Well b back 3,199 Posted May 31, 2020 So here it is details of the next phases and time frames. I don’t wish Covid on anyone but the long and the short of it is if those with the fake vaccine get infected quickly we will have results as early as July. If they don’t ( or of course if those with the vaccine start getting infected ) be 6 months or abandoned if it has no chance of working. The strange thing is this is talking total protection and not just the lungs, so I can only assume those injected to date have no bad side effects, antibodies and didn’t catch it, but that’s just a guess. The Oxford Vaccine Centre COVID-19 Phase II/III Clinical Trial Explained What is the purpose of this research study? The purpose of this study is to test a new vaccine against COVID-19 in healthy volunteers. This study aims to assess how well people across a broad range of ages could be protected from COVID-19 with this new vaccine called ChAdOx1 nCoV-19. It will also provide valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the virus. What is the vaccine being tested? ChAdOx1 nCoV-19 is made from a virus (ChAdOx1), which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, that has been genetically changed so that it is impossible for it to grow in humans. Genetic material has been added to the ChAdOx1 construct, that is used to make proteins from the COVID-19 virus (SARS-CoV-2) called Spike glycoprotein (S). This protein is usually found on the surface of SARS-CoV-2 and plays an essential role in the infection pathway of the SARS-CoV-2 virus. The SARS-CoV-2 coronavirus uses its spike protein to bind to ACE2 receptors on human cells to gain entry to the cells and cause an infection. By vaccinating with ChAdOx1 nCoV-19, we are hoping to make the body recognise and develop an immune response to the Spike protein that will help stop the SARS-CoV-2 virus from entering human cells and therefore prevent infection. Has the vaccine been tested on animals? Our collaborators at Rocky Mountain Laboratories (NIAID/NIH) have conducted a rapid yet thorough investigation and demonstrated good safety and efficacy of a single dose of ChAdOx1 nCoV-19 in the rhesus macaque model that they had previously established. We were able to review the data before vaccinations in the clinical trial were initiated. There are also animal studies underway in Australia and the UK, and the results will be published once those studies are complete. What does the study involve? In total this study will enrol up to 10,260 adults and children across the UK. The phase II part of the study involves expanding the age range of people the vaccine is assessed in, to include a small number of adults and children: Aged 56-69 Aged over 70 Aged between 5-12 years For these groups, researchers are assessing the immune response to the vaccine in people of different ages, to find out if there is variation in how well the immune system responds in older people or children. The phase III part of the study involves assessing how the vaccine works in a large number of people over the age of 18. This group will allow assessment of how well the vaccine works to prevent people from becoming infected with COVID-19. Adult participants in both the Phase II and Phase III groups will be randomised to receive one or two doses of either the ChAdOx1 nCoV-19 vaccine or a licensed vaccine (MenACWY) that will be used as a ‘control’ for comparison. What is the MenACWY vaccine? The MenACWY vaccine is a licensed vaccine against group A, C, W and Y meningococcus which has been given routinely to teenagers in the UK since 2015 and protects against one of the most common causes of meningitis and sepsis. This vaccine is also given as a travel vaccine for high risk countries. The MenACWY vaccine is being used as an ‘active control’ vaccine in this study, to help us understand participants’ response to ChAdOx1 nCoV-19. The reason for using this vaccine, rather than a saline control, is because we expect to see some minor side effects from the ChAdOx1 nCOV-19 vaccine such as a sore arm, headache and fever. Saline does not cause any of these side effects. If participants were to receive only this vaccine or a saline control, and went on to develop side effects, they would be aware that they had received the new vaccine. It is critical for this study that participants remain blinded to whether or not they have received the vaccine, as, if they knew, this could affect their health behaviour in the community following vaccination, and may lead to a bias in the results of the study. Who can take part in the study? Participants must: Participants must NOT: Be in one of the relevant age categories Have tested positive for COVID-19 Be in good health Be pregnant, intending to become pregnant, or breastfeeding during the study Based in one of the recruiting areas Have previously taken part in a trial with an adenoviral vaccine or received any other coronavirus vaccines Full inclusion and exclusion criteria is available in the participant information sheet. Find out more about taking part in the study here. How will the trial work? The main focus of the study is to find out if this vaccine is going to work against COVID-19, if it won’t cause unacceptable side effects and if it induces good immune responses. The dose used in this trial was chosen based on previous experiences with other ChAdOx1 based vaccines. Study participants will not know whether they have received the ChAdOx1 nCoV-19 vaccine until the end of the trial. To recruit the large number of participants needed for this trial, multiple clinical research sites across the UK are involved in delivering the study. This is a collaborative effort led by the University of Oxford and a full list of our study sites is available on our website. Vaccinations will be taking place across the sites in May and June. What about after the vaccination? Some participants will be given an E-diary to record any symptoms experienced for 7 days after receiving the vaccine and if they feel unwell for the following 3 weeks. There is also a weekly survey that participants will be asked to complete about any household exposure to COVID-19. In order to monitor exposure to COVID-19 in people who do not have symptoms, participants in some areas will be asked to collect swabs at home to be sent to the laboratory for testing. Following vaccination, participants will attend a series of short follow-up visits. During these visits, the team will check participants’ observations, take a blood sample and review the completed E-diary and questionnaire. These blood samples will be used to assess the immune response to the vaccine. If participants develop COVID-19 symptoms during the study, they can contact a member of the clinical team, and we will assess them to check whether they have become infected with the virus. If a participant was very unwell, we would call our colleagues in the hospital and ask them to review the volunteer if appropriate. When will the results be available? To assess whether the vaccine works to protect from COVID-19, the statisticians in our team will compare the number of infections in the control group with the number of infections in the vaccinated group. For this purpose, it is necessary for a small number of study participants to develop COVID-19. How quickly we reach the numbers required will depend on the levels of virus transmission in the community. If transmission remains high, we may get enough data in a couple of months to see if the vaccine works, but if transmission levels drop, this could take up to 6 months. Recruitment of those who have a higher chance of being exposed to the SARS-CoV-2 virus is being prioritised, such as frontline healthcare workers, frontline support staff and public-facing key workers, in an effort to capture the efficacy data as quickly as possible. What if it doesn’t work? A significant proportion of vaccines that are tested in clinical trials don’t work. If we are unable to show that the vaccine is protective against the virus, we would review progress, examine alternative approaches, such as using different numbers of doses, and would potentially stop the programme. 2 Share this post Link to post Share on other sites
