Category: Covid-19 Vaccine

Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said he's worried that any problems with Russia's newly approved COVID-19 vaccine will undermine public confidence in any vaccine for the virus. (Aug. 11) AP Domestic

While companies race to produce a safe, effective vaccine for the novel coronavirus, a crucial question remains: Will enough people take it to make a difference?

Early statistics are grim.

Only about one-third of Americans say they'd be very likely to get a vaccine to prevent COVID-19, according to a poll released last month virtually unchanged since the spring.

More people said they would get it if the vaccine were free, and others said they would sign on if there was a second wave of infections a sign that while many Americans are hesitant about a vaccine, their opinions aren't set in stone.

But convincingthem that getting a vaccine is a good idea will take effort and money. And so far, no federal dollars have been set asidefor vaccine education.

Peter Pitts oversaw the Food and Drug Administration's public outreach programs during the George W. Bush administration. Back then, as now, there was no budget.

"It was all bully pulpit stuff, and that only goes so far," said Pitts, now president and co-founder of the Center for Medicine in the Public Interest, a New York-basednonpartisan think tank.

Nowwe're in a global crisis, and funding and attention is urgent, he said. "As far as I can tell, there's no strategy on the federal or state or local levels to educate the public relative the value of a COVID vaccine specifically, or to vaccines just in general."

Two decades ago, the Human Genome Project a $3 billion effort to map every gene set aside 3% to 5% of its budget for public communication, said Emily Brunson, a medical anthropologist at Texas State University. She'd like to see the same thing done with COVID-19 vaccine development.

She and other advocates fear that if the work doesn't start soon, it'll be too late. A vaccine is likely to receive federal approval as soon as later this year.

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Not everyone is hesitant for the same reasons.

People of color often have been treated poorly by the medical establishment, so they have good reason to be distrustful, said Dr. Bisola Ojikutu, an infectious disease specialist at Brigham and Women's and Massachusetts General hospitals in Boston.

Ojikutu said she's confident in the vaccine development process because of her own knowledge of the system and some of the people involved. But others will need to be convinced. "I'm concerned whether or not communities of color are going to take it," she said.

Latinos, for instance, may be afraid of authority because of the administration's aggressive immigration policies. They also often hold essential jobs with inflexible hours, which may make it challenging for them to get a vaccineeven if they want one.

Different strategies will be needed to address different causes of vaccine hesitancy, said Monica Schoch-Spana, who with Brunson co-chaired a Working Group on Readying Populations for COVID-19 Vaccinesthat recently produced a white paper.

People concerned about safety will need reassurance; people of color will need to be engaged in a process that builds trust; and people worried about government overreach will need to be heard, said Schoch-Spana, a senior scholar with the Johns Hopkins Center for Health Security.

More research will also be needed to fully appreciate this hesitation, said Lois Privor-Dumm, a senior research associate with theJohns Hopkins Bloomberg School of Public Health and anexpert in vaccine introduction.

"Understanding and respecting what people believe and what is important to them is really crucial," she said.

Then there are those who won't like any vaccine, regardless of how it was developed or what officials say.

Pitts, the former FDA official, said such anti-vaxxers shouldn't be allowed to control the public discussion around vaccines. "They are a threat to themselves, their families, their neighbors and their communities," he said.

The administration made a mistake emphasizing speed when it announced federal funding for vaccine development, vaccine advocates said. Calling the project "Operation Warp Speed" suggested to many people that it would prioritize speed over safety.

"This issue of speed is not sitting well within Black communities," Ojikutu said, suggesting the title"Operation Safe Recovery" instead.

"Everyone wants a resolution to this devastating pandemic," Ojikutu said."But in communities that have heightened mistrust towards systems, you have to focus in on how you will protect them, not on how you will develop something quickly. The piece of this that is so critical is safety."

In recent weeks, the National Institutes of Health's Dr. Anthony Fauci and other leaders of the government's vaccine development effort have repeatedly said safety is their top priority.

But first impressions linger.

"My concern is that there's be a great deal of pressure on whoever developed and tested the vaccine to get it out as quickly as possible," said Jeffrey Freed, a 59-year-old information technology consultant from Charlotte, North Carolina. "If it takes four years to do it right, then that's what we have to do."

Freed said he's not opposed to vaccines, he just wants to be convinced the science behind one is solid. Once he is and his doctor gives him the all-clear, Freed said he'll be more than willing to get a shot.

