Enhanced Respiratory Disease
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Enhanced Respiratory Disease
Vaccine-associated enhanced respiratory disease (VAERD), or simply enhanced respiratory disease (ERD), is an adverse event where an exacerbated course of respiratory disease occurs with higher incidence in the vaccinated population than in the control group. It is a barrier against vaccine development that can lead to its failure. Immunologically, VAERD is characterized with an exaggerated Th2 response and eosinophilic pulmonary infiltrations. It may result from antibody-mediated complement activation followed by weak neutralization. Historical instances of the phenomenon were seen in vaccine candidates for respiratory syncytial virus (RSV), SARS-CoV, Middle East Respiratory Syndrome (MERS), and some influenza strains. Thus, COVID-19 vaccine clinical research involved monitoring for VAERD because the vaccine target, SARS-CoV-2, belongs to the same viral subfamily as SARS-CoV and MERS. The effect was not shown in phase III clinical trials for Tozinameran or for the Moderna ...
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Exacerbation
In medicine, an exacerbation is the worsening of a disease or an increase in its symptom Signs and symptoms are diagnostic indications of an illness, injury, or condition. Signs are objective and externally observable; symptoms are a person's reported subjective experiences. A sign for example may be a higher or lower temperature ...s. Examples includes an acute exacerbation of chronic obstructive pulmonary disease and acute exacerbation of congestive heart failure. See also * Flare-up References Medical terminology Symptoms {{Symptom-stub ...
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Influenza
Influenza, commonly known as the flu, is an infectious disease caused by influenza viruses. Symptoms range from mild to severe and often include fever, runny nose, sore throat, muscle pain, headache, coughing, and fatigue. These symptoms begin one to four (typically two) days after exposure to the virus and last for about two to eight days. Diarrhea and vomiting can occur, particularly in children. Influenza may progress to pneumonia from the virus or a subsequent bacterial infection. Other complications include acute respiratory distress syndrome, meningitis, encephalitis, and worsening of pre-existing health problems such as asthma and cardiovascular disease. There are four types of influenza virus: types A, B, C, and D. Aquatic birds are the primary source of influenza A virus (IAV), which is also widespread in various mammals, including humans and pigs. Influenza B virus (IBV) and influenza C virus (ICV) primarily infect humans, and influenza D virus (IDV) i ...
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Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is ...
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Moderna Vaccine
The Moderna COVID19 vaccine, sold under the brand name Spikevax, is a COVID-19 vaccine developed by the American company Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA). Depending on the jurisdiction, it is authorized for use in humans aged six months, twelve years, or eighteen years and older. It provides protection against COVID-19, which is caused by infection by the SARS-CoV-2 virus. It is designed to be administered in two or three 0.5- mL doses given by intramuscular injection, primarily into the deltoid muscle, at an interval of at least 28 days apart. The World Health Organization advises an eight-week interval between doses to optimize efficacy. Additional booster doses are approved in some regions to maintain immunity. Clinical trials and real-world data have demonstrated the vaccine's high efficacy, with significant effectiveness observed two weeks pos ...
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Phase III Clinical Trials
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays. Description Clinical trials testing potential medical products are commonly classified into four phases. The drug development process will normally proceed through all four phases over many years. When expressed specifically, a clinical trial phase is capitalized both in name and Roman numeral, such as "Phase I" clinical trial. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory auth ...
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Coronavirus
Coronaviruses are a group of related RNA viruses that cause diseases in mammals and birds. In humans and birds, they cause respiratory tract infections that can range from mild to lethal. Mild illnesses in humans include some cases of the common cold (which is also caused by other viruses, predominantly rhinoviruses), while more lethal varieties can cause SARS, MERS and COVID-19. In cows and pigs they cause diarrhea, while in mice they cause hepatitis and encephalomyelitis. Coronaviruses constitute the subfamily ''Orthocoronavirinae'', in the family ''Coronaviridae'', order ''Nidovirales'' and realm ''Riboviria''. They are enveloped viruses with a Positive-strand RNA virus, positive-sense single-stranded RNA genome and a nucleocapsid of helical symmetry. The genome size of coronaviruses ranges from approximately 26 to 32 kilobases, one of the largest among RNA viruses. They have characteristic club-shaped Spike protein, spikes that project from their surface, which in electron ...