Well b back 3,199 Posted June 1, 2020 This tweet has just appeared on Jenners website. I know some of you have medical backgrounds but does anyone understand it ? thanks An inflammatory cytokine signature helps predict COVID-19 severity and death Diane Marie Del Valle, Seunghee Kim-schulze, Huang Hsin-hui, Noam D Beckmann, Sharon Nirenberg, Bo Wang, Yonit Lavin, View ORCID ProfileTalia Swartz, Deepu Madduri, Aryeh Stock, Thomas Marron, Hui Xie, Manish Kumar Patel, Oliver van Oekelen, View ORCID ProfileAdeeb Rahman, Patricia Kovatch, Judith Aberg, Eric Schadt, Sundar Jagannath, Madhu Mazumdar, Alexander Charney, Adolfo Firpo-Betancourt, Damodara Rao Mendu, Jeffrey Jhang, David Reich, Keith Sigel, Carlos Cordon-Cardo, View ORCID ProfileMarc Feldmann, Samir Parekh, Miriam Merad, View ORCID ProfileSacha Gnjatic doi: https://doi.org/10.1101/2020.05.28.20115758 This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice. Abstract Info/History Metrics Preview PDF Abstract The COVID-19 pandemic caused by infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has led to more than 100,000 deaths in the United States. Several studies have revealed that the hyper-inflammatory response induced by SARS-CoV-2 is a major cause of disease severity and death in infected patients. However, predictive biomarkers of pathogenic inflammation to help guide targetable immune pathways are critically lacking. We implemented a rapid multiplex cytokine assay to measure serum IL-6, IL-8, TNF-α, and IL-1β in hospitalized COVID-19 patients upon admission to the Mount Sinai Health System in New York. Patients (n=1484) were followed up to 41 days (median 8 days) and clinical information, laboratory test results and patient outcomes were collected. In 244 patients, cytokine measurements were repeated over time, and effect of drugs could be assessed. Kaplan-Meier methods were used to compare survival by cytokine strata, followed by Cox regression models to evaluate the independent predictive value of baseline cytokines. We found that high serum IL-6, IL-8, and TNF-α levels at the time of hospitalization were strong and independent predictors of patient survival. Importantly, when adjusting for disease severity score, common laboratory inflammation markers, hypoxia and other vitals, demographics, and a range of comorbidities, IL-6 and TNF-α serum levels remained independent and significant predictors of disease severity and death. We propose that serum IL-6 and TNF-α levels should be considered in the management and treatment of COVID-19 patients to stratify prospective clinical trials, guide resource allocation and inform therapeutic options. We also propose that patients with high IL-6 and TNF-α levels should be assessed for combinatorial blockade of pathogenic inflammation in this disease. Competing Interest Statement S.G. reports consultancy and/or advisory roles for Merck, Neon Therapeutics and OncoMed and research funding from Bristol-Myers Squibb, Genentech, Immune Design, Agenus, Janssen R&D, Pfizer, Takeda, and Regeneron. Funding Statement S.G., D.M.D.V.. S.K.-S., P.K., A.R. and M.M. were supported by NCI U24 grant CA224319. S.G. is additionally supported by grants U01 DK124165 and P01 CA190174. M.M. was supported by the fast-grant fund. The Human Immune Monitoring Center and the Institute for Healthcare Delivery Science received support from Cancer Center P30 grant CA196521. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study was reviewed and approved by the Mount Sinai Institutional Review Board. A waiver of informed consent was obtained to query the patient electronic medical record. Samples for the RT-PCR SARS-CoV-2 lab test were collected via nasopharyngeal or oropharyngeal swab at one of 53 different Mount Sinai locations, representing outpatient, urgent care, emergency and inpatient facilities. Blood specimen for ELLA were collected via venipuncture within the MSHS. All specimen and imaging were collected as part of standard of care. All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Paper in collection COVID-19 SARS-CoV-2 preprints from medRxiv and bioRxiv Share this post Link to post Share on other sites
Well b back 3,199 Posted June 1, 2020 Latest news from Russia Russia to roll out its first approved COVID-19 drug next week Russia will start giving its first drug approved to treat COVID-19 to patients from June 11, its state financial backer, RDIF sovereign wealth fund head Kirill Dmitriev told Reuters. The antiviral drug, Avifavir, known generically as Favipiravir, was first developed in the late 1990s by a Japanese company. Mr Dmitriev said Russian scientists had modified the drug to enhance it, and said Moscow would be ready to share the details of within two weeks. Japan has been trialling the same drug, known there as Avigan. It has won $US128 million in Government funding, but has yet to be approved for use. Mr Dmitriev said clinical trials on 330 people had shown it successfully treated the virus in most cases within four days. Share this post Link to post Share on other sites
Mark .Y. 352 Posted June 2, 2020 18 hours ago, Well b back said: Latest news from Russia Russia to roll out its first approved COVID-19 drug next week Russia will start giving its first drug approved to treat COVID-19 to patients from June 11, its state financial backer, RDIF sovereign wealth fund head Kirill Dmitriev told Reuters. The antiviral drug, Avifavir, known generically as Favipiravir, was first developed in the late 1990s by a Japanese company. Mr Dmitriev said Russian scientists had modified the drug to enhance it, and said Moscow would be ready to share the details of within two weeks. Japan has been trialling the same drug, known there as Avigan. It has won $US128 million in Government funding, but has yet to be approved for use. Mr Dmitriev said clinical trials on 330 people had shown it successfully treated the virus in most cases within four days. Would be very good news if proven to be true. And as for the post before..............no fuggin idea 🙂 1 Share this post Link to post Share on other sites
Barbe bleu 822 Posted June 2, 2020 19 hours ago, Well b back said: This tweet has just appeared on Jenners website. I know some of you have medical backgrounds but does anyone understand it ? thanks An inflammatory cytokine signature helps predict COVID-19 severity and death Diane Marie Del Valle, Seunghee Kim-schulze, Huang Hsin-hui, Noam D Beckmann, Sharon Nirenberg, Bo Wang, Yonit Lavin, View ORCID ProfileTalia Swartz, Deepu Madduri, Aryeh Stock, Thomas Marron, Hui Xie, Manish Kumar Patel, Oliver van Oekelen, View ORCID ProfileAdeeb Rahman, Patricia Kovatch, Judith Aberg, Eric Schadt, Sundar Jagannath, Madhu Mazumdar, Alexander Charney, Adolfo Firpo-Betancourt, Damodara Rao Mendu, Jeffrey Jhang, David Reich, Keith Sigel, Carlos Cordon-Cardo, View ORCID ProfileMarc Feldmann, Samir Parekh, Miriam Merad, View ORCID ProfileSacha Gnjatic doi: https://doi.org/10.1101/2020.05.28.20115758 This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice. Abstract Info/History Metrics Preview PDF Abstract The COVID-19 pandemic caused by infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has led to more than 100,000 deaths in the United States. Several studies have revealed that the hyper-inflammatory response induced by SARS-CoV-2 is a major cause of disease severity and death in infected patients. However, predictive biomarkers of pathogenic inflammation to help guide targetable immune pathways are critically lacking. We implemented a rapid multiplex cytokine assay to measure serum IL-6, IL-8, TNF-α, and IL-1β in hospitalized COVID-19 patients upon admission to the Mount Sinai Health System in New York. Patients (n=1484) were followed up to 41 days (median 8 days) and clinical information, laboratory test results and patient outcomes were collected. In 244 patients, cytokine measurements were repeated over time, and effect of drugs could be assessed. Kaplan-Meier methods were used to compare survival by cytokine strata, followed by Cox regression models to evaluate the independent predictive value of baseline cytokines. We found that high serum IL-6, IL-8, and TNF-α levels at the time of hospitalization were strong and independent predictors of patient survival. Importantly, when adjusting for disease severity score, common laboratory inflammation markers, hypoxia and other vitals, demographics, and a range of comorbidities, IL-6 and TNF-α serum levels remained independent and significant predictors of disease severity and death. We propose that serum IL-6 and TNF-α levels should be considered in the management and treatment of COVID-19 patients to stratify prospective clinical trials, guide resource allocation and inform therapeutic options. We also propose that patients with high IL-6 and TNF-α levels should be assessed for combinatorial blockade of pathogenic inflammation in this disease. Competing Interest Statement S.G. reports consultancy and/or advisory roles for Merck, Neon Therapeutics and OncoMed and research funding from Bristol-Myers Squibb, Genentech, Immune Design, Agenus, Janssen R&D, Pfizer, Takeda, and Regeneron. Funding Statement S.G., D.M.D.V.. S.K.-S., P.K., A.R. and M.M. were supported by NCI U24 grant CA224319. S.G. is additionally supported by grants U01 DK124165 and P01 CA190174. M.M. was supported by the fast-grant fund. The Human Immune Monitoring Center and the Institute for Healthcare Delivery Science received support from Cancer Center P30 grant CA196521. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study was reviewed and approved by the Mount Sinai Institutional Review Board. A waiver of informed consent was obtained to query the patient electronic medical record. Samples for the RT-PCR SARS-CoV-2 lab test were collected via nasopharyngeal or oropharyngeal swab at one of 53 different Mount Sinai locations, representing outpatient, urgent care, emergency and inpatient facilities. Blood specimen for ELLA were collected via venipuncture within the MSHS. All specimen and imaging were collected as part of standard of care. All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Paper in collection COVID-19 SARS-CoV-2 preprints from medRxiv and bioRxiv I read the full report and now I need a lie down. I think it is saying that blood testing for these cytokines gives the best indicator of likely dissease progression. The higher the levels the more likely a outcome. It hints that treatment aimed at reducing these levels might be beneficial but makes no recommendation to do so. 2 Share this post Link to post Share on other sites
