First COVID-19 vaccine tested in US poised for final testing https://apnews.com/e4d5259bfc6c74fcb090d885737c55a6 The first COVID-19 vaccine tested in the U.S. revved up people’s immune systems just the way scientists had hoped, researchers reported Tuesday -- as the shots are poised to begin key final testing. “No matter how you slice this, this is good news,” Dr. Anthony Fauci, the U.S. government’s top infectious disease expert, told The Associated Press. The experimental vaccine, developed by Fauci’s colleagues at the National Institutes of Health and Moderna Inc., will start its most important step around July 27: A 30,000-person study to prove if the shots really are strong enough to protect against the coronavirus. But Tuesday, researchers reported anxiously awaited findings from the first 45 volunteers who rolled up their sleeves back in March. Sure enough, the vaccine provided a hoped-for immune boost. Those early volunteers developed what are called neutralizing antibodies in their bloodstream -- molecules key to blocking infection -- at levels comparable to those found in people who survived COVID-19, the research team reported in the New England Journal of Medicine. “This is an essential building block that is needed to move forward with the trials that could actually determine whether the vaccine does protect against infection,” said Dr. Lisa Jackson of the Kaiser Permanente Washington Research Institute in Seattle, who led the study. There’s no guarantee but the government hopes to have results around the end of the year -- record-setting speed for developing a vaccine. The vaccine requires two doses, a month apart. There were no serious side effects. But more than half the study participants reported flu-like reactions to the shots that aren’t uncommon with other vaccines -- fatigue, headache, chills, fever and pain at the injection site. For three participants given the highest dose, those reactions were more severe; that dose isn’t being pursued. Some of those reactions are similar to coronavirus symptoms but they’re temporary, lasting about a day and occur right after vaccination, researchers noted. “Small price to pay for protection against COVID,” said Dr. William Schaffner of Vanderbilt University Medical Center, a vaccine expert who wasn’t involved with the study. He called the early results “a good first step,” and is optimistic that final testing could deliver answers about whether it’s really safe and effective by the beginning of next year. “It would be wonderful. But that assumes everything’s working right on schedule,” Schaffner cautioned. Moderna’s share price jumped nearly 15 percent in trading after U.S. markets closed. Shares of the company, based in Cambridge, Massachusetts, have nearly quadrupled this year. Full Coverage: Racing for a Remedy Tuesday’s results only included younger adults. The first-step testing later was expanded to include dozens of older adults, the age group most at risk from COVID-19. Those results aren’t public yet but regulators are evaluating them. Fauci said final testing will include older adults, as well as people with chronic health conditions that make them more vulnerable to the virus — and Black and Latino populations likewise affected. Nearly two dozen possible COVID-19 vaccines are in various stages of testing around the world. Candidates from China and Britain’s Oxford University also are entering final testing stages. The 30,000-person study will mark the world’s largest study of a potential COVID-19 vaccine so far. And the NIH-developed shot isn’t the only one set for such massive U.S. testing, crucial to spot rare side effects. The government plans similar large studies of the Oxford candidate and another by Johnson & Johnson; separately, Pfizer Inc. is planning its own huge study. Already, people can start signing up to volunteer for the different studies. People think “this is a race for one winner. Me, I’m cheering every one of them on,” said Fauci, who directs NIH’s National Institute of Allergy and Infectious Diseases. “We need multiple vaccines. We need vaccines for the world, not only for our own country.” Around the world, governments are investing in stockpiles of hundreds of millions of doses of the different candidates, in hopes of speedily starting inoculations if any are proven to work.
