China is ahead of the vaccine race.

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China's COVID-19 complex to produce over 100M vaccine

Workshop complex in Wuhan to produce over 100 million doses of coronavirus vaccine annually, says official

Islamuddin Sajid   |03.07.2020

    

ANKARA

China has completed the construction of a research laboratory and workshop complex in the city of Wuhan for producing vaccines to combat COVID-19 or coronavirus pandemic, the state-run media said on Friday.

While the laboratory is capable to research and study pathogenic virus vaccines, the workshop will produce over 100 million doses of the COVID-19 vaccine annually, reported Xinhua news agency, quoting the China National Pharmaceutical Group (Sinopharm).

The complex was earlier hit by the coronavirus pandemic, which first emerged in Wuhan city located in Central China’s Hubei province last December.

China National Biotec Group has also built another workshop in the capital Beijing which will also produce the anti-COVID-19 vaccines.

"The total annual production capacity of inactivated COVID-19 vaccines is expected to exceed 200 million doses, which will help ensure adequate supply,” the report cited Yang Xiaoming, president of the group, as saying.

Wuhan Institute of Biological Products had started the clinical trials of the vaccine to combat COVID-19 in April. So far it has been tested on 1,120 volunteers, aged between 18-59.

The report claimed, citing no officials, that the results of the trails "showed a good safety record" as "no severe adverse reactions were found."

It noted that the vaccine receivers "were inoculated two injections under different procedures and doses."

"For those receiving two injections at an interval of 28 days, the seroconversion rate of neutralizing antibodies reached 100 percent," claimed the repot.

According to China's National Health Commission, the country reported five new cases, including three imported and two indigenous, both from capital Beijing as the city has seen another wave of infections since the second week of June.

China so far recorded 83,542 pandemic cases with 4,634 deaths. As many as 78,499 people have recovered.

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WHAT I HAVE LEARNED SO FAR.

TESTING AND FAST CONTACT TRACING.

 The Corona virus otherwise known as Covid-19 or SARS-Cov-2 has killed thousands around the world and here in Quebec, because of ignorance and fear, 5600 of our most vulnerable and elderly citizens have fallen to the virus.
 What I have learned so far is that Canada and especially Quebec, need a much faster testing and contact tracing system with an immediate no exceptions lock-down. We need a fast and effective virus tracing detective agency ready to jump the moment a deadly virus is found in a hospital anywhere in Canada. That is the number 1 response all governments around the world must have in face of dangerous epidemics and pandemics created by a changing climate. Of course we could try to change our polluting behaviors in order to slow down climate change and make the environment less hospitable to bacteria and viruses, but that would be like beating a dead Mule. Today's stubborn profit oriented polluters are unlikely to wake up and change direction any time soon. A Green world economy has yet to be created.

  I have also learned that money from our Canadian health care system has been reduced over the years. We can no longer be proud of our "fine" health care system because it has been allowed to shrink into a mix of commercial privatization and government bureaucracy. Unfortunately, the government controlled part of our medicare system was hardest hit by the virus and with most of our vulnerable and elderly people the victims of fear and neglect. 
 Why am I angry! Years ago I wrote a story about a wonderful lady who died under the care of a C.H.S.L.D. A government controlled elder home.  Before the SARS-CoV-2 hit Canada, I realized how badly the conditions were in our elder care homes. Mrs Squires was my 100 year old friend who was left alone and miserable in her final days of life. After her death I wrote to the Canadian government to do something to alleviate the misery of all our elders forced by poverty into these so called "homes" but the government did nothing! Maybe now our politicians will change their attitudes and bring back a world class Medicare system which will again make us proud to live in this place we call Canada. 
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 News about the virus vaccine.
 There is a good chance a vaccine will be developed within Seven months. I hope the vaccine is both effective and the distribution not a problem!
 N.J. Raglione                  

Vaccine candidates advancing slowly. Seven months more before test results.

 PDF version

The genetic sequence of SARS-CoV-2, the coronavirus that causes COVID-19, was published on 11 January 2020, triggering intense global R&D activity to develop a vaccine against the disease. The scale of the humanitarian and economic impact of the COVID-19 pandemic is driving evaluation of next-generation vaccine technology platforms through novel paradigms to accelerate development, and the first COVID-19 vaccine candidate entered human clinical testing with unprecedented rapidity on 16 March 2020.

The Coalition for Epidemic Preparedness Innovations (CEPI) is working with global health authorities and vaccine developers to support the development of vaccines against COVID-19. To facilitate this effort, we have developed and are continuously maintaining an overview of the global landscape of COVID-19 vaccine development activity. Our landscape database includes vaccine development programmes reported through the WHO’s authoritative and continually updated list, along with other projects identified from publicly available and proprietary sources (see Supplementary Box 1). The landscape provides insights into key characteristics of COVID-19 vaccine R&D and serves as a resource for ongoing portfolio management at CEPI. We have also shared our landscape information with others in the global health ecosystem to help improve coordination in the COVID-19 outbreak response and enable global resources and capabilities to be directed towards the most promising vaccine candidates.