Well b back 3,199 Posted June 2, 2020 Latest news from Russia Russia to roll out its first approved COVID-19 drug next week Russia will start giving its first drug approved to treat COVID-19 to patients from June 11, its state financial backer, RDIF sovereign wealth fund head Kirill Dmitriev told Reuters. The antiviral drug, Avifavir, known generically as Favipiravir, was first developed in the late 1990s by a Japanese company. Mr Dmitriev said Russian scientists had modified the drug to enhance it, and said Moscow would be ready to share the details of within two weeks. Japan has been trialling the same drug, known there as Avigan. It has won $US128 million in Government funding, but has yet to be approved for use. Mr Dmitriev said clinical trials on 330 people had shown it successfully treated the virus in most cases within four days. Share this post Link to post Share on other sites
Well b back 3,199 Posted June 3, 2020 Just now, Well b back said: No idea why it keeps making me quote this again, but please ignore that till I sort. latest suggestions for human challenge trial thrown in the melting pot with a big contribution from our friends in Oxford. If I am reading this right I think they are hinting that their results are looking good at the moment, but as usual judge for yourself. https://abcnews.go.com/Health/vaccine-paradox-flattening-curve-stymie-chances-developing-coronavirus/story?id=70885643 Latest news from Russia Russia to roll out its first approved COVID-19 drug next week Russia will start giving its first drug approved to treat COVID-19 to patients from June 11, its state financial backer, RDIF sovereign wealth fund head Kirill Dmitriev told Reuters. The antiviral drug, Avifavir, known generically as Favipiravir, was first developed in the late 1990s by a Japanese company. Mr Dmitriev said Russian scientists had modified the drug to enhance it, and said Moscow would be ready to share the details of within two weeks. Japan has been trialling the same drug, known there as Avigan. It has won $US128 million in Government funding, but has yet to be approved for use. Mr Dmitriev said clinical trials on 330 people had shown it successfully treated the virus in most cases within four days. Share this post Link to post Share on other sites
Well b back 3,199 Posted June 3, 2020 Just to show some of the original misinformation posts over the last few months, this will take most by surprise Coronavirus: Ibuprofen tested as a treatment By Michelle RobertsHealth editor, BBC News online 13 minutes ago Share this with Facebook Share this with Messenger Share this with Twitter Share this with Email Share Related Topics Coronavirus pandemic Image copyrightGETTY IMAGES Scientists are running a trial to see if ibuprofen can help hospital patients who are sick with coronavirus. The team from London's Guy's and St Thomas' hospital and Kings College believe the drug, which is an anti-inflammatory as well as a painkiller, could treat breathing difficulties. They hope the low-cost treatment can keep patients off ventilators. In the trial, called Liberate, half of the patients will receive ibuprofen in addition to usual care. The trial will use a special formulation of ibuprofen rather than the regular tablets that people might usually buy. Some people already take this lipid capsule form of the drug for conditions like arthritis. Studies in animals suggest it might treat acute respiratory distress syndrome - one of the complications of severe coronavirus. Prof Mitul Mehta, one of the team at Kings College London, said: "We need to do a trial to show that the evidence actually matches what we expect to happen." Coronavirus and ibuprofen: Separating fact from fiction Early in the pandemic there were some concerns that ibuprofen might be bad for people to take, should they have the virus with mild symptoms. These were heightened when France's health minister Oliver Veran said that taking non-steroidal anti-inflammatory drugs, such as ibuprofen, could aggravate the infection and advised patients to take paracetamol instead. A review by the Commission on Human Medicines quickly concluded that, like paracetamol, it was safe to take for coronavirus symptoms. Both can bring a temperature down and help with flu-like symptoms. For mild coronavirus symptoms, the NHS advises people try paracetamol first, as it has fewer side-effects than ibuprofen and is the safer choice for most people. You should not take ibuprofen if you have a stomach ulcer, for example. 1 Share this post Link to post Share on other sites
It's Character Forming 1,160 Posted June 3, 2020 That's a really useful post @Well b back (as usual). I had heard the original concerns about Ibuprofen, but not the update that it's ok although paracetomol is preferred. 1 Share this post Link to post Share on other sites
Well b back 3,199 Posted June 3, 2020 23 minutes ago, It's Character Forming said: That's a really useful post @Well b back (as usual). I had heard the original concerns about Ibuprofen, but not the update that it's ok although paracetomol is preferred. Just to show some of the original misinformation posts over the last few months, this will take most by surprise Coronavirus: Ibuprofen tested as a treatment By Michelle RobertsHealth editor, BBC News online 13 minutes ago Share this with Facebook Share this with Messenger Share this with Twitter Share this with Email Share Related Topics Coronavirus pandemic Image copyrightGETTY IMAGES Scientists are running a trial to see if ibuprofen can help hospital patients who are sick with coronavirus. The team from London's Guy's and St Thomas' hospital and Kings College believe the drug, which is an anti-inflammatory as well as a painkiller, could treat breathing difficulties. They hope the low-cost treatment can keep patients off ventilators. In the trial, called Liberate, half of the patients will receive ibuprofen in addition to usual care. The trial will use a special formulation of ibuprofen rather than the regular tablets that people might usually buy. Some people already take this lipid capsule form of the drug for conditions like arthritis. Studies in animals suggest it might treat acute respiratory distress syndrome - one of the complications of severe coronavirus. Prof Mitul Mehta, one of the team at Kings College London, said: "We need to do a trial to show that the evidence actually matches what we expect to happen." Coronavirus and ibuprofen: Separating fact from fiction Early in the pandemic there were some concerns that ibuprofen might be bad for people to take, should they have the virus with mild symptoms. These were heightened when France's health minister Oliver Veran said that taking non-steroidal anti-inflammatory drugs, such as ibuprofen, could aggravate the infection and advised patients to take paracetamol instead. A review by the Commission on Human Medicines quickly concluded that, like paracetamol, it was safe to take for coronavirus symptoms. Both can bring a temperature down and help with flu-like symptoms. For mild coronavirus symptoms, the NHS advises people try paracetamol first, as it has fewer side-effects than ibuprofen and is the safer choice for most people. You should not take ibuprofen if you have a stomach ulcer, for example. Just goes to show. Can’t understand why they don’t just delete these stupid Facebook posts Share this post Link to post Share on other sites
Well b back 3,199 Posted June 3, 2020 Think this post may have been mixed in with a Russia on so post again as this one is important. latest suggestions for human challenge trial thrown in the melting pot with a big contribution from our friends in Oxford. If I am reading this right I think they are hinting that their results are looking good at the moment, but as usual judge for yourself. https://abcnews.go.com/Health/vaccine-paradox-flattening-curve-stymie-chances-developing-coronavirus/story?id=70885643 1 Share this post Link to post Share on other sites
