COVID-19 Vaccine Clinical Research
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COVID-19 Vaccine Clinical Research
COVID-19 vaccine clinical research uses clinical research to establish the characteristics of COVID-19 COVID-19 vaccine, vaccines. These characteristics include #Efficacy, efficacy, #Effectiveness, effectiveness and safety. , 40 vaccines are authorized by at least one national regulation of therapeutic goods, regulatory authority for public use: * one DNA vaccine: ZyCoV-D * four RNA vaccines: Pfizer–BioNTech COVID-19 vaccine, Pfizer–BioNTech, Moderna COVID-19 vaccine, Moderna, Walvax COVID-19 vaccine, Walvax, and HGC019, Gemcovac * twelve inactivated vaccines: Chinese Academy of Medical Sciences COVID-19 vaccine, Chinese Academy of Medical Sciences, CoronaVac, Covaxin, CoviVac (Russia COVID-19 vaccine), CoviVac, COVIran Barekat, FAKHRAVAC, Minhai COVID-19 vaccine, Minhai-Kangtai, QazCovid-in, QazVac, Sinopharm Sinopharm BIBP COVID-19 vaccine, BIBP, Sinopharm WIBP COVID-19 vaccine, WIBP, Turkovac, and Valneva COVID-19 vaccine, VLA2001. * six viral vector vaccines: Sputnik Li ...
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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 two ...
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CoviVac (Russia COVID-19 Vaccine)
CoviVac (russian: КовиВак) is an inactivated virus-based COVID-19 vaccine developed by the , which is an institute of the Russian Academy of Sciences. It was approved for use in Russia in February 2021, being the third COVID-19 vaccine to get approval in Russia. It obtained a permission for phase III clinical trial on 2 June 2021. Medical use The CoviVac shot is given in two doses, 14 days apart. It is transported and stored at normal refrigerated temperatures, of 2 to 8 degrees Celsius (35.6 to 46.4 Fahrenheit). Efficacy has not yet been established in a phase III clinical trial. Chemistry One dose of 0.5 ml is composed only of 3 μg or more of SARS-CoV-2 strain AYDAR-1 antigen inactivated by beta-propiolactone and the following excipients: * 0.3–0.5 mg of aluminum hydroxide (adjuvant) * 0.5 ml or less of phosphate buffer solution composed of disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, and water for injection Man ...
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Convidecia
AD5-nCOV, trade-named Convidecia, is a single-dose viral vector vaccine for COVID-19 developed by CanSino Biologics. It conducted its Phase III trials in Argentina, Chile, Mexico, Pakistan, Russia, and Saudi Arabia with 40,000 participants. In February 2021, global data from Phase III trials and 101 COVID cases showed that the intramuscular version of the vaccine had a 65.7% efficacy in preventing moderate symptoms of COVID-19, and 91% efficacy in preventing severe disease. It has similar efficacy to the Janssen vaccine, another one-shot adenovirus vector vaccine with 66% efficacy in a global trial. Convidecia is similar to other viral vector vaccines like AZD1222, Gam-COVID-Vac, and Ad26.COV2.S. Its single-dose regimen and normal refrigerator storage requirement (2° to 8 °C) could make it a favorable vaccine option for many countries. It is currently under evaluation for emergency use listing by the WHO. On May 19 2022, WHO issued EUL for the vaccine. A Phase I stu ...
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Sputnik V
Sputnik V (russian: Спутник V, the brand name from RDIF) or Gam-COVID-Vac (russian: Гам-КОВИД-Вак, the name under which it is legally registered and produced) is an adenovirus viral vector vaccine for COVID-19 developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Russia. It is the world's first registered combination vector vaccine for the prevention of COVID-19, having been registered on 11 August 2020 by the Russian Ministry of Health. Gam-COVID-Vac was initially approved for distribution in Russia and then in 59 other countries (as of April 2021) on the preliminary results of Phase I– II studies eventually published on 4 September 2020. Approval in early August of Gam-COVID-Vac was met with criticism in mass media and discussions in the scientific community as to whether approval was justified in the absence of robust scientific research confirming safety and efficacy. A large-scale Brazilian study from Dec. 2020 to May 2021 ...
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Sputnik Light
Sputnik Light (russian: Спутник Лайт, Sputnik Layt or Lajt) is a single dose COVID-19 vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology. It consists of the first dose of the Sputnik V vaccine, which is based on the Ad26 vector, and it can be stored at a normal refrigerator temperature of . The institute says this version would be ideally suited for areas with acute outbreaks, allowing more people to be vaccinated quickly. It will also be used as a third (booster) dose for those who received Sputnik V at least 6 months earlier. Effectiveness A vaccine is generally considered effective if the estimate is ≥50% with a >30% lower limit of the 95% confidence interval. As of September 2021, no study on Sputnik Light reported confidence intervals, so it is not possible to know the accuracy of the estimates. Effectiveness is generally expected to slowly decrease over time. A real-world study with participants aged 60–79 years in Ar ...
