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Blood clotting in every organ found inside Covid-19 victims.
Gentle people: Apparently SARScoV-2 can travel undetected into every cell and into every organ of our bodies. Blood clots within every organ have been found inside dead Covid-19 victims. Blood clots have been located inside every organ and I presume that would include the brain. When blood clots are created inside the brain, patients often die.
One important question is what is causing the blood clots? Does the body's immune system attack any area where the SARS Cov-2 finally shows itself, thus creating a blood clot?
Megakaryocytes produce large bone marrow platelet cells. Platelets are implicated in the production of blood clots. Two important questions are 1. How does SARSCoV-2 infect megakaryocytes, and 2. How are large platelet cells stimulated to create blood clots outside the bone marrow? ------------------------------------------------------------------
(CNN)Autopsies on people who died of the coronavirus are helping doctors understand how the disease affects the body -- and one of the most remarkable findings concerned blood clotting, a pathologist says.
Dr. Amy Rapkiewicz, the chairman of the department of pathology at NYU Langone Medical Center, spoke to Erin Burnett on OutFront Thursday night.
Some Covid-19 patients are known to develop blood clotting issues, but the degree and the extent to which that occurs was described as "dramatic" by Rapkiewicz.
In the early stages of the pandemic, bedside clinicians noticed a lot of blood clotting "in lines and various large vessels," she said.
"What we saw at autopsy was sort of an extension of that," she said. "The clotting was not only in the large vessels but also in the smaller vessels.
"And this was dramatic, because though we might have expected it in the lungs, we found it in almost every organ that we looked at in our autopsy study," she said. Rapkiewicz's study outlining her findings was published at the end of June in The Lancet journal EClinicalMedicine.
The autopsies also showed something unusual about megakaryocytes, or large bone marrow cells. They usually don't circulate outside the bones and lungs, Rapkiewicz said.
"We found them in the heart and the kidneys and the liver and other organs," she said. "Notably in the heart, megakaryocytes produce something called platelets that are intimately involved in blood clotting."
Researchers hope to discover how these cells influence small vessel clotting in Covid-19, she said.
Pathologists have been surprised by something they didn't find.
During early stages of the pandemic, doctors thought the virus would provoke inflammation in the heart with myocarditis, she said.
But autopsies have found a very low incidents of myocarditis, Rapkiewicz said.
She said that one of the "opportunities -- if there is one to count in the virus" is that pathologists have had a chance to examine the organs of many Covid-19 victims and investigate the disease processes that take place. She said that opportunity really wasn't available with H1N1 or the original SARS outbreak.
Researchers around the world are developing more than 155 vaccines against the coronavirus, and 22 vaccines are in human trials. Vaccines typically require years of research and testing before reaching the clinic, but scientists are racing to produce a safe and effective vaccine by next year.
Antibody
produced in
response to a
vaccine
SARS-CoV-2
coronavirus
Work began in January with the deciphering of the SARS-CoV-2 genome. The first vaccine safety trials in humans started in March, but the road ahead remains uncertain. Some trials will fail, and others may end without a clear result. But a few may succeed in stimulating the immune system to produce effective antibodies against the virus.
Here is the status of all the vaccines that have reached trials in humans, along with a selection of promising vaccines still being tested in cells or animals.
The development cycle of a vaccine, from lab to clinic.
PRECLINICAL TESTING: Scientists give the vaccine to animals such as mice or monkeys to see if it produces an immune response.
PHASE I SAFETY TRIALS: Scientists give the vaccine to a small number of people to test safety and dosage as well as to confirm that it stimulates the immune system.
PHASE II EXPANDED TRIALS: Scientists give the vaccine to hundreds of people split into groups, such as children and the elderly, to see if the vaccine acts differently in them. These trials further test the vaccine’s safety and ability to stimulate the immune system.
PHASE III EFFICACY TRIALS: Scientists give the vaccine to thousands of people and wait to see how many become infected, compared with volunteers who received a placebo. These trials can determine if the vaccine protects against the coronavirus.
APPROVAL: Regulators in each country review the trial results and decide whether to approve the vaccine or not. During a pandemic, a vaccine may receive emergency use authorization before getting formal approval.
WARP SPEED: The U.S. government’s Operation Warp Speed program is expected to name five or more vaccine projects to receive billions of dollars in federal funding before there’s proof that the vaccines work. We will update the tracker and label the Warp Speed projects when there is an official announcement.
COMBINED PHASES: Another way to accelerate vaccine development is to combine phases. Some coronavirus vaccines are now in Phase I/II trials, for example, in which they are tested for the first time on hundreds of people. (Note that our tracker would count a combined Phase I/II trial as both Phase I and Phase II.)
Filter the list of vaccines:
Genetic Vaccines
Vaccines that use one or more of the coronavirus’s own genes to provoke an immune response.
