Emergency Use Authorization Research Articles

Survey Based Assessment of Adverse Effect in Covid-19 Vaccination Breakthrough Infections

Background: Millions of individuals worldwide have been impacted by COVID-19, which has put a tremendous strain on global economies and healthcare systems. Vaccines are the only way to stop this pandemic, unfortunately. The COVID-19 vaccines were developed more swiftly than previous immunizations and have received global Emergency Use Authorization (EUA) approval. Therefore, our goal was to assess any short-term negative consequences following vaccination. The purpose of this study is to determine the negative effects linked to three different COVID-19 vaccination types. The questionnaire asked questions on COVID-19 infection and the adverse effects of the COVID-19 vaccine after receiving the first, second, or booster dose. Method: With the help of questionnaires from different districts, a cross-sectional study was done. We made the questionnaire and used it to find out things like which side effects happen most often after the first, second, and booster doses of a vaccine. We also find out how many people get the Corona virus after getting the vaccine. Result: People often experience bad side effects like fever, nausea, diarrhoea, weakness, headache, chills with shivering, pain at the injection site, loss of appetite, and weight loss. Even though many people don't have any problems after getting a vaccine, Most of the time, we found that only 4% of people who got the vaccine got the Corona virus. Conclusion: As more people get sick after getting the Covishield vaccine, it may not work as well as the Covaxin and Sputnik V vaccines.

The impact of vaccination on COVID-19

The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratorysyndromecoronavirus2(SARS-CoV-2)becameachallengegloballyrespiratory syndrome coronavirus 2 (SARS-CoV-2) became a challenge globally byaffectingmillionsofpeopleworldwide.COVID-19vaccinationisaneffec-by affecting millions of people worldwide. COVID-19 vaccination is an effec-tiveoptiontostopdiseaseoutbreak.COVID-19vaccinesarefullyapprovedtive option to stop disease outbreak. COVID-19 vaccines are fully approved orcurrentlyauthorizedforusethroughEmergencyUseAuthorization(EUA)or currently authorized for use through Emergency Use Authorization (EUA) fromtheFoodandDrugAdministration(FAD)areessentialforcontrollingfrom the Food and Drug Administration (FAD) are essential for controlling theCOVID-19pandemic.DespiteCOVID-19vaccinesareeffective,someful-the COVID-19 pandemic. Despite COVID-19 vaccines are effective, some ful-lyvaccinatedpersonscanbeinfectedwithSARS-CoV-2calledbreakthroughly vaccinated persons can be infected with SARS-CoV-2 called breakthrough infection.ObservingCOVID-19resultsinpopulationsbyvaccinationstatusisinfection. Observing COVID-19 results in populations by vaccination status is simplifiedthroughdependablecorrelationofCOVID-19casesurveillanceandsimplifi ed through dependable correlation of COVID-19 case surveillance and vaccinationdata.TheincidenceofSARS-CoV-2infection,hospitalization,andvaccination data. The incidence of SARS-CoV-2 infection, hospitalization, and deathiselevatedinunvaccinatedthanvaccinatedpersons,andtheincidencedeath is elevated in unvaccinated than vaccinated persons, and the incidence rateratiosarerelatedtovaccineeffectiveness.Weconductedaretrospectiverate ratios are related to vaccine effectiveness. We conducted a retrospective analysisofmedicalreportsof169patientswithconfirmedCOVID-19.Weas-analysis of medical reports of 169 patients with confirmed COVID-19. We as-sessedvaccineeffectivenessagainstCOVID-19andagainsthospitalizationwithsessed vaccine effectiveness against COVID-19 and against hospitalization with COVID-19intheInfectiousDisease,AIDSandClinicalImmunologyResearchCOVID-19 in the Infectious Disease, AIDS and Clinical Immunology Research Centre,GeorgiafromfromApril1throughOctober31,2021.Ourstudyin-Centre, Georgia from from April 1 through October 31, 2021. Our study in-dicatesthevaccineeffectivenessagainstCOVID-19.Hospitalizationrateweredicates the vaccine effectiveness against COVID-19. Hospitalization rate were higher in unvaccinated patients compared with vaccinated patients. Vaccination isconsideredtobeoneofthemostimportantadvancesinpublichealth.Thereis considered to be one of the most important advances in public health. There aremanypeoplewhoarenotvaccinated.Itisimportanttocreatetheawarenessare many people who are not vaccinated. It is important to create the awareness aboutCOVID-19vaccinesandeducatepeopleabouttheimportanceofvaccineabout COVID-19 vaccines and educate people about the importance of vaccine anditseffectiveness.and its effectiveness.

