Category: Covid-19 Vaccine

After a COVID-19 vaccine deal between four European countries and AstraZeneca, another pharma giant is reportedly in advanced talks to supply its candidate in Europe should it prove safe and effective.

Johnson & Johnson is negotiating with the European Commission to supply its coronavirus vaccine candidate if it succeeds in testing, Reuters reports. The drugmaker plans to start a phase 1/2a test next month under an accelerated timeline unveiled last week.

Beyond that, the company is involved in Operation Warp Speed in the U.S., where officials plan to start late-stage testing for the candidate in September, The Wall Street Journal has reported.

Produce Novel Biologics with High Purity, Quality and Yield

In this Fierce Biotech webinar we will examine a number of the benefits of Lonzas , XS Pichia 2.0 including : speed, simple fermentation regimes, robust and scalable processes that can be tuned according to the specific objectives of a program, helping to advance new drug candidates through the development pipeline.

News of the talks comes after Germany, France, Italy and the Netherlands reached a deal to secure 300 million doses of AstraZenecas potential vaccine for 750 million. That candidate is farther along in development after starting a phase 2/3 trial in May.

Both AstraZeneca and J&J have already signed development deals with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA). Under AstraZenecas $1.2 billion agreement, the drugmaker pledged 300 million doses to the U.S. starting in October. J&J also has a $456 million deal with BARDA, and it promises to scale up manufacturing alongside R&D.

Meanwhile, Sanofi CEO Paul Hudson has said that the U.S., after providing upfront BARDA funding for its vaccine work, expects early access to vaccine doses. Sanofi is also negotiating a potential access deal with Europe, a source told Reuters.

RELATED: Sanofi CEO: Upfront funding wins U.S. first access to coronavirus shot

The developments underscore regional efforts to ensure early access to COVID-19 shots ahead of a worldwide vaccination push reaching billions of people. But even as candidates race forward, signs of hesitance have emerged. A new survey showed only half of Americans plan to get a COVID-19 vaccine, and many are uncertain.

Meanwhile, experts have raised warnings about vaccine nationalism and have said wealthy nations' deals to secure doses threaten poorer countries. AstraZeneca, to address that concern, has inked deals with global groups and the Serum Institute of India to provide shots in low- and middle- income countries.

Original post:

Johnson & Johnson in talks to supply COVID-19 vaccine in Europe: reports - FiercePharma

Creating a vaccine for COVID-19 is just the first step. Policy makers and manufacturers then need to make a lot of it. This week on PODCAST-19, were asking who will be first in line for the immunization. And how do we make sure its eventually available to everyone?

Dont want to miss an episode of PODCAST-19, FiveThirtyEights weekly look at what we know and what we know we dont know about COVID-19? Subscribe on your favorite podcasting app! For example, heres where to do it on Apple Podcasts and Spotify.

See more here:

Who Will Be First To Get A COVID-19 Vaccine? - FiveThirtyEight

Wall Street Expects a Covid-19 Vaccine Before the U.S. Election  Bloomberg

Read the original post:

Wall Street Expects a Covid-19 Vaccine Before the U.S. Election - Bloomberg

You have weight loss and stomach pains for more than a week. Worried that you might be sick, you go to the doctor to find out what could be causing it. Instead of asking questions, examining, and running tests, the doctor jumps to the best-case scenario its just some indigestion and it will go away. You are sent home without any advice about what to do or what to watch for.

Sounds crazy, right? Had I treated patients that way in my 25 years of medical practice, I would certainly have been sued for malpractice and maybe even lost my medical license.

Unfortunately, this, in a nutshell, is the current federal response to the coronavirus crisis: pinning hopes on a best-case scenario against evidence to the contrary.

With more than 20,000 new cases and more than 700 new deaths each day from COVID-19, some of our most powerful national leaders are touting a highly uncertain best-case scenario the discovery of vaccines or medications while willfully ignoring the pandemic-controlling options in front of us.