DNA
RNA
PHASE II Moderna’s vaccine dazzled the stock market in May with Phase I data on just eight people, only to see its stock price drop when experts had a lukewarm reaction to the results. The vaccine uses messenger RNA (mRNA for short) to produce viral proteins. The American company is eyeing Phase III trials in July and hopes to have vaccine doses ready by early 2021.
PHASE IPHASE II The German company BioNTech has entered into collaborations with Pfizer, based in New York, and the Chinese drug maker Fosun Pharma to develop their mRNA vaccine. On July 1, they announced that all the volunteers for their Phase I/II trial produced antibodies against SARS-CoV-2, while some experienced moderate side effects such as sleep disturbances and sore arms. In an interview, Pfizer’s CEO said that he hoped his company could begin delivering vaccines in October, providing hundreds of millions of doses by the end of 2020, and then up to a billion by the end of 2021.
PHASE IPHASE II Imperial College London researchers have developed a “self-amplifying” RNA vaccine, which boosts production of a viral protein to stimulate the immune system. They began Phase I/II trials on June 15 and have partnered with Morningside Ventures to manufacture and distribute the vaccine through a new company called VacEquity Global Health. The researchers expect to know if the vaccine is effective by the end of the year.
PHASE IPHASE II Indian vaccine-maker Zydus Cadila has created a DNA-based vaccine. On July 3 they announced approval to start human trials, becoming the second company in India to enter the Covid-19 vaccine race after Bharat Biotech.
PHASE IPHASE II On June 30, the Japanese biotechnology company AnGesannounced they had started safety trials on a DNA-based vaccine, developed in partnership with Osaka University and Takara Bio.
PHASE I On June 30, the American company Inovioannounced they had interim Phase I data on their DNA-based vaccine. They found no serious adverse effects, and measured an immune response in 34 out of 36 volunteers. They plan to start Phase II/III trials this summer.
PHASE I In March, the Trump administration unsuccessfully tried to entice CureVac to move its research from Germany to the United States. In June, the company launched Phase I trials of its mRNA vaccine. The company said its German facility can make hundreds of millions of vaccine doses a year.
PHASE I The Korean company Genexine started testing the safety of a DNA-based vaccine in June. They anticipate moving to Phase II trials in the fall.
PHASE I In June, Chinese researchers at the Academy of Military Medical Sciences, Suzhou Abogen Biosciences and Walvax Biotechnology announced they would start their country’s first safety trials on a mRNA-based vaccine, called ARCoV. Earlier studies on monkeys reportedly showed protective effects.
PRECLINICAL The French pharmaceutical company Sanofi is developing an mRNA vaccine in partnership with Translate Bio. On June 23, they announced they were planning Phase I trials in the fall.
Viral Vector Vaccines
Vaccines that use a virus to deliver coronavirus genes into cells and provoke an immune response.
PHASE IIPHASE III A vaccine in development by the British-Swedish company AstraZeneca and the University of Oxford is based on a chimpanzee adenovirus called ChAdOx1. The vaccine is in a Phase II/III trial in England and Phase III trials in Brazil and South Africa. The project may deliver emergency vaccines by October. In June, AstraZeneca said their total manufacturing capacity stands at two billion doses.
PHASE IILIMITED APPROVAL The Chinese company CanSino Biologics developed a vaccine based on an adenovirus called Ad5, in partnership with the Institute of Biology at the country’s Academy of Military Medical Sciences. In May, they published promising results from a Phase I safety trial. Unpublished data from Phase II trials demonstrated the vaccine produced a strong immune response, leading the Chinese military to approve it on June 25 for a year as a “specially needed drug.” CanSino would not say whether vaccination would be mandatory or optional for soldiers.
PHASE I The Gamaleya Research Institute, part of Russia’s Ministry of Health, launched a Phase I trial in June of a vaccine they call Gam-Covid-Vac Lyo. It is a combination of two adenoviruses, Ad5 and Ad26, both engineered with a coronavirus gene.
PRECLINICAL Researchers at Beth Israel Deaconess Medical Center in Boston are testing an adenovirus called Ad26 in monkeys. Johnson & Johnson announced in June that they would start Phase I/II trials in late July.
PRECLINICAL The Swiss company Novartis will manufacture a vaccine based on a gene therapy treatment developed by the Massachusetts Eye and Ear Hospital. A virus called an adeno-associated virus delivers coronavirus gene fragments into cells. Phase I trials are set to begin in late 2020.
PRECLINICAL The American company Merck announced in May it would develop a vaccine from vesicular stomatitis viruses, the same approach it successfully used to produce the only approved vaccine for Ebola. The company is partnering with IAVI.
PRECLINICAL Merck is also working with Themis Bioscience, an Austrian firm it is acquiring, to develop a second vaccine, which will use the measles virus to carry genetic material into patients’ cells.
PRECLINICAL Vaxart’s vaccine is an oral tablet containing an adenovirus that delivers coronavirus genes. They are preparing for Phase I trials this summer.
Protein-Based Vaccines
Vaccines that use a coronavirus protein or a protein fragment to provoke an immune response.
