Category: Covid-19 Vaccine

The nasal spray version of the flu vaccine contains live but weakened form of the virus. Researchers think there's a good chance this could help boost the body's immunity and improve its ability to fight off pathogens such as the coronavirus. Tim Sloan/AFP via Getty Images hide caption

The nasal spray version of the flu vaccine contains live but weakened form of the virus. Researchers think there's a good chance this could help boost the body's immunity and improve its ability to fight off pathogens such as the coronavirus.

In case you were still procrastinating getting a flu shot this year, here's another reason to make it a priority.

There's a chance the vaccine could offer some protection against COVID-19 itself, says virologist Robert Gallo, who directs the Institute of Human Virology at the University of Maryland School of Medicine and is chairman of the Global Virus Network.

The key is getting the right flu vaccine, says Gallo, who was one of the main scientists credited with discovering HIV. "The vaccine has to have a live virus in it. The virus is attenuated so it doesn't cause disease, but otherwise the virus is alive."

A live virus may sound a bit terrifying, but it's a standard way to make safe and effective vaccines. In fact, you've probably already had a few "live, attenuated" vaccines in your lifetime, such as the measles vaccine or oral polio vaccine.

Now scientists are just beginning to learn that these vaccines may offer some unexpected advantages to the immune system.

When developing a vaccine, scientists have a few strategies to try. They can take a piece or component of the bacteria and use that to trigger an immune response in a person. They can kill the pathogen and use its corpse as the vaccine. Or they can take a live pathogen and weaken it in the lab.

The latter are called "live, attenuated vaccines," and over the past century, scientists have noticed something peculiar about these vaccines: They seem to offer some protection, not just from the targeted disease, but also against many different diseases, including respiratory infections.

"There's plenty of evidence for it," Gallo says. "The weakness is we don't really know the longevity [of the protection]. It will probably work only for months, but we can't say for sure."

Take for instance, the vaccine for tuberculosis. It's called bacille Calmette-Guerin, or BCG, and it contains a live, but weakened, strain of TB from cows.

When doctors in Sweden first started using BCG back in the 1920s, they noticed not only that the vaccine reduced a child's risk from dying of TB, but also that children who got it had a mortality rate from all causes that was almost three times lower than unvaccinated children. Since the 1970s, scientists in West Africa have documented a similar pattern with both the BCG vaccine and the live measles vaccine. In other words, the vaccines were doing something to boost the immune system's response to many kinds of pathogens.

Recently, doctors in the Netherlands directly tested the BCG vaccine against a placebo, to see if it could help volunteers fight off a weakened form of yellow fever. The conclusion? People who received the BCG vaccine mounted a stronger immune response against the virus and cleared out the virus more effectively than those who received the placebo, the study reported.

It's not just BCG that seems to have this effect. There's growing evidence that any live vaccines can offer some broad, nonspecific protection, including the oral polio vaccine, measles and the live flu vaccine.

Scientists have had a hard time believing the evidence because the idea goes against the way they thought vaccines work, says immunologist Zhou Xing at McMasters University in Ontario. "It's a new concept that has emerged in the field of immunology over the past five to 10 years or so."

In general, vaccines work by tricking the body to produce antibodies. These molecules are very specific. They typically target and neutralize only one type of infection.

Live vaccines also work through antibodies, but they likely do something else, as well. They supercharge our body's front-line defenders the cells that first recognize an invader and try to clear it out before the infection gets out of control, Zhou says. Specifically, scientists think live vaccines epigenetically reprogram immune cells in the bone marrow, called myeloid cells.

Unlike antibodies, myeloid cells are nonspecific they work on many types of invaders. And they work quickly when the virus first enters a person's body.

Now the big question is: Will live vaccines help a person clear out the coronavirus from their body before they get sick or before the infection becomes severe?

To figure that out, scientists around the world are currently running more than a dozen clinical trials with both BCG and the live polio vaccine to see whether they offer some protection against the virus that causes COVID-19.

No one believes the protection will be as strong or as long-lived as that provided by a specific COVID-19 vaccine, says Dr. Moshe Arditi, who leads one of the trials at Cedars Sinai in Los Angeles.

But, he says, the BCG vaccine has several advantages to a specific vaccine. It's cheap. A dose only costs a few dollars. And we already know it's safe. "More than 130 million kids every year every year receive the BCG vaccine so the safety profile has been very strong," Arditi says.

So the BCG vaccine could be approved and available by early next year, he says. "It could be a bridge until we have a safe, effective COVID-19 vaccine."

In the meantime, virologist Robert Gallo says, why not go get the live flu vaccine, if you can?

This year, the flu vaccine comes in two major forms: a shot or a nasal spray. The shot, which is approved for all people above age 6 months who don't have contraindications, contains an inactivated virus or components of the virus. The nasal spray (FluMist), which is approved for people ages 2 to 49, contains live, attenuated flu viruses.

"You watch," Gallo says. "People who get the live flu vaccine will also be protected against the COVID-19. That's the hypothesis."

However, even if you get a vaccine, you should still exercise all the same cautious you would otherwise: Wear a mask, keep your distance, wash your hands and avoid large indoor gatherings.

Original post:

A Vaccine That Protects Against COVID-19 May Be Right Under Our Noses : Shots - Health News - NPR

As governments fight the COVID-19 pandemic, Snopes is fighting an infodemic of rumors and misinformation, and you can help. Read our coronavirus fact checks. Submit any questionable rumors and advice you encounter. Become a Founding Member to help us hire more fact-checkers. And, please, follow the CDC or WHO for guidance on protecting your community from the disease.

