China company says its vaccine could be complete by 'autumn' It claims its COVID-19 vaccine candidate is proving to be effective on humans. https://abcnews.go.com/Health/china-company-vaccine-complete-autumn/story?id=71328018 A China-based pharmaceutical company claims its COVID-19 vaccine candidate is proving to be safe and effective on humans so far, citing early research. A senior member of the company said the vaccine could finish the last phase of human testing as early as this fall. "The vaccine shows [protection] on animal models -- on monkeys," said Helen Yang, senior director of Investor Relations at Sinovac Biotech Ltd. "Currently, we are conducting the trial on humans and we expect some preliminary data for Phase I and Phase II to be available within this month." Sinovac Biotech is a pharmaceutical company with a history in vaccine development based in Beijing, China. Its vaccine, CoronaVac, is one of at least 11 approved for human testing worldwide, according to the World Health Organization. "We were approved to conduct human trials, including children and senior citizens, but currently the trial is on 18 to 59-year-olds," said Yang. "We are about to start the studies on the (elderly) and then, after that, we will conduct the trial on the younger population." Yang said the company is following the same three-phase testing protocol used in western countries and reports that so far they have tested 144 volunteers in phase I and 600 in phase II. Phase I is a small study in healthy adults to test for safety, whereas phase II is a slightly larger study testing for safety and effectiveness. Phase III is a study conducted on an even larger test group. "The vaccine shows a good safety profile," Yang told ABC News regarding their human trials. "We haven't seen any severe adverse reaction after using our vaccines." Yang said the vaccine could finish phase III of testing by the fall -- the final phase needed for the vaccine's approval in China. Although, Yang cautioned, this timeline is dependent on the vaccine's continued alleged success in human trials. This is the same ambitious timeline being offered by the United States' Operation Warp Speed which has a goal of a safe and effective vaccine available for Americans in January 2021. The U.S. has several vaccine candidates in clinical trials and expects to have more by the end of the summer from a number of companies including Moderna, AstraZenaca/Oxford, Pfizer, Merck and Johnson and Johnson. "Phase III trial needs to take a few months, at least," explained Yang. "After we see the phase II, we will know how much of the antibody level can be induced by the vaccine, and then phase III will tell you if the level of antibodies will provide protection." The U.S. government has said any vaccine candidate it partners with as part of "Operation Warp Speed" would be available in America first and then any surplus may be distributed internationally. It's not clear if China would make any of their vaccines available in the U.S. Dr. Anthony Fauci, the nation's top infectious disease expert, said that regulators in the United States and Europe have the most rigorous safety standards in the world for testing and developing new drugs and vaccines. Fauci was also more cautious about the expectations for a Chinese vaccine. "I certainly don't have as much confidence in what comes out of China than I do which comes out of the United States," Fauci said in an interview with ABC News Chief White House Correspondent Jonathan Karl on "Powerhouse Politics" podcast. "I know from experience that the material that has come out of there has been material that has not been first rate." When asked if their leaps in vaccine development may be because of lax protocols in China, Yang said the company was "developing a vaccine based on the regulations from Chinese authorities." "In general, all the steps and required studies has been fully conducted, but we have a good mechanism that, after we have the data, we can immediately submit it -- so we can have a more quicker review," she added. "But it doesn't mean that we miss any steps or reduce the standards." U.S. government officials recently briefed reporters and said that because Chinese scientists shared the sequence of the COVID-19 virus on January 10, an international effort, including literally overnight in the U.S., for a vaccine was started immediately. When it comes to large phase III trials, vaccines are best studied in places where outbreaks are ongoing to ensure that enough people are exposed to the virus to prove the vaccine actually works. In China, the coronavirus epidemic is largely under control. Sinovac announced this week a plan to conduct a phase III clinical trial in Brazil, where infections are increasing -- a sign that the vaccine could be on track to begin phase III testing soon. Sinovac's vaccine is made by using an "inactivated" version of the virus that mimics an infection at a cellular level but does not make people sick. So-called "whole inactivated" vaccines are tried-and-true, used for decades to make shots against polio, flu and other diseases -- giving the body a sneak peek at the germ itself-- but growing the virus is difficult and requires lab precautions. Yang would not say with any assurance when CoronaVac could be available to the general public, but the company stands ready to manufacture 100 million doses. With China's population currently standing at nearly 1.4 billion, it's unclear how quickly other countries would have access to the vaccine if it proves successful. "I don't think we'll keep the vaccines for China," Yang told ABC News. "As we are talking to different -- many countries, they're also discussing about doing the trials and then how to secure the using of vaccines to help them."