COVID-19 vaccine R&D landscape

As of 8 April 2020, the global COVID-19 vaccine R&D landscape includes 115 vaccine candidates (Fig. 1), of which 78 are confirmed as active and 37 are unconfirmed (development status cannot be determined from publicly available or proprietary information sources). Of the 78 confirmed active projects, 73 are currently at exploratory or preclinical stages. The most advanced candidates have recently moved into clinical development, including mRNA-1273 from Moderna, Ad5-nCoV from CanSino Biologicals, INO-4800 from Inovio, and LV-SMENP-DC and pathogen-specific aAPC from Shenzhen Geno-Immune Medical Institute (Table 1). Numerous other vaccine developers have indicated plans to initiate human testing in 2020.
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Investigational vaccine protects monkeys against COVID-19 pneumonia

by National Institutes of Health

Credit: CC0 Public Domain

A single dose of ChAdOx1 nCoV-19, an investigational vaccine against SARS-CoV-2, has protected six rhesus macaques from pneumonia caused by the virus, according to National Institutes of Health scientists and University of Oxford collaborators. SARS-CoV-2 is the virus that causes COVID-19. The researchers posted their data to the preprint server bioRxiv. The findings are not yet peer-reviewed but are being shared to assist the public health response to COVID-19. Based on these data, a Phase 1 trial of the candidate vaccine began on April 23 in healthy volunteers in the United Kingdom.

BAD NEWS!! VACCINES ARE NOT AROUND THE CORNER!

"Vaccine technology has significantly evolved in the last decade, including the development of several RNA and DNA vaccine candidates, licensed vectored vaccines (e.g., Ervebo, a vesicular stomatitis virus [VSV]-vectored ebolavirus vaccine, licensed in the European Union), recombinant protein vaccines (e.g., Flublok, an influenza virus vaccine made in insect cells, licensed in the United States), and cell-culture-based vaccines (e.g., Flucelvax, an influenza virus vaccine made in mammalian cells). SARS-CoV-2 was identified in record time, and its genomic sequence was swiftly made widely available by Chinese researchers (Wu et al., 2020, Zhou et al., 2020, Zhu et al., 2020). In addition, we know from studies on SARS-CoV-1 and the related MERS-CoV vaccines that the S protein on the surface of the virus is an ideal target for a vaccine. In SARS-CoV-1 and SARS-CoV-2, this protein interacts with the receptor ACE2, and antibodies targeting the spike can interfere with this binding, thereby neutralizing the virus (Figure 1). The structure of the S protein of SARS-CoV-2 was solved in record time at high resolution, contributing to our understanding of this vaccine target (Lan et al., 2020a, Wrapp et al., 2020). Therefore, we have a target antigen that can be incorporated into advanced vaccine platforms.

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Figure 1. Overview of Potential SARS-CoV-2 Vaccine Platforms

The structure of a coronavirus particle is depicted on the left, with the different viral proteins indicated. The S protein is the major target for vaccine development. The spike structure shown is based on the trimeric SARS-CoV-1 spike (PDB: 5XL3). One trimer is shown in dark blue, and the receptor binding domain, a main target of neutralizing antibodies, is highlighted in purple. The other two trimers are shown in light blue. SARS-CoV-2 vaccine candidates based on different vaccine platforms have been developed, and for some of them, pre-clinical experiments have been initiated. For one mRNA-based candidate, a clinical trial recently started to enroll volunteers shortly (ClinicalTrials.gov: NCT04283461). However, many additional steps are needed before these vaccines can be used in the population, and this process might take months, if not years. 1For some candidates, cGMP processes have already been established. 2Clinical trial design might be altered to move vaccines through clinical testing quicker.

Several vaccines for SARS-CoV-1 were developed and tested in animal models, including recombinant S-protein-based vaccines, attenuated and whole inactivated vaccines, and vectored vaccines (Roper and Rehm, 2009). Most of these vaccines protect animals from challenge with SARS-CoV-1, although many do not induce sterilizing immunity. In some cases, vaccination with the live virus results in complications, including lung damage and infiltration of eosinophils in a mouse model (e.g., Bolles et al., 2011, Tseng et al., 2012) and liver damage in ferrets (e.g., Weingartl et al., 2004). In another study, vaccination with inactivated SARS-CoV-1 led to enhancement of disease in one NHP, whereas it protected 3 animals from challenge (Wang et al., 2016). The same study identified certain epitopes on the S protein as protective, whereas immunity to others seemed to be enhancing disease. However, in almost all cases, vaccination is associated with greater survival, reduced virus titers, and/or less morbidity compared with that in unvaccinated animals. Similar findings have been reported for MERS-CoV vaccines (Agrawal et al., 2016, Houser et al., 2017). Therefore, whereas vaccines for related coronaviruses are efficacious in animal models, we need to ensure that the vaccines, which are developed for SARS-CoV-2, are sufficiently safe.