Living alone and working from home for months has left him as ready as everyone else for the coronavirus outbreak to end. "I want out," he said.

President Donald Trump and Operation Warp Speed may also have created unrealistic expectations, said Sandra Crouse Quinn, a professor and chair of the department of family science at the University of Maryland.

Unless trials go perfectly, Quinn doesn't believe a vaccine will be ready before the end of the year, as the president has promised, and even if there is one, it won't reach the average citizen for months. But by creating this expectation, Trump may be setting people up for disappointment and potentially disillusionment in the process.

"Operation Warp Speed is raising doubts about safety and cutting corners," she said.

Who delivers a pro-vaccine message will be important, Ojikutu said. If African Americans don't see people who look like them talking about getting vaccinated, they'll be far less likely to take that step themselves, she said.

She suggests enlisting Black community leaders, faith leaders and health care providers "people who have a vested interest in caring for people" in efforts to inform the public about COVID-19 vaccines.

It's not a matter of rebuilding Black confidence in vaccines, she said, because there's so little to begin with. But done right,a COVID-19 vaccination campaign could help build public faith in other vaccines.

Dr. LaTasha Perkins(Photo: courtesy of the American Academy of Family Physicians)

It would be great to have Black doctors recommending vaccines, but only 2% of all doctors in the U.S. are African-American, said Dr. LaTasha Perkins, a family physician and assistant professor at Georgetown University School of Medicine.

Still, role models are essential, as is Black participation in clinical trials that will determine whether a vaccine is safe and effective.

"If you can show that the vaccine works for us, works in us and that we were part of the process, that will build trust," Perkins said.

One way to remove people's hesitancy about vaccines is to make it easy to get them, said Privor-Dumm, at Johns Hopkins. Vaccines should be low-cost or free, and given out at convenient times and locations, she said.

Someone who has to miss work to get a shot or even two, as most of the vaccines under development will require will be much more hesitant about a vaccine than someone who can get one for free, close to home at a time that works, she said.

It's also crucial to counter misinformation with accurate data about an eventual COVID-19 vaccine. There are so many myths right now "it's mind-boggling," said Theresa Horner, chair of the public health department at St. Francis University in Loretto, Pennsylvania.

"Information that can help alleviate that and provide honest answers and truths, it will certainly serve the United States well in trying to eradicate this (virus)," she said.

The bottom line is that the pandemic can't end without a vaccine that the majority of Americans are willing to take, said Dr. Lindsey Baden, director of infectious disease clinical research at theBrigham and Women's Hospital in Boston.

"If we have a successful vaccine and (only)half the people take it, we've failed."

Contact Weintraub at kweintraub@usatoday.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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Experts worry that a COVID-19 vaccine won't help if not enough people are willing to get one - USA TODAY

Determinants of COVID-19 vaccine acceptance in the US  The Lancet

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Determinants of COVID-19 vaccine acceptance in the US - The Lancet

By Graham Lawton

Kirsty Wigglesworth/AP/Shutterstock

IT IS August 2021, and the moment the world has been waiting for has finally arrived. After many false dawns, a vaccine against covid-19 has passed all the tests and is ready to be rolled out.

It has been an arduous journey, but at last vaccine manufacturers around the world are cranking out thousands of doses a day. The end of the pandemic is on the horizon.

But this isnt the end. It isnt even the beginning of the end. There are more than 7.5 billion people in need

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If we ever make a covid-19 vaccine who should be first to get it? - New Scientist

ByHub staff report

The COVID-19 vaccine is on track to become the fastest-developed vaccine in history, but that doesn't mean critical steps are being skipped.

Ruth Karron, who leads the Center for Immunization Research at the Johns Hopkins Bloomberg School of Public Health, is one of the top vaccine experts in the world, serving on vaccine committees for the U.S. Centers for Disease Control and Prevention, the World Health Organization, and the U.S. Food and Drug Administration.

She recently spoke with Josh Sharfstein, professor and vice dean for public health practice and community engagement at the Bloomberg School, about where things stand in the development of a COVID-19 vaccine and how that process will unfold in the months ahead. This conversation is excerpted from the July 31 episode of the Public Health on Call podcast.

There are some very encouraging developments. We have a few vaccines now that will go into Phase 3 clinical trials, also known as efficacy trials. That means that those vaccines have passed certain goalposts in terms of initial evaluations of safety and immune response such that they can be evaluated in larger trials.