PHASE II In July, the Chinese company Anhui Zhifei Longcom began Phase II trials for a vaccine that is a combination of viral proteins and an adjuvant that stimulates the immune system. The company is part of Chongqing Zhifei Biological Products and has partnered with the Chinese Academy of Medical Sciences.
PHASE IPHASE II Maryland-based Novavax has developed a way to stick proteins onto microscopic particles. They’ve created vaccines for a number of different diseases using this platform, and their flu vaccine finished Phase III trials in March. The company launched trials for a Covid-19 vaccine in May, and the Coalition for Epidemic Preparedness Innovations has invested $384 million in the vaccine. On July 6, Novavax announced a U.S. government award of $1.6 billion to support clinical trials and manufacturing. If the trials succeed, Novavax expects to deliver 100 million doses for use in the United States by the first quarter of 2021. Plants in Europe and Asia would be able to satisfy more of the world’s demand.
PHASE I Clover Biopharmaceuticals has developed a vaccine containing a protein from coronaviruses. To further stimulate the immune system, the vaccine is being given in conjunction with so-called adjuvants made by British drugmaker GSK and the American company Dynavax. Investments from CEPI will support the development of manufacturing that could lead to the production of hundreds of millions of doses a year.
PHASE I The Australian company Vaxine launched a Phase I trial in July. Their vaccine combines viral proteins with an adjuvant that stimulates immune cells.
PHASE I Canada-based Medicago uses plants to make vaccines. They inject genes into leaves, causing the plant cells to create protein shells that mimic viruses. In July, Medicago announced they would begin Phase I trials on a plant-based Covid-19 vaccine in combination with adjuvants from drug makers GSK and Dynavax.
PRECLINICAL After the SARS epidemic in 2002, Baylor College of Medicine researchers began developing a vaccine that could prevent a new outbreak. Despite promising early results, support for the research disappeared. Because the coronaviruses that cause SARS and Covid-19 are very similar, the researchers are reviving the project in partnership with the Texas Children’s Hospital.
PRECLINICAL A vaccine in development by the University of Pittsburgh, called PittCoVacc, is a skin patch tipped with 400 tiny needles made of sugar. When placed on the skin, the needles dissolve and deliver virus proteins into the body.
PRECLINICAL A vaccine from Australia’s University of Queensland delivers viral proteins altered to draw a stronger immune response. In June, the university and the company CSL announced a partnership to start Phase I trials, which could lead to millions of doses a year starting in 2021. GSK is providing an adjuvant to further stimulate the immune system.
PRECLINICAL In addition to their mRNA vaccine, Sanofi is developing a vaccine based on viral proteins. They are producing the proteins with engineered viruses that grow inside insect cells. GSK will supplement these proteins with adjuvants that stimulate the immune system. Sanofi has said it could produce at least 600 million doses a year if the vaccine succeeds in trials.
Whole-Virus Vaccines
Vaccines that use a weakened or inactivated version of the coronavirus to provoke an immune response.
Inactivated
virus
PHASE III After promising early testing, the state-owned Chinese company Sinopharmannounced in June that it would be moving into Phase III trials. They reached an agreement with the United Arab Emirates to start testing the efficacy of an inactivated virus vaccine in the Gulf state.
PHASE III The private Chinese company Sinovac Biotech is testing an inactivated vaccine called CoronaVac. In June the company announced that Phase I/II trials on 743 volunteers found no severe adverse effects and produced an immune response. Sinovac then launched a Phase III trial in Brazil in July. The company is also building a facility to manufacture up to 100 million doses annually.
PHASE II Researchers at the Institute of Medical Biology at the Chinese Academy of Medical Sciences, which has invented vaccines for polio and hepatitis A, started a Phase II trial of an inactivated virus vaccine in June.
PHASE IPHASE II In collaboration with the Indian Council of Medical Research and the National Institute of Virology, the Indian company Bharat Biotech designed a vaccine called Covaxin. It is an inactivated rabies virus engineered to carry proteins from the coronavirus. Phase I/II trials are scheduled to begin this month. The Indian Council of Medical Research reportedly envisions having the vaccine ready for public use on August 15, but this target has been met with skepticism.
Repurposed Vaccines
Vaccines already in use for other diseases that may also protect against Covid-19.
PHASE III The Bacillus Calmette-Guerin vaccine was developed in the early 1900s as a protection against tuberculosis. The Murdoch Children’s Research Institute in Australia is conducting a Phase III trial, and several other trials are underway to see if the vaccine partly protects against the coronavirus.
Note: Vaccines will be added to the tracker when they reach Phase I, and tracked until they succeed or fail.
Did we miss something? To notify The Times of new developments, send updates to vaccinetracker@nytimes.com.
Tracking the Coronavirus
Additional reporting by Carlos Tejada and Li Cao.
Sources: World Health Organization, National Institute of Allergy and Infectious Diseases, National Center for Biotechnology Information, New England Journal of Medicine