While scientists around the world raced to find a potential vaccine for COVID-19, the respiratory disease caused by SARS-CoV-2, misleading and misconstrued information continued to engulf the internet. Among these rumors was the claim that a coronavirus vaccine would result in the harvesting and death of as many as 550,000 wild sharks.

The claim originated from non-peer-reviewed research conducted on behalf of Shark Allies, a marine conservation advocacy group, that estimated the amount of squalene required to fulfill the demand of a global vaccine. Squalene is a natural compound found in the livers of sharks among many other species, including humans and is commonly used to create some vaccines. While it is true that some COVID-19 vaccine contenders in clinical trials in October 2020 contained squalene, the 500,000 mark was at the high end of projected estimates and did not account for a number of limitations and variables set forth in the research.

In an email, Shark Allies Founder and Executive Director Stefanie Brendl said that the reporting was a big misunderstanding and was largely based on misleading headlines.

We did not claim that vaccine companies or fishermen would go out to kill 500,000 sharks right now to fill the vaccine demand, Brendl told Snopes. That number, without the many caveats that came with the research, was published in The Daily Telegraph and subsequently picked up by several publications that reiterated the exaggerated claim.

Deep-sea sharks located at depths up to 5,000 feet have large reserves of squalene to help maintain neutral buoyancy. As much as one-quarter of their weight may be composed of squalene, compared to just 5% that of most mammals, according to a report published by Oceana.

Squalene is used as an adjuvant, a particular ingredient used in vaccines to elicit a stronger immune response to protect an individual from the disease, according to the Centers for Disease Control and Prevention (CDC). Applying an adjuvant to a vaccine makes it so that less of a particular virus is needed for production. Squalene-containing adjuvants, especially two known as MF59 and AS03, have been increasingly employed as an immunologic adjuvant in several vaccines, including the novel influenza A (H1N1) 2009 pandemic flu and FLUAD and Chiron seasonal influenza vaccines since 1997. In fact, more than 22 million doses of squalene-containing flu vaccines have been administered globally, according to the World Health Organization (WHO).

Josh Soll, a campaign researcher for Shark Allies, told Snopes that his research used previously prepared squalene quantities in adjuvants to estimate the sharks needed to fulfill COVID-19 vaccine demands based on human populations, which could equate to more than a half-million sharks.To come to his conclusion, Soll said that he turned to published findings that determined the amount of shark squalene in some vaccine adjuvants, as well as information of approximately how many sharks are required to produce one metric ton of squalene.

Previous research that tested shark squalene-based adjuvants for diseases such as influenza and past coronaviruses such as SARS and MERS provided information on the quantity of squalene that is used in a single dose of an adjuvant, which is a component of some vaccines, Sol said. Knowing roughly the amount of squalene needed to produce a given vaccine, Soll was able to estimate the approximate number of sharks that would be required either for a single or double dose, per each person in the world.

WHO noted that AS03 and MF59, the two adjuvants most commonly made from shark squalene, require 10.68 and 9.75 milligrams of squalene per dose, respectively. Based on these estimates, Soll determined that between 2,500 and 3,000 sharks would be needed to produce 1 metric ton of squalene-based adjuvant. With this information, Soll estimated that one round of a squalene-based COVID-19 vaccination given to the global human population would equate to the harvesting of approximately 450,000 and 580,000 sharks.

But that doesnt account for variables and assumptions made by the research. Not only is it unlikely that every person in the world will require a COVID-19 vaccine, but the exact dosage and administration schedule are not known.

While it is true that the development and production of some vaccines, including future vaccinations against COVID-19, may require squalene, the estimates are based on a limited set of data. For starters, the estimate assumes that only squalene from sharks will be used rather than synthetic alternatives or squalene harvested from other sources, or that a vaccine will require squalene in the first place. These estimates may only come to fruition if a shark squalene-based adjuvant is produced and needed for vaccines in the first place, noted Shark Allies.

Many COVID-19 vaccines in the testing phase in October 2020 did not use either an adjuvant or squalene. As of Oct. 2, some 42 candidate vaccines were in clinical evaluation and 151 in pre-clinical evaluation. Of these vaccines, 19 used adjuvants and at least five were shark-squalene based, according to data published by WHO.

We have no idea how many more coronaviruses we will have to deal with in the years to come. That number also doesnt reflect how many years we will be given COVID-19 vaccines. This is going to be the new normal, said Brendl, noting that parsing out whether sharks are harvested only for their squalene or if there are other reasons will be nearly impossible.

So, saying that 500,000 sharks will die only because of a vaccine is a tricky statement, she added.

In late 2020, the squalene market continued to grow and was expected to reach $214 million by 2022. And as squalene demand increases, so does the need for its source. It is estimated that up to 3 million sharks are killed each year for their squalene and Brendl suspects that number could increase if squalene is used in COVID-19 vaccines.

Read the rest here:

Will Over Half A Million Sharks Be Killed for COVID-19 Vaccine? - Snopes.com

Covering COVID-19 is a daily Poynter briefing of story ideas about the coronavirus and other timely topics for journalists, written by senior faculty Al Tompkins. Sign up here to have it delivered to your inbox every weekday morning.

The person who, in theory, knows more than anybody in the U.S. about the rush to develop a COVID-19 vaccine spoke up and said the vaccine will be more effective than expected but will take a little longer than they had hoped to get here.