Crafty Canary 495 Posted June 3, 2020 My eldest son works as a research and development commercialisation manager for Medimune, an Astra-Zeneca subsidiary in the US. He has just started working with Oxford University on the covid-19 vaccine project which suggests to me that there is belief that it will prove efficacious. 2 1 Share this post Link to post Share on other sites
Well b back 3,199 Posted June 3, 2020 1 hour ago, Crafty Canary said: My eldest son works as a research and development commercialisation manager for Medimune, an Astra-Zeneca subsidiary in the US. He has just started working with Oxford University on the covid-19 vaccine project which suggests to me that there is belief that it will prove efficacious. Hi Crafty Please keep us all updated on anything you get to hear. We put lots on here ( there are almost daily releases these days ) and the good news on this thread is we don’t allow political opinion and we accept that it is not all fact. I think there is a growing thought on here as well that Oxford know far more about how their results are going than they are letting on. Thanks again and Come On Sarah Share this post Link to post Share on other sites
Crafty Canary 495 Posted June 3, 2020 1 hour ago, Well b back said: Hi Crafty Please keep us all updated on anything you get to hear. We put lots on here ( there are almost daily releases these days ) and the good news on this thread is we don’t allow political opinion and we accept that it is not all fact. I think there is a growing thought on here as well that Oxford know far more about how their results are going than they are letting on. Thanks again and Come On Sarah All I know at the moment is that he will be involved in the Commercial development of the production of millions of doses before the vaccine is approved provided the early trial results are positive. Share this post Link to post Share on other sites
Van wink 2,994 Posted June 3, 2020 (edited) This looks like a slightly better argued piece than some of the scaremongering I have seen in the past, but still pretty sketchy and politically convenient of course, worth a read, maybe for its novelty value. "Exclusive: Coronavirus began 'as an accident' in Chinese lab, says former MI6 boss Sir Richard Dearlove tells Telegraph's Planet Normal podcast that new scientific report suggests key elements of the virus were 'inserted' ByBill Gardner3 June 2020 • 9:17pm Starling CEO: banking is broken Anne Boden, founder and chief executive of Starling Bank, explores what banks can do to alleviate financial tension whilst... Read more › Sponsored A former head of MI6 has said he believes the coronavirus pandemic "started as an accident" when the virus escaped from a laboratory in China. In an interview with The Telegraph, Sir Richard Dearlove said he had seen an "important" new scientific report suggesting the virus did not emerge naturally but was man-made by Chinese scientists. The apparent discovery will raise the prospect of China paying "reparations" for the death and economic catastrophe wreaked upon the world, the former intelligence chief said. It comes as Beijing faces growing pressure to explain precisely how coronavirus first began to spread late last year. International scientists have reached a near-unanimous consensus, however, that the virus emerged in animals – most likely bats or pangolins – before jumping to the human population. But Sir Richard, 75, pointed to a scientific paper published this week by a Norwegian-British research team who claim to have discovered clues within Covid-19's genetic sequence suggesting key elements were "inserted" and may not have evolved naturally. From the outset, the Chinese government has endeavoured to "lock down" any debate about the origins of the virus and Beijing's handling of the crisis, he claimed. "I do think that this started as an accident," Sir Richard told The Telegraph's new Planet Normal podcast (listen through the player at the top of this story). "It raises the issue, if China ever were to admit responsibility, does it pay reparations? I think it will make every country in the world rethink how it treats its relationship with China and how the international community behaves towards the Chinese leadership." Sir Richard, who was the head of MI6 between 1999 and 2004, cited startling new peer-reviewed research produced by Professor Angus Dalgleish, of St George's Hospital at the University of London, and the Norwegian virologist Birger Sorensen. In their paper, the scientists claim to have identified "inserted sections placed on the SARS-CoV-2 Spike surface" that explain how the virus binds itself to human cells. "The SARS-CoV-2 spike is significantly different from any other Sars that we have studied," the paper says. It warns that current efforts to develop a vaccine are destined for failure because the true aetiology of the virus has been misunderstood. To remedy the problem, the researchers are developing their own vaccine, produced by Immunor AS, a Norwegian pharmaceutical company led by Mr Sorensen. Sir Richard described the study as "a very important contribution to a debate which is now starting about how the virus evolved and how it got out and broke out as a pandemic", adding: "I think this particular article is very important, and I think it will shift the debate." Sir Richard Dearlove CREDIT: Martin Pope He revealed that the Dalgleish/Sorensen paper had been rewritten several times. An earlier version, seen by The Telegraph, concluded that coronavirus should correctly be called "Wuhan virus" and claimed to have proven "beyond reasonable doubt that the Covid-19 virus is engineered". "We are aware that these findings could have political significance and raise troubling questions," the authors originally wrote. The paper was widely circulated behind the scenes after being distributed for peer review, while intelligence officials reportedly examined its findings. People wearing face masks walk by the river in Wuhan, the Chinese city in which the coronavirus outbreak beganCREDIT: Barcroft Media However, one of the authors, John Fredrik Moxnes, the chief scientific adviser to the Norwegian military, asked for his name to be withdrawn from the research, throwing its credibility into doubt. Scientists from the Francis Crick Institute and Imperial College London also dismissed its conclusions, it is understood. Correspondence seen by The Telegraph shows that, in April, the initial paper was rejected by leading academic journals including Nature and the Journal of Virology, which deemed the research "unsuitable for publication". Much of the paper was watered down to remove explicit accusations against China, and the rewritten study was then judged to be of sufficient scientific merit to be accepted for publication in the Quarterly Review of Biophysics Discovery, a journal chaired by leading scientists from Stanford University and the University of Dundee. A further analysis produced by Prof Dalgleish and his colleagues, due for release in the coming days, claims the Covid-19 virus has "unique fingerprints" that cannot have evolved naturally and are instead "indicative of purposive manipulation". Entitled "A Reconstructed Historical Aetiology of the SARS-CoV-2 Spike", the new study, seen by The Telegraph, suggests the virus is "remarkably well-adapted virus for human co-existence" and is likely to be the result of a Wuhan lab experiment to produce "chimeric viruses of high potency". The paper concludes: "Henceforth, those who would maintain that the Covid-19 pandemic arose from zoonotic transfer need to explain precisely why this more parsimonious account is wrong before asserting that their evidence is persuasive, most especially when, as we also show, there are puzzling errors in their use of evidence." The paper has not yet been accepted for publication in any scientific journal. "This [the first] article was submitted to a… journal, which refused it within a week of receiving it, and in the same period accepted for publication two or three Chinese articles that relate to the virus, within 48 hours," Sir Richard said. "So I mean, as this debate about the virus develops, I think all this material is going to be in print and is going to embarrass a number of people, I think. Let's suggest that the Chinese maybe have too much say in their journals, in what appears and what doesn't." Wuhan Seafood Market, where experts believe the outbreak started, was sealed off by authorities in the cityCREDIT: Sophia Yan The Chinese government has always insisted that the outbreak began in a "wet market" in the city of Wuhan late last year. But critics have questioned why some early human cases and their contacts appeared to have no connection to the area. Two laboratories in Wuhan studying bat