Prevalence, Pathophysiology, and Treatment of Urticaria post-COVID-19 Vaccination: A Systematic Review

Background: Vaccination for COVID-19 has been intensively developed since the end of 2020. Its use must also obtain an Emergency Use Authorization (EUA) permit. Some of the vaccines have been used including Sinovac, Astra Zeneca, Moderna, Pfizer, Johnson & Johnson, and Sinopharm. In fact, there are many effects that have developed after the COVID-19 vaccination administration like local reactions, systemic reactions, and other reactions. In addition, one of them is urticaria. However, the existing literature has focused poorly on urticaria caused by COVID-19 vaccines. Aims: This research explores the prevalence, pathophysiology, and treatment of urticaria post-COVID-19 vaccination. Methods: This study conducted a systematic review based on the guideline which is Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). We searched Scopus, ProQuest, Ebsco, and Google Scholar databases from 2020 until 2022 for identifying the data regarding urticaria post-COVID-19 vaccination. In a nutshell, 9 studies were included in the systematic review. Results: Only 28% of urticarial rashes incident among all cutaneous adverse reactions after post-COVID-19, it was higher among females and people aged 45-49 years old, and people with allergy histories. The most frequent reaction is urticarial following the COVID-19 vaccine administration. This concerns hypersensitivity reaction related to Immunoglobulin E (IgE) mediated, Immunoglobulin G (IgG), and sensitizing excipients in COVID-19 vaccines. Conclusion: This systematic review raises the concern of hypersensitivity reaction that related to IgE-mediated, IgG, and sensitizing excipients in COVID-19 vaccines. Urticaria is the most frequent reaction after the COVID-19 vaccine administration. Attention to medical history and immunology/allergy consultation might be advantageous to assess the risk of allergy and the guidance of the vaccine. Received: 9 May 2023; Revised: 8 June 2023; Accepted: 18 July 2023

Pharmaceutical and Medical Device Resilience: Implementation of Emergency Use Authorization in Pharmaceuticals and Medical Devices During the Covid-19 Pandemic: a Literature Review

The COVID-19 pandemic has caused an urgent need for pharmaceuticals and medical devices used for testing, treatment, and prevention. The policy of issuing an Emergency Use Authorization (EUA) for COVID-19 handling products is carried out to fulfill these needs. This study aims to describe and analyze how the EUA mechanism can be used as resilience during the pandemic. The study used Pubmed and ScienceDirect databases to search all articles using inclusion and exclusion criteria. The inclusion criteria were articles in English and Indonesian, national and international research articles covering the application of the EUA, searches limited to the last 3 years, and articles not limited to one study design. The exclusion criteria were articles not available in full text and topics unrelated to EUA in pharmaceuticals and medical devices. A total of 1,009 articles were identified using the keywords “Emergency Use Authorization”, “drug or medical device”, “COVID-19”. Finally, 11 articles that met the criteria were analyzed. The EUA approval for pharmaceuticals and medical devices is a form of resilience in the face of a pandemic and is an effective way to meet increasing needs while looking at clinical evidence and evidence of use in the field. The ability and experience in implementing the EUA can be a guide for learning in dealing with pandemics in the future.

Interim Recommendations for Use of Bivalent mRNA COVID-19 Vaccines for Persons Aged ≥6 Months — United States, April 2023

Throughout the national public health emergency declared in response to the COVID-19 pandemic, CDC, guided by the Advisory Committee on Immunization Practices (ACIP), has offered evidence-based recommendations for the use of COVID-19 vaccines in U.S. populations after each regulatory action by the Food and Drug Administration (FDA). During August 2022-April 2023, FDA amended its Emergency Use Authorizations (EUAs) to authorize the use of a single, age-appropriate, bivalent COVID-19 vaccine dose (i.e., containing components from the ancestral and Omicron BA.4/BA.5 strains in equal amounts) for all persons aged ≥6 years, use of bivalent COVID-19 vaccine doses for children aged 6 months-5 years, and additional bivalent doses for immunocompromised persons and adults aged ≥65 years (1). ACIP voted in September 2022 on the use of the bivalent vaccine, and CDC made recommendations after the September vote and subsequently, through April 2023, with input from ACIP. This transition to a single bivalent COVID-19 vaccine dose for most persons, with additional doses for persons at increased risk for severe disease, facilitates implementation of simpler, more flexible recommendations. Three COVID-19 vaccines are currently available for use in the United States and recommended by ACIP: 1) the bivalent mRNA Pfizer-BioNTech COVID-19 vaccine, 2) the bivalent mRNA Moderna COVID-19 vaccine, and 3) the monovalent adjuvanted, protein subunit-based Novavax COVID-19 vaccine.* As of August 31, 2022, monovalent mRNA vaccines based on the ancestral SARS-CoV-2 strain are no longer authorized for use in the United States (1).

