· Association of Facial Paralysis With mRNA COVID-19 Vaccines: A Disproportionality Analysis Using the World Health Organization Pharmacovigilance Database: A analysis study conducted by doctorate researchers affiliated with Grenoble Alpes University Hospital investigated the World Health Organization pharmacovigilance database on March 9, 2021 which included 133,883 cases of adverse drug reactions. This data included 844 (0.6%) facial paralysis-related events, 749 cases following the Pfizer-BioNTech vaccine and 95 cases following the Moderna vaccine (Table). There was no detected signal of disproportionality of facial paralysis for broad and narrow definitions and no increased incidence of facial paralysis in the mRNA COVID-19 vaccine compared to other viral vaccines (Figure), suggesting that the risk of facial paralysis is likely very low for recipients of the vaccine.
Transmission & Prevention
· Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine - United States, March-April 2021: Researchers on the CDC COVID-19 Response Team discuss the adverse effects of the Janssen COVID-19 vaccine reported to the Vaccine Adverse Events Reporting System (VAERS) and v-safe system. VAERS received 13,725 adverse event reports, including 17 reports of thrombosis with thrombocytopenia syndrome (TTS), 3 of which were due to non-cerebral venous sinus thrombosis (non-CVST) etiology (Table 2). V-safe data reviewed 338,765 people who received the Janssen vaccine, 76% of whom reported at least 1 systemic reaction and 61% had at least 1 injection site reaction (Table 3). These findings describe the safety profile of the Janssen COVID-19 vaccine, with a rare adverse effect of TTS.
· BNT162b2 mRNA Covid-19 Vaccine Effectiveness among Health Care Workers: A letter to the editor from researchers affiliated with Hadassah Hebrew University Medical Center (HHUMC) in Jerusalem investigated efficacy of the BNT162b2 vaccine among HHUMC health care workers. They discusses how 689 out of 6680 (10.3%) workers had been infected with COVID-19 through January 31, 2021, similar to the overall rates in Jerusalem which has the highest COVID-19 incidence in Israel. The trend in weekly incidence of COVID-19 decreased dramatically and remained low after 4 weeks (Table 1) despite the B.1.1.7 variant surge in up to 80% of cases. These findings suggest the effectiveness of the BNT162b2 vaccine among high-incidence areas and against variants.
Adjusting Practice During COVID-19
· Antibody Response to 2-Dose SARS-CoV-2 mRNA Vaccine Series in Solid Organ Transplant Recipients: In a research letter, surgery and pathology specialists associated with Johns Hopkins University School of Medicine discuss their study on antibody responses by 2-dose SARS-CoV-2 mRNA vaccination in 658 transplant recipients. At a median of 21 days after dose 1, antibody was detected in 98 participants (15%) with median antibody levels of > 250 U/mL (Roche Elecsys anti–SARS-CoV-2 S enzyme immunoassay) and 9.23 arbitrary units (EUROIMMUN enzyme immunoassay) (Figure). Antibodies were detected in 357 participants (54%) after a median of 29 days after dose 2, with a median antibody level of 142.1 U/mL (Roche) and 6.48 arbitrary units (EUROIMMUN). These results suggest that although a higher antibody response was noted after dose 2, transplant recipients still have a substantial risk of acquiring COVID-19.
R&D: Diagnosis & Treatments
· SARS-CoV-2 RNAemia predicts clinical deterioration and extrapulmonary complications from COVID-19: A prospective cohort study conducted by researchers from Stanford University School of Medicine collected plasma and analyzed quantitative (qPCR) and digital PCR (dPCR) to quantify SARS-CoV-2 RNA from 191 patients who presented to the ED with COVID-19 infection. Twenty-three percent (44/191) of SARS-CoV-2 positive patients had viral RNA detected in plasma by dPCR compared to 1.4% (2/147) by qPCR, indicating than dPCR is more sensitive than qPCR for detection of SARS-CoV-2 RNAemia. Compared with non-RNAemic patients, those with RNAemia were more likely to develop severe disease (odds ratio 6.72 [95% CI, 2.45 – 19.79]) (Figure 2), and require hospital admission (90.9% vs 70.1%, difference = 20.8% [95% CI, 8.1%-33.6%]), and tended toward higher rates of all EPC categories (p < 0.05) (Figure 4). These findings demonstrate how RNAemia on presentation could serve as an indicator for early therapies to be administered for the patients at highest risk for severe COVID-19 infection and deterioration.
· Remdesivir for coronavirus disease 2019 (COVID-19): a systematic review with meta-analysis and trial sequential analysis of randomized controlled trials: Researchers from University of Manitoba, Canada conducted a systematic review and meta-analysis on 5 studies examining remdesivir use in COVID-19 treatment (Table 1). Results indicated that a 10-day course of 100 mg remdesivir did not reduce all-cause mortality (RR 0.94, 95% CI 0.82-1.07; I^2=0%) or clinical progression of COVID-19 (RR 0.82, 95% CI 0.40-1.66; I^2=0%) (Figure 3). A 5-day course improved clinical progression (RR 1.05, 95% CI 1.01–1.10), but trial sequential analysis was inconclusive (Figure 4). This suggests that despite use of remdesivir for COVID-19 patients, no significant benefits are seen after 10 days of use in comparison to no treatment/placebo.
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