BBV154
iNCOVACC (codenamed BBV154) is an intranasal COVID-19 vaccine candidate developed by Bharat Biotech, American company Precision Virologics and the Washington University School of Medicine in St Louis, Missouri, United States. History Clinical trials Phase I trials On recommendation by the Subject Expert Committee (SEC) under the Indian drug regulator, the company is going to conduct phase 1 clinical trials using 75 volunteers and submit safety and immunogenicity data for the committee's consideration before it proceeds to the second phase of the trial. Phase II and III trials On 12 August 2021, after evaluating the results of phase I trial data, the drug regulator approved for phase II/III randomized trials that involves evaluation of the immunogenicity and safety of Covaxin Covaxin (codenamed as BBV152) is a whole inactivated virus-based COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research - National Institute of ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
|
Bharat Biotech
Bharat Biotech International Limited (BBIL) is an Indian multinational biotechnology company headquartered in the city of Hyderabad, India engaged in the drug discovery, drug development, manufacture of vaccines, bio-therapeutics, pharmaceuticals and health care products. Overview Bharat Biotech has its manufacturing facility situated at Genome Valley, Hyderabad, India. As of July 2020, the company has over 700 employees and has a presence worldwide. The company has been responsible for developing an eco-friendly recombinant and a naturally attenuated strain derived Rotavirus vaccine called ROTAVAC. They were one of the first to develop vaccines for viral diseases like Chikungunya and Zika. The company also produces vaccines for Japanese Encephalitis. Bharat Biotech has biosafety level 3 (BSL3) laboratories. COVID-19 vaccine development In April 2020, the company announced that they have partnered with US-based company FluGen and University of Wisconsin-Madison to develop ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
|
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 two ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
|
Covaxin
Covaxin (codenamed as BBV152) is a whole inactivated virus-based COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research - National Institute of Virology. As of October 2021, 110.6 million people in India have received Covaxin. On 3 November 2021, the World Health Organization (WHO) validated the vaccine for emergency use. As of 31 January 2022, Covaxin has been granted emergency use approval in 13 countries Medical uses Effectiveness A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval. Effectiveness is generally expected to slowly decrease over time. Efficacy A phase 3 clinical trial with 25,798 participants found that the vaccine is effective against asymptomatic cases, effective against symptomatic disease, effective against severe disease, and effective against the Delta variant. Manufacturing As an inactivated vaccine, Covaxin uses a m ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
|
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 Novel coronavirus, 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 disease, contagious in humans. SARS‑CoV‑2 is a virus of the species ''severe acute respiratory syndrome–related coronavirus'' (SARSr-CoV), related to the Severe acute respiratory syndrome coronavirus 1, SARS-CoV-1 virus that caused the 2002–2004 SARS outbreak. Despite its close relation to SARS-CoV-1, i ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
|
Nasal Administration
Nasal administration, popularly known as snorting, is a route of administration in which drugs are insufflated through the nose. It can be a form of either topical administration or systemic administration, as the drugs thus locally delivered can go on to have either purely local or systemic effects. Nasal sprays are locally acting drugs such as decongestants for cold and allergy treatment, whose systemic effects are usually minimal. Examples of systemically active drugs available as nasal sprays are migraine drugs, rescue medications for overdose and seizure emergencies, nicotine replacement, and hormone treatments. Advantages with nasal systemic drug delivery The nasal cavity is covered by a thin mucosa which is well vascularised. Therefore, a drug molecule can be transferred quickly across the single epithelial cell layer directly to the systemic blood circulation without first-pass hepatic and intestinal metabolism. The effect is often reached within 5 min for smaller ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
|
Nasal Vaccine
A nasal vaccine is a vaccine administered to a person via the nose and does not require a needle. It induces immunity through the inner surface of the nose, a surface that naturally comes in contact with many airborne microbes. Administration Administering a vaccine via the nose is painless, non-invasive and easier to perform than using a needle, which has risks of needle stick injuries and issues relating to safe disposal. Nasal vaccine technology A few different devices have become available for the nasal delivery of vaccines. Live attenuated influenza vaccine Nasal live attenuated influenza vaccine (LAIV) is available under the brand name FluMist Quadrivalent in the United States and the brand name Fluenz Tetra in Europe. In addition to the antigens (active ingredient), nasal flu vaccine contains gelatin, small amounts of amino acids and sucrose, which act as stabilizers. Veterinary medicine In veterinary medicine, vaccination against ''Bordetella bronchiseptica'', a cau ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