Moncef Slaoui, the immunologist who runs the Trump administrations Operation Warp Speed program to develop vaccines against the coronavirus, says he expects that drug companies will file their paperwork for emergency authorization around Thanksgiving. That would mean vaccinations would not begin until 2021. Slaoui says he expects the vaccines will be between 80 to 90% effective, which is much higher than the Food and Drug Administration set as a benchmark.

Slaoui told MarketWatch that he expects 300 million doses to be available in January. What he says here is not a clear short sound bite, but I am passing it along to you so you can think about the step-by-step process that is involved. Slaoui said:

We will know if a vaccine works anytime late October, or November, or in December. But I expect the (emergency use authorization) filing to happen three (or) four weeks after that moment of when we know the vaccine is efficacious, maybe if we work like crazy we make it happen in two weeks.

He went on to explain the practicalities of how the approval would move:

What is likely to happen is that the companies are going to first take a certain number of days from the time the number of cases are accrued to clean up the data. There are always clarifications on the case report form. You call the clinical trial sites, ask for questions that are called queries. This is all regulated in the (good clinical practice) requirements. That usually is going to take, frankly, easily a week to make sure every case is a real case, whether it corresponds to a primary endpoint definition or secondary endpoint definition. Otherwise youre going to be creating a mess.

Lets say if the number of cases is obtained, Im going to even say Oct. 29, (though) it may be until Nov. 10 or Nov. 7. And then it may be until the end of November when the file is actually fully completed and submitted to the FDA for emergency use. Its important to factor in those periods of time. Things dont happen overnight; otherwise, you will be making mistakes.

Grounded planes from United Airlines (mpi34/MediaPunch /IPX)

House Speaker Nancy Pelosi said Thursday that she is not interested in a stimulus bill that only helps airlines.

There is no stand-alone bill without a bigger bill, she said. She and Treasury Secretary Steven Mnuchin have talked more than once this week about a stand-alone plan that might bail out airlines. President Donald Trump has spoken favorably about the idea.

Earlier this week, Congress and the president seemed to be warming to the notion of a special bail-out bill that would target the airlines, which are laying off around 35,000 workers right before Election Day. Airline CEOs and labor unions have been pleading for $25 billion or so that they say might forestall widespread layoffs.

The airlines say a bailout would help them make it until the end of March, when they hope flying will pick up again. The airlines do not expect to return to 2019 passenger levels until at least 2023 and it could take years to pay off the debt they are incurring right now.

According to industry trade group Airlines for America, domestic air travel is still down 62% compared to September 2019 and international travel has fallen by 84%. Airline revenues plummeted by 86.5% in the second quarter of 2020, and sales for future travel are down 84%.

Airlines represent a $1.7 trillion churn in the U.S. economy. The airlines say they employ 750,000 workers and that they are connected to more than 10 million jobs in America.

The airlines took $25 billion in the first round of relief with the promise not to lay off workers. That promise expired on Oct 1.

Back in March, The Boston Globe, for one, opposed special treatment for not only airlines but also for hotels, saying:

Airlines, hotels, and cruise companies should be eligible for whatever general economic assistance programs the government develops. Their size, and the extent of their losses, should put them in line for sizable aid at least in the form of low-cost loans.

But if Congress is to set aside money just for airlines or hotels or cruise ships, it needs to attach some awfully stringent conditions to justify exceptional treatment on the taxpayers dime. The criteria should be aimed at ensuring such businesses contribute more to society in their practices with respect to employees, customers, and the environment.

While there is some support for a separate airline bailout, the American Hotel and Lodging Association says its members are in dire shape and without help, the hotel industry is on the brink of collapse. The AHLA recently said, Nearly 4,000 hotel industry leaders sent an urgent letter to Congress urging immediate action to help hotels avoid foreclosure and the loss of tens of thousands of jobs.

The U.S. Travel Association says, Without immediate aid, 50% of all travel-supported jobs will be lost by December an additional loss of 1.3 million jobs. As travel supported 11% of all pre-pandemic jobs, it is simply not possible for the U.S. to expect a nationwide economic recovery without meaningful federal relief.

Restaurants are slowly making a comeback. But the National Restaurant Association says eating and drinking place staffing levels are still down 2.3 million jobs from Februarys peak.

What happens to outdoor dining when winter arrives? For the majority of the National Restaurant Associations members, outdoor dining has helped save their businesses. Three-fourths of full-service members offer outdoor options. The association tells this story:

At Lumen, Detroit, restaurateur Scott LaPage invested in several patio igloos last year, well before the pandemic, because he was looking for a novel way to increase his sales during the cold winter months.

The move allowed him to increase his revenues during those months, and then the pandemic hit. Now, he believes they will help his business weather the COVID-19 storm by allowing parties of up to six people to dine in the igloo, which is outfitted with space heaters, an electric fireplace, and fresh air circulating through two open flaps in the back of the structure. Parties enter through a zippered door. Guests can relax for up to two hours inside the globes.

LaPage said each igloo, made of fiberglass rods and clear tent material, costs about $1,200, and is easy to assemble. Its imperative to make sure your local jurisdiction allows these types of structures, especially with space heaters, he advises.

Without a new stimulus package from Congress and President Trump, the weeks ahead are going to be more than tough for a lot of Americans.

Absent more aid, CNBC said, jobless Americans will be living off their current allotment of benefits from the state or federal government. In some cases, that amounts to just $5 a week.

