- Liittynyt
- 1.4.2007
- Viestejä
- 10 251
Totta, se on politiikkaa, huonoa sellaista. 25Mrd€:lla olisi varmasti saanut aika hyvin parannettua resursseja jos poliittista tahtoa olisi ollut. Tai edes sillä parilla miljardilla, jotka on käytetty testeihin.
- Liittynyt
- 20.1.2010
- Viestejä
- 2 763
Onhan tuohon nenänkaiveluunkin löytynyt rahaa vaikka kuinka, kumma ettei terveydenhuollon kapasiteetin lisäämiseen.
- Liittynyt
- 17.8.2006
- Viestejä
- 15 545
- Ikä
- 34
Clinical trials[edit]
In September 2020, Sanofi-GSK started for phase I trials with 440 participants in the United States.[7][full citation needed]In February 2021, Sanofi-GSK started for phase II trials with 722 participants in the United States.[8][full citation needed]
On 27 May 2021, the vaccine began a Phase III trial involving 35,000 participants,[9][10][11] which increased to 37,430 participants with trials in Colombia, Dominican Republic, Ghana, Honduras, India, Japan, Kenya, Mexico,[12] Nigeria, Pakistan, Sri Lanka, Uganda, and the United States.[13]
In September 2021, Sanofi-GSK started a booster trial in the United Kingdom. In this study, they will enroll up to 3,145 volunteers who have previously completed a COVID-19 a full vaccine course between 4 to 10 months previously. The purpose of this study is to determine if the investigational COVID-19 vaccines are safe and can stimulate and broaden the immune response against the different COVID-19 variants that cause COVID-19 when given as a single booster injection in participants who have previously been vaccinated with a full course of an authorized COVID-19 vaccine. [14]
- Liittynyt
- 17.8.2006
- Viestejä
- 15 545
- Ikä
- 34
GSK medicago. Tää sopii vegaaneillekki. ;)
December 7, 2021
Efficacy demonstrated against all variants seen in the study, including 75.3% efficacy against COVID-19 of any severity caused by the globally dominant Delta variant
Vaccine candidate was well-tolerated, with no related serious adverse events reported in the vaccine group
Final regulatory submission to be filed with Health Canada imminently
Quebec City, London, December 7th, 2021 – Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) today announce positive efficacy and safety results from the global Phase 3 placebo-controlled efficacy study of Medicago’s plant-based COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant, conducted in over 24,000 subjects, adults 18y and above, across six countries.
Vaccine efficacy was demonstrated in an environment dominated by SARS-CoV-2 variants, unlike most published Phase 3 efficacy trials for currently licensed COVID-19 vaccines that were conducted when only the ancestral virus was circulating, making direct comparisons impossible. The overall vaccine efficacy rate against all variants of SARS-COV-2 was 71% (95% Confidence Interval: CI 58.7, 80.0; Per Protocol Analysis: PP). The corresponding number for people with an initial seronegative status indicating no previous exposure to COVID-19 was 75.6% (95% CI: 64.2-83.7; PP). The vaccine candidate demonstrated efficacy of 75.3% (95% CI: 52.8, 87.9; PP) against COVID-19 of any severity for the globally dominant Delta variant. Efficacy was 88.6% (95% CI: 74.6, 95.6; PP) against the Gamma variant. Although only a small number of severe cases occurred in this study, none occurred in the vaccinated group. No cases of the Alpha, Lambda and Mu variants were observed in the vaccinated group while 12 cases were observed in the placebo group. The Omicron variant was not circulating during the study.
During the study, no related serious adverse events were reported and reactogenicity was generally mild to moderate and transient; symptoms lasting on average only 1 to 3 days. To date, the Phase 3 results have confirmed the safety profile is consistent with Phase 2 results. The frequency of mild fever was low (<10%), even after the second dose.
Full results of the Phase 3 study will be released in a peer-reviewed publication as soon as possible.
Based on these results, Medicago will imminently seek regulatory approval from Health Canada as part of its rolling submission. The vaccine candidate is not approved yet by any regulatory authorities.