Well you might as well test the vaccine in a epicenter where the cases are through the roof... South Florida Facilities To Participate In Moderna’s Phase 3 Study For COVID-19 Vaccine https://miami.cbslocal.com/2020/07/...te-in-moderna-phase-3-study-covid-19-vaccine/ Moderna’s Phase 3 study to find a COVID-19 vaccine is set to include volunteers from South Florida. On Tuesday, the pharmaceutical company announced that the mRNA-1273 vaccine has induced immune responses in all volunteers in this Phase 1 study. The vaccine was given 28 days apart in three dose levels to 45 healthy participants between the ages of 18 and 55. The vaccine induced binding antibodies to the coronavirus spike protein after the first vaccination, the release said. After two vaccinations, at day 57 of the study, antibody titers exceeded those in convalescent sera taken from 38 people who had COVID-19, a Moderna news release said. Moderna said the vaccine was “generally safe and well-tolerated.” “The most commonly reported systemic adverse events following second vaccination at the 100 µg (microgram) dose were fatigue (80%), chills (80%), headache (60%) and myalgia (53%), all of which were transient and mild or moderate in severity,” Moderna said in the news release. “The most common solicited local adverse event at the 100 µg dose was pain at the injection site (100%), which was also transient and mild or moderate in severity. Evaluation of clinical safety laboratory values grade 2 or higher and unsolicited adverse events revealed no patterns of concern.” Moderna’s next step will be a 30,000-participant Phase 3 study set to start July 27. According to ClinicalTrials.gov, the following South Florida facilities will be participating: Research Centers of America Hollywood, Florida, United States, 33024 Suncoast Research Group Miami, Florida, United States, 33135 University of Miami Miami, Florida, United States, 33136 Palm Beach Research Center West Palm Beach, Florida, United States, 33409 If the Phase 3 trial goes well, regulators would have to give final approval. Moderna said it will have as many as a billion doses beginning next year.
Could be more than one available too, by the end of the year. Which would be very desireable not just for health reasons but because having just one but mostly owned by the Americans is unpretty. I know the reason and the rationale but it is still unpretty.
The Supply Chain to Save the World Is Unprepared for a Vaccine Freight companies say they need a coordinated strategy fast Air cargo capacity has shrunk and shipping costs are elevated https://www.bloomberg.com/news/arti...to-save-the-world-is-unprepared-for-a-vaccine The industries that shepherd goods around the world on ships, planes and trucks acknowledge they aren’t ready to handle the challenges of shipping an eventual Covid-19 vaccine from drugmakers to billions of people. Already stretched thin by the pandemic, freight companies face problems ranging from shrinking capacity on container ships and cargo aircraft to a lack of visibility on when a vaccine will arrive. Shippers have struggled for years to reduce cumbersome paperwork and upgrade old technology that, unless addressed soon, will slow the relay race to transport fragile vials of medicine in unprecedented quantities. Making a vaccine quickly is hard enough but distributing one worldwide offers a host of other variables, and conflicting forces may work against the effort: The infrastructure powering the global economy is scaling down for a protracted downturn just as pharmaceutical companies need to scale up for the biggest and most consequential product launch in modern history. “We’re not prepared,” Neel Jones Shah, global head of air carrier relationships at San Francisco-based freight forwarder Flexport, said during a webinar this week with other logistics executives. “Let’s all be honest here, vaccine supply chains are exponentially more complex than PPE supply chain,” he said, referring to personal protective equipment like surgical masks and gloves. “You can’t ruin PPE by leaving it on the tarmac for a couple of days. You will destroy vaccines.” 8,000 Cargo Planes Julian Sutch, head of Emirates SkyCargo’s pharmaceutical division, estimated recently that a single Boeing Co. 777 freighter can carry 1 million individual doses of a vaccine. That means airlifting double-dose regimens to protect half the world’s population would require the space in about 8,000 cargo planes. It’s doable, but not without a coordinated global strategy. For now, what’s helping to free up air freight capacity is retrofitting idled passenger planes so they can carry products ranging from medical gear to mangoes. Emirates is using 70 passenger 777s to move cargo, according to Sutch. Another capacity issue involves refrigeration. Health officials have said a vaccine that eventually comes to market will likely need to be maintained at 2 to 8 degrees Celsius (35.6 to 46.4 degrees Fahrenheit) throughout the shipping process. Some newer technologies could require more advanced freezers that can keep them at a frigid minus 80 degrees Celsius. Any deviation can ruin the shots. Among the big questions involving fairness and accessibility: Exactly how will medicine requiring such delicate and expensive transportation reach remote, impoverished