#3317 THE EFFECT OF HEMOPERFUSION ON SURVIVAL AMONG COVID-19 CRITICALLY ILL PATIENTS IN A TERTIARY HOSPITAL IN DAVAO CITY, PHILIPPINES

Abstract Background and Aims Cytokine storm in COVID-19 is an excessive immune response through the overproduction of inflammatory cytokines which significantly increases mortality. Hemoperfusion has been granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) in an effort to eliminate circulating inflammatory mediators among COVID-19 critical patients to improve clinical outcomes and survival. This study aims to determine the 8 – day survival of critical COVID-19 patients who received hemoperfusion. Method This is a descriptive study conducted among critically ill COVID-19 patients who completed hemoperfusion treatment admitted from October 2020 to October 2021 in a tertiary hospital in Davao City, Philippines. The inclusion criteria were adult patients greater than 18 years of age with RT-PCR confirmed SARS-CoV-2 infection who underwent and completed hemoperfusion during hospitalization for COVID-19. While those patients who did not complete the hemoperfusion treatment because of hemodynamic instability or death were excluded. All of the patients classified as COVID-19 critical received the standard treatment for COVID-19 such as steroids (dexamethasone) and antiviral (Remdesevir). Among the 1,037 COVID-19 adult patients admitted from October 2020 to October 2021, 28 of them were classified as critical and received hemoperfusion, but only 19 patients completed the treatment. Results Majority of patients in the study were males (14/19, 73.68%) with a mean age of 59 years (SD 12.90). Hypertension (n = 15, 78.95%) and Diabetes Mellitus (n = 14, 73.68%) were the most common comorbid illnesses. Cough (n = 15, 78.95%), fever (n = 11, 57.90%), and dyspnea (n = 7, 36.84%) were the frequent symptoms. The laboratory parameters (median hemoglobin, leukocytes, thrombocytes, creatinine, and ALT were within normal range except for an elevated median AST (54 U/L). Forty-two percent (8/19) of patients survived at day 8 (Figure 1). Survivors had higher baseline oxygen saturation compared to non-survivors (89% vs 78%), but in both groups, the oxygen saturation increased after hemoperfusion (Figure 2). All inflammatory markers (CRP, ferritin, LDH, and procalcitonin) decreased among survivors post-hemoperfusion. However, the ferritin, LDH, and procalcitonin remained elevated among non-survivors (Figure 3A, B, C D). The median time from symptoms onset to hemoperfusion initiation was longer in non-survivors compared to survivors (10 days vs 8 days) (Figure 4). Conclusion Close to half (42.11%) of the critical COVID-19 patients who underwent hemoperfusion survived at day 8. Therefore, hemoperfusion remains to be a beneficial adjunct treatment for critical COVID-19 patients especially if initiated early.

#4960 TIXAGEVIMAB AND CILGAVIMAB (EVUSHELD) FOR PRE-EXPOSURE PROPHYLAXIS OF COVID-19: A MONOCENTRIC STUDY IN KIDNEY TRANSPLANT RECIPIENTS

Abstract Background and Aims Patients, who underwent kidney transplantation, may be at particularly high risk of mortality due to immunosuppressive therapy and underlying comorbidity such as hypertension, cardiovascular disease and diabetes mellitus finally increasing the risk of a severe form of SARS-CoV-2 infection. According to the ERA-EDTA DESCARTES expert opinion, management of immunosuppression in SARS-CoV-2 infection suggests withdrawal of antimetabolite (mycophenolate or azathioprine) in patients with mild upper respiratory and/or gastrointestinal symptoms and discontinuation of all immunosuppressive drugs with maintenance of steroid for severe bilateral pneumonia. Despite SARS-CoV-2 vaccination, kidney transplant patients remain at increased risk for severe COVID-19 infection and mortality and at high priority for additional strategies for preexposure prophylaxis.Tixagevimab and cilgavimab are long-acting monoclonal antibodies against the spike protein of SARS-CoV-2, which block the virus’ attachment and entry into human cells. This combined monoclonal antibody (Evusheld®) has been granted emergency use authorization (EUA) by the U. S food and drug administration (FDA) for individuals 12 years and older who have a moderate to severe immunocompromising condition and may not mount an adequate vaccination response.This single cohort observational study reports the incidence and outcomes of COVID-19 among kidney transplant recipients receiving Evusheld® as preexposure prophylaxis. Method Observational monocentric cohort study of 119 kidney transplant patients receiving Evusheld® 150/150 mg intramuscularly as preexposure prophylaxis between July 1, 2022 and December 31, 2022. Inclusion criteria: kidney or combined kidney-pancreas transplantation within 1 year; recent acute allograft rejection; time since COVID-19 infection of 120 days and time since last vaccine dose of 2 weeks. Results After a median (range) follow-up of 150 days, COVID-19 was confirmed in 48/119 patients (40.3%), who had only a light form of COVID-19 infection. No one complained side. Conclusion Our study reported a low rate of infections with only light symptoms among kidney transplant patients treated with Evusheld®. A long-term study with a larger cohort might better evaluate the efficacy, outcomes and safety of this preexposure prophylaxis.