coronaviruses – the Wuhan Institute of Virology and the Wuhan Centre for Disease Control – have been suggested as the possible true sources of the outbreak. Sir Richard suggested scientists may have been conducting secret gene-splicing experiments on bat coronaviruses when Covid-19 somehow escaped through a lapse in biosecurity. "It's a risky business if you make a mistake," he said. "Look at the stories... of the attempts by the leadership to lockdown any debate about the origins of the pandemic and the way that people have been arrested or silenced. "I mean, we shouldn't really have any doubt any longer about what we're dealing with." Sir Richard said he did not believe the Chinese had released the virus deliberately, but accused Beijing of subsequently covering up the scale of its spread. "Of course, the Chinese must have felt, well, if they've got to suffer a pandemic maybe we shouldn't try too hard to stop, as it were, our competitors suffering the same disadvantages we've got," he said. "Look, the Chinese understand us extremely well. They have made a study of us over the last decade or longer, particularly through attending our universities. We understand the Chinese very poorly. It's an imbalanced relationship in that respect." Last month, the US Secretary of State, Mike Pompeo, claimed there was "enormous evidence" that the coronavirus outbreak originated in a Chinese laboratory, but did not provide any proof. However, the US National Intelligence Director's office later said it had determined that Covid-19 "was not manmade or genetically modified". During a television interview on May 9, Matt Hancock, the Health Secretary, said: "We don't have any evidence that this is a man-made coronavirus." Matt Hancock said: 'We don't have any evidence that this is a man-made coronavirus.' CREDIT: Shutterstock Scientists analysing Covid-19 have also reported no signs that the genetic sequence was manipulated or distorted in any way. Nevertheless, Beijing is facing growing pressure to reveal everything it knows about the origins of Covid-19 amid accusations that the rest of the world may have been misled. Sir Richard praised the Australian government for leading calls for an official inquiry after Scott Morrison, the Prime Minister, suggested that the World Health Organisation needed tough new "weapons inspector" powers to investigate the origins of Covid-19. "I think it's very courageous of the Australians to take China on," Sir Richard said. "I mean, there's an obvious, huge imbalance in terms of power, both economic and military and political, but they are showing the way. You have to have a critical relationship with China." He urged the UK Government to abandon plans to allow the Chinese telecoms firm Huawei to have a role in building Britain's new 5G network, and to reduce the reliance on Chinese factories to make cheap personal protective equipment (PPE) for frontline NHS health workers. "We need to go into reverse," he said. "It's important that we do not put any of our critical infrastructure in the hands of Chinese interests. So telecommunications, Huawei, nuclear power stations, and then things that, you know, we require and need in a crisis, like PPE. "We have allowed China so much rope that we are now suffering the consequences, and it's time to pull the rope in and to tighten the way we do business. It's very, very important that we keep a keen eye on this and do not allow the Chinese to, as it were, benefit strategically from this situation that has been imposed on all of us." Sir Richard criticised George Osborne, the former Chancellor, for proclaiming that Britain would be China's "best partner in the West" during a charm offensive in September 2015. "I think the problem with young politicians, and when he was in office he was young, is that they lack experience and they lack depth of knowledge, and I don't think that George Osborne really understood what the leadership of a real communist party is like," Sir Richard said. "I spent most of my career dealing with the issue of communism, with the autocratic nature of the way that these parties are run and their immense disregard for law, for human rights, for all of these areas, and I mean George Osborne just conveniently disregarded all of that." Earlier this week, Liu Xiaoming, the Chinese ambassador to the UK, said Beijing would welcome an international investigation into the origins of the pandemic, insisting his country had nothing to hide. "China's record is clean. It can stand the test of time and history," he said. Edited June 3, 2020 by Van wink 1 Share this post Link to post Share on other sites
Well b back 3,199 Posted June 4, 2020 Heres a treatment back on the table. Wonder if Donald told them if they don’t withdraw their papers to Lancet they would be shot lol. But seriously what makes this interesting is I am sure Hancock was getting stick from journalists the other date for not stopping our trial. Three authors retract Hydroxychloroquine study Three of the authors behind a study in medical journal The Lancet that raised safety concerns over the use of the anti-malarial drug hydroxychloroquine to treat Covid-19 have retracted their paper. Hydroxychloroquine is being studied by a number of scientists to see if it is a viable treatment for Covid-19. US President Donald Trump took a two-week course of the drug as a preventative measure. The Lancet said the company that provided the data used in the study would not transfer the full statistics for an independent review. They concluded they "can no longer vouch for the veracity of the primary data sources", a statement from the medical journal said. The study claimed there were no benefits to treating coronavirus patients with the drug and said taking it might even increase the number of deaths among those in hospital with the disease. Following the publication of the study, the World Health Organization (WHO) halted its trial, but it announced on Wednesday that this work would resume. Share this post Link to post Share on other sites
Well b back 3,199 Posted June 4, 2020 Do you really buy into this on the basis you have no idea if it will work. If you see towards the middle AstraZeneca are already manufacturing doses, ready for the U.K. and USA. The last sentence as well sounds promising, that they are still confident Oxford will have their results by the end of August. AstraZeneca has struck two deals to provide 1.3 billion doses of its coronavirus vaccine to low- and middle-income countries. The company says it has agreed to provide these doses at cost and will make no profit from the arrangement. The vaccine, which it is developing alongside researchers from Oxford University, is among the most promising of dozens of possible candidates being developed around the world. It is currently in advanced human clinical trials. The new agreements follow on earlier deals AstraZeneca struck with the U.S. government to supply 300 million doses of the vaccine and with the U.K. government to provide it with 100 million doses. Shipment is expected to start in September or October. Those deals raised concerns that wealthy nations might try to monopolize supplies of vital COVID-19 vaccines and treatments for their own populations, leaving little for the developing nations where a large percentage of the world's population lives. Poorer nations also can't afford to pay for expensive vaccines and treatments, so AstraZeneca says it has agreed to provide the doses at cost. "Our goal is not to leave anyone behind, and we will keep working very hard to make sure this vaccine is rapidly and widely available to everyone around the world," said AstraZeneca CEO Pascal Soriot during a press conference Thursday. The new deals include an agreement with two global vaccine organizations, which will see them spending $750 million to enable 300 million doses of the vaccine to be produced and distributed to places with the most need, starting by the end of the year. Richard Hatchett, the chief executive officer of the Coalition for Epidemic Preparedness Innovations (CEPI), one of the two vaccine organizations, called the deal with AstraZeneca "groundbreaking." He said that CEPI was taking an unprecedented risk paying for a manufacturing program while a vaccine was still undergoing clinical trials. The idea is to have doses of the vaccine already in production when the clinical trial results are announced, so that if the trial is successful—and if global regulators grant emergency approval—the vaccine can begin shipping immediately. CEPI is a foundation funded by both governments and global charities that finances vaccines against emerging infectious diseases. It is leading the effort on vaccine development and manufacturing. The other organization involved in the deal is Gavi, another public-private alliance dedicated to vaccine development, which will be responsible for setting up