Fauci ‘cautiously optimistic’ vaccine could be available by end of 2020 or early 2021 https://www.bostonglobe.com/2020/06/23/nation/fauci-testify-fraught-time-us-pandemic-response/ Dr. Anthony Fauci said Tuesday he is cautiously optimistic there will be a COVID-19 vaccine by the end of the year or early 2021, but warned that the next few weeks will be critical to tamping down coronavirus hot spots around the country. Related: The main highlights from Fauci’s testimony before Congress today Fauci and other top health officials also said they have not been asked to slow down testing for coronavirus, a controversial issue after President Trump said last weekend that he had asked them to do just that because it was uncovering too many infections. Trump said earlier in the day that he wasn’t kidding. “We will be doing more testing,” Fauci, the government’s top infectious disease expert, told a House committee. The US has tested more than 27 million people, with about 2.3 million — or 8.4% — testing positive. The health officials returned to Capitol Hill at a fraught moment in the nation’s pandemic response, with coronavirus cases rising in about half the states and political polarization competing for attention with public health recommendations. “We’ve been hit badly,” Fauci said. He said he was “really quite concerned” about rising community spread in some states, including Arizona, which Trump was visiting Tuesday to view construction of a border wall and for a rally at a megachurch. “The next couple of weeks are going to be critical in our ability to address those surges,” he said. Fauci, who heads the National Institute of Allergy and Infectious Diseases, was testifying along with Centers for Disease Control director Dr. Robert Redfield, Federal Drug Administration chief Dr. Stephen Hahn and the head of the US Public Health Service, Adm. Brett Giroir. Since Fauci’s last appearance at a high-profile hearing more than a month ago, the US has begun emerging from weeks of stay-at-home orders and business shutdowns. But it’s being done in an uneven way, with some states far less cautious than others. A trio of states with Republican governors who are bullish on reopening — Arizona, Florida and Texas — are among those seeing worrisome increases in cases. Last week, Vice President Mike Pence published an opinion article in The Wall Street Journal saying the administration’s efforts have strengthened the nation’s ability to counter the virus and should be “a cause for celebration.” Then at his weekend rally in Tulsa, Trump called for slowing testing. White House officials later tried to walk back Trump’s comment, suggesting it wasn’t meant to be taken literally. Rep. Frank Pallone of New Jersey, who chairs the Energy and Commerce Committee, said during Tuesday’s hearing that Trump’s testing comment at the rally “was an extremely reckless action, and unfortunately it continues the president’s pattern of ignoring the advice of his own public health experts.” Trump played down those comments Tuesday, saying under his administration the US is doing more testing than any other country. Fauci has recently warned that the US is still in the first wave of the pandemic and has continued to urge the American public to practice social distancing. And, in a recent ABC News interview, he said political demonstrations such as protests against racial injustice are “risky” to all involved. Asked if that applied to Trump rallies, he said it did. Fauci continues to recognize widespread testing as critical for catching clusters of COVID-19 cases before they turn into full outbreaks in a given community. About 2.3 million Americans have been sickened in the pandemic, and some 120,000 have died, according to data from Johns Hopkins University. Giroir was tapped by the White House to oversee the expansion of coronavirus testing. But he gained notoriety after a whistleblower complaint flagged him for trying to push a malaria drug touted by Trump to treat COVID-19 without conclusive scientific evidence. The FDA has since withdrawn its emergency use authorization for hydroxychloroquine. “There have been a lot of unfortunate missteps in the Trump administration’s response to the COVID-19 pandemic,‘' Pallone said. ‘'As communities across the country ease social distancing guidance and reopen their economies, it is critically important that both the administration and Congress remain focused on containing the spread of the coronavirus and providing the resources and support Americans need during this time of crisis.” There is still no vaccine for COVID-19, and there are no treatments specifically developed for the disease, although the antiviral drug remdesivir has been shown to help some patients, as well as a steroid called dexamethasone, and plasma from patients who have recovered. Earlier this month, Cambridge-based Moderna announced the experimental COVID-19 vaccine it is developing with the US National Institutes of Health was on track to be tested in 30,000 volunteers. Since Fauci last testified, hospital physicians have become more skilled in treating coronavirus patients with the techniques and medications at their disposal. The US continues to ramp up testing, with some 27.5 million Americans, or more than 8% of the population, tested thus far. But most communities still lack enough health workers trained in doing contact tracing, the work of identifying people who have had interactions with an infected person. That could make it more difficult to tamp down emerging outbreaks. The Energy and Commerce Committee has oversight over drugs and vaccines, among other facets of the US health care system. Committee Democrats have been harshly critical of the administration. However, not all Republicans have lined up to defend the White House. Some GOP members were growing concerned early in the year that the administration wasn’t doing enough to prepare.