THE RED FLAG OF EMERGENCY USE AUTHORIZATION (EUA)

The Emergency Use Authorization (EUA) policy, a representative biodefense policy, was legislated in the United States in 2001 based on lessons learned from Amerithrax, whereas Korea's EUA policy was based on lessons learned from the Middle East Respiratory Syndrome outbreak in 2015. Due to these divergent origins, the U.S. EUA's homeland security objectives were specialized to deal with highly pathogenic biological agents that could be exploited for bioterrorism, whereas the Korean EUA pursues disease containment purposes to strengthen mass‐testing practices. During the early phase of the COVID‐19 pandemic, the U.S. EUA revealed limitations in its integration with public health surveillance, laboratory partnerships, and insurance systems, which hampered the rapid expansion of testing capacities. Thereafter, once the limitations of the EUA were circumvented, the testing capacity of the United States began to catch up with that of South Korea, and later skyrocketed after solving these issues.

Inpatient remdesivir versus nirmatrelvir-ritonavir in the progression of COVID-19

Background: Nirmatrelvir-ritonavir received emergency use authorization (EUA) for the prevention of progression of COVID-19 in December 2021. Most data supporting this authorization are limited to the outpatient setting in unvaccinated patients, and high-quality head-to-head comparisons to other antivirals such as remdesivir are lacking. Patients at high risk of disease progression, such as advanced age, smokers, and those with cardiovascular disease, diabetes, obesity, or cancer continue to be admitted to acute-care settings for various indications, and some are incidentally found to have mild COVID-19. The objective of this project was to compare rates of progression of mild-to-moderate COVID-19 for inpatients treated with remdesivir versus nirmatrelvir-ritonavir. Methods: This study was a single-center, retrospective cohort study that included patients aged ≥18 years with PCR-confirmed SARS-CoV-2 infection who were initiated on nirmatrelvir-ritonavir within 5 days or remdesivir within 7 days of symptom onset between June 2022 and August 2022. The primary outcome was the worsening of symptoms via the WHO ordinal clinical severity scale for COVID-19. Secondary outcomes included escalation of care or readmission due to COVID-19, discharge prior to treatment completion, and any adverse drug reactions (ADRs). Within our institutional guidelines, prior approval is needed for COVID-19 treatment through collaboration between the primary team and antimicrobial stewards. Nirmatrelvir-ritonavir is the preferred agent for both in- and outpatients unless the patient had drug interactions or lack of enteral access, in which case remdesivir was considered. Results: In total, 58 patients were screened and 50 patients were included, 25 patients in each arm. Most were non-Hispanic, white males with at least 1 comorbidity. Compared to the remdesivir arm, the nirmatrelvir-ritonavir arm had more patients with at least a primary COVID-19 vaccine (44% vs 34%). Also, 88% of patients in each arm had a baseline ordinal score of 4, and 12% had a score of 5. Ordinal score changes between the start and end of therapy were similar between groups, and neither had an increase in oxygen requirements (Fig. 1). No readmissions were due to COVID-19, and both medications were well tolerated. Refer to Fig. 2 for secondary outcomes. Conclusions: Nirmatrelvir-ritonavir and remdesivir showed similar safety and efficacy in the treatment of hospitalized patients with mild-to-moderate COVID-19. Current evidence-based guidelines and treatment costs favor nirmatrelvir-ritonavir for patients who can receive this drug.Disclosures: None

TIXAGEVIMAB‐CILGAVIMAB THERAPY IN THE PREVENTION OF SARS‐COV2 INFECTION IN NON HODGKIN‐B LYMPHOMAS AND HODGKIN LYMPHOMAS UNDER TREATMENT: OUR EXPERIENCE