areas where drones are now used to distribute pharmaceuticals? Such details aren’t sorted out yet and shippers are aware of the need to get organized. But they’re waiting on signals from the drugmakers. Shah said Flexport is in early discussions with a number of pharmaceutical companies involved in vaccine manufacturing that are still unsure about what they’re going to need. “To a T, they’re all extremely nervous about being able to bring these to market as quickly as people might expect,” he said. There are more than 160 coronavirus vaccines in development, according to the World Health Organization, though only 25 are currently in human studies. The candidates furthest along are now launching late-stage trials, and have ambitions of securing an emergency use authorization from regulators before year end. That could allow for a limited availability of shots for health-care workers and other vulnerable groups. Targeting 2021 Ultimately, countries will need far broader access to Covid-19 shots to halt the virus that has devastated economies and so far taken more than 633,000 lives globally. But by all accounts that’s not likely to occur until well into 2021 at the earliest. In the meantime, manufacturing deals are being clinched, and facilities are getting retrofitted to produce the still-experimental shots at the risk they fail in the clinic. Though the science underscoring the inoculations is still unproven, and mass production remains a daunting task, top pharmaceutical executives speculate that distribution will pose the greatest challenge of all. “Often people are talking about the scientific conundrum of coming forward with a vaccine that works. In some ways, maybe even a harder problem is what you just put your finger on, which is distribution,” Merck & Co. Chief Executive Officer Kenneth Frazier said in an interview on Leadership Live With David Rubenstein on Bloomberg Television. “None of us are safe until all of us are safe, so it’s got to be given broadly to humanity. We need a vaccine that we can make and distribute around the world.” Throughout nearly six months of the crisis, the closing and reopening of economies has thrown out of sync the usual seasonal flow of goods from China and other large manufacturing hubs, rendering forecasts useless for shipping plans. Making the future even harder to predict is the wide time range health experts are discussing for the arrival of an antidote to the coronavirus. Airport Readiness “I don’t think we’re ready because I don’t think we know what to expect,” said Emir Pineda, manager of aviation trade and logistics at Miami International Airport, which is among a limited number of airports around the world with carriers certified to handle pharmaceuticals. “If all of a sudden 20 to 30 charter flights land at Miami International Airport full of pharmaceuticals for distribution throughout the Americas, we’re going to have a challenge.” Another complicating factor could be the behavior of some protectionist governments intent on hobbling international cooperation by exerting sovereignty over supply chains. That attitude was on display this week at a hearing in Washington before a House Energy and Commerce subcommittee, where some lawmakers grilled executives of AstraZeneca Plc, Johnson & Johnson, Merck, Moderna Inc. and Pfizer Inc. about whether their vaccines would be made in the U.S., and what countries they would acquire materials from. “Systemic health threats are the least promising subjects for global cooperation,” said Simon Evenett, a professor at the University of St. Gallen in Switzerland who tracks trade barriers. If private industry doesn’t rise to the delivery task, one option is outright government intervention. In the U.S., for instance, the Pentagon can call on commercial airlines contracted as part of the Civil Reserve Air Fleet, a program established in 1951 after the Berlin airlift that can be invoked in peacetime for national security reasons. Amid the political noise is the steady hum of economies trying to recover, and the busy time of year for companies to stock up ahead of the end-of-year holidays typically is in August and September. Vaccine distribution aside, already elevated shipping prices may stay that way and remain more volatile than ever given the capacity shortages and the demand uncertainty. “We are going to see spikes driven by commercial freight” over the next several months, said Michael Steen, executive vice president and chief commercial officer at the Purchase, New York-based shipping company Atlas Air Worldwide. “The typical calendar peak will be strong -- that’s what we’re expecting.” The branded and generic drug industry has already stomached the high cost of transportation as the pandemic has thrown the airline industry into chaos. Even at the outset of February, industry trade groups and nonprofits struggled to help drug companies navigate the dearth of commercial and cargo flights. “This is an issue of demand where the pricing is four, five, ten times of what they normally would be,” said Anne McDonald Pritchett, the senior vice president of policy and research for the Pharmaceutical Research and Manufacturers of America, during a virtual meeting meeting on supply-chain hurdles in June. Companies are getting creative, with some going