“This is an incredible moment for Medicago and for novel vaccine platforms. The results of our clinical trials show the power of plant-based vaccine manufacturing technology. If approved, we will be contributing to the world’s fight against the COVID-19 pandemic with the world’s first plant-based vaccine for use in humans,” said Takashi Nagao, CEO and President at Medicago. “I want to thank everyone who participated in our clinical trials, our collaborators at clinical trial sites, our partners at GSK, the Government of Canada and Government of Quebec, Mitsubishi Tanabe Pharma Corporation, and all of our employees and our shareholders, for their commitment to advancing vaccine science when the world needs it.”
Thomas Breuer, GSK’s global COVID-19 adjuvanted vaccines lead and Chief Global Health Officer, said, “These are encouraging results given data were obtained in an environment with no ancestral virus circulating. The global COVID-19 pandemic is continuing to show new facets with the current dominance of the Delta variant, upcoming Omicron and other variants likely to follow. The combination of GSK’s established pandemic adjuvant with Medicago’s plant-based vaccine technology has significant potential to be an effective, refrigerator-stable option to help protect people against SARS-CoV-2.”
Medicago has been developing its plant-based technology for the past 20 years, using unique technology to produce Virus-Like Particles (VLP) for its protein vaccines. VLPs are designed to mimic the native structure of viruses, allowing them to be easily recognized by the immune system. Because the VLPs lack core genetic material, they are non-infectious and unable to replicate. VLP vaccines developed by other technologies have traditionally been used worldwide for more than 30 years.
“I am pleased to see our vaccine candidate moving forward and bringing to the world the first plant-based vaccine against COVID-19, diversifying the pool of vaccines available to help improve public health and protect more people,” said Yosuke Kimura, Chief Scientific Officer at Medicago.
About the Phase 2/3 study
The Phase 2/3 study has a multi-portion design to confirm that the chosen formulation and dosing regimen of the vaccine candidate (two doses of 3.75 µg of antigen combined with GSK’s pandemic adjuvant given 21 days apart) has an acceptable vaccine profile in healthy adults 18-64 years of age, elderly subjects aged 65 and over and adults with comorbidities.
The Phase 2 portion of the trial was a randomized, observer-blind, placebo-controlled study to evaluate the safety and immunogenicity of the adjuvanted recombinant COVID-19 plant-based vaccine candidate in subjects aged 18 and above. It was conducted in multiples sites in Canada and the United States in a population composed of healthy adults (18-64y), elderly adults (over 65y) and adults with comorbidities. Each age group enrolled up to 306 subjects randomized 5:1 to receive the adjuvanted vaccine candidate: placebo and with 2:1 stratification in older adults (65-74 and ≥75). All subjects are being followed for a period of 12 months after the last vaccination for assessment of safety and the durability of the immune responses which will be the final analysis.
The Phase 3 portion of the trial was launched on March 16th, 2021, and was an event-driven, randomized, observer-blinded, crossover placebo-controlled design that evaluated the efficacy and safety of the vaccine candidate formulation, compared to placebo, in over 24,000 subjects across Canada, United States, United Kingdom, Mexico, Argentina, and Brazil.
The data communicated are Per-Protocol, meaning only data from participants who followed the protocol throughout the study are included. A parallel Intention to Treat (ITT) analysis that considers the treatment received by all participants, without regard to protocol adherence yielded very similar results.
The vaccination regimen calls for two doses (3.75 microgram of antigen in combination with GSK’s pandemic adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2 °C to 8 °C, enabling the use of traditional vaccine supply and cold chain channels.
December 7, 2021
Medicago and GSK announce positive Phase 3 efficacy and safety results for adjuvanted plant-based COVID-19 vaccine candidate
Primary endpoints, and secondary endpoints for which data are available were met in trial dominated by COVID-19 variantsEfficacy demonstrated against all variants seen in the study, including 75.3% efficacy against COVID-19 of any severity caused by the globally dominant Delta variant
Vaccine candidate was well-tolerated, with no related serious adverse events reported in the vaccine group
Final regulatory submission to be filed with Health Canada imminently
Quebec City, London, December 7th, 2021 – Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) today announce positive efficacy and safety results from the global Phase 3 placebo-controlled efficacy study of Medicago’s plant-based COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant, conducted in over 24,000 subjects, adults 18y and above, across six countries.