Patients with B-cell malignancies who become infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are at an increased risk of morbidity and mortality due to advanced age, use of B-cell-depleting therapies, and immunodeficiency. Despite development of COVID-19 messenger RNA vaccines, the majority of patients with B-cell malignancies fail to develop anti-SARS-CoV-2 spike antibodies in response to vaccination, and mortality rates secondary to COVID-19 infection over 10% have been reported. Preexposure prophylaxis with tixagevimab-cilgavimab may be an alternative strategy to decrease the incidence or severity of COVID-19 for patients with NHL B-cell malignancies. Tixagevimab-cilgavimab is a monoclonal antibody (MoAb) that inhibits attachment of the SARS-CoV-2 spike protein to the surface of cells, thereby preventing viral entry and infection by the COVID-19 virus. In December 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for its use in individuals 12 years and older with moderate to severe immunodeficiency. Tixagevimabcilgavimab was authorized based on results of the phase III PROVENT study, which demonstrated a breakthrough infection rate of 0.5% in unvaccinated adults at an increased risk of inadequate response or exposure toCOVID-19. However, only 7% of patients had cancer or a history of cancer, and 3% were actively receiving immunosuppressive therapy. The aim of the study is to evaluate the impact of prevention with texagevimab-cilgavimab in a cohort of patients, observed in our Division, with non-Hodgin B lymphoma or Hodgkin's lymphoma under treatment or who had finished treatment in the previous 6 months. From 1 July 2022 to 31 January 2023, we evaluated 101 pts 48 F and 53 M with a median age of 65 years (range 16–91 years) a cohort of patients (pts), who started or were under specific treatment, to whom we performed tixagevimab-cilgavimab in the prevention of SARS-CoV-2. 95% of pts had previously received the recommended vaccine doses, median 2 (range 2–4 doses). 12HD; 88 NHLs; 1 HCL. In 33 (33%) pts has been effectued before the start of treatment and 68 (67%) during treatment. 47 (46.5%) were on induction treatment, 47 (46.5%) on maintenance therapy with anti-CD20 or imbruvica or venetoclax and 7 (7%) had finished treatment within the previous 3 months. Of the 101 pts, 21% were developed covid infection during observation: 12 M and 9 F median age 65 years (range 21–83 years) 2 HD and 19 NHL. 14 pts were in maintenance therapy (9 rituximab; 4 Obinutuzumab and 1 pc ibrutinib + Rituximab) and 7 in induction treatment (2 AdAVD;1 G-CVP;2 R-MACOP-B;1 R-BAC and 1 R-COMP) . 12 pts (57%) had mild symptoms (median age 55 years) while 9 (43%) had severe symptoms who has required hospitalization (median age 75 years). 6 patients (28.5%), with a median age of 75 years, died of COVID. In 9/21 pts (43%) the treatment was not interrupted (4 patients in induction therapy and 5 patients in maintenance therapy) all with mild COVID symptoms, no COVID-related complication was documented in these patient. 4 pts regularly terminated the treatment while 5 are still in treatment. Of the patients who died, 1 had finished induction therapy (R-BAC) while 5 were on maintenance therapy (3 rituximab and 2 obinutuzumab). From our experience, prevention therapy does not seem to have changed the incidence and prognosis of the SARS-COV2 infection, certainly variables that seem to influence are age (75 vs 55 years) and the total IgG value (patients with severe symptoms had a median IgG of 415 mg/dl vs 817 mg/dl in patients with mildly symptomatic COVID), further in patients with mild symptoms the COVID infection did not interfere with the continuation of the specific treatment, we do not know if in these cases it could to helping the preventive therapy. A larger cohort of patients is needed to consolidate or confirm the data of our observation. Encore Abstract - previously submitted to EHA 2023 No conflicts of interests pertinent to the abstract.

COVID-19 update: An EUA for vilobelimab (Gohibic) for COVID-19.

The investigational anti-complement component 5a (C5a) antibody vilobelimab (Gohibic – InflaRx) has been granted an FDA Emergency Use Authorization (EUA) for IV treatment of hospitalized adults with COVID-19 beginning within 48 hours after invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) is started. Vilobelimab is the first anti-C5a antibody to become available in the US.

Safety of the NVX-CoV2373 COVID-19 vaccine in randomized placebo-controlled clinical trials