through Canada and using trucks to haul products into the U.S. Others have chartered private planes to deliver finished therapeutics into the country. Those quick-fix, costly solutions aren’t likely to work when combined with the complex transport requirements of a coronavirus vaccine. Hence the urgent need for a game plan. “We’re not planning proactively for accommodating that vaccine distribution going forward because the various parties here are not connecting,” Steen said Thursday during the industry webinar, hosted by STAT Media Group, a trade industry publisher in Mumbai. “Shippers and manufacturers are not connecting.” The good news, he said, is that drug manufacturers, companies along the distribution chain and governments still have time to understand how to “take this very scarce capacity and support the distribution of those vaccines in order to stimulate the economies and most importantly make people healthy again.” (More at above url including charts and videos)
Germany: Coronavirus vaccine unlikely to be widely available before mid-2021 https://www.reuters.com/article/us-health-coronavirus-germany-vaccine-idUSKCN24U0WN Germany awarded three biotech companies grants to help them speed up the development of coronavirus vaccine candidates, but Research Minister Anja Karliczek said any vaccine was unlikely to be widely available before the middle of next year. Europe’s largest economy has reported a rise in infections in recent days, with the head of Germany’s Robert Koch Institute (RKI) for infectious diseases blaming negligence and saying it was unclear if a second wave was underway. “We should not expect a miracle,” Karliczek told a news conference, calling for people to maintain social distancing and mask-wearing to avoid jeopardising what Germany had achieved in recent weeks in terms of bringing the pandemic under control. “We must continue to assume that vaccines for the broader population will only be available from the middle of next year at the earliest.” Government advisers had recommended making awards from a 750 million euro ($882.23 million) pot for vaccine development the government announced last month to German biotech firms BioNtech (BNTX.O), CureVac and IDT Biologika, which are working on coronavirus vaccines, she said. “All three of them are promising candidates but we must of course always expect setbacks during the testing phase because it’s one thing to have an effective vaccine but it’s another to have a safe vaccine that people want,” Karliczek said. The money is designed to help the companies scale up production and clinical testing of their offerings. More than 150 vaccine candidates are in various stages of development, with 23 prospects in human trials across the globe. With 206,000 confirmed cases and just over 9,000 deaths, Germany wants to avoid a second wave, which would bring back lockdowns after economically crippling restrictions that closed many businesses for six weeks in March and April.
Coronavirus: Russia plans mass vaccination campaign in October BBC - https://tinyurl.com/y432xmf2 Russian health authorities are preparing to start a mass vaccination campaign against coronavirus in October, the health minister has said. Russian media quoted Mikhail Murashko as saying that doctors and teachers would be the first to receive the vaccine. Reuters, citing anonymous sources, said Russia's first potential vaccine would be approved by regulators this month. However, some experts are concerned at Russia's fast-track approach. On Friday, the leading infectious disease expert in the US, Dr Anthony Fauci, said he hoped that Russia - and China - were "actually testing the vaccine" before administering them to anyone. Dr Fauci has said that the US should have a "safe and effective" vaccine by the end of this year. "I do not believe that there will be vaccines so far ahead of us that we will have to depend on other countries to get us vaccines," he told US lawmakers. Scores of possible coronavirus vaccines are being developed around the world and more than 20 are currently in clinical trials. Mr Murashko, quoted by Interfax news agency, said that the Gamaleya Institute, a research facility in Moscow, had finished clinical trials of a vaccine and that paperwork was being prepared to register it. "We plan wider vaccinations for October," he said, adding that teachers and doctors would be the first to receive it. Last month, Russian scientists said that early-stage trials of an adenovirus-based vaccine developed by the Gamaleya Institute had been completed and that the results were a success. Last month the UK, US and Canada security services said a Russian hacking group had targeted various organisations involved in Covid-19 vaccine development, with the likely intention of stealing information. The UK's National Cyber Security Centre (NCSC) said it was more than 95% certain that the group called APT29 - also known as The Dukes or Cozy Bear - was part of Russian intelligence services. Russia's ambassador to the UK, Andrei Kelin, rejected the accusation, telling the BBC that there was "no sense in it". In the UK, trials of a vaccine developed by Oxford University have shown that it can trigger an immune response and a deal has been signed with AstraZeneca to supply 100 million doses in Britain alone.