a distribution process for the vaccine. The money for the deal is being provided by a fund set up by the Bill & Melinda Gates Foundation and the World Health Organization that is designed to ensure low- and middle-income countries have fair access to COVID-19 drugs. Separately, the Serum Institute of India, a private company in India that makes vaccines, has agreed to a licensing arrangement with AstraZeneca to produce 1 billion doses for India and other low-income countries, with 400 million doses to be delivered by year-end. No dollar figure was given for the value of that deal. Soriot said AstraZeneca had secured manufacturing capacity for an additional 300 million doses and was involved in ongoing discussions with global health bodies about how those would be distributed. This bring the company's total COVID-19 vaccine manufacturing capability to 2 billion doses, he said. The drug company CEO declined to say how optimistic he was that the vaccine's clinical trials would succeed. "With this sort of pandemic and the tremendous impact it has on people, the economy, etc., you can’t second-guess what is going to happen," he said. "You just have to commit—that is what you have to do in our industry. You make a bet on something and commit. That is what we are doing." The AstraZeneca/Oxford University vaccine is considered to be one of the most promising in the world—and is at the most advanced stage of clinical trials—because it is based on a similar vaccine that Oxford researchers developed to treat another coronavirus, the one that causes Middle Eastern respiratory syndrome (MERS). He said that one problem AstraZeneca and the Oxford University researchers were having is that infection rates have fallen so quickly in countries were the pandemic first struck, that it has been difficult to find enough people to enroll in the vaccine trials in areas where infection rates remain high enough that the scientists can tell if the vaccine will actually prevent people from becoming infected. "We are chasing the disease in many parts of the world," Soriot said. He said that this might delay how quickly the company can get a valid clinical trial result and, if it is successful, how fast a vaccine can be distributed. But he said the clinical trial still seemed to be on track to be able to announce a result in August. Share this post Link to post Share on other sites
Well b back 3,199 Posted June 4, 2020 USA getting more confident about several vaccines as well. I wonder if Donald has tried them all lol https://www.businessinsider.com/fauci-offers-coronavirus-vaccine-timeline-phase-3-trial-2020-6?r=US&IR=T Share this post Link to post Share on other sites
Well b back 3,199 Posted June 5, 2020 As reported earlier that it was likely Oxford now confirm they will be trialing in Brazil. Strangely they also confirm they will be trialling 30,000 doses in the USA. In yesterday’s links were the USA not claiming it was their own vaccine being used ? This alone gives further hope that the results so far a very encouraging. This is the tweet from Jenner. Brazilian Health Regulatory Agency approves trial of Oxford COVID-19 Vaccine CORONAVIRUSCOVID-19 VACCINEHEALTHRESEARCH On 2 June, the Brazilian Health Regulatory Agency (ANVISA) approved the inclusion of Brazil in the clinical trials conducted by Oxford University and supported by AstraZeneca, considering 2,000 volunteers to be tested in the country. Our vaccine work is progressing quickly. To ensure you have the latest information or to find out more about the trial, please check our latest COVID-19 research news or visit the COVID-19 trial website. On April 30, the University of Oxford and AstraZeneca announced an agreement for the global development and distribution of the University’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2. A Phase I/II clinical trial of the Oxford vaccine began in April in the UK to assess safety and immune response in over 1,000 healthy volunteers aged 18 to 55 years across several trial centres in southern England. As the vaccine trials move to Phase III a larger population is being enrolled consisting of 10,000 participants in the UK with AstraZeneca enrolling 30,000 particpants in the US. On 2 June, the Brazilian Health Regulatory Agency (ANVISA) approved the inclusion of Brazil in the clinical trials conducted by Oxford University and supported by AstraZeneca, considering 2,000 volunteers to be tested in the country. “The most important thing is to carry out this stage of the study now, when the epidemiological curve is still rising and the results may be more assertive,” said Lily Yin Weckx, coordinator of the Reference Center for Special Immunobiologicals (CRIE) at the Federal University of Sao Paulo Unifesp. “We are delighted to be working with the talented team of investigators in Brazil on the COVID19 vaccine trial, as researchers and scientists around the world collaborate on clinical development work with unprecedented urgency to combat the global threat to human health that is coronavirus.” Says Professor Andrew Pollard, Chief investigator of the Oxford Vaccine Trial at Oxford University. Although the university is advancing fast on its ongoing response to address the unprecedented challenges of COVID-19, it is working with AstraZeneca to define next steps on the supply of the vaccine widely to make it accessible around the world in an equitable manner. The agreement includes a commitment to make the vaccine available on a not-for-profit basis during the pandemic and to ensure broad and equitable access around the world. To achieve this, Oxford University and AstraZeneca are collaborating with a number of countries and multilateral organisations, including organizations in Brazil to address local needs. Brazil is a priority for the study because of the ascendant curve of the COVID-19. To date AstraZeneca has concluded agreements for at least 400 million doses and secured total manufacturing capacity for 1bn billion doses of the Oxford vaccine. Share this post Link to post Share on other sites
Well b back 3,199 Posted June 5, 2020 Sarah speaks to the UN UN Talk – Professor Sarah Gilbert UN Talk – Professor Sarah Gilbert On 13 May Professor Sarah Gilbert gave a short talk and participated in an informal discussion with ambassadors of the United Nations member states, hosted by the UK mission. Here is a summary of her talk. Background In the wake of the 2014 Ebola outbreak the WHO R&D Blueprint programme was established to review platform technologies for Diagnostics, Vaccines and Therapeutics, in order to be better prepared for future outbreaks or pandemics. Oxford’s ChAdOx1 vaccine platform technology was presented to this newly formed programme, and it was approved by the WHO. Following the formation of CEPI, Oxford, in partnership with Janssen vaccines, was funded by CEPI to develop vaccines against the first three outbreak pathogens selected by CEPI: MERS, Nipah and Lassa. What is the ChAdOx1 vaccine technology? ChAdOx1 is based on an adenovirus, which is another virus that causes mild upper respiratory tract infections. We have removed some of the adenovirus genes so that when we use it as a vaccine, the adenovirus can’t spread through the body. That makes it very safe, even in people with a weak immune system. But because it is still a live virus, it is good at inducing a strong immune response after vaccination. There are lots of strains of adenoviruses that infect humans, which means that many people have antibodies against those adenoviruses. These antibodies would interfere with using the human adenoviruses as a vaccine vector. We started from an adenovirus that was isolated from a chimpanzee and doesn’t circulate in human populations, so there is no prior immunity to it. Then we add a gene to encode one of the proteins from the pathogen that we want to vaccinate against – for SARS-CoV-2 we use the spike protein, which covers the surface of the coronavirus. How have we used the ChAdOx1 vaccine technology previously? We have already used the ChAdOx1 vaccine technology to produce candidate vaccines against a number of pathogens including flu, chikungunya, Zika and another coronavirus, Middle East Respiratory Syndrome (MERS). The MERS vaccine completed a phase I clinical trial. It was safe and induced strong immune responses. It was tested in non-human primates who were vaccinated and then exposed to the MERS virus, and the vaccination was protective. The origin of the ChAdOx1 COVID-19 vaccine We had started to work on pandemic preparedness with ChAdOx1, to be ready to move as quickly as possible when a new outbreak occurred. We had not been successful in receiving funding for this work, and as a result the work had not progressed very far. In the first few days of this year there were reports of an outbreak of SARS-like pneumonia in China. I began to follow the reports with interest, and