Category: Corona Virus Vaccine

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaks during a news conference at the White House on April 16. Chris Kleponis/Polaris/Bloomberg via Getty Images hide caption

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaks during a news conference at the White House on April 16.

There's a chance that hundreds of millions of doses of a potential COVID-19 vaccine could be available by early next year, Dr. Anthony Fauci, a key member of the White House coronavirus task force, said Thursday, even though the federal government has not approved a vaccine against the virus.

In an appearance on NBC's Today Show, Fauci was asked whether he thought it was "in the realm of possibility" to have a potential vaccine ready for wide distribution by January.

"I do," Fauci replied. "I mean, I'm obviously part of the team that's involved in that."

Fauci, who heads the National Institute of Allergy and Infectious Diseases, noted that the ideal plan for a potential vaccine is to ensure it is safe and effective and can be rapidly scaled up for distribution.

Of course, the Food and Drug Administration has not approved a vaccine for the coronavirus. Noting that vaccine trials are still in the early phase, Fauci added that to accelerate production, the companies making the medicine would need to do so "at risk."

"In other words, you don't wait until you get an answer before you start manufacturing. You at risk proactively start making it, assuming it's going to work," Fauci said. "And if it does, then you can scale up and hopefully get to that timeline."

"I think that is doable if things fall in the right place," Fauci said.

Fauci was responding to a question about media reports that the Trump administration is launching a project dubbed Operation Warp Speed, to speed up delivery of a vaccine against COVID-19. The deadly disease has been diagnosed in more than a million people in the U.S.

The White House plan aims to bring together pharmaceutical companies, government agencies and the military with the goal of substantially shrinking the development time for a vaccine.

Bloomberg News, which first reported the existence of the plan to accelerate vaccine delivery, says the government's goal is to have as many as 300 million vaccine doses by early 2021.

As NPR science correspondent Joe Palca has reported, advances in science have revolutionized the speed at which vaccines can be developed.

"In the past it used to take 5-10 years to make a vaccine, and now people are talking about a year or 18 months. So it's really going faster than expected," Palca reported on NPR's Morning Edition this month.

He added that in addition to a vaccine that is safe for people, there are other factors to consider.

"You want one that generates a strong and lasting immune response. You need to be able to manufacture it. Sometimes you come up with a brilliant idea of how to package the virus and you just can't make it at a scale that would be useful. You want to have a vaccine that doesn't require special handling," Palca reports.

During the NBC interview, Fauci was asked whether he is nervous that stay-at-home orders are beginning to lift in many states, including Alabama, Texas, Arizona and Florida.

White House social distancing guidelines are set to expire at the end of April.

Fauci declined to give detailed assessments on individual states, but he pointed to White House guidelines for reopening state and local economies, which call for a "downward trajectory" of documented COVID-19 cases over a 14-day period.

Fauci said he expects to see an uptick in coronavirus cases when towns and states reopen for business.

"When you pull back, there will be cases," Fauci said. "And what we need to do is make sure they have in place the capability of identifying, isolating and contact-tracing individuals."

While he said he was "cautiously optimistic," Fauci also said governments must have "the core principles of the guidelines" before reopening.

"You can't just leap over things and get into a situation where you're really tempting a rebound. That's the thing I get concerned about," Fauci said. "I hope they don't do that."

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Fauci Says It's 'Doable' To Have Millions Of Doses Of COVID-19 Vaccine By January - NPR

A vaccine would be the ultimate weapon against the coronavirus and the best route back to normal life. Officials like Dr. Anthony S. Fauci, the top infectious disease expert on the Trump administrations coronavirus task force, estimate a vaccine could arrive in at least 12 to 18 months.

The grim truth behind this rosy forecast is that a vaccine probably wont arrive any time soon. Clinical trials almost never succeed. Weve never released a coronavirus vaccine for humans before. Our record for developing an entirely new vaccine is at least four years more time than the public or the economy can tolerate social-distancing orders.

But if there was any time to fast-track a vaccine, it is now. So Times Opinion asked vaccine experts how we could condense the timeline and get a vaccine in the next few months instead of years.

Heres how we might achieve the impossible.

Start trials early

Rely on work from studying SARS and MERS to shorten preparations before clinical trials

Dont wait for academic research

Skip to clinical phases using what we know about the coronavirus so far

Normally, researchers need years to secure funding, get approvals and study results piece by piece. But these are not normal times.

There are already at least 254 therapies and 95 vaccines related to Covid-19 being explored.

If you want to make that 18-month timeframe, one way to do that is put as many horses in the race as you can, said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine.

Select vaccines by clinical trial start date

Wuhan Institute and Sinopharm

Uses 1 microgram of

mRNA, meaning it

could be more easily

mass produced

Exploring a new form of

oral vaccine, which has

never been licensed

Select vaccines by clinical trial start date

Wuhan Institute and

Sinopharm

Uses

1 microgram

of mRNA, so

it may be

more easily

mass

produced

Exploring a new form of

oral vaccine, which has

never been licensed

Note: Clinical trial start dates are approximate. Compiled by Robert van Exan.

Despite the unprecedented push for a vaccine, researchers caution that less than 10 percent of drugs that enter clinical trials are ever approved by the Food and Drug Administration.

The rest fail in one way or another: They are not effective, dont perform better than existing drugs or have too many side effects.

Note: Between 2006 and 2015. Source: Biotechnology Innovation Organization, Biomedtracker, Amplion.

Fortunately, we already have a head start on the first phase of vaccine development: research. The outbreaks of SARS and MERS, which are also caused by coronaviruses, spurred lots of research. SARS and SARS-CoV-2, the virus that causes Covid-19, are roughly 80 percent identical, and both use so-called spike proteins to grab onto a specific receptor found on cells in human lungs. This helps explain how scientists developed a test for Covid-19 so quickly.