Wait $5 a week? Lets fact-check that one. For starters, every state sets its own unemployment benefits rate. And it is possible, in Hawaii, to qualify for only $5. But that is not typical, even though in some states, the low end approaches that figure.

(CNBC)

The Labor Department says somewhere around 26 million Americans are collecting unemployment benefits as of Oct. 1. Keep in mind that is a moving target that, for example, does not include the thousands of new claims being filed after big airline and Disney layoffs, among others. The Labor Department said:

The largest increases in initial claims for the week ending September 19 were in New York (+7,893), Georgia (+7,336), Massachusetts (+5,186), New Jersey (+5,038), and Oregon (+3,251), while the largest decreases were in Maryland (-2,197), Michigan (-2,169), Indiana (-1,543), Illinois (-1,408), and Louisiana (-1,340).

CNBC reported that in the second quarter of this year, unemployment benefits paid a little more than a third of the wages the average worker earned before being laid off:

On average, states paid $305 a week (about $1,220 a month, before tax) in unemployment insurance to workers in August, according to Labor Department data.

Some paid much less. Louisiana and Mississippi, for example, paid just over $180 a week ($720 a month) the lowest average among the states.

However, some workers get less still. States pay unemployment benefits within a range, between a minimum and maximum weekly amount. Those ranges vary significantly by state.

Then there is a whole segment of workers who are not eligible for unemployment: the so-called gig-workers, those who are self-employed and freelancers. The Pandemic Unemployment Assistance Act that helped those workers expires at the end of December.

The two social media giants say they will not accept political ads after the polls close and that the ban may last at least a week or two. This is a step beyond Facebooks initial ban on political ads in the week before Election Day.

Facebook said:

While ads are an important way to express voice, we plan to temporarily stop running all social issue, electoral, or political ads in the U.S. after the polls close on Nov. 3, to reduce opportunities for confusion or abuse.

The policy appears to be aimed at preventing disruption while votes are still being counted, a concern raised after President Trumps refusal to promise an orderly transition of power if he doesnt win reelection.

It will be interesting to see what, if any, policies TV stations and cable companies will use to sell such ads.

You can track ad spending on Facebook by state, topic and timing by going to their ad library.

Make no mistake, while TV spending is still the main place candidates buy ads, CNBC reports spending on social media is heating up:

President Trumps campaign has largely gone off the air with TV ads in Ohio, Texas, Iowa and Nebraska, which he easily won in 2016.

But he is outspending Joe Biden with targeted Facebook ads in those states over at least the past week, according to the social media giants ad tracker.

Anti-Trump super PAC Defeat by Tweet launched in June and has run up an advertising bill of more than $800,000 with an online campaign that encourages people to automatically donate money every time the president tweets.

(Screenshot, Facebook ad library)

A reader who did not wish to be named made the great point that we should clarify that COVID-19 and coronavirus should not be used interchangeably, which I suspect I have done.

The disease that comes from the virus is called COVID-19.

The virus that causes it is called severe acute respiratory syndrome coronavirus 2, or the novel coronavirus.

This is similar to referring to HIV and AIDS. HIV is the virus; AIDS is the disease.

If you want to know how viruses and diseases get named, you can go to this World Health Organization page. Go ahead, we will wait for you. You know you want to know.

CNNs Martin Savidge is back in Lake Charles, Louisiana, covering another hurricane. An entire high-rise is covered in plywood from the last storm that blew through.

In Lake Charles, LA this plywood high rise is the after effect of hurricane Laura now threatened by hurricane Delta. pic.twitter.com/8GcN4JKZ1m

Martin Savidge (@MartinSavidge) October 8, 2020

In Lake Charles as Hurricane Delta targets the area, the debris from Hurricane Laura will be its own destructive danger. pic.twitter.com/1hBFs8DFRs

Martin Savidge (@MartinSavidge) October 8, 2020

Well be back Monday with a new edition of Covering COVID-19. Sign up hereto get it delivered right to your inbox.

Al Tompkins is senior faculty at Poynter. He can be reached at atompkins@poynter.org or on Twitter, @atompkins.

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COVID-19 vaccines should be ready in January, head of Operation Warp Speed says - Poynter

GENEVA (Reuters) - A vaccine against COVID-19 may be ready by year-end, the head of the World Health Organization said on Tuesday.

FILE PHOTO: World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus attends a news conference organized by Geneva Association of United Nations Correspondents (ACANU) amid the COVID-19 outbreak, caused by the novel coronavirus, at the WHO headquarters in Geneva Switzerland July 3, 2020. Fabrice Coffrini/Pool via REUTERS

WHO Director-General Tedros Adhanom Ghebreyesus called for solidarity and political commitment by all leaders to ensure equal distribution of vaccines when they become available.

We will need vaccines and there is hope that by the end of this year we may have a vaccine. There is hope, Tedros said in final remarks to the WHOs Executive Board, without elaborating.

Nine experimental vaccines are in the pipeline of the WHOs COVAX global vaccine facility that aims to distribute 2 billion doses by the end of 2021.

The two-day board meeting, which examined the global response to the pandemic, heard calls from countries including Germany, Britain and Australia for reforms to strengthen the U.N. agency.

U.S. President Donald Trumps administration has strongly criticised the WHOs role in the crisis, accusing it of being too close to China and not doing enough to question Beijings actions late last year when the virus first emerged in Wuhan.

Tedros has dismissed the suggestions and said his agency has kept the world informed.

Three independent panels reviewing WHO performance including its 2005 International Health Regulations - which set guidelines on trade and travel restrictions imposed during health emergencies - gave updates on their work.

