected Medical Dictionary for Drug Regulatory Activities (MedDRA®) Preferred Terms (PTs) and subsequent clinical review were used to characterize COVID-19 cases based on 2 groups: (1) cases of COVID-19 (as events or medical history) reported during treatment with Pfizer products and (2) cases reporting product use for COVID-19 treatment.
Results: As of 01 February 2023, 63,237 relevant cases were cumulatively identified. The most frequent reporting countries included the U.S., Canada and the U.K. Majority of cases involved adults, with 1.5% and 32% of cases encompassing pediatric and elderly patients, respectively. Immunosuppressant/immunomodulating agents (including corticosteroids) were consistently the most frequently reported therapeutic classes, as these agents are reported both in association with COVID-19 events, and to a lesser extent, for COVID-19 treatment. Other reported COVID-19 treatments included antimicrobials (e.g., antibiotics, antiretrovirals, antivirals) and other supportive therapy (e.g., antithrombotic agents). Most treatments were used concomitantly (often consisting of >2 drug combinations), with reported AEs confounded by multiple agents. At various time points during this surveillance, subgroup analyses included observational trends involving pregnancy cases, in which the majority of maternal cases involved severe/prolonged COVID-19, necessitating emergent delivery to achieve clinical stabilization/improvement. Also, among cases reporting potential COVID-19 reinfection, a relatively small percentage (~15%) reported use of immunosuppressant/immunomodulating agents. Among the 63,237 total cases, < 1% reported post-acute COVID-19 syndrome (“long Covid”).
Conclusions: This pharmacovigilance surveillance study provides a unique characterization of cases in which a broad range of pharmaceutical products was reported in relation to COVID-19; pharmacovigilance information (particularly via spontaneous reporting) is vital to patient treatment and safety.