What a Liberty!! Coronavirus cases are rising in all states. The Left really has no clue how to interpret data. GWB is one of the worst.
Brazil tests COVID shot, without deal to use it if it works https://www.cbs17.com/news/brazil-tests-covid-shot-without-deal-to-use-it-if-it-works/ Brazil is testing an experimental COVID-19 vaccine, but interim Health Minister Eduardo Pazuello acknowledged on Tuesday that his government has yet to strike a deal to get it if it works. Other nations have already secured hundreds of millions of doses of the shot created by Oxford University. The country’s coronavirus response has faced criticism since March, when President Jair Bolsonaro started defying social distancing recommendations. Hours before Brazil’s health minister spoke at congress, a judge ordered Bolsonaro to wear a face mask whenever he is outdoors in the capital of Brasilia. Pazuello, an army general who made his career in logistics, discussed Brazil’s efforts to buy a vaccine for COVID-19 or acquire the technology to make it. The country’s health regulator Anvisa approved human clinical trials for the potential vaccine this month. Pazuello said a decision on a deal for Brazil to acquire the planned vaccine is expected by the end of the week, but will depend on the government’s chief of staff. British researchers started testing the experimental shot in May aiming to immunize more than 10,000 people, including older people and children. The vaccine created at Oxford is one of about a dozen in early stages of human testing. Brazil, where the pandemic is still on the rise, is the only country other than the United Kingdom testing that vaccine. The country counts more than 1 million confirmed COVID-19 cases and almost 52,000 fatalities. Clinical trials began in Sao Paulo on Monday and will start in Rio de Janeiro on Wednesday. The British embassy in Brazil says 5,000 health professionals are being vaccinated. “We are working directly with the three most promising (vaccines),” Pazuello said, naming the Oxford shot, the vaccine under development by American company Moderna and one of the Chinese experiments, which he did not disclose. Bolsonaro has been criticized for downplaying his government’s response to the pandemic, comparing the disease to “a little flu.” On May 21, the United States announced a deal for at least 300 million doses of the Oxford shot, and committed up to $1.2 billion to the effort. On June 13, pharmaceutical company AstraZeneca agreed to supply up to 400 million doses of the experimental vaccine to European Union nations. Other negotiations are ongoing with Russia and Japan, among other countries, the company’s CEO said this month. Another experimental vaccine in development by Chinese company Sinovac Biotech will be tested in Brazil in July, according to the Sao Paulo state government. Sinovac has a deal with the state’s Instituto Butantan to produce it. Some 9,000 Brazilians are expected to participate. Earlier Tuesday, a Brazilian federal judge ordered Bolsonaro to comply with local rules to wear a face mask or be fined. In recent weekends, a sometimes unmasked Bolsonaro has joined throngs of people protesting against Brazil’s Congress and Supreme Court and he has visited bakeries and outdoor food stalls, drawing crowds around him. Since the end of April, Brazil’s federal district has required people to wear face masks in public to help control the spread of the new coronavirus. Failure to comply carries a possible daily fine of $390. Judge Renato Coelho Borelli said in his ruling that Bolsonaro “has exposed other people to the contagion of a disease that has caused national commotion.” The Brazilian president did not immediately comment on the decision. An earlier court ruling required him to publish the results of three COVID-19 tests he took early March, and all were negative for the virus. He has not disclosed any tests since then. Bolsonaro sometimes appears in public events with a mask, unlike some other heads of state, including U.S. President Donald Trump, Mexico’s Andrés Manuel López Obrador and Argentina’s Alberto Fernandez, who has often hugged supporters and taken selfies with them while not wearing a mask, although use of a mask is mandatory in Argentina’s capital.