Theres a cost to moving so quickly, however. The potential Covid-19 vaccines now in the pipeline might be more likely to fail because of the swift march through the research phase, said Robert van Exan, a cell biologist who has worked in the vaccine industry for decades. He predicts we wont see a vaccine approved until at least 2021 or 2022, and even then, this is very optimistic and of relatively low probability.

And yet, he said, this kind of fast-tracking is worth the try maybe we will get lucky.

Note: Rotavirus and HPV vaccines include time from filing of the first investigational new drug to approval. Source: Plotkins Vaccines (7th edition)

The next step in the process is pre-clinical and preparation work, where a pilot factory is readied to produce enough vaccine for trials. Researchers relying on groundwork from the SARS and MERS outbreaks could theoretically move through planning steps swiftly.

Sanofi, a French biopharmaceutical company, expects to begin clinical trials late this year for a Covid-19 vaccine that it repurposed from work on a SARS vaccine. If successful, the vaccine could be ready by late 2021.

Use pandemic speed timeline

Start subsequent steps before previous phases are completed

Push to large-scale tests sooner

Move more swiftly to Phase 3 trials by combining phases

Use emergency provision

Vaccinate front-line and essential workers early

As a rule, researchers dont begin jabbing people with experimental vaccines until after rigorous safety checks.

They test the vaccine first on small batches of people a few dozen during Phase 1, then a few hundred in Phase 2, then thousands in Phase 3. Months normally pass between phases so that researchers can review the findings and get approvals for subsequent phases.

But if we do it the conventional way, theres no way were going to be reaching that timeline of 18 months, said Akiko Iwasaki, a professor of immunobiology at Yale University School of Medicine and an investigator at the Howard Hughes Medical Institute.

There are ways to slash time off this process by combining several phases and testing vaccines on more people without as much waiting.

Last week the National Academy of Sciences showed an overlapping timeline, describing it as moving at pandemic speed.

Its here that talk of fast-tracking the timeline meets the messiness of real life: What if a promising vaccine actually makes it easier to catch the virus, or makes the disease worse after someones infected?

Thats been the case for a few H.I.V. drugs and vaccines for dengue fever, because of a process called vaccine-induced enhancement, in which the body reacts unexpectedly and makes the disease more dangerous.

Researchers cant easily infect vaccinated participants with the coronavirus to see how the body behaves. They normally wait until some volunteers contract the virus naturally. That means dosing people in regions hit hardest by the virus, like New York, or vaccinating family members of an infected person to see if they get the virus next. If the pandemic subsides, this step could be slowed.

Thats why vaccines take such a long time, said Dr. Iwasaki. But were making everything very short. Hopefully we can evaluate these risks as they occur, as soon as possible.

This is where the vaccine timelines start to diverge depending on who you are, and where some people might get left behind.

If a vaccine proves successful in early trials, regulators could issue an emergency-use provision so that doctors, nurses and other essential workers could get vaccinated right away even before the end of the year. Researchers at Oxford announced this week that their coronavirus vaccine could be ready for emergency use by September if trials prove successful.

So researchers might produce a viable vaccine in just 12 to 18 months, but that doesnt mean youre going to get it. Millions of people could be in line before you. And thats only if the United States finds a vaccine first. If another country, like China, beats us to it, we could wait even longer while it doses its citizens first.

You might be glad of that, though, if it turned out that the fast-tracked vaccine caused unexpected problems. Only after hundreds or thousands are vaccinated would researchers be able to see if a fast-tracked vaccine led to problems like vaccine-induced enhancement.

Its true that any new technology comes with a learning curve, said Dr. Paul Offit, the director of the Vaccine Education Center at the Childrens Hospital of Philadelphia. And sometimes that learning curve has a human price.

Make vaccines early

Build and manufacture early, anticipating that factories will be useful for a future vaccine and that the product will clear regulatory hurdles

Take a bet on a successful mRNA vaccine

This experimental technology may be faster to produce than traditional vaccines

Once we have a working vaccine in hand, companies will need to start producing millions perhaps billions of doses, in addition to the millions of vaccine doses that are already made each year for mumps, measles and other illnesses. Its an undertaking almost unimaginable in scope.

Companies normally build new facilities perfectly tailored to any given vaccine because each vaccine requires different equipment. Some flu vaccines are produced using chicken eggs, using large facilities where a version of the virus is incubated and harvested. Other vaccines require vats in which a virus is cultured in a broth of animal cells and later inactivated and purified.

Those factories follow strict guidelines governing biological facilities and usually take around five years to build, costing at least three times more than conventional pharmaceutical factories. Manufacturers may be able to speed this up by creating or repurposing existing facilities in the middle of clinical trials, long before the vaccine in question receives F.D.A. approval.

They just cant wait, said Dr. Iwasaki. If it turns out to be a terrible vaccine, they wont distribute it. But at least theyll have the capability to do so if the vaccine is successful.

The Bill and Melinda Gates Foundation says it will build factories for seven different vaccines. Even though well end up picking at most two of them, were going to fund factories for all seven, just so that we dont waste time, Bill Gates said during an appearance on The Daily Show.

In the end, the United States will have the capacity to mass-produce only two or three vaccines, said Vijay Samant, the former head of vaccine manufacturing at Merck.

The manufacturing task is insurmountable, Mr. Samant said. I get sleepless nights thinking about it.

Consider just one seemingly simple step: putting the vaccine into vials. Manufacturers need to procure billions of vials, and billions of stoppers to seal them. Sophisticated machines are needed to fill them precisely, and each vial is inspected on a high-speed line. Then vials are stored, shipped and released to the public using a chain of temperature-controlled facilities and trucks. At each of these stages, producers are already stretched to meet existing demands, Mr. Samant said.

Its a bottleneck similar to the one that caused a dearth of ventilators, masks and other personal protective equipment just as Covid-19 surged across America.

If you talk about vaccines long enough, a new type of vaccine, called Messenger RNA (or mRNA for short), inevitably comes up. There are hopes it could be manufactured at a record clip. Mr. Gates even included it on his Time magazine list of six innovations that could change the world. Is it the miracle were waiting for?