Vaccine efficacy was demonstrated in an environment dominated by SARS-CoV-2 variants, unlike most published Phase 3 efficacy trials for currently licensed COVID-19 vaccines that were conducted when only the ancestral virus was circulating, making direct comparisons impossible. The overall vaccine efficacy rate against all variants of SARS-COV-2 was 71% (95% Confidence Interval: CI 58.7, 80.0; Per Protocol Analysis: PP). The corresponding number for people with an initial seronegative status indicating no previous exposure to COVID-19 was 75.6% (95% CI: 64.2-83.7; PP). The vaccine candidate demonstrated efficacy of 75.3% (95% CI: 52.8, 87.9; PP) against COVID-19 of any severity for the globally dominant Delta variant. Efficacy was 88.6% (95% CI: 74.6, 95.6; PP) against the Gamma variant. Although only a small number of severe cases occurred in this study, none occurred in the vaccinated group. No cases of the Alpha, Lambda and Mu variants were observed in the vaccinated group while 12 cases were observed in the placebo group. The Omicron variant was not circulating during the study.
During the study, no related serious adverse events were reported and reactogenicity was generally mild to moderate and transient; symptoms lasting on average only 1 to 3 days. To date, the Phase 3 results have confirmed the safety profile is consistent with Phase 2 results. The frequency of mild fever was low (<10%), even after the second dose.
Full results of the Phase 3 study will be released in a peer-reviewed publication as soon as possible.
Based on these results, Medicago will imminently seek regulatory approval from Health Canada as part of its rolling submission. The vaccine candidate is not approved yet by any regulatory authorities.
“This is an incredible moment for Medicago and for novel vaccine platforms. The results of our clinical trials show the power of plant-based vaccine manufacturing technology. If approved, we will be contributing to the world’s fight against the COVID-19 pandemic with the world’s first plant-based vaccine for use in humans,” said Takashi Nagao, CEO and President at Medicago. “I want to thank everyone who participated in our clinical trials, our collaborators at clinical trial sites, our partners at GSK, the Government of Canada and Government of Quebec, Mitsubishi Tanabe Pharma Corporation, and all of our employees and our shareholders, for their commitment to advancing vaccine science when the world needs it.”
Thomas Breuer, GSK’s global COVID-19 adjuvanted vaccines lead and Chief Global Health Officer, said, “These are encouraging results given data were obtained in an environment with no ancestral virus circulating. The global COVID-19 pandemic is continuing to show new facets with the current dominance of the Delta variant, upcoming Omicron and other variants likely to follow. The combination of GSK’s established pandemic adjuvant with Medicago’s plant-based vaccine technology has significant potential to be an effective, refrigerator-stable option to help protect people against SARS-CoV-2.”
Medicago has been developing its plant-based technology for the past 20 years, using unique technology to produce Virus-Like Particles (VLP) for its protein vaccines. VLPs are designed to mimic the native structure of viruses, allowing them to be easily recognized by the immune system. Because the VLPs lack core genetic material, they are non-infectious and unable to replicate. VLP vaccines developed by other technologies have traditionally been used worldwide for more than 30 years.
“I am pleased to see our vaccine candidate moving forward and bringing to the world the first plant-based vaccine against COVID-19, diversifying the pool of vaccines available to help improve public health and protect more people,” said Yosuke Kimura, Chief Scientific Officer at Medicago.
About the Phase 2/3 study
The Phase 2/3 study has a multi-portion design to confirm that the chosen formulation and dosing regimen of the vaccine candidate (two doses of 3.75 µg of antigen combined with GSK’s pandemic adjuvant given 21 days apart) has an acceptable vaccine profile in healthy adults 18-64 years of age, elderly subjects aged 65 and over and adults with comorbidities.