Another consideration for effective coronavirus vaccine development might be waning of the antibody response. Infection with human coronaviruses does not always induce long-lived antibody responses, and re-infection of an individual with the same virus is possible after an extended period of time (but only in a fraction of individuals and resulting in mild or no symtpoms), as shown in human challenge studies (Callow et al., 1990). Antibody titers in individuals that survived SARS-CoV-1 or MERS-CoV infections often waned after 2–3 years (Liu et al., 2006, Wu et al., 2007) or were weak initially (Choe et al., 2017). Despite that, re-infections are unlikely in the short term. Of note, re-infections after days of recovery have been reported recently but appear to be the consequences of false negative test results (Lan et al., 2020b). However, they could happen when humoral immunity wanes over months and years. An effective SARS-CoV-2 vaccine will need to overcome these issues to protect in a scenario in which the virus becomes endemic and causes recurrent seasonal epidemics.

SARS-CoV-2 infection causes the most severe pathology in individuals above 50 years of age. The reason for this is not clear, but many viral infections have milder manifestations in naive younger individuals than in naive older individuals. Because older individuals are more affected, it will be important to develop vaccines that protect this segment of the population. Unfortunately, older individuals typically respond less well to vaccination because of immune senescence (Sambhara and McElhaney, 2009). For influenza, which is problematic for older adults, specific formulations for this segment of the population include more antigen or an adjuvant (DiazGranados et al., 2013, Tsai, 2013). Protection in older individuals appears to require higher neutralization titers against influenza virus than in younger individuals (Benoit et al., 2015), and this issue might need to be addressed for SARS-CoV-2. If vaccination in older individuals is not effective, they could still benefit indirectly if vaccination is able to stop transmission of the virus in younger individuals.

Only a small number of SARS-CoV-1 vaccines made it to phase I clinical trials before funding dried up because of eradication of the virus from the human population through non-pharmaceutical interventions when case numbers were still small. Results from these trials, performed with an inactivated virus vaccine and a spike-based DNA vaccine, are encouraging because the vaccines were safe and induced neutralizing antibody titers (Lin et al., 2007, Martin et al., 2008). Some neutralizing monoclonal antibodies isolated against SARS-CoV-1, like CR3022 (ter Meulen et al., 2006, Tian et al., 2020), can cross-react to the receptor binding domain of SARS-CoV-2. This suggests that SARS-CoV-1 vaccines might cross-protect against SARS-CoV-2. However, because these vaccines have not been developed further than phase I, they are currently not available for use. Vaccines against MERS-CoV, also targeting the MERS-CoV S protein, are in pre-clinical and clinical development, including vaccines based on modified vaccinia Ankara vectors, adenovirus vectors, and DNA-based vaccines, and several of them are supported by the Coalition for Epidemic Preparedness Innovation (CEPI) (Yong et al., 2019). However, it is unlikely that MERS-CoV vaccines induce strong cross-neutralizing antibodies to SARS-CoV-2 because of the phylogenetic distance between the two viruses. Nevertheless, we can still learn a lot from these vaccines about how to move forward with SARS-CoV-2 vaccine design (Pallesen et al., 2017).

The Current Pipeline for SARS-CoV-2 Vaccines

The development of vaccines for human use can take years, especially when novel technologies are used that have not been extensively tested for safety or scaled up for mass production. Because no coronavirus vaccines are on the market and no large-scale manufacturing capacity for these vaccines exists as yet (Table 1), we will need to build these processes and capacities. Doing this for the first time can be tedious and time consuming (Figure 1). CEPI has awarded funds to several highly innovative players in the field, and many of them will likely succeed in eventually making a SARS-CoV-2 vaccine. However, none of these companies and institutions have an established pipeline to bring such a vaccine to late-stage clinical trials that allow licensure by regulatory agencies, and they do not currently have the capacity to produce the number of doses needed. An mRNA-based vaccine, which expresses target antigen in vivo in the vaccinee after injection of mRNA encapsulated in lipid nanoparticles, co-developed by Moderna and the Vaccine Research Center at the National Institutes of Health, is currently the furthest along, and a phase I clinical trial recently started (ClinicalTrials.gov: NCT04283461). Curevac is working on a similar vaccine but is still in the pre-clinical phase. Additional approaches in the pre-clinical stage include recombinant-protein-based vaccines (focused on the S protein, e.g., ExpresS2ion, iBio, Novavax, Baylor College of Medicine, University of Queensland, and Sichuan Clover Biopharmaceuticals), viral-vector-based vaccines (focused on the S protein, e.g., Vaxart, Geovax, University of Oxford, and Cansino Biologics), DNA vaccines (focused on the S protein, e.g., Inovio and Applied DNA Sciences), live attenuated vaccines (Codagenix with the Serum Institute of India, etc.), and inactivated virus vaccines (Figure 1; Table 1). All of these platforms have advantages and disadvantages (Table 1), and it is not possible to predict which strategy will be faster or more successful. Johnson & Johnson (J&J) (Johnson & Johnson, 2020) and Sanofi (2020) recently joined efforts to develop SARS-CoV-2 vaccines. However, J&J is using an experimental adenovirus vector platform that has not yet resulted in a licensed vaccine. Sanofi’s vaccine, to be made using a process similar to the process used for their approved Flublok recombinant influenza virus vaccine (Zhou et al., 2006), is also months, if not years, from being ready for use in the human population."