BackgroundNVX-CoV2373 (Nuvaxovid™ or the Novavax COVID-19 Vaccine, Adjuvanted), the first protein-based COVID-19 vaccine, received emergency use authorization (EUA) as a primary series/booster and is available globally. NVX-CoV2373 primary series demonstrated efficacy rates of 89.7–90.4 % and an acceptable safety profile. This article summarizes safety in adult recipients (aged ≥ 18 years) of primary series NVX-CoV2373 in four randomized placebo-controlled trials. MethodsAll participants who received NVX-CoV2373 primary series or placebo (pre-crossover) were included according to actual received treatment. The safety period was from Day 0 (first vaccination) to unblinding/receipt of EUA-approved/crossover vaccine, end of each study (EOS), or last visit date/cutoff date minus 14 days. The analysis reviewed local and systemic solicited adverse events (AEs) within 7 days after NVX-CoV2373 or placebo; unsolicited AEs from after Dose 1 to 28 days after Dose 2; serious AEs (SAEs), deaths, AEs of special interest, and vaccine-related medically attended AEs from Day 0 through end of follow-up (incidence rate per 100 person-years). FindingsPooled data from 49,950 participants (NVX-CoV2373, n = 30,058; placebo, n = 19,892) were included. Solicited reactions after any dose were more frequent in NVX-CoV2373 recipients (local, 76 %/systemic, 70 %) than placebo recipients (local, 29 %/systemic, 47 %), and were mostly of mild-to-moderate severity. Grade 3+ reactions were infrequent, with greater frequency in NVX-CoV2373 recipients (local, 6.28 %/systemic, 11.36 %) than placebo recipients (local, 0.48 %/systemic, 3.58 %). SAEs and deaths occurred with similarly low frequency in NVX-CoV2373 (SAEs: 0.91 %, deaths: 0.07 %) and placebo recipients (SAEs: 1.0 %, deaths: 0.06 %). InterpretationTo date, NVX-CoV2373 has displayed an acceptable safety profile in healthy adults. FundingSupported by Novavax, Inc.

Tweeting about the COVID-19 vaccine: A content analysis

ABSTRACT Twitter has been an influential and often controversial strategy for disseminating, discussing, and sharing information about the COVID-19 vaccine during the pandemic. This study focuses on using Twitter as a data collection and analysis tool to understand the narrative surrounding the COVID-19 vaccine in the days after the first emergency-use authorization (EUA). We conducted a content analysis of tweets we collected over a 30-day period (n = 419,495) and developed an iterative codebook that contained six domains (tweet source, location, tweet characteristics, COVID-19 specific topics, demographic descriptors, and sentiment) and thirty-six codes. Despite the abundance of misinformation on Twitter about the vaccine, we found that more tweets were positive than negative in tone and contained mostly reliable and up-to-date information about the vaccine. Most tweets came from individuals though many came from organizations. We found little discussion of demographic descriptors such as race/ethnicity, religion, or socioeconomic status, nor did we see discussion of misinformation or mask-wearing. Additionally, few tweets came from politicians or political organizations, and we found little talk of politics. This article contributes to the growing body of evidence of using Twitter to understand the narrative surrounding health topics during public health crises such as COVID-19.

Real world effectiveness of tixagevimab/cilgavimab (Evusheld) in the Omicron era.

Pre-exposure prophylaxis for COVID-19 with tixagevimab/cilgavimab (T/C) received Emergency Use Authorization (EUA) based on results of a clinical trial conducted prior to the emergence of the Omicron variant. The clinical effectiveness of T/C has not been well described in the Omicron era. We examined the incidence of symptomatic illness and hospitalizations among T/C recipients when Omicron accounted for virtually all local cases. Through retrospective electronic medical record chart review, we identified patients who received T/C between January 1 -July 31, 2022 within our quaternary referral health system. We determined the incidence of symptomatic COVID-19 infections and hospitalizations due to or presumed to be caused by early Omicron variants before and after receiving T/C (pre-T/C and post-T/C). Chi square and Mann-Whitney Wilcoxon two-sample tests were used to examine differences between the characteristics of those who got COVID-19 before or after T/C prophylaxis, and rate ratios (RR) and 95% confidence intervals (CI) were calculated to assess differences in hospitalization rates for the two groups. Of 1295 T/C recipients, 105 (8.1%) developed symptomatic COVID-19 infection before receiving T/C, and 102 (7.9%) developed symptomatic disease after receiving it. Of the 105 patients who developed symptomatic infection pre-T/C, 26 (24.8%) were hospitalized, compared with six of the 102 patients (5.9%) who were diagnosed with COVID-19 post-T/C (RR = 0.24; 95% CI = 0.10-0.55; p = 0.0002). Seven of the 105 (6.7%) patients infected pre-T/C, but none of the 102 infected post-T/C required ICU care. No COVID-related deaths occurred in either group. The majority of COVID-19 cases among those infected pre-T/C treatment occurred during the Omicron BA.1 surge, while the majority of post-T/C cases occurred when Omicron BA.5 was predominant. In both groups, having at least one dose of vaccine strongly protected against hospitalization (pre-T/C group RR = 0.31, 95% CI = 0.17-0.57, p = 0.02; post-T/C group RR = 0.15; 95% CI = 0.03-0.94; p = 0.04). We identified COVID-19 infections after T/C prophylaxis. Among patients who received T/C at our institution, COVID-19 Omicron cases occurring after T/C were one-fourth as likely to require hospitalization compared to those with Omicron prior to T/C. However, due to the presence of changing vaccine coverage, multiple therapies, and changing variants, the effectiveness of T/C in the Omicron era remains difficult to assess.