We know that these vaccines are promising, but we don't yet know if they are going to work. That's what the purpose of an efficacy trial isas well as to provide a broader assessment of safety of the vaccine in a large number of people.

They involve large numbers of people: In these particular trials for COVID vaccines, there are going to be about 30,000 people enrolled per trial. Individuals are given a vaccine, and then they are followed both to make sure that the side effects from the vaccine are acceptable and to see whether they develop a SARS-CoV-2 infection along with some symptoms.

These are placebo-controlled trials, meaning that some individuals will get a COVID vaccine and some will get a placebo. Then the rates of disease will be compared in the people who got placebo and the people who got the vaccine to determine the efficacy of the vaccine.

The FDA recently issued guidance to vaccine manufacturers about the development of COVID vaccines stating that a vaccine would need to be at least 50% effective. This means that an individual who was vaccinated would be 50% less likely to get COVID diseaseor whatever the particular endpoint is that's measured in the trialthan individuals that weren't vaccinated.

This is a reasonable goal for a number of reasons. Typically, the more severe a disease is, the better chance a vaccine has of preventing that disease. So a vaccine that's 50% effective against mild COVID diseasewhich might be the endpoint that's measured in a clinical trial, or any evidence of COVID infection with any symptom, which is how a lot of trials are designedmight be more effective against severe disease.

When you have a disease that's as prevalent as COVIDand if we think about what the U.S. has experienced in the past several months in terms of severe disease and deatheven if we were only able to cut those numbers in half, that would be a major achievement.

Time will tellthe short answer is that we don't yet know. We haven't yet had the opportunity to follow individuals for very longthe very first people who got the very first vaccine were immunized in March and it's only July. So we don't know very much about the durability of the immune response in people.

Our hope would be [that protection would last] at least a year or more, and then people might need boosters.

It's also possible that a vaccine might not entirely protect against mild disease. So you might actually experience mild disease and then have a boost in your immune response and not suffer severe disease. From a public health perspective, that would be completely acceptable. If we turned a severe disease not into "no disease" but into mild disease, that would be a real victory.

Every person who is enrolled in the trial will complete information about the kinds of acute symptoms that you might expect following an infection. People will need to provide information about swelling, redness, tenderness around the injection site, fever, and any other symptoms they might experience in the three to seven days following vaccination.

More long term, people will be looking to make sure that when COVID disease is experienced, there's not any evidence of more severe disease with vaccination, which is known as disease enhancement.

There was a lot of discussion as these vaccines were being developed of a concern about disease enhancement. This is based on some animal modelsnot with SARS-CoV-2, but with other coronaviruses. We haven't seen any evidence of enhanced disease thus far and there are a number of scientific reasons why we don't think it should occur with these vaccines. But, of course, it's something we would still watch for very carefully just as with any other safety signal.

There are a couple of things to mention about that, and one is that individuals with these trials will be followed for a year or longer. It may be that a vaccine is either approved for emergency use or licensed before all of that long-term follow up is completed. Nevertheless, companies will be obligated to complete that follow up and report those results back to the FDA.

Ruth Karron

Director of the Center for Immunization Research

It's important to enroll older adults in these studies. All of these large efficacy trials will be stratified so there will be some younger adults and some older adults enrolled.

In addition, it's very likelyand this would not just happen with COVID vaccines, but whenever the FDA licenses vaccinesthat there is an obligation for post-licensure assessments. If a COVID vaccine is licensed, the companies will work with the FDA to determine exactly what kind of post-licensure safety assessments will need to be done.

I think it will be important to enroll older adults across an age span. A 65-year-old is not the same as an 85-year-old. Also, a healthy older adult is not the same as a frail older adult who might be living in a care facility.

We'll need some information about diverse elderly populations in order to think about how to allocate vaccines. There may also be other alternatives for older adults if they don't respond well to vaccines. There's a lot of work going on on development of monoclonal antibodies as an alternative for groups that don't respond well to vaccines such as elderly, frail adults.

It's critically important that we have racial and ethnic diversity.

We know that COVID causes increased rates of severe disease in Latinx and Black populations and in Native American populations. We will certainly want to be able to offer these COVID vaccines to these high-risk populations and encourage their use. But we need to know how well these vaccines work in these populationsif different vaccines work differentlyso that we can offer the most effective vaccines.