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SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) is a strain of coronavirus that causes COVID-19, the respiratory illness responsible for the COVID-19 pandemic. The virus previously had the Novel coronavirus, provisional name 2019 novel coronavirus (2019-nCoV), and has also been called human coronavirus 2019 (HCoV-19 or hCoV-19). First identified in the city of Wuhan, Hubei, China, the World Health Organization designated the outbreak a public health emergency of international concern from January 30, 2020, to May 5, 2023. SARS‑CoV‑2 is a positive-sense single-stranded RNA virus that is Contagious disease, contagious in humans. SARS‑CoV‑2 is a strain of the species ''Betacoronavirus pandemicum'' (SARSr-CoV), as is SARS-CoV-1, the virus that caused the 2002–2004 SARS outbreak. There are animal-borne coronavirus strains more closely related to SARS-CoV-2, the most closely known relative being the BANAL-52 bat coronavirus. SARS-CoV-2 is of Zoonosis, z ...
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Monitoring (medicine)
In medicine, monitoring is the observation of a disease, condition or one or several medical parameters over time. It can be performed by continuously measuring certain parameters by using a medical monitor (for example, by continuously measuring vital signs by a bedside monitor), and/or by repeatedly performing medical tests (such as blood glucose monitoring with a glucose meter in people with diabetes mellitus). Transmitting data from a monitor to a distant monitoring station is known as telemetry or biotelemetry. Classification by target parameter Monitoring can be classified by the target of interest, including: * Cardiac monitoring, which generally refers to continuous electrocardiography with assessment of the patient's condition relative to their cardiac rhythm. A small monitor worn by an ambulatory patient for this purpose is known as a Holter monitor. Cardiac monitoring can also involve cardiac output monitoring via an invasive Swan-Ganz catheter. * Hemodynam ...
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COVID-19 Vaccine Clinical Research
COVID-19 vaccine clinical research uses clinical research to establish the characteristics of COVID-19 vaccines. These characteristics include efficacy, effectiveness, and safety. , 40 vaccines are authorized by at least one national regulatory authority for public use: * one DNA vaccine: ZyCoV-D * four RNA vaccines: Pfizer–BioNTech, Moderna, Walvax, and Gemcovac * twelve inactivated vaccines: Chinese Academy of Medical Sciences, CoronaVac, Covaxin, CoviVac, COVIran Barekat, FAKHRAVAC, Minhai-Kangtai, QazVac, Sinopharm BIBP, WIBP, Turkovac, and VLA2001. * six viral vector vaccines: Sputnik Light, Sputnik V, Oxford–AstraZeneca, Convidecia, Janssen, and iNCOVACC * sixteen subunit vaccines: Abdala, Corbevax, COVAX-19, EpiVacCorona, IndoVac, MVC-COV1901, Noora, Novavax, Razi Cov Pars, Sanofi–GSK, Sinopharm CNBG, Skycovione, Soberana 02, Soberana Plus, V-01, and ZF2001. * one virus-like particle vaccine: CoVLP , 353 vaccine candidates are in var ...
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Middle East Respiratory Syndrome
Middle East respiratory syndrome (MERS) is a viral respiratory infection caused by '' Middle East respiratory syndrome–related coronavirus'' (MERS-CoV). Symptoms may range from none, to mild, to severe depending on age and risk level. Typical symptoms include fever, cough, diarrhea, and shortness of breath. The disease is typically more severe in those with other health problems. The first case was identified in June 2012 by Egyptian physician Ali Mohamed Zaki at the Dr. Soliman Fakeeh Hospital in Jeddah, Saudi Arabia, and most cases have occurred in the Arabian Peninsula. Over 2,600 cases have been reported as of January 2021, including 45 cases in the year 2020. About 35% of those who are diagnosed with the disease die from it. Larger outbreaks have occurred in South Korea in 2015 and in Saudi Arabia in 2018. MERS-CoV is a virus in the coronavirus family believed to be originally from bats. However, humans are typically infected from camels, either during direct ...
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Course (medicine)
In medicine the term course generally takes one of two meanings, both reflecting the sense of " path that something or someone moves along...process or sequence or steps": * A course of medication is a period of continual treatment with drugs, sometimes with variable dosage and in particular combinations. For instance treatment with some drugs should not end abruptly. Instead, their course should end with a tapering dosage. :* Antibiotics: Taking the full course of antibiotics is important to prevent reinfection and/or development of drug-resistant bacteria. :* Steroids: For both short-term and long-term steroid treatment, when stopping treatment, the dosage is tapered rather than abruptly ended. This permits the adrenal glands to resume the body's natural production of cortisol. Abrupt discontinuation can result in adrenal insufficiency; and/or steroid withdrawal syndrome (a rebound effect in which exaggerated symptoms return). * The course of a disease, also called its natura ...
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