DTSEA: A network-based drug target set enrichment analysis method for drug repurposing against COVID-19

The Coronavirus Disease 2019 (COVID-19) pandemic is still wreaking havoc worldwide. Therefore, the urgent need for efficient treatments pushes researchers and clinicians into screening effective drugs. Drug repurposing may be a promising and time-saving strategy to identify potential drugs against this disease. Here, we developed a novel computational approach, named Drug Target Set Enrichment Analysis (DTSEA), to identify potent drugs against COVID-19. DTSEA first mapped the disease-related genes into a gene functional interaction network, and then it used a network propagation algorithm to rank all genes in the network by calculating the network proximity of genes to disease-related genes. Finally, an enrichment analysis was performed on drug target sets to prioritize disease-candidate drugs. It was shown that the top three drugs predicted by DTSEA, including Ataluren, Carfilzomib, and Aripiprazole, were significantly enriched in the immune response pathways indicating the potential for use as promising COVID-19 inhibitors. In addition to these drugs, DTSEA also identified several drugs (such as Remdesivir and Olumiant), which have obtained emergency use authorization (EUA) for COVID-19. These results indicated that DTSEA could effectively identify the candidate drugs for COVID-19, which will help to accelerate the development of drugs for COVID-19. We then performed several validations to ensure the reliability and validity of DTSEA, including topological analysis, robustness analysis, and prediction consistency. Collectively, DTSEA successfully predicted candidate drugs against COVID-19 with high accuracy and reliability, thus making it a formidable tool to identify potential drugs for a specific disease and facilitate further investigation.

Use of monoclonal antibody therapy in hematologic patients with mild‐to‐moderate COVID‐19: A retrospective single‐center experience

In November 2020, the FDA issued an emergency use authorization (EUA) for monoclonal antibody (mAb) therapy in patients with mild-to-moderate COVID-19 at high risk for disease progression. We retrospectively reviewed 38 adult hematology patients who received mAbs from 11/2020 to 2/2021. Thirty (79%) patients received bamlanivimab and 8 (21%) casirivimab-imdevimab. Four (11%) patients were hospitalized due to COVID-19, two (5%) progressed to severe disease and one patient (3%) died within 30 days from COVID-19 disease. Most patients (n= 34, 89%) ultimately tested negative for SARS-CoV-2, with 34% (n= 13) clearing the virus within 14 days after mAb infusion. The median time to clearance of viral shedding was 25.5 days (range: 7-138). After mAb infusion, most patients with hematological malignancies (HM) (n= 10/15; 67%) resumed therapy for underlying disease with a median delay of 21.5 days (range: 12-42). We observed a significant difference in hospitalization among patients who received a HCT versus non-HCT (0% n= 0/26 and 36% n= 4/11, respectively; p< 0.01). This study demonstrates that SARS-CoV-2 specific mAb was safe and may reduce hospitalization compared to what is reported in malignant hematology patients at high risk for disease progression. Our HCT cohort patients had less hospitalization rate compared with HM cohort patients.

COVID-19 Update: Pfizer Bivalent Vaccine Booster Dose for Children 6 Months to 4 Years Old

The FDA has expanded its Emergency Use Authorization (EUA) for the COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) to permit use of the bivalent formulation (containing mRNA from the original and BA.4/5 Omicron strains of SARS-CoV-2) as a booster dose in children 6 months to 4 years old who completed the primary series with 3 doses of the monovalent formulation &gt;=2 months previously.

Evolving Real-World Effectiveness of Monoclonal Antibodies for Treatment of COVID-19