The Independent Panel for Pandemic Preparedness and Response, led by former New Zealand Prime Minister Helen Clark and former Liberian President Ellen Johnson Sirleaf, met for the first time last month.

We hope to get the real lessons that we can implement and prevent the same thing from happening, Tedros said. But I would like to assure you that WHO is ready to learn from this and change this organisation.

During our transformation we promised this, we promised to keep change as a constant, he said, referring to his programme since taking the helm in 2017.

Reporting by Stephanie Nebehay in Geneva; Editing by Michael Shields, Alexandra Hudson and Giles Elgood

Continued here:

COVID-19 vaccine may be ready by year-end, says WHO's Tedros - Reuters

This is an article from World Review: The State of Democracy, a special section that examines global policy and affairs through the perspectives of thought leaders and commentators, and is published in conjunction with the annual Athens Democracy Forum.

Crises wake us up to harsh truths. Just as the wildfires raging across the West Coast in September jolted our attention to the realities of climate change, the economic downfall and health disaster caused by Covid-19 are forcing us to reckon with longstanding problems in capitalism.

Even before the pandemic caused millions to lose their jobs, workers were struggling with the precariousness of work caused by the rise of the gig economy and the deterioration of their bargaining power. Decades of budget cuts have eroded public services. In many large businesses, the practice of rewarding shareholders through stock-buyback schemes instead of investing in research and development and in wages and worker training has stifled long-term economic growth. An era of deregulation has allowed businesses to pursue short-term returns, leading to disasters like the 2008 financial crisis.

Things must change. Governments can use the Covid-19 crisis to address flaws in our systems and structures. The race for a vaccine is a good place to start.

The only way to end the pandemic is to develop a Covid-19 vaccine and make it available for free to every person in the world. To achieve this, the public sector needs to shape the drug-innovation process: steering innovation, getting fair prices, preserving supplies, ensuring that patents and competition work effectively and using collective intelligence for a positive impact on public health. This is the intent behind the World Health Organizations call for a patent pool.

Most countries, however, are not invested in this goal, nor are they investing in global health systems to get through the next wave of the virus. While over 300 vaccine projects are underway, the nations leading those projects are competing instead of cooperating. The wealthiest countries are focused on crossing regulatory finish lines, not developing measures to make a vaccine equitably available or guiding the broader health-innovation system to focus on public health.

Some countries are also failing to address access issues for their own citizens. The United States has no safeguards in place to ensure that Covid-19 treatments and vaccines will be affordable for all Americans, even though the research and development of those drugs is substantially funded with taxpayers money. In June, the pharmaceutical company Gilead Sciences announced that it would charge privately insured patients $3,120 per treatment course for remdesivir, a Covid-19 drug developed with a contribution of at least $70 million from taxpayers.

These mistakes are putting lives at risk while prolonging a global economic crisis.

On an international level, governments need to work collaboratively to set firm rules on intellectual property, pricing and manufacturing. They must reach a consensus on the objective of making a vaccine universally available and accessible, as this will affect how production of the vaccine is carried out and governed. Governments also need to write strong conditions into contracts to prevent pharmaceutical companies from charging outrageous prices for Covid-19 therapies and vaccines. This will ensure that the pricing reflects the public contribution to the drugs creation.

But the principles behind these changes must apply beyond a Covid-19 vaccine. This is not about punishing companies, but about building a stakeholder approach sharing both the risks and rewards of wealth and value creation and directing economic growth so all citizens benefit.

We need to improve worker conditions, rebalance public-private relationships and reduce the practice of using corporate profits to boost short-term gains in stock prices. We can also foster a green recovery, making both reductions to carbon dioxide emissions and the creation of environmentally beneficial jobs central to economic recovery packages.

The solution to our problems is not just to drum up more stimulus funding; it is to steer that funding toward building a more inclusive, sustainable economy. We have to transform, not just stimulate, the economy or we risk repeating the mistakes of 2008 when governments injected huge amounts of unconditional liquidity into the system, which drove up asset prices in financial markets but did little to help the real economy.

Conditions that protect public interests are key. In the current crisis, the countries that attached smart conditions to bailouts have made the most headway in recalibrating the public-private relationship.

Austria, for example, made its airline-industry bailouts conditional on the adoption of climate targets. France introduced a five-year target for increased production of electric and hybrid cars to lower carbon dioxide emissions and committed to directing its 8-billion-euro stimulus package toward transforming its automobile industry to support a green recovery. Denmark, France, Belgium and Poland introduced legislation to block companies linked to tax havens from accessing state aid and the European Central Bank urged banks not to pay dividends until 2021 and to exercise extreme moderation with regard to bonuses. In the United States, leaders like Senator Elizabeth Warren have called for conditions such as a higher federal minimum wage and the democratization of corporate boards through worker and stakeholder representation, as well as restrictions on dividends, stock buybacks and executive bonuses.

Now is the time to do things differently not only because Covid-19 poses a major threat to our health and economy, but because greater challenges lie ahead as our planet continues to heat up. Unless we use this crisis to change our ways, well diminish our chances of overcoming the next one.

Mariana Mazzucato is a professor at University College London and the author of The Value of Everything: Making and Taking in the Global Economy.