The Phase 2 portion of the trial was a randomized, observer-blind, placebo-controlled study to evaluate the safety and immunogenicity of the adjuvanted recombinant COVID-19 plant-based vaccine candidate in subjects aged 18 and above. It was conducted in multiples sites in Canada and the United States in a population composed of healthy adults (18-64y), elderly adults (over 65y) and adults with comorbidities. Each age group enrolled up to 306 subjects randomized 5:1 to receive the adjuvanted vaccine candidate: placebo and with 2:1 stratification in older adults (65-74 and ≥75). All subjects are being followed for a period of 12 months after the last vaccination for assessment of safety and the durability of the immune responses which will be the final analysis.
The Phase 3 portion of the trial was launched on March 16th, 2021, and was an event-driven, randomized, observer-blinded, crossover placebo-controlled design that evaluated the efficacy and safety of the vaccine candidate formulation, compared to placebo, in over 24,000 subjects across Canada, United States, United Kingdom, Mexico, Argentina, and Brazil.
The data communicated are Per-Protocol, meaning only data from participants who followed the protocol throughout the study are included. A parallel Intention to Treat (ITT) analysis that considers the treatment received by all participants, without regard to protocol adherence yielded very similar results.
The vaccination regimen calls for two doses (3.75 microgram of antigen in combination with GSK’s pandemic adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2 °C to 8 °C, enabling the use of traditional vaccine supply and cold chain channels.
Tartsan
VIP
- Liittynyt
- 14.8.2004
- Viestejä
- 6 244
Nenänkaiveluun turvautuminen on politiikolle paljon helpompi valinta, kun se antaa vaikutelman, että nyt "joku tekee jotain". Terveydenhuollon kapasiteettien lisäämiset ovat sen verran pitkäjänteisiä prosesseja, ettei siitä päästä saman vaalikauden aikana niittämään gloriaa ja siksi ei-niin-kiinnostava vaihtoehto.Onhan tuohon nenänkaiveluunkin löytynyt rahaa vaikka kuinka, kumma ettei terveydenhuollon kapasiteetin lisäämiseen.
Deleted member 108056
no hukkaan meni tuo tutkimus..
- Liittynyt
- 18.6.2007
- Viestejä
- 6 512
- Liittynyt
- 26.7.2019
- Viestejä
- 634
Mutta huhtikuusta tähän päivään asti oot silti puhunut vain tästä aiheesta yli 5000 viestin verran.. ok.
- Liittynyt
- 8.4.2021
- Viestejä
- 15 364
Jännä miten ihmisoikeudet taas voidaan kuukausissa mitätöidä.
On ne melkoisen monimutkaisia asioita..
- Liittynyt
- 8.4.2021
- Viestejä
- 15 364
Eli mikä on pointtisi liittyen perheeni jouluun sekä täällä kirjoittamiseen?
Onko siis kaikki koronatoimet peruttu eikä passeja enää ole? hmmm? Mielelläni en tästä aiheesta kirjoittaisi sanaakaan, mutta se ei ole käsissäni.
Eli mikä oli pointtisi?
- Liittynyt
- 20.1.2010
- Viestejä
- 2 763
Tämäpä, näyttää tavan tallaajalle paremmalta muttei oikeastaan edistä mitään kurjuutta kummempaa.
- Liittynyt
- 17.8.2006
- Viestejä
- 15 545
- Ikä
- 34
University of Hong Kong and Xiamen University created a nasal-spray vaccine for the flu based on a genetically weakened form of the influenza virus. In early 2020, they engineered the vaccine to produce part of the coronavirus spike protein as well. On Sept. 9, they received approval to start clinical trials in partnership with Beijing Wantai Biological Pharmacy. They registered a Phase 1 trial on March 22, 2021. At a June 11 press conference, a researcher for the Chinese Center for Disease Control and Prevention said that this vaccine has completed Phase 2 trials. And on Sept. 22, the researchers registered a Phase 3 trial. The researchers are receiving $5.4 million in support from CEPI, the Coalition for Epidemic Preparedness Innovations.
