Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G decreased, COVID-19, Laboratory test, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19; This spontaneous report was received from literature. This report concerned multiple patients. Any race, and Unknown race patients were included in this study. 2,362 (64.0%) patients were unvaccinated; 476 (12.9%) were fully vaccinated with the Moderna vaccine; 738 (20.0%) were fully vaccinated with the Pfizer-BioNTech vaccine; and 113 (3.1%) were fully vaccinated with the Janssen vaccine.  The objective of this study was to compare the effectiveness of Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson) vaccines in preventing COVID-19 hospitalizations among adults without immunocompromising conditions. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered 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.  A patient was considered fully vaccinated was received =14 days before illness onset. Because a limited number of patients received Janssen vaccine >120 days before illness onset (19 total), VE for the Janssen vaccine was not stratified by time. In addition to a VE estimate defining full vaccination as 14 days after a Janssen vaccine dose, a sensitivity analysis was conducted defining full vaccination as 28 days after a Janssen vaccine dose. VE against COVID-19 hospitalization was during 11-MAR-2021 to 15-AUG-2021. Case patients were admitted to a hospital with COVID-19 like illness (confirmed covid-19) and a positive SARS-CoV-2 reverse transcriptionpolymerase chain reaction (RT-PCR) or antigen test result (confirmed clinical vaccine failure). Control-patients were adults admitted to a hospital who received a negative SARS-CoV-2 RT-PCR test result. Number of days hospitalized and discharge information was not reported. For the post vaccination antibody analysis, healthy adults aged more than or equal 18 years with no known prior SARS-CoV-2 infection were recruited during 06-APR-2021 to 04-JUN-2021. Blood was collected 2 to 6 weeks (approximately after 35 days) after receipt of the single Janssen vaccine dose. Were shipped to CDC, where they underwent testing for IgG against three SARS-CoV-2 antigens: the spike protein (anti-spike); the spike RBD (anti-RBD); and nucleocapsid (anti-nucleocapsid). IgG levels were measured. Post vaccination anti-spike IgG and anti-RBD IgG levels were significantly lower in persons vaccinated with the Janssen vaccine than the Moderna or Pfizer-BioNTech vaccines. Anti-RBD levels were higher in participants vaccinated with the Moderna vaccine than in those who received the Pfizer-BioNTech vaccine or the Janssen vaccine. Anti-spike IgG levels in participants vaccinated with the Moderna vaccine did not significantly differ from those in recipients of the Pfizer-BioNTech vaccine but were significantly higher than levels in participants who received the Janssen vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 and confirmed clinical vaccine failure was not reported. The authors emphasized VE against COVID-19 hospitalization for Moderna and Pfizer-BioNTech vaccines was 93% and 88%, respectively, whereas the single-dose Janssen vaccine had somewhat lower VE at 71%. Persons vaccinated with Janssen vaccine also had lower post-vaccination anti-SARS-CoV-2 antibody levels than did recipients of mRNA vaccines. Although the Janssen vaccine had lower observed VE, 1 dose of Janssen vaccine still reduced risk for COVID-19 associated hospitalization by 71%. Although these real-world data suggest some variation in levels of protection by vaccine, all FDA-approved or authorized COVID-19 vaccines provide substantial protection against COVID-19 hospitalization. This report was serious (Hospitalization Caused / Prolonged) This report was associated with product quality complaint: 90000263596.; Sender's Comments: V0-20221233645-Confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration  20221233645-Confirmed covid-19 infection. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.  .