Like an overly optimistic doctor, some policymakers are banking on a future vaccine that, at best, may arrive in 2021 while people are sick and dying now and the economy continues to be hobbled with an unclear path forward to stability.

The tragedy is that there is a playbook that can reduce the number of cases and deaths right now a national program to test, trace and isolate people who are infected. Increasing evidence shows that this coronavirus can be beaten back if everyone follows simple rules while in public: wearing masks, staying at least six feet away from others and avoiding indoor crowds.

Other countries, like Germany, which locked down for eight weeks and brought new cases down from more than 6,000 per day to around 500 a day, have followed this playbook. By employing these basic public health practices, they have enabled their economies to restart safely.

If we want the same results here, our leaders have to focus on what we know is possible right now. They need to consider that a quickly available, highly effective vaccine could be just a mirage on the horizon. That any new treatment could be insufficient. That this disease, now established nearly everywhere in this country, could keep spreading and causing deadly outbreaks for years.

Refusing to acknowledge and plan for these events and clinging to the rosiest outcome increases the likelihood we will end up in a worst-case scenario one where ongoing infections and outbreaks continue to pose deadly risks; fear of infection makes consumers unwilling to return to shopping and traveling; and infections and deaths overload our hospitals and mortuaries. Aside from the terrible danger to American lives, the continuing costs for private insurers and the government in treating COVID-19 patients would be enormous.

It is not too late for us to avoid the worst-case scenario by facing it now. We need a far more comprehensive program of state-based testing and contact tracing that is well-supported by federal government. Congress already has legislation that deals with testing and contact-tracing programs. Federal agencies like the Centers for Disease Control and Prevention and the Department of Health and Human Services should work together to assist states in collecting, analyzing and reporting data. The CDCs Epidemic Intelligence Service officers have the knowledge and experience to make this happen.

We cant sit around waiting for vaccines and treatments. They are only part of a whole package of steps to save ourselves and our economy. Our window of opportunity is closing. In nearly half of the states, new cases are rising rather than declining. If COVID-19 cases surge above the current level of 20,000 per day, it will be even more difficult and more costly to bring the disease under control and get the economy running. We can work toward a vaccine and a cure even while we take steps to drive new cases and deaths down as New York and New Jersey have done.

When my patients sought care, they also came looking for hope. Even in the most dire health crises, I could offer that. Not because I focused on the best-case scenario, but because they knew I was also planning for the worst outcome, leaving no stone unturned to help them get better.

The American public deserves the same professional commitment from all of our leaders. Action now will minimize the risks to the public and also minimize the economic pain while scientists develop the medications and vaccines that will help keep all of us healthy.

Eric Schneider is a physician and senior vice president for policy and research at the Commonwealth Fund.

See the original post:

Why we can't afford to wait for a COVID-19 vaccine to save us - Los Angeles Times

Can a vaccine be an October surprise? Are journal publishers running a racket? And why is genetics so white?

We discuss all that and more this week on The Readout LOUD, STATs biotech podcast. First, we run through a busy week in news, discussing the results of a major study on Covid-19 treatment, an escalating fight in the publishing world, and the drug industrys biggest-ever IPO. Then, physician and health care policy expert Ezekiel Emanuel joins us to discuss his nightmare scenario: President Trump, desperate for re-election, forces the approval of an ineffective coronavirus vaccine. Finally, we talk to geneticist Tshaka Cunningham about the deep racial inequities in the field of genomics and what can be done to correct them.

For more on what we cover, heres the news on a potential Covid-19 treatment; heres more on the the fight over academic publishing; heres a look at inequality in genetics; and heres the latest in STATs coronavirus coverage.

advertisement

Well be back next Thursday evening and every Thursday evening so be sure to sign up onApple Podcasts,Stitcher,Google Play, or wherever you get your podcasts.