Rather than injecting subjects with disease-specific antigens to stimulate antibody production, mRNA vaccines give the body instructions to create those antigens itself. Because mRNA vaccines dont need to be cultured in large quantities and then purified, they are much faster to produce. They could change the course of the fight against Covid-19.

On the other hand, said Dr. van Exan, no one has ever made an RNA vaccine for humans.

Researchers conducting dozens of trials hope to change that, including one by the pharmaceutical company Moderna. Backed by investor capital and spurred by federal funding of up to $483 million to tackle Covid-19, Moderna has already fast-tracked an mRNA vaccine. Its entering Phase 1 trials this year and the company says it could have a vaccine ready for front-line workers later this year.

Could it work? Yeah, it could work, said Dr. Fred Ledley, a professor of natural biology and applied sciences at Bentley University. But in terms of the probability of success, what our data says is that theres a lower chance of approval and the trials take longer.

The technology is decades old, yet mRNA is not very stable and can break down inside the body.

At this point, Im hoping for anything to work, said Dr. Iwasaki. If it does work, wonderful, thats great. We just dont know.

The fixation on mRNA shows the allure of new and untested treatments during a medical crisis. Faced with the unsatisfying reality that our standard arsenal takes years to progress, the mRNA vaccine offers an enticing story mixed with hope and a hint of mystery. But its riskier than other established approaches.

Fast-track federal approvals

Shorten approval window from a year to six months

Imagine that the fateful day arrives. Scientists have created a successful vaccine. Theyve manufactured huge quantities of it. People are dying. The economy is crumbling. Its time to start injecting people.

But first, the federal government wants to take a peek.

That might seem like a bureaucratic nightmare, a rubber stamp that could cost lives. Theres even a common gripe among researchers: For every scientist employed by the F.D.A., there are three lawyers. And all they care about is liability.

Yet F.D.A. approvals are no mere formality. Approvals typically take a full year, during which time scientists and advisory committees review the studies to make sure that the vaccine is as safe and effective as drug makers say it is.

While some steps in the vaccine timeline can be fast-tracked or skipped entirely, approvals arent one of them. There are horror stories from the past where vaccines were not properly tested. In the 1950s, for example, a poorly produced batch of a polio vaccine was approved in a few hours. It contained a version of the virus that wasnt quite dead, so patients who got it actually contracted polio. Several children died.

The same scenario playing out today could be devastating for Covid-19, with the anti-vaccination movement and online conspiracy theorists eager to disrupt the public health response. So while the F.D.A. might do this as fast as possible, expect months to pass before any vaccine gets a green light for mass public use.

At this point you might be asking: Why are all these research teams announcing such optimistic forecasts when so many experts are skeptical about even an 18-month timeline? Perhaps because its not just the public listening its investors, too.

These biotechs are putting out all these press announcements, said Dr. Hotez. You just need to recognize theyre writing this for their shareholders, not for the purposes of public health.

Covid-19 lives in the shadow of the most vexing virus weve ever faced: H.I.V. After nearly 40 years of work, here is what we have to show for our vaccine efforts: a few Phase 3 clinical trials, one of which actually made the disease worse, and another with a success rate of just 30 percent.

Deaths from

Covid-19 in

the U.S.

Deaths from

H.I.V./AIDS

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Opinion | How Long Will a Vaccine Really Take? - The New York Times

There is currently no vaccine for SARS-CoV-2, the virus that causes the novel coronavirus disease COVID-19 that has infected millions of people around the world.

But some posts on Facebook point out that a canine coronavirus vaccine has been around for years, and question why it hasnt been made for humans.

One post shares a photo displaying a vial of the vaccine, with text along the top that says, "Now this was 2001 tell me why 19 years later they say there is no vaccine share before they take it down again."

The posts caption reads: "Canine vaccine for dogs and not humans? And since 2001.....STAY WOKE PEOPLE!!" Other versions that have been debunked went even further and questioned why the dog vaccine isnt being used in humans.

A couple of key problems here:

The vaccine is for dogs, not humans.

Its not for COVID-19.

The post was flagged as part of Facebooks efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Facebook.)

RELATED: Bovine coronavirus vaccine wont help humans

The term "coronavirus" refers to a large family of viruses that are known to cause various illnesses ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS), according to the World Health Organization.

The novel coronavirus SARS-CoV-2 at the center of the current pandemic was discovered in 2019. It had not been previously identified in humans. No vaccine for it could have been developed before that.

The vaccine in the photo is real, but its for canine coronavirus disease, known also as CCoV.

Merck Animal Health makes the vaccine and now includes a note on its webpage explaining that canine coronaviruses "are not the same virus as SARS-CoV-2 that is responsible for causing the COVID-19 infection."

According to VCA Animal Hospitals, which operates nearly 800 animal hospitals in the U.S., the canine coronavirus comes from the Coronaviridae family and is a "highly infectious intestinal infection in dogs, especially puppies."

"There are many types of coronavirus, each affecting different animal species, including humans. Canine coronavirus (CCoV) is not the same virus as SARS-CoV-2," which causes COVID-19, the company says. "CCoV does not affect people. CCoV causes gastrointestinal problems in dogs, as opposed to respiratory disease."

A vaccine is available for dogs with canine coronavirus, which causes gastrointestinal issues. It is not for prevention of COVID-19 in humans; there is no vaccine for that.

We rate this False.

Originally posted here:

A canine coronavirus vaccine exists. But it has nothing to do with COVID-19 - PolitiFact

As the world waits for a coronavirus vaccine, tens of thousands of people could die. But some scientists believe a vaccine might already exist.

Surprising new research in a niche area of immunology suggests that certain live vaccines that have been around for decades could, possibly, protect against the coronavirus. The theory is that these vaccines could make people less likely to experience serious symptoms or even any symptoms if they catch it.