|
Washington University School Of Medicine
Washington University School of Medicine (WUSM) is the medical school of Washington University in St. Louis in St. Louis, Missouri. Founded in 1891, the School of Medicine has 1,260 students, 604 of which are pursuing a medical degree with or without a combined Doctor of Philosophy or other advanced degree. It also offers doctorate degrees in biomedical research through the Division of Biology and Biological Sciences. The School has developed large physical therapy (273 students) and occupational therapy (233 students) programs, as well as the Program in Audiology and Communication Sciences (100 students) which includes a Doctor of Audiology (Au.D.) degree and a Master of Science in Deaf Education (M.S.D.E.) degree. There are 1,772 faculty, 1,022 residents, and 765 fellows. The clinical service is provided by Washington University Physicians, a comprehensive medical and surgical practice providing treatment in more than 75 medical specialties. Washington University Physicians ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
|
St Louis
St. Louis () is the second-largest city in Missouri, United States. It sits near the confluence of the Mississippi and the Missouri Rivers. In 2020, the city proper had a population of 301,578, while the bi-state metropolitan area, which extends into Illinois, had an estimated population of over 2.8 million, making it the largest metropolitan area in Missouri and the second-largest in Illinois. Before European settlement, the area was a regional center of Native American Mississippian culture. St. Louis was founded on February 14, 1764, by French fur traders Gilbert Antoine de St. Maxent, Pierre Laclède and Auguste Chouteau, who named it for Louis IX of France. In 1764, following France's defeat in the Seven Years' War, the area was ceded to Spain. In 1800, it was retroceded to France, which sold it three years later to the United States as part of the Louisiana Purchase; the city was then the point of embarkation for the Corps of Discovery on the Lewis and Clark Expe ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
|
Missouri
Missouri is a U.S. state, state in the Midwestern United States, Midwestern region of the United States. Ranking List of U.S. states and territories by area, 21st in land area, it is bordered by eight states (tied for the most with Tennessee): Iowa to the north, Illinois, Kentucky and Tennessee to the east, Arkansas to the south and Oklahoma, Kansas and Nebraska to the west. In the south are the Ozarks, a forested highland, providing timber, minerals, and recreation. The Missouri River, after which the state is named, flows through the center into the Mississippi River, which makes up the eastern border. With more than six million residents, it is the List of U.S. states and territories by population, 19th-most populous state of the country. The largest urban areas are St. Louis, Kansas City, Missouri, Kansas City, Springfield, Missouri, Springfield and Columbia, Missouri, Columbia; the Capital city, capital is Jefferson City, Missouri, Jefferson City. Humans have inhabited w ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
|
United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territories, nine Minor Outlying Islands, and 326 Indian reservations. The United States is also in free association with three Pacific Island sovereign states: the Federated States of Micronesia, the Marshall Islands, and the Republic of Palau. It is the world's third-largest country by both land and total area. It shares land borders with Canada to its north and with Mexico to its south and has maritime borders with the Bahamas, Cuba, Russia, and other nations. With a population of over 333 million, it is the most populous country in the Americas and the third most populous in the world. The national capital of the United States is Washington, D.C. and its most populous city and principal financial center is New York City. Paleo-Americ ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
|
Phase 1 Clinical Trial
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 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. Summary 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. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV trials are 'post-marketing' or 'surveillance' studies conducted to monitor safety over severa ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |
|
Immunogenicity
Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal. It may be wanted or unwanted: * Wanted immunogenicity typically relates to vaccines, where the injection of an antigen (the vaccine) provokes an immune response against the pathogen, protecting the organism from future exposure. Immunogenicity is a central aspect of vaccine development. * Unwanted immunogenicity is an immune response by an organism against a therapeutic antigen. This reaction leads to production of anti-drug-antibodies (ADAs), inactivating the therapeutic effects of the treatment and potentially inducing adverse effects. A challenge in biotherapy is predicting the immunogenic potential of novel protein therapeutics. For example, immunogenicity data from high-income countries are not always transferable to low-income and middle-income countries. Another challenge is considering how the immunogenicity of vaccines changes with ... [...More Info...]       [...Related Items...]     OR:     [Wikipedia]   [Google]   [Baidu]   |