It's really important to engage those communities in a number of ways. One way is to engage local leaders early in the process. Lay leaders and leaders of faith communities can have focus groups to find out what their concerns are and how those can be allayed.

I think a very important issue that has been raised by some people who might potentially volunteer for some of these trials has to do with eventual access. People want to have some sense that if they participate in a trial, not only might they have access to the vaccine at the end of that trial, but their families and their communities would, too. Ensuring access among these high risk and vulnerable communities is really critical.

That's absolutely the case. It's great that you brought up the "without charge" piece, too, because a vaccine that's made available but costs something to the individual may not be used. Particularly for people who don't have health insurance or people who are undocumented. It has to be broadly and freely available.

I've done some work in this areaparticularly with Ruth Faden and Carleigh Krubiner in the Berman Institute of Bioethicsspecifically related to ensuring that pregnant women are considered and included in vaccine development and implementation for vaccines against epidemic and pandemic diseases.

When thinking about trials, there needs to be a justification for excluding pregnant women from trials rather than a justification for including them. The justification often isand certainly is the case with these early COVID vaccinesthat we don't know enough yet about the vaccine or the vaccine platform or the safety of the vaccine to do a study in pregnant people.

With the mRNA vaccine, for example, [the type of vaccine being considered for COVID-19] we don't currently have a licensed mRNA vaccine. It's a new platform and we're just learning about the safety of that platform so it wouldn't have been appropriate to include pregnant women in the early stage trials.

Coverage of how the COVID-19 pandemic is affecting operations at JHU and how Hopkins experts and scientists are responding to the outbreak

But these 30,000-person studies are going to be really big studies. They will certainly enroll people of child-bearing potential. And even though there's what we call an exclusion criterionwomen are not supposed to be pregnant at the time they are enrolled, and usually women of child-bearing potential will take a pregnancy test prior to enrollment and immunizationwe know from previous experience that it's quite likely that some women will become pregnant in the months immediately following immunization. It happens quite frequently. So, it's important for companies and the government to anticipate that this will be the case and to think about how they will systematically collect data from women who do become pregnant during these trials.

It's not that the data needs to be interpreted cautiouslybecause pregnant women aren't being formally randomized and we don't have that kind of trial designbut there are things that could be learned and it's important to think now about how to collect those data. It's also important to think about how pregnant women could be directly included in both trials and deployment later down the road.

Yes. I think we need to learn a bit more about the epidemiology in children. Fortunately, children don't seem to suffer from acute COVID disease at the rates that adults do. But we need to learn more about that and we also need to learn from our trials in adults before we make decisions about how and whether children will be included in vaccine trials.

The best vaccine in the world won't work if it isn't used. Use has two parts to it: One is availability and access, and the other part is acceptance.

We need to think about what kind of infrastructure we should be planning now for what we're going to need to deliver this vaccine. We'll set priorities; certainly not everyone is going to get a vaccine all at once. But certainly, over time we will expect that all adults will receive the vaccine and perhaps children. So we'll need to have systems in place that can deliver the vaccine. At the same time, we need to make sure that the vaccine is acceptable. We need to communicate the importance of vaccination to the public and address their concerns so that we can not only be able to deliver vaccines, but have those be accepted by the public.

Yes. If you think back to the fact that in January, we barely knew what this virus was, and here we are, seven months later, embarking on efficacy trials, it's really a remarkable accomplishment. We have a lot to do yet, but in the time that we're assessing the efficacy of these vaccines and making sure that they can be delivered to the public, people really need to stay safe and do all the things we've been encouraging them to do all along.

But we are well on our way to developing vaccines not only for people in the U.S., but for people all over the world.

This article originally appeared online as part of the Bloomberg School of Public Health's COVID-19 Expert Insights.

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How close are we to a safe, effective COVID-19 vaccine? - The Hub at Johns Hopkins

At "Cats" world premiere in New York, composer Sir Andrew Lloyd Webber talks of unusual concept transforming T.S. Eliot poems into the beloved musical, calls star Taylor Swift "absolutely fantastic." (Dec. 17) AP Entertainment

He is not throwing away his shot.

One day after announcing that he would be taking part in a COVID-19 vaccine trial, legendary composer Andrew Lloyd Webber said that he had received the experimentalimmunization.

"Just completed the Oxford Covid-19 vaccine trial. Ill do anything to get theatres large and small open again and actors and musicians back to work," he wrote on social media on Thursday.