At more than 25 universities and clinical centers around the world, researchers have begun clinical trials, primarily in health care workers, to test whether a live tuberculosis vaccine that has been in use for 99 years called the bacillus Calmette-Gurin, or B.C.G., vaccine, could reduce the risks associated with the coronavirus.

Another small but esteemed group of scientists is raising money to test the potential protective effects of a 60-year-old live polio vaccine called O.P.V.

Its counterintuitive to think that old vaccines created to fight very different pathogens could defend against the coronavirus. The idea is controversial in part because it challenges the dogma about how vaccines work.

But scientists understanding of an arm of immunology known as innate immunity has shifted in recent years. A growing body of research suggests that live vaccines, which are made from living but attenuated pathogens (as opposed to inactivated vaccines, which use dead pathogens) provide broad protection against infections in ways that no one anticipated.

We cant be certain as to what the outcome will be, but I suspect itll have an effect on the coronavirus, said Jeffrey Cirillo, a microbiologist and immunologist at Texas A&M University who is leading one of the B.C.G. trials. Question is, how big will it be?

Scientists stress that these vaccines will not be a panacea. They might make symptoms milder, but they probably wont eliminate them. And the protection, if it occurs, would most likely last only a few years.

Still, these could be a first step, said Dr. Mihai Netea, an immunologist at Radboud University in the Netherlands who is leading another one of the trials. They can be the bridge until you have the time to develop a specific vaccine.

The first evidence to suggest that live vaccines could be broadly protective trickled in nearly a century ago, but no one knew what to make of it. In 1927, soon after B.C.G. was rolled out, Carl Naslund of the Swedish Tuberculosis Society observed that children vaccinated with the live tuberculosis vaccine were three times less likely to die of any cause compared with kids who werent.

One is tempted to explain this very low mortality among vaccinated children by the idea that B.C.G. vaccine provokes a nonspecific immunity, he wrote in 1932.

Then, in clinical trials conducted in the 1940s and 50s in the United States and Britain, researchers found that B.C.G. reduced nonaccidental deaths from causes other than tuberculosis by an average of 25 percent.

Also in the 1950s, Russian researchers, including Marina Voroshilova of the Academy of Medical Science in Moscow, noticed that people who had been given the live polio vaccine, compared with people who hadnt, were far less likely to fall ill with the seasonal flu and other respiratory infections. She and other scientists undertook a clinical trial involving 320,000 Russians to more carefully test these mysterious effects.

They found that among individuals who had received the live polio vaccine, the incidence of seasonal influenza was reduced by 75 percent, said Konstantin Chumakov, Voroshilovas son, who is now an associate director for research in the U.S. Food and Drug Administrations Office of Vaccines Research and Review.

Recent studies have produced similar findings. In a 2016 review of 68 papers commissioned by the World Health Organization, a team of researchers concluded that B.C.G., along with other live vaccines, reduce overall mortality by more than would be expected through their effects on the diseases they prevent.

The W.H.O. has long been skeptical about these nonspecific effects, in part because much of the research on them has involved observational studies that dont establish cause and effect. But in a recent report incorporating newer results from some clinical trials, the organization described nonspecific vaccine effects as plausible and common.

Dr. Stanley Plotkin, a vaccinologist and emeritus professor at the University of Pennsylvania who developed the rubella vaccine but has no involvement in the current research, agreed. Vaccines can affect the immune system beyond the response to the specific pathogen, he said.

Peter Aaby, a Danish anthropologist who has spent 40 years studying the nonspecific effects of vaccines in Guinea-Bissau, in West Africa, and whose findings have been criticized as implausible, is hopeful that these trials will be a tipping point for research in the field. Its kind of a golden moment in terms of actually having this taken seriously, he said.

The possibility that vaccines could have nonspecific effects is brow-furrowing in part because scientists have long believed that vaccines work by stimulating the bodys highly specific adaptive immune system.

After receiving a vaccine against, say, polio, a persons body creates an army of polio-specific antibodies that recognize and attack the virus before it has a chance to take hold. Antibodies against polio cant fight off infections caused by other pathogens, though so, based on this framework, polio vaccines should not be able to reduce the risk associated with other viruses, such as the coronavirus.

But over the past decade, immunologists have discovered that live vaccines also stimulate the innate immune system, which is less specific but much faster. They have found that the innate immune system can be trained by live vaccines to better fight off various kinds of pathogens.

For instance, in a 2018 study, Dr. Netea and his colleagues vaccinated volunteers with either B.C.G. or a placebo and then infected them all with a harmless version of the yellow fever virus. Those who had been given B.C.G. were better able to fight off yellow fever.

Research by Dr. Netea and others shows that live vaccines train the bodys immune system by initiating changes in some stem cells. Among other things, the vaccines initiate the creation of tiny marks that help cells turn on genes involved in immune protection against multiple pathogens.

This area of innate immunity is one of the hottest areas in fundamental immunology today, said Dr. Robert Gallo, the director of the Institute of Human Virology at the University of Maryland School of Medicine and co-founder of the Global Virus Network, a coalition of virologists from more than 30 countries. In the 1980s, Dr. Gallo helped to identify H.I.V. as the cause of AIDS.

Dr. Gallo is leading the charge to test the O.P.V. live polio vaccine as a treatment for coronavirus. He and his colleagues hope to start a clinical trial on health care workers in New York City and Maryland within six weeks.

O.P.V. is routinely used in 143 countries, but no longer in the United States. An inactivated polio vaccine was reintroduced here in 1997, in part because one out of every 2.7 million people who receive the live vaccine can actually develop polio from it.

But O.P.V. does not pose this risk to Americans who have received a polio vaccine in the past. We believe this is very, very, very safe, Dr. Gallo said. Its also inexpensive at 12 cents a dose, and is administered orally, so it doesnt require needles.

Some scientists have raised concerns over whether these vaccines could increase the risk for cytokine storms deadly inflammatory reactions that have been observed in some people weeks after they have been infected with the coronavirus. Dr. Netea and others said that they were taking these concerns seriously but did not anticipate problems. For one thing, the vaccines will be given only to healthy people not to people who are already infected.