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Capitalism Is Broken. The Fix Begins With a Free Covid-19 Vaccine. - The New York Times

COVID-19 Vaccine Patent Spat and Matchmaking Site Contract Disputes: What's Happening in California Litigation? | The Recorder  Law.com

See the article here:

COVID-19 Vaccine Patent Spat and Matchmaking Site Contract Disputes: What's Happening in California Litigation? | The Recorder - Law.com

Dr. Rahul Gupta, Opinion contributor Published 7:00 a.m. ET Oct. 9, 2020 | Updated 11:51 a.m. ET Oct. 9, 2020

Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time. USA TODAY

The March of Dimes won public trust for the polio vaccine. A non-profit might be our best bet now given skepticism about the federal government and CDC.

A vaccine might be able to stem the coronavirus, but its no match for our ailing body politic.

The United States is very likely speeding toward the approval and distribution of a vaccine that a sizable portion of the population will forgo. A new Pew Research Center survey reveals a 21 percentage point drop since May from 72% to 51% among adults who would get a COVID-19 vaccine today,with a decline across all major political and demographic groups. Unless we correct course, well remain in the global basement of this pandemic even after a vaccine arrives, with spikes in cases and loss of life well into 2021 and beyond, regardless of who is president.

In normal times, the federal government in coordination with state and local public health authorities would be the trusted voice in planning, operationalizing and communicating to the public every stage of vaccine development and distribution. An in-charge Centers for Disease Control and Prevention would be the hub of these efforts. But these are not normal times, and political hands continue to undermine the CDC and diminish its work and standing. Thats why we should borrow from the nations playbook response to the polio epidemic during the 1950s as a possible path forward. A credible, non-partisan and nationally renowned non-governmental organization or a coalition of such organizations should be enlisted now to engage in states and communities to help Operation Warp Speed (OWS) launch a COVID-19 vaccination campaign. This worked 65 years ago, and it could work today.

Polio was the coronavirus of the mid-20th century. Potentially fatal and disabling, this viral infection was transmitted person to person around the world and driven by asymptomatic carriers. Social distancing protocols were put in place each summer, and there was a run on iron lung machines, which were that periods version of ventilators. The race to develop a vaccine was funded by the National Foundation for Infantile Paralysis (now March of Dimes), and it became one of the most rapid examples of benchtobedside translation in the history of medicine. March of Dimes organized the largest clinical trial in U.S. history, with 1.8 million children, that was funded by the donations of a concerned nation one dime at a time.

The vaccine effort was nearly derailed in 1955, when Cutter Laboratories in California produced some batches of the vaccine with a live virus, resulting in thousands of cases of paralytic polio and sending a new wave of fear across the nation. The incident undercut the trust in government at precisely the wrong time. The transparency, independence and trust of our outside organization helped the United States overcome the vaccine hesitancy that existed even then, and in the wake of the Cutter incident, so the scourge of polio could be stopped.

Dr. Richard J. Mulvaney gives injection to Randy Kerr, Polio Pioneer No. 1, on April 26, 1954, in McLean, Virginia.(Photo: March of Dimes Birth Defects Foundation handout)

Today, as researchers across the globe race to find a COVID-19 vaccine, fear and uncertainty surround not only the virus but the vaccine to stop it. The scientific community broadly agrees that the deployment of a safe and efficacious vaccine across the United States will almost immediately interrupt disease transmission and lead to fewer cases, complications and deaths.However, despite biotechnological advancements, a basic underlying human factor vaccine hesitancy might ultimately dictate the success or failure of any vaccine campaign. The highly unusual public assurances issued lastmonth by the pharmaceutical companies developing these vaccines tells us how dire the concern about trust is.

Harvard Medical deans: Push for COVID-19 vaccine must put health above politics

Vaccine hesitancy is as old as vaccines, but whats different today is the level of distrust in our government and institutions. Even before COVID-19 entered our vernacular, a Pew Research Center survey found that three-quarters of Americans said their trust in the federal government had been eroding. A majority reported trouble discerning what is true, given a growing distrust of both elected officials and the news media.Factor in the divisiveness of a presidential election year, and America finds itself in an unenviable and dangerous predicament.

President Trump has repeatedly said a vaccine will be available by November, no matter the protestations of scientists, including his own CDC director. It is likely that by late October, just before Election Day, congressional candidates will be forced to take a position on vaccinations whether about effectiveness or mandatory inoculation. The vaccination effort may itself become a red or blue litmus test, just as the nation is experiencing with face coverings. When Americans already do not find their government trustworthy, any attempt by that same government to persuade the public of the safety and efficacy of a rapidly developed vaccine will be in vain.

This administration is not equipped to establish that trust, but history shows us a path forward. The role the March of Dimes played in eliminating polio in the U.S. and setting the stage for global eradication of the disease provides a sound model for what America needs today. The greatest public service the federal government could do now is to enlist a group of non-partisan truth-tellers outside of government to become the face of this vaccination effort. These experts would have the authority and unfettered access into OWS and the resources to communicate directly with the American public without government interference. Communities across the U.S. would begin to notice that information both positive and negative was being communicated without political influence. This type of straight-forward, timely information sharing on vaccines would allow Americans to begin once again to develop trust in the messages being communicated, and ultimately help them make more informed decisions.

COVID-19 vaccine: If Trump announces a preelection COVID vaccine, who'd believe him or go and get one?

Theres an old African proverb: If you want to go fast, go alone. If you want to go far, go together. This fall and into winter, Americans need to come together and go far in protecting our health and saving lives. However, we can only do so by ensuring that truth, transparency and trust are embedded in the nations vaccination campaign.