And if you have any feedback for us topics to cover, guests to invite, vocal tics to cease you can emailreadoutloud@statnews.com.

advertisement

Interested in sponsoring a future episode of The Readout LOUD? Email us atmarketing@statnews.com.

Continued here:

Listen: The latest on Covid-19, vaccine politics, and diversifying genetics - STAT

A doctor lifts a vial containing a potential vaccine for Covid-19 in Gaithersburg, Md. (Andrew Caballero-Reynolds / AFP via Getty Images)

EDITORS NOTE: The Nation believes that helping readers stay informed about the impact of the coronavirus crisis is a form of public service. For that reason, this article, and all of our coronavirus coverage, is now free. Please subscribe to support our writers and staff, and stay healthy.

Subscribe now for as little as $2 a month!

Within weeks, President Donald Trump is expected to announce a short list of promising Covid-19 vaccine candidates. As part of its Operation Warp Speed program, the Trump administration has given Big Pharma billions of dollars to expedite vaccine development, but provided little assurance that corporations will not profiteer. This raises a crucial question: If we get a safe and effective vaccine, will everyone be able to afford it?Ad Policy

The idea that some people would not receive a vaccine was once unthinkable. In a now legendary story, Jonas Salk developed the polio vaccine in 1955and then gave it away for free. An interviewer once asked Salk who owned the patent for his polio vaccine. He responded, Well, the people, I would say. There is no patent. Salk was incredulous. Could you patent the sun?

Since then, pharmaceutical corporations have patented the medical equivalent of the moon and the stars. Patent monopolies have fueled the current drug pricing crisis, and they may block access to any future Covid-19 vaccine.

Consider the case of Moderna, the biotechnology company developing a short-listed vaccine with the National Institutes of Health. Moderna brags about its broad and deep patent estate on its website. The company has been granted over a hundred patent monopolies globally. If its vaccine proves safe and effective, Modernas monopolies will allow the corporation to set an exorbitant price. Monopolies will also allow Moderna to block other manufacturers from supplying the vaccine. It could throttle supply. The decision would rest with Stphane Bancel, the CEO of Moderna.

Will Bancel be a hero like Salk? Salk refused a monopoly and trained scientists around the world to shore up supply. Bancel, on the other hand, has watched as Wall Street investors pumped his corporations stock price and made him a billionaire. Bancel has vaguely pledged to set a price in line with other respiratory vaccineswhich cost up to $800and flatly said, We wont have enough supply at the global level. Despite this, Bancel has refused to relinquish his corporations monopolies.

The public should get a say. Like Salk, Bancel has benefited greatly from public dollars. His corporation received millions in funding as early as 2013 to help develop its new way of making vaccines. Federal scientists helped design the new Covid-19 vaccine and are now running the critical human tests. The government also just gave $483 million to scale manufacturing. The public is paying at every stage for this potential vaccineand so many others. All five candidates Trump is expected to short-list have benefited from public funding.

Fortunately, we do not have to wait for Big Pharma to find it in its heart to be benevolent. We can force executives to be like Salk. The US government has the authority, under existing law, to break patent monopolies. In exchange for a modest royalty, the government can and should allow any manufacturer to produce promising Covid-19 medicines. The government threatened to use the approach to lower prices for a critical antibiotic when letters containing anthrax spores were sent to media outlets and the offices of Democratic Senators Tom Daschle and Patrick Leahy in 2001. The government should also require companies to share know-how, and ramp up public production for promising medicines. All contracts should safeguard affordability and availability for all.Current Issue

Subscribe today and Save up to $129.

The pharmaceutical industrys principal objection to this approach would be its potential impact on innovation. We understand the need for medical innovation more than most. One of us was diagnosed at age 32 with ALS, a debilitating disease with a life expectancy of three to four years after diagnosis. The industry claims that without extravagant rewards, there would be no extravagant effort. But that story ignores just how deeply corporations like Moderna rely on public science. The National Institutes of Health alone spends $41 billion annually advancing medical research. Congress has appropriated billions more for Covid-19 work. Yet the corporations who benefit from this investment will be under no obligation to act in the public interest.