Also, B.C.G. may actually be able to ramp up the bodys initial immune response in ways that reduce the amount of virus in the body, such that an inflammatory response never occurs. It may lead to less infection to start with, said Dr. Moshe Arditi, the director of the Infectious and Immunological Diseases Research Center at Cedars-Sinai Medical Center in Los Angeles, who is leading one of the trial arms.

The science on this is still early days. Several pre-prints scientific papers that have not yet been peer-reviewed published over the past few months support the idea that B.C.G. could protect against the coronavirus. They have reported, for instance, that death rates are lower in countries that routinely vaccinate children with B.C.G. But these studies can be fraught with bias and difficult to interpret; its impossible to know whether the vaccinations, or something else, provided the protection.

Such studies are at the very bottom of the evidence hierarchy, said Dr. Christine Stabell Benn, who is raising funds for a Danish B.C.G trial. She added that the protective effects of a dose of B.C.G given to adults decades ago, when they were infants, may well differ from the protective effects the vaccine could provide when given to adults during an outbreak.

In the end, said Dr. Netea, only the clinical trials will give the answer.

Thankfully, that answer will come very soon. Initial results from the trials that are underway may be available within a few months. If these researchers are right, these old vaccines could buy us time and save thousands of lives while we work to develop a new one.

Melinda Wenner Moyer is a science and health writer and the author of a forthcoming book on raising children.

Originally posted here:

Could Innate Immunology Save Us From the Coronavirus? - The New York Times

NEW YORK (CBSNewYork) In what is thought to be the Holy Grail of this COVID-19 pandemic, dozens of companies are racing to produce a vaccine that will be safe and effective at preventing the novel coronavirus infection.

But coronaviruses have been notoriously difficult to make vaccines against, and we dont know which of the many vaccine approaches will actually work. Thats why federal health officials announced a new kind of vaccine Manhattan Project, called Operation Warp Speed.

The ambitious effort calls for making 300 million doses of a vaccine by the end of the year.

Were in phase one. When you go to next phase, you work quickly to get an answer as to whether it works and is safe. And if it is, you ramp up production, you dont wait to get the answer before you start production, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

In other words, the government wants all of the potential manufacturers to go ahead and make their vaccines, risking that theirs will be proven safe and effective, and then be prepared to manufacture the millions of doses required.

Theres risk here. That means choosing in advance which vaccine you think will work, putting capital at risk, manufacturing it with the hope that they work, said CBS News medical contributor Dr. David Agus.

But Agus says its also key to think forward.

Watch Jessica Laytons report

Perhaps the vaccine furthest along in testing comes from the University of Oxford in England. That team says it has already vaccinated hundreds of people with their experimental COVID-19 vaccine and expect trial results in mid-June. At that point, thousands of volunteers will have to be vaccinated to see if they are truly protected and get fewer infections than a control group.

The probably earliest time that we could probably scale manufacturing would be the beginning of July, but the intention is to make enough doses so that were it approved in, say, September, we would actually have 30 million doses, said Dr. John Bell, of the University of Oxford.

Its pretty wild. I mean, this is the university that survived the plague in the 1300s. They had developed a vaccine for MERS, a former virus, that was tried in patients, did not spread the virus, so the vaccine was shelved. And they just switched out the portion from MERS to COVID-19 and put it into monkeys and challenged monkeys with the virus, After 28 days, no signs or symptoms from the virus at all, said CBS News contributor Dr. David Agus. So, because it had already been in patients, a similar virus, theyre starting out with 6,000 patients over the next six weeks.

That test phase can take many months, unless regulators are willing to conditionally approve the vaccine based on preliminary evidence.

The university is partnering with U.K.-based global biopharmaceutical company AstraZeneca to manufacture this vaccine on a large scale. Both groups have agreed to operate on a not-for-profit basis for the duration of the pandemic.

Fauci is also expressing hope about a drug called Remdesivir, which could be used on patients hospitalized with the with the virus. Its being tested now at the National Institutes of Health, although it is still early in that process.

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Agus spoke about the potential treatment on CBS This Morning.

You know, mid-January was my first meeting on COVID-19, and literally every day since then, weve dreamt of the moment we could say that we have a drug that we know works. And we can say that here, Agus said. We have something in our arsenal to treat the disease. That is exciting.

Agus said the drug has been tried on 1,000 patients and decreased hospitalizations by about four days and a declining death rate. The drug has been tried on people who are moderately to severely ill.

Agus cautioned the National Institutes of Health study hasnt yet been peer reviewed.

He called the two developments big, big steps.

Certainly, an amazing day in the fight against COVID-19. First positive one in a while, Agus said.

Its an optimistic and aggressive timeline, but if it happens, it would be just in time for a potential second wave of the virus.

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Coronavirus Vaccines Being Developed By Dozens Of Companies As Part Of Operation Warp Speed - CBS New York

Fewer than half of Americans plan to go to sports events, concerts, movies and amusement parks when they reopen to the public until there is a proven coronavirus vaccine, according to a Reuters/Ipsos opinion poll released on Tuesday.

That includes those who have attended such events in the past, an ominous sign for the sports and entertainment industries hoping to return to the spotlight after being shut down by the pandemic.

Only about four in 10 who follow sports avidly and go to arts and entertainment venues and amusement parks said they would do so again if they reopened before a vaccine was available, the poll found.

Another four in 10 said they were willing to wait, even if it takes more than a year to develop a vaccine.

The rest said they either dont know what to do or may never attend those events again.

Just because people say we can go back, until people feel fully safe they arent going to go back, said Victor Matheson, a specialist in sports economics at the College of the Holy Cross in Massachusetts.

We go to games for entertainment and youre not going to be very entertained if youre not worrying about who the next player to bat is and instead worrying about that person who just coughed two rows down.