Dr. Rahul Guptais the chief medical and health officer for the March of Dimes. He is the former public health commissioner for the state of West Virginia.

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Polio campaign of the 1950s is a sound model for what America needs for COVID-19 - USA TODAY

The CDC has told states to prepare to begin COVID-19 vaccination as early as November 1.

To better understand EMS agency vaccination mandates and provider practices, and how these might impact COVID-19 vaccination amongst frontline personnel, we surveyed EMS providers, supervisors and chiefs. More than 500 AEMTs, EMTs, paramedics, chiefs and medical first responders completed the survey. Their responses provided insights into EMS vaccination policies, practices and perceptions in regards to influenza and COVID-19 vaccination.

[Read the results: Survey: Will EMS providers get vaccinated against COVID-19?]

The responses were mixed, but one takeaway was clear: vaccination is largely voluntary among EMS providers. Just 24% of respondents noted their agency mandates influenza vaccination for frontline personnel. Of those, 83% noted there are either religious or health exemptions (or both) to their mandate, signifying most vaccinated EMS personnel are opting into their vaccines.

The topic of COVID-19 vaccination has been widely debated on social media as well. Following are some of the comments weve received through Facebook, polls, and a survey of readers. Where do you stand? Do you feel obligated to get vaccinated against COVID-19 as a first responder? Will you get a COVID-19 vaccine when one becomes available? Check out the comments below and weigh in by filling out this short form.

Readers' responses to the questions: Are you ethically obligated to get vaccinated for COVID-19? Will you get vaccinated?

Yes, the first thing we are taught is to do no harm. Martin Grillo

Not ethically bound, but will get vaccinated when I feel confident with approval by scientists and epidemiologists that the vaccine has met all criteria for testing and not by a politician. Melissa Mason

I do not feel ethically obligated to get the vaccine. I will not be taking the the vaccine for a couple of years because I do not trust that it will be problem free. David Winkles

I feel obligated IF the vaccine goes through the stringent approval process and trials. I'll only be vaccinated if I feel comfortable with the trials and results. Paul Bowling

Yes, to protect patients, students, and myself and so I can remain healthy to keep working both in providing patient care and EMS education Michael Freeman

I do not feel obligated. I will not be vaccinated until the vaccine has undergone at least 5 years of trials, as it takes at least that long to develop a viable vaccine worthy to be on the market. Rushed things end in disaster. Amanda Langham

No I do not feel obligated to get a vaccine for COVID. No I will not be getting a vaccine. I do not feel this vaccination has been tested properly, and has been rushed for political reasons. Larry Swander

If there are five vaccines and we're not sure which one is effective I'll take all five. Being more afraid of vaccines than a novel corona virus with multi-organ pathology isn't rational. Steve Whitehead

If you have a choice be glad. Many of us will be given the option to be employed or not. JW Wernecke

The real reason? We all had time to watch I Am Legend at work. Mike Weller

I feel obligated, but I'm definitely not happy about it. Matt H.

I haven't had any vaccines in years and do not plan to get any now. I will let nature do its job and allow my body to build up immunity on its own. John Fischer

Yes. We have a duty to promote good health in the communities we serve and setting the example. Getting appropriate vaccines and wearing PPE even when it becomes tiresome is a part of enhancing the health of the communities we serve. Chris Williams

I have no faith in a rushed through vaccination. Ill pass, thank you. Denise Westcott

After a year of people getting it and not having issues, sure Brenda Morrissey

Not gonna be a first round Guinea Pig... On something rushed to market. Not when something is so low risk for me. Todd Semko

I dont even get the flu shot, and after 7 years of people breathing on me in the box...I think ill take my chances without it Jessica Blackwell

LoL look at the difference

Paramedics: okay, sure. As long as its backed by sound medicine

Boomers/EMTs/vollys/ FF: NO WAY, conspiracy! Danny Hofstedt

Well, a lot of us have had COVID already soo.... Jason Greene

Ill check the science. Probably would. Jim Steffen

I have no problem getting the vaccine IF it is studied completely, correctly and not rushed for political reasons. John Dix

Too many conspiracy theories believed even by people who should know better. Jake Sanders

Why. Already tested positive and was sick with it for 3 weeks. What can the vaccine do that catching it naturally couldn't do? Zach Briggs

Nope not going to get something that is being rushed for someone political gain. Something that hasnt been through phase 3 and being approved is a receipt for disaster. Dylan J. Wertman

I'd be ambivalent to say the least about being one of the first people to get the vaccination... however, serious long lasting side effects are so remote compared to say..... getting covid and dying.

You can't be a medical professional and anti-vax.

Don't want to be first? That's fine. But understand inoculation and how it works if you're going to work in this field.

The most likely worst scenario you get a mild immune response and an ineffective vaccination. Colin J. Williams

No, were not obligated to take any medication. Our patients have the right of refusal, so do we. Let congress and the pharmaceutical execs go first and lets see what happens. Scott Davis

Read next: Operation Warp Speed boldly going where no mass inoculation has gone before

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EMS providers on whether they will get a COVID-19 vaccine - EMS1.com

Numerous candidates are in late-stage assessment. An expert shares what the diverse agents should show before being considered for regulation.

A quartet of coronavirus 2019 (COVID-19) vaccine candidates are in phase 3 assessment, with another anticipated to reach the late-stage analysis phase later this month.

Clinicians and experts sitting idly by, awaiting more robust, longer, and stratified efficacy and safety data for the would-be first prophylaxes for the pandemic. What will be the first vaccine be, and what are clinicians looking for in data?