In this Jan. 28, 2018 photo, Andrew Lloyd Webber arrives at the 60th annual Grammy Awards at Madison Square Garden in New York. A new permanent exhibit opening Tuesday, June 11, 2019, offers visitors an Instagram-ready chance to put on costumes and sing some of Broadway's most famous show tunes, but also a taste of what's going on backstage, from controlling fog to switching on lights. While it's billed as "The Ultimate Broadway Experience," the truth is it's more a Lloyd Webber experience, featuring only props, music and characters from the theater icon's work: "The Phantom of the Opera," "Joseph and the Technicolor Dreamcoat," "Evita," "Sunset Boulevard," and "Cats."(Photo: Evan Agostini/Invision/AP)

The post accompanied a photo of himself sitting in a chair next to a medical professional who is preparing to give him the shot. Lloyd Webber is wearing a black T-shirt emblazoned with "Save Our Stages," the same hashtag he ended his post with.

On Facebook he tagged the National Independent Venue Association, which works at "securing financial support to preserve the national ecosystem of independent venues and promoters," according to its mission statement. The group reposted Lloyd Webber'smessage and added a thank you note.

On Wednesday, Lloyd Webber announced that he was taking part in thetrial.

"I am excited that tomorrow I am going to be vaccinated for the Oxford Covid 19 trial. Ill do anything to prove that theatres can re-open safely," he tweeted.

Lloyd Webber, composer of "The Phantom of the Opera," "Cats,""Evita," "School of Rock" and other musicals produced both in the West End and on Broadway, has been vocal about the reopening of London's theaters.

A few weeks ago, after "Phantom of the Opera"producer Cameron Mackintosh said that the pandemic has caused the London and UK touring productions of the show to permanently shut down, Lloyd Webber responded: As far as Im concernedPhantomwill reopen as soon as is possible.

In the United States, Broadway shows have been shut down since March 12, and are officially closed at least through the new year, though most expect the shutdown to last longer than that.

Lloyd Webber also has been busy engaging with fans on social media and bringing experiences to at-home audiences with his "Composer in Isolation" video series and the introduction of "The Shows Must Go On," which made professional recordings of musicalsavailable on YouTube for a weekend at a time.

Virtual cabaret

Broadway From Home will present its first Coaches Concert at 8 p.m. on Saturday, Aug. 15.

The virtual cabaret will feature Broadway actors singing popular stage tunes and serve as a benefit to help provide scholarships to the organization'sworkshops. The suggested donation is $15.

Set to perform are Broadway and Hollywood actors includingMolly McCook("Modern Family," "Last Man Standing"),Nik Walker("Hamilton," "Ain't Too Proud"),Sara Jean Ford("Phantom of the Opera", "Cats," "A Little Night Music"),John Krause ("Hadestown"),Jane Bruce("Jagged Little Pill"),Alan Wiggins("Pretty Woman," "The Lion King"),Tess Primack("Fiddler on the Roof"),Harley Harrison("The Finest Hours"),Perry Sherman("Fun Home"),Monica Rodrigues("The Buddy Holly Story") and more.

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Broadway From Home was created by entrepreneur and actorHarley Harrison Yanoff as "a solution for school-aged theater kids looking for at-home activities during quarantine and a way to employ out-of-work actors during theBroadwayshutdown."

It offers workshops including acting, singing, dance, improv, audition technique and more five days a week via Zoom. A portion of its proceeds benefit The Actors Fund and City Harvest.

To learn more about the organization and its virtual cabaret, visitbwayfromhome.com or follow them onInstagram (@bwayfromhome) andFacebook.

Ilana Keller is anaward-winning journalist and lifelong New Jersey resident who loves Broadway and really bad puns. She highlights arts advocacyand education, theater fundraisers and morethrough her column,"Sightlines." Reach out onTwitter: @ilanakeller;ikeller@gannettnj.com

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Andrew Lloyd Webber gets experimental COVID-19 vaccine: 'Ill do anything' for theater - Asbury Park Press

In the race to develop a COVID-19 vaccine, the contenders arent about to cross the finish line just yet. As the deadly virus resurfaces in several countries, the world is anxiously waiting to see which name will be the first to bring the coveted solution to market. Already underway for months now, its still anyones game in this battle of the ages.