as the situation gradually advanced, I discussed making a vaccine with members of my research team and our collaborators at NIH who have worked with us on preclinical vaccine efficacy studies. As soon as the virus sequence was released, we started to make the vaccine based on the approach we had used for MERS, using a small amount of flexible funding that was available to me. The work so far Since January, the project has developed rapidly, moving into GMP manufacturing, with two vaccine efficacy studies in non-human primates now completed, and two further studies in ferrets underway. In the UK we have now vaccinated over 1000 people in a phase I clinical trial. Unusually for a phase I study, participants are randomised to receive either the COVID-19 vaccine, or an unrelated vaccine. During the follow-up period any participant experiencing symptoms of COVID-19 will contact us to be tested. When enough of the participants have tested positive, the statisticians will review the data and tell us the vaccine efficacy. Vaccinations in the phase I study in healthy adults aged between 18 and 55 were completed on 29 April. Next steps in the clinical trial We will shortly begin vaccinating older adults in a phase II study, and also initiate a phase III study with 10,000 participants aged over 18 years. All of the clinical trials so far are in the UK. We had hoped to have enough people vaccinated before the outbreak reached a peak, but the virus spread rapidly triggering a lockdown, and rates of infections are now falling. Unless some of the trial participants do become infected, we cannot know that the vaccine is effective. We are thus focusing on vaccinating healthcare workers as they have the highest rates of virus infections. Further, as measures to ease the lockdown are being introduced, transmission may rise again. Many discussions are underway but are confidential for now. We need to manufacture more vaccine for the trials, and plan to start trials in more than one country to give ourselves the best chance of determining vaccine efficacy. Manufacture of the vaccine In parallel with the clinical trials we are working with a number of contract vaccine manufacturers to get them ready to make large quantities of the vaccine (if it is found to be safe and effective). Development of Oxford’s vaccine is now funded by the UK government and we have a new partnership with AstraZeneca, to prepare for very large-scale vaccine supply. The contract was recently finalized. Vision for future collaboration If Oxford’s vaccine is successful, others’ will be as well. One of the lessons learned from Ebola must be to enable multiple vaccines to be licensed rather than end up with a monopoly. But it is not likely that ALL candidate vaccines now in development will be effective, and many will require more than one dose. Vaccine developers should work together to compare immune responses, and assess different vaccine platforms. Technologies which can be manufactured at large scale and low costs should be prioritised, but they also need to be highly effective. What should the way forward be for future outbreaks and pandemics? The world needs a small number of pandemic response research institutes. These would have advantages over both biotechs and large pharma companies in being able to respond rapidly, with a range of different technologies available. The institutes need core funding as well as access to flexible funding when needed. Funding for the early stage of pandemic response should not be a bottleneck. These institutes should be independent but also collaborative, and may be complementary in their skills. Access to flexible vaccine manufacturing facilities capable of making millions of doses of vaccine will be needed, but this may be achieved through partnerships with contract manufacturing organisations in some cases. Or there could be advance arrangements in place with large companies to take over activities in the event of a new large outbreak. There must also be connection with many clinical trials sites in many parts of the world, as Oxford has in place, to enable rapid clinical development. In some parts of the world there are delays in ethical or regulatory approvals for trials to be initiated, and there is work to be done on that. Immunology assays must be shared, or at least results must be able to be compared, with core labs for key samples. One idea would be for each institute to act as a core lab for certain types of assays. More capacity for preclinical research is also needed. Conclusion We did learn some lessons from Ebola, but we were still not sufficiently prepared. Again, clinical trial protocols are still being discussed and whilst funding has been pledged for vaccine purchases, much needs to be done on funding efficacy trials, and getting manufacturing sites ready for large scale manufacture. Efficacy trials should be conducted with vaccines using well known technologies, that have a high chance of success, can be manufactured at large scale, and will be affordable. We need to vaccinate across the world now and will need many manufacturers to make enough doses to achieve that. 1 Share this post Link to post Share on other sites
Well b back 3,199 Posted June 5, 2020 AstraZeneca confirm first doses will be ready as planned for September. Company working on a number of agreements in parallel to ensure broad and equitable supply of the vaccine throughout the world at no profit during the pandemic First agreements to supply at least 400 million doses; Company has total capacity sourced for one billion doses through 2020 and into 2021; continues to increase capacity further More than $1bn US BARDA investment to support development and production of the vaccine AstraZeneca is advancing its ongoing response to address the unprecedented challenges of COVID-19, collaborating with a number of countries and multilateral organisations to make the University of Oxford’s potential vaccine widely accessible around the world in an equitable manner. The Company has concluded the first agreements for at least 400 million doses and has secured total manufacturing capacity for one billion doses so far and will begin first deliveries in September 2020. AstraZeneca aims to conclude further agreements supported by several parallel supply chains, which will expand capacity further over the next months to ensure the delivery of a globally accessible vaccine. AstraZeneca today received support of more than $1bn from the US Biomedical Advanced Research and Development Authority (BARDA) for the development, production and delivery of the vaccine, starting in the fall. The development programme includes a Phase III clinical trial with 30,000 participants and a paediatric trial. In addition, the Company is engaging with international organisations such as the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance and the World Health Organisation (WHO), for the fair allocation and distribution of the potential vaccine around the world. AstraZeneca is also in discussions with governments around the world to increase access. Furthermore, AstraZeneca is in discussions with the Serum Institute of India and other potential partners to increase production and distribution. AstraZeneca recently joined forces with the UK Government to support Oxford University’s potential vaccine and has progressed rapidly in its efforts to expand access around the world. The Company will supply 100m doses to the UK and is thankful for the Government’s commitment and overall work on vaccines. Pascal Soriot, Chief Executive Officer, said: “This pandemic is a global tragedy and it is a challenge for all of humanity. We need to defeat the virus together or it will continue to inflict huge personal suffering and leave long-lasting economic and social scars in every country around the world. We are so proud to be collaborating with Oxford University to turn their ground-breaking work into a medicine that can be produced on a global scale. We would like to thank the US and UK governments for their substantial support to accelerate the development and production of the vaccine. We will do everything in our power to make this vaccine quickly and widely available.” AstraZeneca has now finalised its licence agreement with Oxford University for the recombinant adenovirus vaccine. The licensing of the vaccine, formerly ChAdOx1 nCoV-19 and now known as AZD1222, follows the recent global development and distribution agreement with the University’s Jenner Institute and the Oxford Vaccine Group. AstraZeneca has also agreed to support the establishment of a joint research centre at Oxford University for pandemic preparedness research. A Phase I/II clinical trial of AZD1222 began last month to assess safety, immunogenicity and efficacy in over 1,000 healthy volunteers aged 18 to 55 years across several trial centres in southern England. Data from the trial is expected shortly which, if positive, would lead to late-stage trials in a number of countries. AstraZeneca recognises that the vaccine may not work but is committed to progressing the clinical program with speed and scaling up manufacturing at risk. The Company’s comprehensive pandemic response also includes rapid mobilisation of AstraZeneca’s global research efforts to discover novel coronavirus-neutralising antibodies to prevent and treat progression of the COVID-19 disease, with the aim of reaching clinical trials in the next three to five months. Additionally, the Company has quickly moved into testing of new and existing medicines across multiple therapy areas to treat the infection. Share this post Link to post Share on other sites
