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Spikevax
The Moderna COVID19 vaccine (INN: elasomeran), sold under the brand name Spikevax, is a COVID-19 vaccine developed by 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 people 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 as two or three 0.5 mL doses given by intramuscular injection at an interval of at least 28 days apart. It is an mRNA vaccine composed of nucleoside-modified mRNA (modRNA) encoding a spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles. It is authorized for use at some level in many countries. In August and September 2022, bivalent versions of the vaccine (Moderna COVID-19 Vaccine, Bivalent) containing elasome ...
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List Of COVID-19 Vaccine Authorizations
National regulatory authorities have granted full or emergency use authorizations for 40 COVID-19 vaccines. Ten vaccines have been approved for emergency or full use by at least one stringent regulatory authority recognized by the World Health Organization (WHO): Pfizer–BioNTech, Oxford–AstraZeneca, Sinopharm BIBP, Moderna, Janssen, CoronaVac, Covaxin, Novavax, Convidecia, and Sanofi–GSK. Seven others are under assessment by the WHO: Sputnik V, Sinopharm WIBP, Abdala, Zifivax, Corbevax, COVIran Barekat, and SCB-2019. Of the 40 vaccines, 16 have a full or emergency authorization in only one country, 12 in ten or fewer countries, and 12 in more than ten countries. Note that in some countries, vaccines may be authorized solely for travel purposes. They may not be approved for the general population. For example, the CoronaVac, Covishield, BBIBP-CorV and Covaxin vaccines are not part of Australia's national vaccination program; however, they are recognized for ...
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Moderna
Moderna, Inc. ( ) is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts that focuses on RNA therapeutics, primarily mRNA vaccines. These vaccines use a copy of a molecule called messenger RNA (mRNA) to produce an immune response. The company's only commercial product is the Moderna COVID-19 vaccine, marketed as Spikevax. As of 2022, the company has 44 treatment and vaccine candidates, of which 21 have entered clinical trials. Targets for vaccine candidates include influenza, HIV, respiratory syncytial virus, Epstein–Barr virus, the Nipah virus, chikungunya, a combined single-shot COVID-19 booster and influenza vaccine, a cytomegalovirus vaccine, and two cancer vaccines. The company's pipeline also includes candidates for cancer immunotherapy using OX40 ligand, interleukin 23, IL36G, and interleukin 12 as well as, in partnership with AstraZeneca, a regenerative medicine treatment that encodes vascular endothelial growth factor A to stim ...
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COVID-19 Vaccine
A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 (COVID19). Prior to the COVID19 pandemic, an established body of knowledge existed about the structure and function of coronaviruses causing diseases like severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). This knowledge accelerated the development of various vaccine platforms during early 2020. The initial focus of SARS-CoV-2 vaccines was on preventing symptomatic, often severe illness. In January 2020, the SARS-CoV-2 genetic sequence data was shared through GISAID, and by March 2020, the global pharmaceutical industry announced a major commitment to address COVID19. In 2020, the first COVID19 vaccines were developed and made available to the public through emergency authorizations and conditional approvals. Initially, most COVID19 vaccines were t ...
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Nucleoside-modified Messenger RNA
A nucleoside-modified messenger RNA (modRNA) is a synthetic messenger RNA (mRNA) in which some nucleosides are replaced by other naturally modified nucleosides or by synthetic nucleoside analogues. modRNA is used to induce the production of a desired protein in certain cells. An important application is the development of mRNA vaccines, of which the first authorized were COVID-19 vaccines (such as Comirnaty and Spikevax). Background mRNA is produced by synthesising a ribonucleic acid (RNA) strand from nucleotide building blocks according to a deoxyribonucleic acid (DNA) template, a process that is called transcription. When the building blocks provided to the RNA polymerase include non-standard nucleosides such as pseudouridine — instead of the standard adenosine, cytidine, guanosine, and uridine nucleosides — the resulting mRNA is described as nucleoside-modified. Production of protein begins with assembly of ribosomes on the mRNA, the latter then serving as ...
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Severe Acute Respiratory Syndrome Coronavirus 2
Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) is a strain of coronavirus that causes COVID-19 (coronavirus disease 2019), the respiratory illness responsible for the ongoing COVID-19 pandemic. The virus previously had a provisional name, 2019 novel coronavirus (2019-nCoV), and has also been called the human coronavirus 2019 (HCoV-19 or hCoV-19). First identified in the city of Wuhan, Hubei, China, the World Health Organization declared the outbreak a public health emergency of international concern on January 30, 2020, and a pandemic on March 11, 2020. SARS‑CoV‑2 is a positive-sense single-stranded RNA virus that is contagious in humans. SARS‑CoV‑2 is a virus of the species '' severe acute respiratory syndrome–related coronavirus'' (SARSr-CoV), related to the SARS-CoV-1 virus that caused the 2002–2004 SARS outbreak. Despite its close relation to SARS-CoV-1, its closest known relatives, with which it forms a sister group, are the derived ...