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Viral Vector Vaccine
A viral vector vaccine is a vaccine that uses a viral vector to deliver genetic material ( DNA), which can be transcribed by the recipient's host cells as mRNA coding for a desired protein (or: antigen) to elicit an immune response. , six viral vector vaccines have been authorized for use in humans in at least one country: four COVID-19 vaccines and two Ebola vaccines. Technology Viral vector vaccines use a modified version of one virus as a vector to deliver to a cell a nucleic acid coding for an antigen for another infectious agent. Viral vector vaccines do not cause infection with either the virus used as the vector, or the source of the antigen. The genetic material it delivers does not integrate into a person's genome. Viral vector vaccines enable antigen expression within cells and induce a robust cytotoxic T cell response, unlike subunit vaccines which only confer humoral immunity. Most viral vectors are designed to be incapable of replication because the necessary gene ...
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Valneva COVID-19 Vaccine
Valneva COVID-19 vaccine is a COVID-19 vaccine developed by French biotechnology company Valneva SE in collaboration with the American biopharmaceutical company Dynavax Technologies. In April 2022, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) approved the vaccine, being the first in the world to do so. It was approved for medical use in the European Union in June 2022. Technology It is a whole inactivated virus vaccine, grown in culture using the Vero cell line and inactivated with BPL. It also contains two adjuvants: alum and CpG 1018. It uses the same manufacturing technology as Valneva's Ixiaro vaccine for Japanese encephalitis. History Clinical trials Valneva COVID-19 vaccine completed phase I/II trial with 153 participants in the United Kingdom. The trials were supported by the UK National Institute for Health Research and four British universities. In April 2021, Valneva COVID-19 vaccine commenced phase III trials with approxim ...
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Sinopharm WIBP COVID-19 Vaccine
The Sinopharm WIBP COVID-19 vaccine, also known as WIBP-CorV, is one of two inactivated virus COVID-19 vaccines developed by Sinopharm. Peer-reviewed results show that the vaccine is 72.8% effective against symptomatic cases and 100% against severe cases (26 cases in vaccinated group vs. 95 cases in placebo group). The other inactivated virus COVID-19 vaccine developed by Sinopharm is the BIBP vaccine (BBIBP-CorV) which is comparably more successful. 1 billion doses are expected to be produced per year. Medical uses The vaccine is given by intramuscular injection. The administered is 2 doses in 3 weeks. Efficacy In May 2021, peer-reviewed results published in JAMA of Phase III trials in United Arab Emirates and Bahrain showed that the vaccine is 72.8% effective against symptomatic cases and 100% against severe cases (26 cases in vaccinated group vs. 95 cases in placebo group). 12,743 people received the vaccine and 12,737 people received the placebo in these trials. Manuf ...
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Sinopharm BIBP COVID-19 Vaccine
The Sinopharm BIBP COVID-19 vaccine, also known as BBIBP-CorV, the Sinopharm COVID-19 vaccine, or BIBP vaccine, is one of two whole inactivated virus COVID-19 vaccines developed by Sinopharm's Beijing Institute of Biological Products (sometimes written as Beijing Bio-Institute of Biological Products, resulting in the two different acronyms BBIBP and BIBP for the same vaccine). It completed Phase III trials in Argentina, Bahrain, Egypt, Morocco, Pakistan, Peru, and the United Arab Emirates (UAE) with over 60,000 participants. BBIBP-CorV shares similar technology with CoronaVac and Covaxin, other inactivated virus vaccines for COVID-19. Its product name is SARS-CoV-2 Vaccine (Vero Cell), not to be confused with the similar product name of CoronaVac. Peer-reviewed results published in ''JAMA'' of Phase III trials in United Arab Emirates and Bahrain showed that the vaccine is 78.1% effective against symptomatic cases and 100% against severe cases (21 cases in vaccinated group vs. 95 c ...
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QazCovid-in
QazCovid-in, commercially known as QazVac, is a COVID-19 vaccine developed by the Research Institute for Biological Safety Problems in Kazakhstan. QazCoVac-P is a second COVID-19 vaccine developed by the Kazakh Biosafety Research Institute and in clinical trials. Manufacturing The vaccine can be stored at standard refrigeration temperatures (2°C-8°C) and is a two-dose régime with the doses administered twenty-one days apart.The vaccine was first manufactured by Kazakhstan's Research Institute of Biological Safety Problems. Production capacity has been capped at 50,000 doses per month. Beginning in June 2021, the vaccine is slated to be packaged in large bulk to be bottled in Turkey Turkey ( tr, Türkiye ), officially the Republic of Türkiye ( tr, Türkiye Cumhuriyeti, links=no ), is a list of transcontinental countries, transcontinental country located mainly on the Anatolia, Anatolian Peninsula in Western Asia, with ... by a major Turkish company. This will allo ...
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