---------
The Italian biotechnology company ReiThera has developed a Covid-19 vaccine, called GRAd-COV2, that is based on an adenovirus that infects gorillas. Working in collaboration with the Lazzaro Spallanzani National Institute for Infectious Diseases in Rome, they found that it produced strong levels of antibodies in mice and monkeys.
In May, Reuters reported, a court in Italy struck down the government’s plan to fund the Phase 3 trial. The government later said it was ready to support the vaccine trial, but has yet to offer up the funds. In November 2021, the Bill & Melinda Gates Foundation awarded ReiThera a grant of $1.4 million to continue to develop the vaccine.
--------------
Researchers at Washington University designed a nasal spray vaccine that can produce high levels of coronavirus antibodies in mice with just a single dose. It contains a chimpanzee adenovirus engineered to carry the spike protein gene. Phase 2/3 trial was set to begin in a matter of days. (syyskuussa päivitetty)
------
Cuba’s Finlay Vaccine Institute developed a vaccine known as Soberana 2. It contains a part of the coronavirus spike protein, fused to a standard tetanus vaccine to make it stable. Soberana 2 also contains aluminum hydroxide as an adjuvant to boost the immune system. On March 3, 2021, the Finlay Vaccine Institute registered a Phase 3 trial for Soberana 2, with plans to recruit 44,010 participants in Havana.
Välikysymys, miten vitussa jollain kuuballa voi olla pariki version kehitys noin pitkällä?
------------
After the SARS epidemic in 2002, Baylor College of Medicine researchers began developing a vaccine that could prevent a new outbreak. Despite promising early results, support for the research disappeared. Because the coronaviruses that cause SARS and Covid-19 are very similar, the researchers revived the project in 2020, working in partnership with the Texas Children’s Hospital.
On Oct. 13, the Hindustan Times reported that Biological E was seeking permission to run a Phase 3 trial of Corbevax as a booster for two vaccines authorized in India, Covaxin and Covishield
------
Shionogi, a Japanese pharmaceutical giant, launched a Phase 1/2 trial of a coronavirus vaccine on Dec. 16, 2020. The company developed it in collaboration with the National Institute of Infectious Diseases and Kyushu University. The vaccine is based on a coronavirus protein which is produced in insect cells by genetically altered viruses. They combined the protein with an adjuvant to stimulate the immune system.
For months, the trial advanced slowly and ultimately delivered disappointing results. In the summer, Shionogi switched to a new adjuvant and started a new Phase 1/2 trial in August 2021. Results from the trial, released on Dec. 7, showed that the vaccine produced levels of antibodies on par with those in people who recovered from Covid-19.
On Oct. 21, the company announced that it had moved to a Phase 2/3 trial. Shionogi is also testing the vaccine as a booster shot.
---------
The Italian biotechnology company ReiThera has developed a Covid-19 vaccine, called GRAd-COV2, that is based on an adenovirus that infects gorillas. Working in collaboration with the Lazzaro Spallanzani National Institute for Infectious Diseases in Rome, they found that it produced strong levels of antibodies in mice and monkeys.
In May, Reuters reported, a court in Italy struck down the government’s plan to fund the Phase 3 trial. The government later said it was ready to support the vaccine trial, but has yet to offer up the funds. In November 2021, the Bill & Melinda Gates Foundation awarded ReiThera a grant of $1.4 million to continue to develop the vaccine.
--------------
Researchers at Washington University designed a nasal spray vaccine that can produce high levels of coronavirus antibodies in mice with just a single dose. It contains a chimpanzee adenovirus engineered to carry the spike protein gene. Phase 2/3 trial was set to begin in a matter of days. (syyskuussa päivitetty)
------
Cuba’s Finlay Vaccine Institute developed a vaccine known as Soberana 2. It contains a part of the coronavirus spike protein, fused to a standard tetanus vaccine to make it stable. Soberana 2 also contains aluminum hydroxide as an adjuvant to boost the immune system. On March 3, 2021, the Finlay Vaccine Institute registered a Phase 3 trial for Soberana 2, with plans to recruit 44,010 participants in Havana.