Japan is another example of a nation that nearly eliminated COVID-19 through proper lockdowns and solid public health policy. This leads to their next problem which is the testing of a vaccine and treatments. Japan has curbed the spread of the coronavirus so well within the country that it is facing a shortage of patients for clinical trials https://www.businessinsider.com/jap...d-patient-shortage-for-clinical-trials-2020-6 Japan was successful in containing the spread of the coronavirus within the country, so much so that it is now facing a shortage of patients to enroll in clinical trials. While the epidemic drove Japan's medical system to the brink of collapse in recent months, serious cases now number about 60 nationwide. "Due to the decreasing number of coronavirus infections, we believe it will take some time before clinical research is completed," said Tetsuya Nakamura, who is running a trial of Avigan at Gunma University Hospital in central Japan. With a dearth of domestic patients, Japan may have to rely more on overseas data and results to aid in regulatory approvals. As nations race to develop treatments and vaccines for COVID-19, Japan has become a victim of its own success as slowing new infections has led to a shortage of patients to enroll in clinical trials. Clinical trials are underway for more than a dozen potential vaccines, including at least six in China, but Japan's first human trials are expected to start next month. In development of treatments, Russia and India approved Fujifilm Holdings Corp's Avigan as a COVID-19 therapy, but Japan, whose Prime Minister Shinzo Abe has touted the drug's potential and hoped to approve it in May, won't see a decision until at least July. "Due to the decreasing number of coronavirus infections, we believe it will take some time before clinical research is completed," said Tetsuya Nakamura, who is running a trial of Avigan at Gunma University Hospital in central Japan. "It's a pity that Avigan has been approved overseas but not in Japan." Japan has fared better than most developed nations in tackling the disease that has killed more than 470,000 worldwide. While the epidemic drove Japan's medical system to the brink of collapse in recent months, serious cases now number about 60 nationwide. Some 54 COVID-19 related clinical trials have been launched in Japan, but most are still in the patient recruitment phase, according to trials' tracking data. Interest in Avigan, known generically as favipiravir, soared in March after a Chinese official said it appeared to help patients recover from COVID-19. It is now the subject of at least 25 clinical trials around the world. (More at above url)
Vaccine makers face biggest medical manufacturing challenge in history https://www.reuters.com/article/us-health-coronavirus-vaccines-manufactu-idUSKBN23W1ND Developing a COVID-19 vaccine in record time will be tough. Producing enough to end the pandemic will be the biggest medical manufacturing feat in history. That work is underway. From deploying experts amid global travel restrictions to managing extreme storage conditions, and even inventing new kinds of vials and syringes for billions of doses, the path is strewn with formidable hurdles, according to Reuters interviews with more than a dozen vaccine developers and their backers. Any hitch in an untested supply chain - which could stretch from Pune in India to England’s Oxford and Baltimore in the United States - could torpedo or delay the complex process. Col. Nelson Michael, director of the U.S. Army’s Center for Infectious Disease Research who is working on the government’s “Warp Speed” project to deliver a vaccine at scale by January, said companies usually have years to figure this stuff out. “Now, they have weeks.” Much of the world’s attention is focused on the scientific race to develop a vaccine. But behind the scenes, experts are facing a stark reality: we may simply not have enough capacity to make, package and distribute billions of doses all at once. Companies and governments are racing to scale-up machinery to address a critical shortage in automated filling and finishing capacity - the final step in the manufacturing process of putting the vaccine into vials or syringes, sealing them and packaging them up for shipping. “This is the biggest logistical challenge the world has ever faced,” said Toby Peters, an engineering and technology expert at Britain’s Birmingham university. “We could be looking at vaccinating 60% of the population.” Several developers, including frontrunner Moderna, are experimenting with new ways to mitigate the extreme cold storage demands of their vaccines, which at present need to be kept at minus 80 degrees Celsius (-112 Fahrenheit). SiO2 Materials Science is working on producing vials that won’t