The United States leads the world with almost 1 million coronavirus infections and more than 56,000 deaths as of late Monday.

While as many as 100 potential vaccines are in development around the world, scientists are projecting that bringing one to market could take 18 months.

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Most Americans to avoid sports, other live events until there's a coronavirus vaccine - New York Post

The world is racing to find ways to treat and prevent the novel coronavirus.

Both preventing and treating the disease, experts say, are critical to lessening social distancing measure that have been put in place to minimize the spread of the coronavirus.

While we might never get back to the "normal life" we knew before the pandemic, getting out from under lockdown-like conditions will hinge greatly on whether a vaccine can be developed, and if we can get treatments that are effective in treating COVID-19, the disease caused by the novel coronavirus.

Vaccines are used to prepare the body's immune system to fight off infections. They work by giving the body a small taste of what the virus is like so that way it can produce antibodies that fight off an intruding virus, ideally keeping people from falling ill. Some vaccines protect better than others, and they're typically administered across broad populations.

There are vaccines for some infectious diseases, like the flu, smallpox, measles, and chickenpox. But others, like HIV and hepatitis C, don't have vaccines that protect against them. Vaccines that protect against two other deadly outbreaks, MERS and SARS, have yet to be approved after the outbreaks subsided.

There are more than 70 potential coronavirus vaccines in the works, with a number in early human trials. Drugmakers are looking into ways to produce the billions of doses that might be needed to suppress the pandemic.

Read more: There are more than 70 potential coronavirus vaccines in the works. Here are the top efforts to watch, including the 16 vaccines set to be tested in people this year.

FILE - In this March 2020 photo provided by Gilead Sciences, a vial of the investigational drug remdesivir is visually inspected at a Gilead manufacturing site in the United States. Given through an IV, the medication is designed to interfere with an enzyme that reproduces viral genetic material. (Gilead Sciences via AP) Associated Press

Treatments,on the other hand, are meant to do just that: treat COVID-19, helping patients sickened by the virus survive and recover more quickly. Treatments for disease are there to lessen symptoms and ultimately improve the outcomes of a particular disease.

Sometimes, medications can be used preventatively. For instance, patients with high cholesterol might be prescribed a medication called a statin to prevent heart attacks. Some potential coronavirus treatments are being studied to see if they can prevent people from contracting the virus in the first place.

For COVID-19, researchers are testing everything from antimalarial medications to antivirals, to even common heartburn medications in hospitalized patients with the hopes that more patients will survive severe forms of the illness and potentially recover faster. Some are looking at ways to use patients' own bodies to fight the virus with antibody treatments.

Read more: We just got more promising data on Gilead's potential coronavirus drug. Here's everything we know about remdesivir and 14 other leading coronavirus treatments.

On Wednesday, Gilead Sciences, a biotech company that makes remdesivir, one of the experimental treatments being tested in coronavirus patients, said it had succeeded in a crucial study, raising hopes for the drug's use in treating patients.

Treatments, especially for hospitalized patients, are critical to develop to provide more tools for doctors to treat the disease. Ultimately, as social distancing measures lessen, it'll keep hospitals from being overrun with patients who tend to be hospitalized for weeks.

Read more: Here's how 13 top drugmakers are sprinting to develop a coronavirus vaccine or treatment that can halt this pandemic

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What's the difference between a vaccine and a treatment for coronavirus - Business Insider - Business Insider

Support is growing around the world for initiatives that involve deliberate infection of healthy young people with the coronavirus to test the effectiveness of experimental vaccines. An organization called 1 Day Sooner has already enlisted more than 3,400 people from 52 countries, who have volunteered to be vaccinated in this controversial approach, also known as human challenge trials (HCT). The initiative is not linked to any companies or research groups that are currently working to develop a vaccine, but it exemplifies the mounting interest in smart ways to find an effective vaccine sooner than predicted.

One reason for the lengthy time frame needed to develop a new vaccine is the standard structure what is typically the last stage of testing: efficacy testing, or phase III trials. Usually, a vaccine is initially developed in a lab.

Then its efficacy is tested in vitro and in animals. After these trials show that the vaccine prevents infection of animals that were exposed to the virus, researchers move to the first clinical stage testing the safety of the vaccine for use in humans. At this stage, it is given to a small group of healthy subjects, and researchers check to see whether there are any negative side effects.

Aftersafety testingis complete, complete, and there are some demonstrated effects on recipients immune systems, comes efficacy testing. Development teams give the vaccine to a large group of volunteers, and a placebo vaccine to control groups. Both are monitored over time to see if there is any difference in the rate of infection or high viral load in those who received the vaccine and the control group.

The advantage of HCT is that by deliberately exposing subjects to the virus, which is not done in standard trials, a clear answer concerning the vaccines efficacy can be obtained more quickly.

In an article published in late March in The Journal of Infectious Diseases, Nir Eyal of Rutgers University, Mark Lipsitch of Harvard University and Peter G. Smith of the School of Hygiene & Tropical Medicine in London, laid out the advantages of HCT. Vaccines are our ticket out of the crisis, says Prof. Eyal. If we have a vaccine a few months sooner, well be able to save millions of people from dying from the coronavirus, other diseases and of famine on a biblical scale (as per the UN).

This isnt the first time that the idea of human challenge testing has been considered by the international scientific community. Edward Jenner, the physician who developed the worlds first vaccine, against smallpox, exposed his gardeners son, eight-year-old James Phipps, to cowpox after he discovered that milkmaids who developed this disease displayed immunity to smallpox. A few weeks later, he exposed the child to smallpox, and saw that the boy did not develop the disease. Based on this experiment, Jenner produced the worlds first vaccine in 1796.

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But even today, when scientists and physicians must follow strict rules of ethics and cannot expose poor children to serious diseases, human challenge testing is being done though mostly for relatively mild illnesses.