Who is emerging as a likely winner? If you ask 5-star analyst Vernon Bernardino, of H.C. Wainwright, of the 165-plus vaccine candidates (38 in clinical-stage testing) in development, Vaxarts (VXRT) chances are looking pretty good.

Based on the companys Q2 2020 corporate update, it has reached multiple milestones that position it at the front of the pack. That being said, the analyst cites one accomplishment in particular as deserving of a major shoutout.

Bernardino believes its selection to take part in a non-human primate (NHP) challenge study organized and funded by Operation Warp Speed (OWS) is the most notable of these milestones. Highlighting the candidates broad potential in the battle against the virus, the analyst argues the Street might just be underestimating the role it could play.

Expounding on this, the H.C. Wainwright analyst stated, ...our positive view of Vaxarts oral COVID-19 vaccine program advancing was bolstered by its selection for OWS participation, as this, in our opinion, represents recognition by BARDA that oral vaccines tested by Vaxart for other infectious diseases, such as influenza, norovirus and respiratory syncytial virus (RSV), point to an oral vaccine as a potentially important approach to vaccinating what is likely to be more than 100 million people in the U.S., and perhaps billions of people globally, most of which have no existing immunity to SARS-CoV-2.

The implications of the OWS selection go even further. NHPs are a rare resource for conducting preclinical studies, with only seven primate research centers able to perform NHP studies. In addition, the number of subjects is limited and the waiting lists are long.

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Given that the task of conducting the NHP challenge study has been assigned to the U.S. National Institutes of Health (NIH), its unclear what the timeline for completion and release of results will be.

Nonetheless, Bernardino remains confident in VXRTs prospects. ...in line with the pace of progression of competitor COVID-19 vaccine candidates, we expect the NHP study with Vaxarts vaccine to be given high priority and be conducted quickly. We look for results in late Q3 2020 to be a positive catalyst, he explained.

Accordingly, Bernardino keeps a Buy rating on the stock. The positive assessment also warrants a substantial increase to the price target, which moves from $7 to $17. This target suggests shares could jump 87% in the year ahead. (To watch Bernardinos track record, click here)

VXRT has kept a relatively low profile, as only one other analyst has thrown an opinion into the mix. The additional bullish call means that the stock gets a Moderate Buy consensus rating. At $19.50, the average price target is more aggressive than Bernardinos and implies 114.5% upside potential. (See Vaxart stock analysis on TipRanks)

To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks Best Stocks to Buy, a newly launched tool that unites all of TipRanks equity insights.

Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

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Vaxart Positioned to Further Advance Oral COVID-19 Vaccine; Analyst Says Buy - Yahoo Finance

YERUSHALAYIM -

Thursday, August 13, 2020 at 10:24 am | ""

Three coronavirus patients treated at Hadassah Hospital in Yerushalayim with an experimental passive vaccine treatment by administering Immunoglobulin G (IgG) have fully recovered, giving hope for other patients, the hospital said Thursday.

The three were treated as part of a clinical study, jointly conducted by Hadassah Hospital and the public biomedical company Kamada.

For three months, despite the initial opposition of the former director general of the Health Ministry, Hadassah has been collecting plasma donations from coronavirus patients, Hadassah head Prof. Zeev Rotstein said, with the aim of producing a treatment for severely ill patients.

Specifically, the plasma was collected with the help of the chareidi chessed organization Yad Avraham and the chareidi community, Hadassah hospital noted. Patients who tested negative for the coronavirus twice and showed high levels of antibodies in their blood were asked to donate plasma.

Those who develop any virus, including the coronavirus, develop special antivirus proteins or antibodies in their plasma, which can help sick patients cope with the disease.

The plasmas, collected from the recoverees, were processed by the Kamada company at Kibbutz Beit Kama in the Negev for an IgG-based antibody treatment for patients in severe condition, patients who suffer from pneumonia due to the virus.

Kamada produced what it calls its anti-SARS-CoV-2 plasma-derived immunoglobulin (IgG) product.

The first three patients who recovered as part of the clinical study demonstrated a rapid clinical benefit and have been discharged home from the hospital.

Hadassah administered the worlds first passive vaccine to a seriously ill patient, a young woman with underlying illnesses whose CT results showed completely white lungs, and all known treatment methods have not affected her condition.

Several hours after receiving the treatment, the patients condition appears to have stabilized, giving room for cautious optimism.