Bridget Calhoun, DrPH, MMS, Associate Dean for Academic Affairs and Research, and Chair and Associate Professor at Rangos School of Health Sciences at Duquesne University, joined Contagion to discuss how past vaccine development plansboth successful and failedinformed the communitys pursuit of diverse COVID-19 vaccine candidates, from varying platforms and dosages, to variable antigen makeup.

A lot of science goes into this, a lot of brilliant people are working on itand all from different approaches, Calhoun said.

Calhoun discussed the emphasis on short-term detectable antibodies, and the long-term hope for immunity longevity that may come from phase 3 results in the near future. Accomplishing the former has already been observed in early phases; the latter is an uncertainty relative to a still mostly unknown viral infection.

One of the biggest challenges is that viruses are dynamic, Calhoun said. Once we have the structure and sequencing of a virus, it can change.

Calhoun also discussed matters of vaccine distribution and prioritization in the US, and her hopes for a post-pandemic mindset that reflects lessons learned from the ordeal.

Hopefully well all resume back to some level of normalcy, but I hope people have a greater respect for infectious diseases, she said. In the war between viruses and man, we dont always win.

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What Should Be Achieved in Phase 3 COVID-19 Vaccine Trials? - Contagionlive.com

The race for a Covid-19 vaccine slowed on Tuesday, as both U.S. regulators and the head of the Trump administrations Operation Warp Speed initiative tapped ever so softly on the brakes.

The Food and Drug Administration released strengthened rules for authorizing any Covid-19 vaccine on an emergency basis. And Moncef Slaoui, co-chair of Operation Warp Speed, revealed that the governments vaccine fast-tracking effort has urged manufacturers not to apply for emergency use authorization until they have significant amounts of vaccines to deploy.

That could push back even the first such authorization expected to be for a vaccine being made by Pfizer and BioNTech, if it proves to be effective into sometime in mid- to late November.

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The one learning message that we came to was to recommend to the companies that we are supporting that if they achieve efficacy demonstration [of their vaccine] while there are no vaccine doses available at industrial scale to be able to immunize at least a relevant fraction of the population, that they should refrain or at least consider refraining for filing for an EUA, Slaoui said during a Covid-19 vaccines symposium on Tuesday.

Approval of a vaccine that wasnt actually available to use would be a major disappointment to the public, Slaoui said.

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There has been deep concern in the public health world that President Trump would seek to force the FDA to approve Covid-19 vaccines before Election Day and before large clinical trials currently underway to determine safety and efficacy have reached statistically significant conclusions. Polls suggest many Americans are wary of the vaccines being produced through Operation Warp Speed, and public health experts fear political interference in the approval process would further undermine public confidence.

The FDA has been attempting to strengthen the rules by which it would agree to issue an emergency use authorization, or EUA, for Covid-19 vaccines, but had been stymied by the White House. On Tuesday, the regulatory agency released the updated safety standards amid a number of guidance documents it posted online in advance of an important meeting on Oct. 22 of the vaccines and related biological products advisory committee, which advises the FDA on vaccine approvals.

According to the revised rules, the FDA wants vaccine manufacturers to collect safety data on at least half of their clinical trial subjects for two months after they have received their second dose of vaccine, if the candidate vaccine is a two-dose vaccine. (Of the current frontrunners in the vaccine race, only the Johnson & Johnson vaccine, which only recently began its Phase 3 trial, uses a one-dose regimen.)

Pfizer and BioNTech are viewed as most likely to deliver an early answer from trials of their vaccine, which uses a new technology called mRNA to mount an immune response to the virus. But at Pfizers virtual investor day on Sept. 15, the company said that 12,000 of its then-planned 30,000 volunteers had received a second dose meaning that Pfizer and BioNTech would not have enough data to apply for an EUA until mid-November at the earliest.

Pfizer and BioNTech have since said they would expand their study to include 44,000 patients. Its not clear whether the FDA would want two months of data on half the patients on the larger number, or the original 30,000.

Slaoui also stressed Tuesday that he expected the first efficacy data from Covid-19 vaccines to become available in November or December.

Peter Marks, the FDAs top vaccine regulator, insisted Tuesday that the two-month follow-up timeline was guided by data showing that the majority of adverse events occur roughly within two to three months after vaccine administration.

Theres something thats really amazing that you can actually use sometimes you can sometimes actually use data, Marks said during the symposium, staged by Johns Hopkins University and the University of Washington. We picked two months as something that was reasonably aggressive yet also somewhat kind of in the middle not too aggressive, not too conservative.

Former FDA Commissioner Scott Gottlieb groused during the event over how much political dust was kicked up by political officials over the FDAs guidance, for, he said, little gain. Gottlieb, who served in the Trump administration from 2017 to 2019 and now serves on the board of Pfizer, appeared to be referencing reportingthat White House officials were blocking release of the FDAs guidance, although he did not name specific officials nor specific media reports in his comments.

In addition to the Pfizer-BioNTech vaccine, an mRNA vaccine being produced by Cambridge, Mass.-based Moderna, is expected to have data within that time frame.

Slaoui told the symposium that though mRNA vaccines have never before been approved, both Moderna and Pfizer-BioNTech are now able to produce vaccine at industrial scale.

We are in the process of stockpiling doses in the single-digit million doses in the months of October and then in the tens of millions of doses in November, Slaoui said.

Nicholas Florko contributed reporting.

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Race for Covid-19 vaccine slows as US officials tap the brakes - STAT