Välikysymys, miten vitussa jollain kuuballa voi olla pariki version kehitys noin pitkällä?
------------
After the SARS epidemic in 2002, Baylor College of Medicine researchers began developing a vaccine that could prevent a new outbreak. Despite promising early results, support for the research disappeared. Because the coronaviruses that cause SARS and Covid-19 are very similar, the researchers revived the project in 2020, working in partnership with the Texas Children’s Hospital.
On Oct. 13, the Hindustan Times reported that Biological E was seeking permission to run a Phase 3 trial of Corbevax as a booster for two vaccines authorized in India, Covaxin and Covishield
------
Shionogi, a Japanese pharmaceutical giant, launched a Phase 1/2 trial of a coronavirus vaccine on Dec. 16, 2020. The company developed it in collaboration with the National Institute of Infectious Diseases and Kyushu University. The vaccine is based on a coronavirus protein which is produced in insect cells by genetically altered viruses. They combined the protein with an adjuvant to stimulate the immune system.
For months, the trial advanced slowly and ultimately delivered disappointing results. In the summer, Shionogi switched to a new adjuvant and started a new Phase 1/2 trial in August 2021. Results from the trial, released on Dec. 7, showed that the vaccine produced levels of antibodies on par with those in people who recovered from Covid-19.
On Oct. 21, the company announced that it had moved to a Phase 2/3 trial. Shionogi is also testing the vaccine as a booster shot.
- Liittynyt
- 16.5.2021
- Viestejä
- 596
Pakotettua koronainjektiota vastustavan kutsuminen "rokotevastaiseksi" on sama kuin kutsuisi raiskausta vastaan puolustautuvaa seksivastaiseksi.
- Liittynyt
- 8.4.2021
- Viestejä
- 15 364
huikea vertaus
käytän tätä myöhemmissä jaksoissa
- Liittynyt
- 18.6.2007
- Viestejä
- 6 512
Lohi parhaillaan eduskunnassa julistaa, että hoitohenkilökunnan pakottaminen rokotteisiin perustuu vain ja ainoastaan parhaaseen ja ajankohtaiseen tutkittuun lääketieteellisen tietoon. Ja se tieto on : rokotetut levittävät tautia selvästi vähemmän kuin rokottamattomat. Näin sitä puhellaan täyttä paskaa ja valetta suorassa lähetyksessä.
Seuraava puhuja jatkaa samaa paskaa. Koko sali on psykoosissa.
Seuraava puhuja jatkaa samaa paskaa. Koko sali on psykoosissa.
- Liittynyt
- 18.4.2019
- Viestejä
- 17 356
Kuubassa oli neukkulan aikaan suhteellisen hyvin koulutettua väkeä joka kävi koulut siellä neukkulassa ja muissa varsovan liiton maissa.
Jenkeistä kun ei saanut tuotteita ja muutenkin vissiin kauppasaartoa ja sitten kun hupskeikkaa ei enää ollut neukkulaa niin joutuivat panostamaan aika paljon omaan lääketeollisuuteen, tästähän teki tämä yksi bigmac journalisti dokkarin että miten sairaanhoito ja lääkkeet voi olla sellaisessa kehitysmaassa kuin Kuuba niin halpaa verrattuna rikkaaseen jenkkilään.
Deleted member 50104
Suomessa ei ketään edelleenkään pakoteta ottamaan rokote. Jos joku ei usko omaan alaansa ja alan tutkijoihin, niin alaa voi aina vaihtaa.
- Liittynyt
- 13.6.2003
- Viestejä
- 3 210
- Liittynyt
- 8.4.2021
- Viestejä
- 15 364
Sulle ei edes pfizer maksa mitään. Sulla ei oo mitään tekosyytä.
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Thread 'Ufot, aikamatkustus, valonnopeus ja elämä muilla planeetooilla :)'
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