In recent years, researchers have been testing the efficacy of a number of flu vaccines versus various strains of the flu virus. In previous decades, the development of vaccines for cholera and malaria also relied in part on human challenge testing. More recently, various groups around the world have conducted human testing trials for vaccines against weakened versions of the viruses that cause dengue fever and typhoid.

Increased risk

Regulatory standards for HCT vary widely among different countries. In Britain, the authorities are more inclined to permit such testing than those in the U.S. In 2016, a research group at Oxford University used HCT in a trial where subjects who had received an experimental vaccine were exposed to the abdominal typhus bacterium and then sent home (despite a concern that they could infect others).

Regulations for this type of testing are stricter in the United States. A few years ago, the U.S. considered HCT for a vaccine against the Zika virus, but ultimately decided to avoid the risk.

In the current pandemic, there is pressure to change the U.S. approach. Thirty-five members of Congress recently signed a statement calling on the Food and Drug Adminsitration, as well as the Department of Health and Human Services, to approve HCT for vaccine trials for the novel coronavirus citing the article by Eyal and his colleagues. In the past, regulatory authorities saw human challenge trials as an initial filter before moving on to wide-scale testing. But given the intensity of the current medical, economic and social crisis, We think the regulator should deviate from its habits. Eyal told Haaretz.

Opponents of the approach say there are still too many unknowns about how the novel coronavirus works. Human challenge trials require the controlled breeding of the virus and determination of the optimal dosage for exposure. Another problem is that certain vaccines may actually exacerbate the illness rather than prevent the infection. This increases the risk and thus the ethical concerns of deliberately exposing healthy subjects to the virus.

Eyal says HCT also has significant advantages for the subjects. First, the number of participants in a trial is low (between 100 and 200), so it is possible to ensure access to intensive care for them if necessary, which could be vital if the subjects are recruited, as he recommends, from areas where there is a high rate of infection and ICUs are not accepting new patients. Second, the risk of complications due to the vaccine is reduced with HCT, since the subjects are kept in isolation under constant medical supervision, unlike the thousands of participants in ordinary vaccine trials. And third, with HCT, the subjects know there is no risk that they will infect their family members.

People may conclude that they have a high risk of getting infected and so they would rather do it in a supervised way under safe conditions, Eyal says. The Rutgers University researcher adds that, because of the need to first breed the virus in a controlled fashion and to determine the correct dosage, preliminary studies for HCT should already begin and suitable research facilities should be prepared, so if the go-ahead for these trials is given, no time will be wasted.

Some say, however, that the controversial approach is not needed in the current crisis. Myron Levine, an infectious disease specialist from the University of Maryland who has been conducting human challenge trials for other vaccines for over 40 years, told the news website of Science magazine that he believes standard vaccine testing will be much faster than many people think. Because of the high rates of infection occurring in many places, standard trials will be able to draw conclusions about the vaccines efficacy within a similar time frame to that of HCT, he says.

For example, the Chinese company Sinovac Biotech, which began clinical trials of a COVID-19 vaccine last week, announced that it hopes to complete the first two phases of testing by the end of June. If the trials are successful, the company hopes to apply for regulatory approval to conduct the third phase of testing on at-risk populations such as medical personnel, which is an alternative way to accelerate the efficacy testing of the vaccine without seeking volunteers to be deliberately infected.

On the other hand, says Eyal, regular vaccine studies can take a long time, and sometimes they are never completed as with a study of an experimental vaccine for Ebola that was suspended because the epidemic abated in the place where the trial was being conducted. In China the disease is on the decline, and its unclear if there will be enough doctors who are candidates to get the vaccine. In HCT, results are promised within a limited time frame.

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American-Israeli professor is spearheading efforts to accelerate coronavirus vaccine. Thousands line up to get infected - Haaretz

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SUMMARY: Yes, we'll waste billions and risk lives in a fast search for a coronavirus vaccine but it's worth it. More corroboration for the Biden sexual-assault allegation. College presidents are right: Colleges need to open in the fall. Open the parks and beaches! Stop judging people who go outside! Biden to announce a "committee" to evaluate VP candidates? Come on!

A lab technician working on samples from people to be tested for the new coronavirus at "Fire Eye" laboratory in Wuhan in China's central Hubei Province. Getty

Insider's Bill Bostock reports that the world's largest vaccine maker is going to manufacture 40 million doses of a COVID-19 vaccine candidate this summer, even though the vaccine hasn't been tested yet, might not be safe, or might not work. That's great news.

This is just one of what promise to be many apparently wasteful and risky attempts to create a vaccine most of which will fail. Other pharma and biotech firms like Johnson & Johnson and Moderna are similarly ramping up vaccine manufacturing, before they know if the shots will work.

Bill Gates has proposed spending billions of dollars to build multiple vaccine-manufacturing plants to scale up production of seven different untested vaccines, though only one is likely to be effective. The Coalition for Epidemic Preparedness Innovations (CEPI) is going to spend $2 billion to accelerate production of several vaccine candidates, most of which will likely go to waste.

Others propose to risk human lives to speed up vaccine testing. Some leading scientists want to launch "human challenge" trials for coronavirus vaccines. In these trials, volunteers would be given experimental vaccines or a placebo and then deliberately exposed to the coronavirus.

This would massively accelerate knowledge about whether the vaccine works, because we wouldn't have to wait months to see if the test subjects contract the disease in the normal course of life. But some of the volunteer subjects would also fall ill especially if it's a placebo trial and given how terrible COVID-19 is, some would likely die. This is also especially worrying in the current context because we have no effective treatment to help those who do get sick.

Wasting money and potentially harming people obviously aren't good. But, right now, the risks are worth it. That's because our enemy is time.

The normal processes of pharmaceutical research manufacturing only when you know a drug works, and only testing in the safest ways make sense in normal situations. But every day we don't have a vaccine, thousands die, billions of dollars in economic activity are lost, and human welfare declines. Our future selves become poorer and sicker.

So there is literally almost nothing we shouldn't try to get us a vaccine quicker, even if that means building factories that make vaccines that don't work and conducting potentially deadly trials on volunteers. DP

We now have more corroboration of the sexual-assault allegation against then-Sen. Biden in 1993.