ACE2 CAN INHIBIT SARS-CoV-2 infections.

Volume 181, Issue 4, 14 May 2020, Pages 905-913.e7

Article

Inhibition of SARS-CoV-2 Infections in Engineered Human Tissues Using Clinical-Grade Soluble Human ACE2

Author links open overlay panelVanessaMonteil1HyesooKwon2PatriciaPrado3AstridHagelkrüys4Reiner A.Wimmer4MartinStahl5AlexandraLeopoldi4ElenaGarreta3CarmenHurtado del Pozo3FelipeProsper6Juan PabloRomero6GeraldWirnsberger7HaiboZhang8Arthur S.Slutsky8RyanConder5NuriaMontserrat3910AliMirazimi12Josef M.Penninger41112

https://doi.org/10.1016/j.cell.2020.04.004Get rights and content

open access

Highlights

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Soluble human ACE2 can inhibit SARS-CoV-2 infections

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SARS-CoV-2 can directly infect human blood vessel and kidney organoids

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Human organoids as model systems to study SARS-CoV-2 infections/COVID-19

Summary

We have previously provided the first genetic evidence that angiotensin converting enzyme 2 (ACE2) is the critical receptor for severe acute respiratory syndrome coronavirus (SARS-CoV), and ACE2 protects the lung from injury, providing a molecular explanation for the severe lung failure and death due to SARS-CoV infections. ACE2 has now also been identified as a key receptor for SARS-CoV-2 infections, and it has been proposed that inhibiting this interaction might be used in treating patients with COVID-19. However, it is not known whether human recombinant soluble ACE2 (hrsACE2) blocks growth of SARS-CoV-2. Here, we show that clinical grade hrsACE2 reduced SARS-CoV-2 recovery from Vero cells by a factor of 1,000–5,000. An equivalent mouse rsACE2 had no effect. We also show that SARS-CoV-2 can directly infect engineered human blood vessel organoids and human kidney organoids, which can be inhibited by hrsACE2. These data demonstrate that hrsACE2 can significantly block early stages of SARS-CoV-2 infections.

Graphical Abstract

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DEXAMETHASONE? First drug shown to reduce Covid-19 deaths.

 (Editors note: The Chinese used Potassium ions.)

The steroid dexamethasone is the first drug shown to reduce COVID-19 deaths.

Dexamethasone, a steroid in use for decades, reduced deaths of COVID-19 patients on ventilators by about a third compared with standard care, researchers reported in a news release June 16. Deaths of COVID-19 patients on supplemental oxygen were reduced by about 20 percent.

If the results hold up to scrutiny once scientists have a chance to review the full data, the drug would be the first to reduce the risk of death from the disease, Tina Hesman Saey reports.

Although the results are important for treating the sickest patients with COVID-19, those patients represent only about 5 percent of people diagnosed with the coronavirus, says Rajesh Gandhi, an infectious diseases doctor at Massachusetts General Hospital and Harvard Medical School in Boston, who wasn’t involved in the new research. “It’s not steroids for all.”  Read more
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MAY 18, 2020

Investigational vaccine protects monkeys against COVID-19 pneumonia

by National Institutes of Health

Credit: CC0 Public Domain

A single dose of ChAdOx1 nCoV-19, an investigational vaccine against SARS-CoV-2, has protected six rhesus macaques from pneumonia caused by the virus, according to National Institutes of Health scientists and University of Oxford collaborators. SARS-CoV-2 is the virus that causes COVID-19. The researchers posted their data to the preprint server bioRxiv. The findings are not yet peer-reviewed but are being shared to assist the public health response to COVID-19. Based on these data, a Phase 1 trial of the candidate vaccine began on April 23 in healthy volunteers in the United Kingdom.