shatter at super-cold temperatures. Travel restrictions, meanwhile, are posing more prosaic problems; Johnson & Johnson, which plans to start clinical trials this summer, has struggled to send its vaccine experts to oversee the launch of production sites, for example. ‘NEVER IN HISTORY’ By setting up massive clinical trials involving 10,000 to 30,000 volunteers per vaccine, scientists hope to get an answer on whether a vaccine works as early as this October. But even if they succeed, manufacturing in bulk, getting regulators to sign off and packaging billions of doses is a monumental challenge. Seth Berkley, chief executive of the GAVI vaccines alliance, said in reality, the world is unlikely to go straight from having zero vaccines to having enough doses for everyone. “It’s likely to be a tailored approach to start with,” he said in an interview. “We’re looking to have something like one to two billion doses of vaccine in the first year, spread out over the world population.” J&J has partnered with the U.S. government on a $1 billion investment to speed development and production of its vaccine, even before it’s proven to work. It has contracted Emergent Biosolutions and Catalent to manufacture in bulk in the United States. Catalent will also do some fill-and-finish work. “Never in history has so much vaccine been developed at the same time - so that capacity doesn’t exist,” said Paul Stoffels, J&J’s chief scientific officer, who sees filling capacity as the main limiting factor. Emergent’s manufacturing plant in Bayview, Maryland, can accommodate four vaccines in parallel using different manufacturing platforms and equipment. Funded by the government in 2012, the plant includes single-use disposable bioreactor equipment featuring plastic bags rather than stainless steel fermentation equipment, which makes it easier to switch from one vaccine to another. This month, the company received an additional $628 million to make those four suites available to support any candidate the government selects, CEO Bob Kramer told Reuters. As well as working with J&J, New Jersey-based Catalent signed a deal with British drugmaker AstraZeneca last week to provide vial-filling and packaging services at its plant in Anagni, Italy. It aims to handle hundreds of millions of doses, starting as early as August 2020 and possibly running through until March 2022. It has ordered high-speed vial-filling equipment to boost output at its Indiana plant, where it is also hiring an additional 300 workers. Michael Riley, Catalent’s North American president for biologics, told Reuters his biggest challenge was trying to compress work that normally takes years into months. Adding to the challenge is that glass vials are in short supply. To save glass, companies plan to use larger vials of five to 20 doses - but this raises new problems, such as potential waste, if not all the doses are used before the vaccine spoils. “The downside is that after a healthcare practitioner opens a vial, they need to then vaccinate 20 people in a short, 24-hour time,” said Prashant Yadav, a global healthcare supply-chain expert at the Center for Global Development in Washington. As part of the same drive, the U.S. Department of Health and Human Services and the Department of Defense have awarded ApiJect Systems up to $138 million to upgrade its facilities to be able to make up to 100 million plastic pre-filled syringes by the end of this year, and as many as 600 million in 2021. The company plans to use a technology called Blow-Fill-Seal, where syringes are blown out of plastic, filled with vaccine and sealed in seconds. This will need Food and Drug Administration approval, CEO Jay Walker told Reuters. BREAKING COLD CHAIN SiO2 Materials Science is, meanwhile, ramping up capacity of plastic vials with a glass lining, which are more stable at ultra-low temperatures. “You can bring us down to minus 196 Celsius, which none of the vaccines need,” Chief Business Officer Lawrence Ganti said. “You can throw it against the wall and it doesn’t break. Our founder has done that. He’s thrown frozen vials at me.” The company expects to boost production from the current 5-10 million vials a year to 120 million within three-and-a-half months, he told Reuters. Once packaged, many vaccines need to be kept cold - and some leading contenders made from genetic material such as messenger RNA need to be kept very cold - presenting another challenge that may limit access. “People who work with mRNA store it at minus 80 degrees centigrade, which is not something you’re gonna find in most pharmacies or doctor’s offices,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and co-inventor of the rotavirus vaccine. Peters of Birmingham university has been gathering data from poorer regions of Africa and Asia, and