Moderna is pricing coronavirus vaccine at $32 to $37 per dose for some customers https://www.cnbc.com/2020/08/05/mod...-at-32-to-37-per-dose-for-some-customers.html Moderna is charging between $32 to $37 per dose for its coronavirus vaccine for some customers, under cheaper “pandemic pricing,” the company said. The company defines a small order of its vaccine as “in the millions.” The price Moderna is charging for small orders is higher than the $19.50 per dose agreed to by U.S. drugmaker Pfizer and German biotech BioNTech with the U.S. government. Moderna is charging between $32 to $37 per dose for its coronavirus vaccine for some customers, under cheaper “pandemic pricing,” it said Wednesday. The Cambridge, Massachusetts-based company is currently in discussion for larger volume agreements that will have a lower price, Moderna CEO Stephane Bancel said on a conference call discussing the company’s second-quarter financial results. “We are working with governments around the world and others to ensure a vaccine is accessible regardless of ability to pay,” he said.“We’re currently in a pandemic as defined by WHO. At Moderna, like many experts, we believe the virus is not going away and there will be a need to vaccinate people or give them a boost for many years to come.” Moderna defines a small order of its vaccine as “in the millions,” he said. The price the company is charging for small orders is higher than the $19.50 per dose agreed to by U.S. drugmaker Pfizer and German biotech BioNTech in a deal with the U.S. government. Bancel said the vaccine will be priced “well-below value” during the pandemic period. After the virus is under control and considered endemic, the pricing will follow the traditional market in line with other commercial vaccines, he said. “We’ll work with the market,” Bancel said. Moderna said it has begun talks with multiple countries to supply its potential coronavirus vaccine, called mRNA-1273, and has already received about $400 million in deposits as of July 31. Last week, the company started a phase three trial testing how safe and effective it is on 30,000 people with results expected as early as October. The company said it anticipates completing enrollment for its phase three trial in September. Moderna’s experimental vaccine, which is being developed with the help of the National Institutes of Health, contains genetic material called messenger RNA, or mRNA, which scientists hope provokes the immune system to fight the virus. The company received $483 million from the Biomedical Advanced Research and Development Authority in April to support its vaccine development. Last month, it announced it received an additional $472 million from the U.S. government. Earlier Wednesday, Moderna reported a fivefold increase in second-quarter revenue primarily on its coronavirus vaccine work. Revenue jumped to $66.4 million during the quarter, more than five times the $13.1 million it took in during the same period last year.
You read the Moderna news in isolation and it looks like they are in the driver's seat and the government has padded their arse and given them a leg up. Somewhat but not necessarily. They are also nervous kitties about how their competitors not just in the U.S. but worldwide are making serious progress. True, they got a big lift from the U.S. government under the Warp Speed program but that program also includes funding to some of their serious competitors. Moderna is not going to be able to do any serious gouging unless they are the only ones in town with an effective vaccine long run and it is not looking that way. They have a lot of pressure on their pricing model. The government needs to be vigilant though in regard to collusion and price fixing between the bastards. US signs $1 billion vaccine deal with Johnson & Johnson The US government Wednesday announced a new $1 billion investment in a COVID-19 vaccine being developed by Johnson & Johnson, guaranteeing 100 million doses. https://medicalxpress.com/news/2020-08-billion-vaccine-johnson.html
Putin Announces Russia Has Approved a Coronavirus Vaccine and That His Daughter Has Been Given a Shot https://www.thedailybeast.com/putin...e-and-that-his-daughter-has-been-given-a-shot Russian President Vladimir Putin announced Tuesday that his country has become the first to approve a coronavirus vaccine, and that his own daughter has received the shot. The vaccine is in production and millions of people, including teachers and front line health-care workers, will be given the shot beginning this month, he claimed. China has already authorized one vaccine for use in its military, ahead of definitive data that it is safe and effective. The Russian vaccine was reportedly given to the scientists who developed it as well as 50 members of the Russian military and a handful of other volunteers. Putin made the announcement during a televised video conference call with government ministers, saying: “This morning, for the first time in the world, a vaccine against the new coronavirus was registered,” adding that his daughter was among those to be inoculated.