Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: BREAKTHROUGH SARS-COV-2 INFECTION; This solicited report received from a health care professional concerned a patient of unspecified age and sex. The patient was enrolled in a non-company sponsored study. This patients were also referenced in literature  The patient's weight and height were not reported. The patient's concurrent conditions included: myeloid neoplasm. Method: performed SARS-CoV-2 virus neutralization assays, which in contrast to conventional assays that measure SARS-CoV-2 binding antibodies, can distinguish the capacity of immune sera to block cell entry by the prototype WA1/2020 strain, used in the vaccines, as well as individual VOCs. Virus neutralization titers have been correlated with protection against SARS-CoV-2 infections and especially against severe disease. Postvaccination sera were evaluated in a qualified SARS-CoV-2 pseudovirion neutralization assay (PsVNA) using SARS-CoV-2 WA1/2020 strain and the 5 VOC strains: Alpha, Beta, Gamma, Delta, and Omicron (supplemental Methods). SARS-CoV-2 neutralizing activity measured by PsVNA as 50% neutralization titers (PsVNA50) correlated with plaque reduction neutralization test with authentic SARS-CoV-2 virus in our previous studies. The median time intervals between vaccination and evaluation of sera in MDS/ AML patients were 150.5 days following the second vaccination  and 30.5 days following the third vaccination  whereas for healthy controls, it was 38 days after the second vaccination  and 57.5 days after the third vaccination.  After 2 vaccinations, the control group demonstrated a robust response (100% with PsVNA50 .1:40) against the vaccine homologous WA1/2020 (PsVNA50 geometric mean titer [GMT] of 1:1713). In contrast, patients with myeloid neoplasms displayed significantly weaker neutralization titers with GMT of 1:139 (7/38 nonresponders with PsVNA50 of ,1:20) . It did not observe significant differences in vaccine response between patients with AML (n 5 9), MDS , or myeloproliferative neoplasms) after 2 vaccine doses. Booster (third) vaccination in the healthy controls resulted in consistently strong neutralizing antibody responses against the WA1/2020 strain (PsVNA50 .1:500; GMT, 1:3141). In contrast, among 11 patients with myeloid neoplasms (diagnosed as MDS or AML) who received 3 vaccine doses, WA1/2020 neutralizing antibodies were highly variable (GMT, 1:304), with 2/11 demonstrating no neutralization response 4/11 strong responders (PsVNA50 .1:500) against WA1/2020.  The patient had received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) (dose series 1) dose, start therapy date were not reported for COVID-19 prophylaxis.The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced breakthrough sars-cov-2 infection (dose series 1) Two patients had documented breakthrough SARS-CoV-2 infection after 2 vaccine doses, with 1 patient (P-8) having prolonged hospitalization but ultimately recovered, and a second patient (P-30) with mild symptoms and was managed as an outpatient (supplemental Table 1). After the third vaccine dose, 1 patient (P-53) had documented breakthrough SARS-CoV-2 infection resulting in hospitalization and recovered fully. These observations highlight the immunodeficiency in this patient population. Even patients with MDS on observation generated weak neutralizing antibody response following SARS-CoV-2 vaccination. These patients are likely to be at increased risk for breakthrough infection, especially from Omicron, and therefore should be prioritized for postexposure treatments early after SARS-CoV-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough sars-cov-2 infection. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and breakthrough sars-cov-2 infection was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0-Breakthrough COVID-19. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered related.