Mark .Y. 352 Posted June 5, 2020 11 hours ago, Well b back said: Heres a treatment back on the table. Wonder if Donald told them if they don’t withdraw their papers to Lancet they would be shot lol. But seriously what makes this interesting is I am sure Hancock was getting stick from journalists the other date for not stopping our trial. Three authors retract Hydroxychloroquine study Three of the authors behind a study in medical journal The Lancet that raised safety concerns over the use of the anti-malarial drug hydroxychloroquine to treat Covid-19 have retracted their paper. Hydroxychloroquine is being studied by a number of scientists to see if it is a viable treatment for Covid-19. US President Donald Trump took a two-week course of the drug as a preventative measure. The Lancet said the company that provided the data used in the study would not transfer the full statistics for an independent review. They concluded they "can no longer vouch for the veracity of the primary data sources", a statement from the medical journal said. The study claimed there were no benefits to treating coronavirus patients with the drug and said taking it might even increase the number of deaths among those in hospital with the disease. Following the publication of the study, the World Health Organization (WHO) halted its trial, but it announced on Wednesday that this work would resume. That is interesting isn't it. Not so much just this particular subject, but the way the "science" plays out and can change. I remember reading some articles weeks ago about how putting people on ventilators wasn't the best treatment and that using anti-clotting agents for the blood was more effective - but I don't think I ever really saw any conclusions or any definitive ways people should be treated. I wonder whether the journalists will hold their hands up and apologise 🙂 Share this post Link to post Share on other sites
Well b back 3,199 Posted June 5, 2020 7 minutes ago, Mark .Y. said: That is interesting isn't it. Not so much just this particular subject, but the way the "science" plays out and can change. I remember reading some articles weeks ago about how putting people on ventilators wasn't the best treatment and that using anti-clotting agents for the blood was more effective - but I don't think I ever really saw any conclusions or any definitive ways people should be treated. I wonder whether the journalists will hold their hands up and apologise 🙂 Spot on. That’s probably what makes this thread so interesting and we are finding the smaller the source that we get it from the more likely it is to be right and the larger sources are piggy backing info often weeks old. It is interesting as well that the US keep running the Oxford vaccine down and a couple of days ago they claimed 30,000 were to receive it in July, yet the AstraZeneca press release says they are injecting 30,000 in US with the Oxford vaccine. To be fair however Trump has said they will manufacture several vaccines on the basis 1 will work. 1 Share this post Link to post Share on other sites
Well b back 3,199 Posted June 5, 2020 28 minutes ago, Mark .Y. said: With Share this post Link to post Share on other sites
Well b back 3,199 Posted June 5, 2020 With AstraZeneca making the headlines at the moment this will be worth a watch. :: AstraZeneca chief executive Pascal Soriot will be on Ian King Live on Sky News at 9.30am, Friday 5 June Share this post Link to post Share on other sites
Well b back 3,199 Posted June 5, 2020 Wow don’t know if anyone else just watched the interview with AstraZeneca on Sky but here were the bullet points I can remember * 50,000 to be given vaccine for testing in hotspots in U.K., US, Brazil and Kenya * Confident they will know results by August * They are speaking to all the major regulators throughout the world so this can be approved straight away and not have to wait for regulators * They will have hundreds of millions of doses ready by September * They could have enough doses for the world by the end of the year * can’t commit as to wether the vaccine will 100% work but said everything so far looks good but they need people still catching it to prove it works. Why the likes of BBC are not interviewing this guy I have no idea. Maybe they prefer negative news. This thread should now be renamed ‘ Come on Sarah and Pascal ‘ ( Pascal being CEO of AstraZeneca ) one last shout out this is for Bill Gates who is giving billions for 3rd world Countries to get the vaccine. In view of what he has already done should this guy not be being put forward as a Saint. Have a good day everyone 2 1 Share this post Link to post Share on other sites
Mark .Y. 352 Posted June 5, 2020 31 minutes ago, Well b back said: Wow don’t know if anyone else just watched the interview with AstraZeneca on Sky but here were the bullet points I can remember * 50,000 to be given vaccine for testing in hotspots in U.K., US, Brazil and Kenya * Confident they will know results by August * They are speaking to all the major regulators throughout the world so this can be approved straight away and not have to wait for regulators * They will have hundreds of millions of doses ready by September * They could have enough doses for the world by the end of the year * can’t commit as to wether the vaccine will 100% work but said everything so far looks good but they need people still catching it to prove it works. Why the likes of BBC are not interviewing this guy I have no idea. Maybe they prefer negative news. This thread should now be renamed ‘ Come on Sarah and Pascal ‘ ( Pascal being CEO of AstraZeneca ) one last shout out this is for Bill Gates who is giving billions for 3rd world Countries to get the vaccine. In view of what he has already done should this guy not be being put forward as a Saint. Have a good day everyone That sounds like great news. Brazil should really prove to be the "acid test" shouldn't it. Hopefully they have enough of the correctly qualified people available to ensure the tests are run correctly. And yes, you would think they would have a very good idea of the efficacy of the vaccine by August, not sure how long they would "normally" allow for any side/adverse effects to be seen though ?? Sadly, I have lost a lot of faith in the BBC recently, I grew up in a time when they were viewed as the leading news reporters in the world (not sure whether they were or not, was just the way it seemed) but I think they have stumbled badly over the last few years, and maybe longer. And good for Bill Gates, shows not all Americans are brainless morons (but working for a US company, I already knew that), he has put a lot into malaria prevention too. Share this post Link to post Share on other sites
Barbe bleu 822 Posted June 5, 2020 The report above is that the UK have ordered 100 million doses and the US 300million. That's either too much for us or far to little for them. I wonder what the thinking is here? Share this post Link to post Share on other sites
Van wink 2,994 Posted June 5, 2020 2 minutes ago, Barbe bleu said: The report above is that the UK have ordered 100 million doses and the US 300million. That's either too much for us or far to little for them. I wonder what the thinking is here? I would like to think we would be supplying vaccine to third world countries Share this post Link to post Share on other sites
Barbe bleu 822 Posted June 5, 2020 2 hours ago, Mark .Y. said: That sounds like great news. Brazil should really prove to be the "acid test" shouldn't it. Hopefully they have enough of the correctly qualified people available to ensure the tests are run correctly. And yes, you would think they would have a very good idea of the efficacy of the vaccine by August, not sure how long they would "normally" allow for any side/adverse effects to be seen though ?? Brazil figures looking awful. (Reported) 1000-1500 deaths daily and the infection rate is climbing. Growing throughout south America. If the vaccine is ready for production by august it will be utterly incredible and maybe timely for the whole of this continent. Share this post Link to post Share on other sites