When Salk developed the polio vaccine, President Dwight Eisenhower said he was a benefactor to mankind. His work was in the highest tradition of selfless and dedicated medical research. Salk taught us that vaccines belong to the people.

It is time we claim them as ours.

See the rest here:

The Covid-19 Vaccine Should Belong to the People - The Nation

If in-person classes resume in the fall, students will likely be attending before a vaccine for COVID-19 is released.

SEATTLE Students in Washington state may return to the classroom this fall before a COVID-19 vaccine is available.

Though state officials have said the goal is to have at least some face-to-face instruction this fall, Dr. Ali Mokdad with the Institute for Health Metrics and Evaluation (IHME) at the University of Washington says we need to be prepared to dial back and close schools if coronavirus cases begin to increase.

The IHME predicts there could be a powerful second wave of the coronavirus that could lead to tens of thousands of new deaths from COVID-19.

The IHME predicts the second wave will start September 15, around the same time school starts for many students in Washington.

The predictions estimate nationwide deaths will reach 169,890 by October 1, which is an increase of about 60,000 from today. The prediction has a possible range between 133,201 and 290,222 deaths.

"Deaths nationwide are predicted to remain fairly level through August and begin to rise again in the fourth week of August with a more pronounced increase during September, although some states will see the increase earlier due to increased mobility and relaxation of social distancing mandates," according to a release from IHME.

In Washington state, experts predict about 1,400 total deaths, which is about 300 more than the state has right now.

The state's Office of the Superintendent of Public Instruction released guidance for reopening schools after months of coronavirus closures. A panel of 123 people, including some from eastern Washington, worked to develop it.

The guidance includes a mask requirement for all students and staff in K-12 settings.

In order to meet state Department of Health guidelines, some schools may reopen in the fall with a hybrid of face-to-face or online instruction, Washington State Superintendent of Public Instruction Chris Reykdal said. All districts will also need an alternative plan to return to fully remote learning if local health authorities or Gov. Jay Inslee mandate future closures.

"Changing health conditions in a county or region may cause a local health authority or even the Governor to have to reconsider this opportunity to open, but the primary planning of most districts should be a presumption of a fall opening," Reykdal wrote.

Inslee reiterated the need to reassess plans to reopen schools if coronavirus cases spike or spread in Washington.

"We cannot guarantee that school will open in fall. But for now, this guidance provides a path that schools, educators and families need to plan for the coming months and the fall," Inslee said. "Kids need to be learning but they also need to be safe and healthy.

Read the original here:

Very likely Washington schools will reopen before COVID-19 vaccine is released - KING5.com

HHS looking at early 2021 for COVID-19 vaccine; telehealth is here to stay  Healthcare Finance News

See the original post:

HHS looking at early 2021 for COVID-19 vaccine; telehealth is here to stay - Healthcare Finance News

Why do I have to complete a CAPTCHA?

Completing the CAPTCHA proves you are a human and gives you temporary access to the web property.

If you are on a personal connection, like at home, you can run an anti-virus scan on your device to make sure it is not infected with malware.

If you are at an office or shared network, you can ask the network administrator to run a scan across the network looking for misconfigured or infected devices.

Another way to prevent getting this page in the future is to use Privacy Pass. You may need to download version 2.0 now from the Firefox Add-ons Store.

Visit link:

UK Identifies First Recipients Of Future COVID-19 Vaccine - Pink Sheet

WUWM's Chuck Quirmbach looks into a Bubbler Talk question on recovering from COVID-19 in Wisconsin.

How many people in Wisconsin have survived a COVID-19 diagnosis?

Thats the Bubbler Talk question listener Gene Kelber, of Shorewood, sent our way. He says he and his wife are in a high-risk age group for the disease.

