Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 BREAKTHROUGH INFECTION; LACK OF EFFICACY IN LIFE THREATENING DISEASES DRUG-INDUCED; This solicited report received from a health care professional via COV19VAC-NONCOMP: Jansen COVID 19 Non Company Solicited Study by a Regulatory Authority (RA) on 28-SEP-2024 was received on 30-SEP-2024 and concerned multiple patients. This patient was also referenced in literature: The trade name of covid-19 vaccine ad26.cov2.s was not reported. It was assumed to be Janssen drug for reporting purposes. SARS-CoV-2 vaccines reduce the risk of COVID-19.13 However, some disease-modifying anti-rheumatic drugs (DMARDs), particularly glucocorticoids, methotrexate, mycophenolate mofetil and rituximab, may blunt the immunological response to COVID-19 vaccination.4 Little is known about the clinical efficacy of these vaccines at preventing COVID-19 infection in patients with systemic autoimmune rheumatic diseases (SARDs). Patients with SARDs with a positive SARS-CoV-2 PCR or antigen test between 30 January 2020 and 30 July 2021 at hospital were identified using diagnostic billing codes or were referred by physicians, as previously described. From this cohort, we identified breakthrough infections in fully vaccinated patients, defined as a positive test =14 days after the final vaccine dose. The patients height, and weight were not reported. The patients concurrent conditions included: systemic autoimmune rheumatic diseases. The patients initiated vaccination with covid-19 vaccine ad26.cov2.s (Dose in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch number. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 breakthrough infection (Dose in series 1), and lack of efficacy in life threatening diseases drug-induced (Dose in series 1), and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 breakthrough infection and lack of efficacy in life threatening diseases drug-induced was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and lack of efficacy in life threatening diseases drug-induced, and covid-19 breakthrough infection was not related.  In conclusion, a small portion of COVID-19 cases among patients with SARDs in a large healthcare system occurred among fully vaccinated patients. However, some patients required hospitalisation that ultimately culminated in death. The most common SARD treatments at the time of vaccination included those associated with blunted antibody responses to SARS-CoV-2 vaccination. These findings suggest that the blunted SARS-CoV-2 antibody response following COVID-19 vaccination in certain DMARD users may be associated with an increased risk of breakthrough infections that may be severe and even fatal. Of note, the blunted response observed among glucocorticoid users is dose dependent, especially above 10 mg/day of prednisone. Some DMARD users may require alternative risk mitigation strategies, including passive immunity or booster vaccines and may need to continue shielding practices. Our study has certain limitations. First, we did not study the risk of breakthrough infections among a cohort of vaccinated patients with a known denominator. Therefore, we cannot estimate the rate of breakthrough infections among patients with SARDs. It is possible that the observed number of cases might be expected since no vaccine will prevent every infection. Second, the proportion of asymptomatic breakthrough infections observed in our study may be an underestimate because we only included patients who presented for testing. Third, we did not have SARS-CoV-2 antibody testing available for all patients and cannot rule out the possibility that SARD manifestations (eg, interstitial lung disease) commonly treated with these medications contributed to the severity of the presentation. In light of our findings, additional studies are urgently needed to estimate the risk of breakthrough infections among patients with SARDs and to evaluate the efficacy of booster vaccines and other strategies for DMARD users with poor immunological response to COVID-19 vaccination. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0;  COVID-19; The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: NATURE OF EVENT. Therefore, this event(s) is considered not related. Drug ineffective; The event is a special reporting situation and owing to its nature, it is not possible to attribute this occurrence to the suspect drug. Hence, the causality is considered as not related.