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Coronavirus Spike Protein
Spike (S) glycoprotein (sometimes also called spike protein, formerly known as E2) is the largest of the four major structural proteins found in coronaviruses. The spike protein assembles into trimers that form large structures, called spikes or peplomers, that project from the surface of the virion. The distinctive appearance of these spikes when visualized using negative stain transmission electron microscopy, "recalling the solar corona", gives the virus family its name. The function of the spike glycoprotein is to mediate viral entry into the host cell by first interacting with molecules on the exterior cell surface and then fusing the viral and cellular membranes. Spike glycoprotein is a class I fusion protein that contains two regions, known as S1 and S2, responsible for these two functions. The S1 region contains the receptor-binding domain that binds to receptors on the cell surface. Coronaviruses use a very diverse range of receptors; SARS-CoV (which causes ...
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Infectious Diseases Society Of America
The Infectious Diseases Society of America (IDSA) is a medical association representing physicians, scientists and other health care professionals who specialize in infectious diseases. It was founded in 1963 and is based in Arlington, Virginia. As of 2018 IDSA had more than 11,000 members from across the United States and nearly 100 other countries on six different continents. IDSA's purpose is to improve the health of individuals, communities, and society by promoting excellence in patient care, education, research, public health, and prevention relating to infectious diseases. It is a 501(c)(6) organization. History The IDSA was formed from two different groups. Jay P. Sanford and a group that included members of the American Federation for Clinical Research, American Society for Clinical Investigation, and the Association of American Physicians met each spring in Atlantic City, New Jersey to discuss infectious disease topics. Another group formed from the American Society fo ...
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MRNA Vaccine
An mRNA vaccine is a type of vaccine that uses a copy of a molecule called messenger RNA (mRNA) to produce an immune response. The vaccine delivers molecules of antigen-encoding mRNA into immune cells, which use the designed mRNA as a blueprint to build foreign protein that would normally be produced by a pathogen (such as a virus) or by a cancer cell. These protein molecules stimulate an adaptive immune response that teaches the body to identify and destroy the corresponding pathogen or cancer cells. The mRNA is delivered by a co-formulation of the RNA encapsulated in lipid nanoparticles that protect the RNA strands and help their absorption into the cells. Reactogenicity, the tendency of a vaccine to produce adverse reactions, is similar to that of conventional non-RNA vaccines. People susceptible to an autoimmune response may have an adverse reaction to messenger RNA vaccines. The advantages of mRNA vaccines over traditional vaccines are ease of design, speed and lowe ...
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Solid Lipid Nanoparticle
lipid nanoparticles (LNPs), are nanoparticles composed of lipids. They are a novel pharmaceutical drug delivery system (and part of nanoparticle drug delivery), and a novel pharmaceutical formulation. LNPs as a drug delivery vehicle were first approved in 2018 for the siRNA drug Onpattro. LNPs became more widely known in late 2020, as some COVID-19 vaccines that use RNA vaccine technology coat the fragile mRNA strands with PEGylated lipid nanoparticles as their delivery vehicle (including both the Moderna and the Pfizer–BioNTech COVID-19 vaccines). Characteristics A lipid nanoparticle is typically spherical with an average diameter between 10 and 1000 nanometers. Solid lipid nanoparticles possess a solid lipid core matrix that can solubilize lipophilic molecules. The lipid core is stabilized by surfactants (emulsifiers). The emulsifier used depends on administration routes and is more limited for parenteral administrations. The term lipid is used here in a broader sens ...
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Litre
The litre (international spelling) or liter (American English spelling) (SI symbols L and l, other symbol used: ℓ) is a metric unit of volume. It is equal to 1 cubic decimetre (dm3), 1000 cubic centimetres (cm3) or 0.001 cubic metre (m3). A cubic decimetre (or litre) occupies a volume of (see figure) and is thus equal to one-thousandth of a cubic metre. The original French metric system used the litre as a base unit. The word ''litre'' is derived from an older French unit, the '' litron'', whose name came from Byzantine Greek—where it was a unit of weight, not volume—via Late Medieval Latin, and which equalled approximately 0.831 litres. The litre was also used in several subsequent versions of the metric system and is accepted for use with the SI,Bureau International des Poids et ...
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McGill University
McGill University (french: link=no, Université McGill) is an English-language public research university located in Montreal, Quebec, Canada. Founded in 1821 by royal charter granted by King George IV,Frost, Stanley Brice. ''McGill University, Vol. I. For the Advancement of Learning, 1801–1895.'' McGill-Queen's University Press, 1980. the university bears the name of James McGill, a Scottish merchant whose bequest in 1813 formed the university's precursor, University of McGill College (or simply, McGill College); the name was officially changed to McGill University in 1885. McGill's main campus is on the slope of Mount Royal in downtown Montreal in the borough of Ville-Marie, with a second campus situated in Sainte-Anne-de-Bellevue, west of the main campus on Montreal Island. The university is one of two members of the Association of American Universities located outside the United States, alongside the University of Toronto, and is the only Canadian member of the Glob ...
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Swissmedic
The Swiss Agency for Therapeutic Products (Swissmedic) is the Swiss surveillance authority for medicines and medical devices, registered in Bern. It began operations on 1 January 2002 as successor of ''Interkantonale Kontrollstelle für Heilmittel'' (IKS), which was itself the successor of ''Schweizerische Arzneimittelnebenwirkungszentrale'' (SANZ). Swissmedic is affiliated to the Federal Department of Home Affairs. Structure Swissmedic is a federal institution subject to public law Public law is the part of law that governs relations between legal persons and a government, between different institutions within a State (polity), state, between Separation of powers, different branches of governments, as well as relationship ... and was created by the Federal Act on Medicinal Products and Medical Devices.
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