ABSTRACT
Objective: To describe the elapsed time between vaccination against SARS-COV2 and development of COVID19 pneumonia. To analyse the relation between COVID19 pneumonia and the time between doses as well as with patient profile. Material and/or methods: Cross-sectional descriptive study of patients diagnosed with COVID19 pneumonia and correctly vaccinated who have been notified to SEFV-h. The search for cases was carried out using the FEDRA 3 application between January and September 2021. Results: 99 cases of pneumonia in correctly vaccinated patients were identified;of these, 75 were vaccinated with Comirnaty, 12 with Janssen, 9 with Vaxzevria and 3 with Spikevax. Fifty-seven percent of pneumonias occurred 60 to 129 days after vaccination with a maximum ranging from 90 to 99 days (median 96). For analysis of the time between doses, the 87 cases that required two doses to complete vaccination schedule were considered. Nine of them had more than 2 months between doses, while 78 had less than 1 month (in 54% of the 87 cases 21 days had passed). There was no apparent association with the frequency of developing pneumonia. Thirty-seven percent were women and 60% men. To assess age, the cases were distributed by decade. Thus, the age group >79 had the highest number of cases (52), while the groups 60-69 and 70-79 comprised 18 cases each. The least cases were in the remaining groups: 8 (50-59), 2 (40-49) and 1 (30-39). There was none in the lower age groups. Conclusions: The data indicate that most cases of vaccine failure with severe disease occur 3 months after vaccination. Compared to pre-vaccination data collected from other sources, a decrease in severe cases was observed, with unchanged patient profile in terms of age and sex.
ABSTRACT
Objective: To assess the safety of high-dose bolus methylprednisolone versus intermediate-dose dexamethasone in COVID-19 patients with non-critical respiratory failure (RF). Material and/or methods: Low-intervention, phase IV, open-label, randomized 1:1, low-intervention clinical trial (CT): • Arm 1: Dexamethasone 6 mg/24 h/10 days. • Arm 2: Methylprednisolone boluses 250 mg/24 h/3 days Safety preliminary results are presented for 127 patients. This CT has been approved by the Spanish Medicines Agency and the Medicines Ethics Committee of the Salamanca Health Area. EudraCT Number: 2020-005026-28. Results: 127 hospitalized patients, diagnosed with acutephase SARS-CoV-2 infection and non-critical RF, were recruited between January and August 2021. The mean age was 59.5 years and 66.14% were male. The 93.70% were in stage 5 disease according to WHO criteria and 6.30% in stage 4. There were 55 serious adverse events (SAEs) (32 patients, 78% men) and 7 of them (12.7%) were considered serious adverse reactions (SARs), all of them expected. Six patients died (three in the methylprednisolone group). Of these seven SARs, two (28.5%) belonged to the methylprednisolone group, all in men (mean age 67.5 years) and none resulted in death. The classification by organ and system (SOC) of the registered 55 AEs and SAEs, was as follows: 5 vascular disorders cases (methylprednisolone arm: 2), 21 respiratory, thoracic and mediastinal disorders cases (methylprednisolone arm: 12), 2 gastrointestinal disorders cases (methylprednisolone arm: 0), 1 nervous system disorders case (methylprednisolone arm), 26 infections and infestations cases (methylprednisolone arm: 13) and 1 cardiac disorders case no related with methylprednisolone. For the seven adverse reactions reported, the classification by SOC was as follows: one infections and infestations case and one gastrointestinal disorders case no related with methylprednisolone and five vascular disorders cases (methylprednisolone arm: 2). Conclusions: Based on the results obtained, there is no evidence of safety risks associated with high-dose methylprednisolone bolus versus intermediate-dose dexamethasone in patients with COVID-19 with non-critical respiratory failure.