Rich McHugh writes in Insider that a neighbor of Tara Reade, the former Biden staffer who recently filed a criminal complaint accusing him of assaulting her in a hallway, has come forward to corroborate her story.

The neighbor, Lynda LaCasse, says Reade told her about the alleged incident in 1995 or 1996, a few years after Reade says it occurred. LaCasse said Reade shared with her many of the same details that Reade has recently alleged.

LaCasse says Reade did not ask her to come forward now. She adds that she is a Democrat and plans to vote for Biden. She says she came forward because she believes it was the right thing to do.

A second corroborator, Lorraine Sanchez, was a colleague of Reade's in a California state senator's office after she left Washington DC. Sanchez says Reade told her that her former boss in Washington had harassed her. Sanchez did not recall whether Reade went into detail.

Biden's campaign has said Reade's allegation is false. Biden himself has not commented on it. He's going to have to.

Read Rich McHugh's latest report here.

The Purdue marching band. Chris T Pehlivan / Shutterstock.com

Crowded parties, football stadiums, dorms, lecture halls colleges are paradise for a zealous coronavirus, which is why they all shut down, and fast, in March. But most universities and colleges can't afford to stay closed for long. They carry huge faculty and staff costs, and own expensive physical plants.

Colleges also depend on tuition to pay their bills. And most can't simply transition to remote learning, because students won't stand for it. They're paying for the college experience, for working together in labs and studios, living together in dorms.

So it's expected and encouraging that we're now seeing a rush of college presidents pushing bold ideas about how to reopen in the fall, even without a coronavirus vaccine or treatment.

In an inspiring letter, president Mitch Daniels said Purdue University is "determined not to surrender helplessly to those [COVID-19] difficulties but to tackle and manage them aggressively and creatively." Daniels argues that the virus is not an intolerable risk for the young. He proposes to test everyone in August, reopen campus for those under 35 years old, segregate those older than 35 or at particular risk from the general population, and track and contact trace the infected.

Will it work? Who knows? But it's heartening to see this kind of practical problem-solving from one of the world's greatest engineering schools. We're not going to learn how to live with the virus without some creative, even unorthodox thinking, and it makes sense to use universities which are the front lines of American research, after all as laboratories.

For example, Brown University president Christina Paxson acknowledges that reopening colleges will almost certainly require using technology that infringes on civil liberties to vigorously track students and faculty. That seems like an infringement worth a test, and no better place to try it out than in the limited space of a campus.

What Purdue president Daniels doesn't say is that the decision by some schools to reopen will put pressure on other schools, since no college will want to risk losing its students to rivals that have reopened. But not every college will have the resources to test and track in the way Purdue or Brown can, so there will definitely be campus COVID-19 clusters in the fall. DP

Fort Greene Park on April 23, 2020, in the Clinton Hill neighborhood of Brooklyn, New York. Mike Lawrie/Getty Images

As pressure builds for lockdowns to be relaxed or dropped, it's time to get more sophisticated about which measures actually have a big effect on slowing the coronavirus and which don't.

Concentrating our efforts on measures that really matter, while giving us more freedom by relaxing those that don't, will enable us to keep the crucial tactics in place for longer.

So here's a suggestion:

Relax restrictions that encourage or compel people to stay indoors.

The virus spreads primarily by droplets getting from one infected person's nose and mouth to another person's, in sufficient quantities and duration to cause an infection. Sunlight kills the virus quickly, and wind disperses it. Studies suggest that transmission almost exclusively occurs indoors.

As Insider's Anna Medaris Miller explains, experts are confident that being outside is low risk, especially when you are properly distanced. When you're distanced and wearing a mask, in fact, it would take something amounting to a "freak accident" for you to catch the virus or infect someone else outside, even if you passed close by each other.

A new study from China underscores this. It looked at 318 "outbreaks" that involved three or more cases. Not a single one of these infections occurred outdoors. (Most of them occurred within homes, with one family member infecting others. It has another important implication for more sophisticated distancing measures namely, creating isolation and quarantine facilities outside of homes but we'll leave that for another day.)

In a broader look at 7,324 cases, in fact, the researchers found only one case in which infection appears to have occurred outdoors. It involved two people in a village who had a conversation after one of them returned from a visit to Wuhan.

To be clear: It's not impossible to catch or transmit the virus outside. But it's rare. And with minimal precautions some distancing and a mask it should be extremely rare.

Meanwhile, going outside has all sorts of psychological and physiological benefits, including allowing us to feel more free and less trapped. As Anna Medaris Miller posits, even experts who fully support distancing measures believe that these benefits offset the risks. Respected Harvard epidemiologist Marc Lipsitch who generally supports strict distancing measures believes there is a net benefit to keeping open spaces open.

So open the parks!

And go outside! HB

Everyone's eager to know who VP Biden will choose as his running mate.

Instead of just making the decision and then telling us the answer, however, Biden reportedly plans to first announce the selection of a "committee" who will evaluate the candidates.

Yes, the Trump habit of dismissing experts and making impulsive decisions with minimal consideration based on his own "gut instinct" leads to imprecision and mistakes. And, yes, the country is suffering for this.

But announcing a committee to evaluate potential VP candidates is going too far the other way.

Of course Biden should have a team evaluate prospective candidates. But he doesn't need to announce in advance who these people are. He also doesn't need to remind Americans that Democrats have a reputation for being overly bureaucratic in their decision-making. HB

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INSIDER TODAY: Yes, we should waste billions and risk lives to get a vaccine - Business Insider - Business Insider

As experts across the world race to find a vaccine for the coronavirus, a team at Oxford University say their version is showing early promise. They hope to have it ready by September. As the NBC News series The Search for Solutions continues, Kelly Cobiella reports for TODAY from London.April 29, 2020

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Oxford team may lead in race to find a coronavirus vaccine - TODAY