said breaks in the temperature-controlled supply chain - “cold chain” - are already frequent. In some places, it is common to lose 25% or more of vaccines because of broken cold chains, he told Reuters. “So if you’re looking to manufacture four billion, and you reckon you’re going to lose 25%, then you have to manufacture five billion,” he said. “It’s all the elements to move it from the point of manufacture to the point of aggregation, right down to the health centres and then out to the community.” QUARANTINE QUAGMIRE Companies developing mRNA vaccines, including Moderna and Translate Bio, which is partnering with Sanofi, are working to make candidates stable at higher temperatures. Ron Renaud, CEO of Translate Bio, said he was confident this would happen “within a short amount of time”. Colleen Hussey, a Moderna spokeswoman, said: “We are getting more confident that we could run our supply chain at -20C, which is an easier storage condition than deep freezing,” she said. Moderna plans to add a small period of time in which the vaccine can be stored at normal fridge temperatures of 2 to 8 degrees Celsius in doctors’ offices or clinics. “We will know more in the next 2-3 months,” she said. The pandemic is also presenting obstacles of a less technical nature. Catalent, which has some 30 plants globally, has had to write special permission slips in eight languages explaining that their workers are considered essential. J&J is having trouble getting experienced personnel to far-flung labs to oversee the transfer of technology to contract manufacturers because they’re subject to 14-day quarantines. “It is absolutely a factor,” said Stoffels. “If you have to send your people to the middle of India to get to filling capacity, that’s not easy at the moment.”
Covid-19 vaccine from Pfizer and BioNTech shows positive results https://www.cnbc.com/2020/07/01/cor...ntech-shows-positive-results-report-says.html An experimental Covid-19 vaccine being developed by the drug giant Pfizer and the biotech firm BioNTech spurred immune responses in healthy patients, but also caused fever and other side effects, especially at higher doses. The first clinical data on the vaccine were disclosed Wednesday in a paper released on MedRXiv, a preprint server, meaning it has not yet been peer-reviewed or published in a journal. The Pfizer study randomly assigned 45 patients to get one of three doses of the vaccine or placebo. Twelve receive a 10 microgram dose, 12 a 30 μg dose, 12 a 100 μg dose, and nine a placebo. The 100 μg dose caused fevers in half of patients; a second dose was not given at that level. Following a second injection three weeks later of the other doses, 8.3% of the participants in the 10 μg group and 75% of those in the 30 μg group developed fevers. More than 50% of the patients who received one of those doses reported some kind of adverse event, including fever and sleep disturbances. None of these side effects was deemed serious, meaning they did not result in hospitalization or disability and were not life-threatening. The vaccine generated antibodies against SARS-CoV-2, the virus that causes Covid-19, and some of these antibodies were neutralizing, meaning that they appear to prevent the virus from functioning. Levels of neutralizing antibodies were 1.8- to 2.8-times the level of that in the recovered patients. It’s not certain that higher antibody levels will lead to immunity to the virus. To prove that, Pfizer will need to conduct large studies that aim to prove that people who have received the vaccine are at least 50% less likely to become infected. Those studies are expected to begin this summer, mostly in the United States. Pfizer is testing four different versions of the vaccine, but only one will advance to larger studies. The current study did not include pregnant women, and no other information on the ethnic diversity of participants was noted, although the paper does say that future studies will need to include a more diverse group. The second dose, a booster shot, was required for immunity. The patients who received the single 100 μg dose had lower antibody levels than those who received two shots of the lower doses. Fourteen Covid-19 vaccines are currently in human trials, according to the Milken Institute, including entrants from Inovio, CanSino, AstraZeneca, and Moderna. More are expected to start soon, including entrants from Merck, Johnson & Johnson, and Sanofi. In total, 178 vaccines are in various stages of development. The Pfizer/BioNTech vaccine, like the Moderna vaccine, is based on a technology called messenger RNA, which uses a key genetic messenger found in cells to create protein that the immune system then learns to attack. Moderna has not yet published data on its vaccine but is expected to do so soon.