Treatment guidelines and U.S. Food and Drug Administration emergency use authorizations (EUAs) of monoclonal antibodies (mAbs) for treatment of high-risk outpatients with mild to moderate COVID-19 changed frequently as different SARS-CoV-2 variants emerged. To evaluate whether early outpatient treatment with mAbs, overall and by mAb product, presumed SARS-CoV-2 variant, and immunocompromised status, is associated with reduced risk for hospitalization or death at 28 days. Hypothetical pragmatic randomized trial from observational data comparing mAb-treated patients with a propensity score-matched, nontreated control group. Large U.S. health care system. High-risk outpatients eligible for mAb treatment under any EUA with a positive SARS-CoV-2 test result from 8 December 2020 to 31 August 2022. Single-dose intravenous mAb treatment with bamlanivimab, bamlanivimab-etesevimab, sotrovimab, bebtelovimab, or intravenous or subcutaneous casirivimab-imdevimab administered within 2 days of a positive SARS-CoV-2 test result. The primary outcome was hospitalization or death at 28 days among treated patients versus a nontreated control group (no treatment or treatment ≥3 days after SARS-CoV-2 test date). The risk for hospitalization or death at 28 days was 4.6% in 2571 treated patients and 7.6% in 5135 nontreated control patients (risk ratio [RR], 0.61 [95% CI, 0.50 to 0.74]). In sensitivity analyses, the corresponding RRs for 1- and 3-day treatment grace periods were 0.59 and 0.49, respectively. In subgroup analyses, those receiving mAbs when the Alpha and Delta variants were presumed to be predominant had estimated RRs of 0.55 and 0.53, respectively, compared with 0.71 for the Omicron variant period. Relative risk estimates for individual mAb products all suggested lower risk for hospitalization or death. Among immunocompromised patients, the RR was 0.45 (CI, 0.28 to 0.71). Observational study design, SARS-CoV-2 variant presumed by date rather than genotyping, no data on symptom severity, and partial data on vaccination status. Early mAb treatment among outpatients with COVID-19 is associated with lower risk for hospitalization or death for various mAb products and SARS-CoV-2 variants. None.

Research on Korean Translation in the Context of Epidemic Prevention and Control

An emergency like COVID-19 requires a theoretical framework for policy implementation that involves public and private sector collaborations. After policy failures, new institutions have formed that trigger PPP's later, allowing the incumbent administration to continue in office longer. It focuses on novel approaches to dealing with pandemics. The present administration put these rules in place to keep COVID-19 under control. When it comes to Real Time - polymerase chain reaction (RT-PCR) testing, South Korea's government and corporations partnered to swiftly raise the quantity of testing in the country. Models of policy change are shown to be dynamic, cyclical, and recursive. During the COVID-19 outbreak in South Korea, an empirical content research was conducted. Even though South Korea's leader was at risk of losing public support to the point where impeachment was mentioned as a possible option, he dramatically reversed public mood to win general elections by a wide margin in April 2020, while the pandemic scenario persisted. To win reelection, democratic administrations are under more pressure to effectively perform crisis management when faced with a crisis. As a result, they are under even more pressure to immediately mobilize public and private resources. The emergency use authorization (EUA) protocol for test kits is an example of "leapfrogging actors" – up-and-coming innovators – who helped turn a pandemic tragedy into a possibility for sustained leadership and for them. The results based on infected premises culling rate ratio is 82.3%, number of measles cases report is 86.4%, spread and epidemic ratio is 84.2%, important of epidemiology is 89.35%, transmission potential of COVID-19 is 91.24% and illustration of epidemic control is 92.45. The results based on infected premises culling rate ratio is 82.3%, number of measles cases report is 86.4%, spread and epidemic ratio is 84.2%, important of epidemiology is 89.35%, transmission potential of COVID-19 is 91.24% and illustration of epidemic control is 92.45.

JYNNEOS Vaccination Coverage Among Persons at Risk for Mpox — United States, May 22, 2022–January 31, 2023

From May 2022 through the end of January 2023, approximately 30,000 cases of monkeypox (mpox) have been reported in the United States and >86,000 cases reported internationally.* JYNNEOS (Modified Vaccinia Ankara vaccine, Bavarian Nordic) is recommended for subcutaneous administration to persons at increased risk for mpox (1,2) and has been demonstrated to provide protection against infection (3-5). To increase the total number of vaccine doses available, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) on August 9, 2022, recommending administration of the vaccine intradermally (0.1 mL per dose) for persons aged ≥18 years who are recommended to receive it (6); intradermal administration can generate an equivalent immune response to that achieved through subcutaneous injection using approximately one fifth the subcutaneous dose (7). CDC analyzed JYNNEOS vaccine administration data submitted to CDC from jurisdictional immunization information systems (IIS)† to assess the impact of the EUA and to estimate vaccination coverage among the population at risk for mpox. During May 22, 2022-January 31, 2023, a total of 1,189,651 JYNNEOS doses (734,510 first doses and 452,884 second doses)§ were administered. Through the week of August 20, 2022, the predominant route of administration was subcutaneous, after which intradermal administration became predominant, in accordance with FDA guidance. As of January 31, 2023, 1-dose and 2-dose (full vaccination) coverage among persons at risk for mpox is estimated to have reached 36.7% and 22.7%, respectively. Despite a steady decline in mpox cases from a 7-day daily average of more than 400 cases on August 1, 2022, to five cases on January 31, 2023, vaccination for persons at risk for mpox continues to be recommended (1). Targeted outreach and continued access to and availability of mpox vaccines to persons at risk are important to help prevent and minimize the impact of a resurgence of mpox.