"We're both over 70 and we wondered how this is going to impact our life and relationship with our friends, our children, and our grandchildren who live in Shorewood, Kelber says.

>>WUWM & NPR Coronavirus Coverage

Here are some answers, as well as an update on scientific research into ways to help people get well or stay well:

Wisconsin statistics indicate statewide, 76% of the people with confirmed COVID-19 recover. In Milwaukee County, the percentage is a bit lower 71%. Recovery, by the states definition, means there'sdocumentation of resolved symptoms,documentation of release from public health isolation, or 30 days since symptom onset or diagnosis.

In Wisconsin, 76% of people with confirmed COVID-19 recover.

With about 24,000 COVID-19 cases in Wisconsin, that means about 18,000 people have recovered.

Dr. Ryan Westergaard, chief medical officer of the state Bureau of Communicable Diseases, says a lot has to do with the ability of a patient's immune system to fight off the coronavirus. Westergaard says human-produced proteins called antibodies are part of the equation.

"In response to any foreign protein, whether it's a bacteria or a virus, the body generally makes antibodies in response. Sometimes, those antibodies play a large role in neutralizing the infection and doing damage to the body, and sometimes, less so. So, there are other blood cells called leukocytes and a whole range of white blood cells that are part of the body's response. There's a lot we're still learning about why some people have more severe illness than others, Westergaard said.

>>Coronavirus Antibody Tests Now Available In Wisconsin Amid Caution

Some relatives of COVID-19 survivors also credit quick access to high quality health care, and even some say it's luck, when their family member stays alive. But Wisconsin alone, there are still more than 5,000 active COVID-19 cases. About 720 people in the state have died due to COVID-19 69% were age 70 and up.

Across the world, more than 450,000 people have passed away.

So, some researchers are working on ways to heal patients faster or reduce their symptoms.

Dr. Amy Jenkins is with the Defense Department's Defense Advanced Research Projects Agency (DARPA.) She recently told a webcast offered by the journalism resource group SciLine that DARPA is working on a bigger version of what's being tried in Milwaukee and elsewhere taking plasma from recovered patients and using those antibodies to help current patients.

"That's great, but it's not particularly scalable. For each person who wants to donate their plasma, you may only be able to treat a handful of people with that plasma. What we want to do is go into that plasma, that blood, find the best antibodies, because not all of them are great, find what are really the good ones and then manufacture them in large bio-reactors. Then, give them back to hundreds of thousands, if not millions of people, Jenkins said, adding the manufactured antibodies could even be used as a vaccine.

Other researchers are also going the large-scale antibody route and some preliminary test results are due this summer.

As many as 150 groups worldwide are working just on potential COVID-19 vaccines. At the UW-Madison, researcher Peter Halfmann is part of a team developing what they call CoroFlu, which he says is based on an existing influenza vaccine.

"We're taking out one of the proteins, the genes, of the coronavirus, putting it into a vaccine vector that's already going through Phase 2 clinical trial in Europe as a flu vaccine. So, we have some efficacy and we have some safety data for this platform that we're using. We modified the platform, so it will now target the coronavirus. It kind of gives us a leg up, Halfmann told WUWM.

Halfmann says more work isahead, and human testing is still six months away. He says other vaccines are likely to be ready first. But he says there may be a role for CoroFlu.

"As vaccines come out, we're going to see what's working and what doesn't work, and we can try to modify our vaccine to fill in the part that other vaccines are not working for, Halfmann said.

The Trump administration's COVID-19 vaccine effort, called Operation Warp Speed, hopes to roll out a vaccine by the end of the year. Some scientists and Democrats are skeptical.

In Shorewood, Bubbler Talk questioner Gene Kelber says he'll keep his fingers crossed. But in the meantime, hell make sure friends and family practice social distancing.

Have a question you'd like WUWM to answer? Submit your query below.

_

Continued here:

Wisconsin Experts On COVID-19 Recovery, Therapy And Vaccines - WUWM