Kamada updated in its reports that the virus neutralization test showed encouraging neutralization activity of the product and that the company plans to further test the antibody product as a potential preventative treatment for COVID-19 on healthy volunteers at risk.

Prof. Rotstein said that the vaccine, which could also be called a medicine, is being targeted toward COVID-19 patients whose situation is worsening and need a booster to fight the disease. However, it may also be used prophylactically in cases where a high-risk patient contracts coronavirus and the hospital wants to stop the diseases progression.

It is evident that the Hadassah team is very satisfied with the clinical research, said Dr. Assa Kessler, a doctor in the hospitals coronavirus unit. She said the plasma is being distributed to COVID-19 patients who develop pneumonia and for now, we are very encouraged by the results.

Rotstein said that these preliminary results should raise hope in Israel and around the world.

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Three Israelis Treated With Passive COVID-19 Vaccine Fully Recover - http://hamodia.com

The commissioner of the US Food and Drug Administration assured physicians and other healthcare providers that vaccine and therapeutics approvals for the COVID-19 pandemic will be based on good science and sound data.Nothing else will be used to guide our decisions, said Stephen Hahn, MD, speaking at a virtual meeting held by the Reagan-Udall Foundation on 10 August.Hahn delivered prepared remarks along with American Medical Association president Patrice Harris, MD; Harris then fielded questions for Hahn from attendees. Much of Hahns presentation and Harris subsequent questions focused on FDAs projected process to approve vaccines for SARS-CoV2, the virus that causes COVID-19.Vaccine decisions will be deliberativeHahns remarks frequently turned to reassurances about FDAs plans to run a rigorous approval program despite the press of the pandemic. Because of the speed with which we need to make decisions, there has been discussion about whether FDA will compromise any of our scientific principles in reviewing data and making decisions about new products, said Hahn.Let me assure you that we will not cut corners All of our decisions will continue to be based on good science and the same careful, deliberative processes which we have always used when reviewing medical products.Hahn also announced a new initiative termed the Pandemic Recovery and Preparedness Plan (PREPP) that he said will help systematically review FDAs actions to date and identify lessons learned.The commissioner said that the US has made significant progress on many fronts during the pandemic. Yet with cases continuing to rise, it is evident that further action is needed for our country to chart a course for recovery, he said: We all know in medicine that a look back on our actions can help us in improving care and service delivery. This is the important part of the PREPP goal for FDA. Our goal is both to make needed adjustments to the ongoing COVID-19 response as well as improve our capacity to respond to public health emergencies in the future.Hahns discussion at the Reagan-Udall Foundation event followed a 7 August Viewpoint article in JAMA authored by Hahn, together with Anand Shah, MD, FDAs deputy commissioner for medical and scientific affairs, and Peter Marks, MD, who heads the Center for Biologics Evaluation and Research (CBER). That editorial also promised unwavering regulatory safeguards for the FDA COVID-19 vaccine approval process in the face of public anxiety about the safety and effectiveness of vaccines developed on expedited timelines.Hahn and his coauthors cited a recent poll showing that nearly a third of US adults were uncertain whether they would take a COVID-19 vaccine when it becomes available; one in five said they would not receive a vaccine.The BLA path versus an EUA They also noted that the most likely pathways through FDA for a vaccine would either be the traditional biologics license application (BLA) review or an emergency use authorization (EUA). Sponsors are still advised to file for review via traditional market authorization, however, considering that any vaccine would be intended for widespread use.In anticipation of an influx of vaccine candidates, FDA is adding members to the Vaccines and Related Biological Products Advisory Committee, where Hahn and his colleagues said transparent discussion will be needed before any authorization or licensure, to make sure the public has a clear understanding of the evidence underpinning any recommendations.During the Reagan-Udall event, Harris and attendees had several questions about the specifics of the vaccine approval process, including under what circumstances the agency might issue an emergency use authorization (EUA). Asked Harris, What type of evidence would you have to have in a phase 3 trial to be able to make an EUA?We would have to be very secure about the safety of a vaccine, Hahn responded. We would have to see the evidence of clinical efficacy. Were not going to back away from what weve said with respect to these data. Weve set a floor of 50% for efficacy, he said, referencing the figure given in a June 2020 guidance. (RELATED: FDA issues COVID-19 vaccine guidance, setting 50% effectiveness threshold, Regulatory Focus 30 June 2020)Hahn noted that the streamlined nature of the EUA process means the timetable may be tightened up for coronavirus vaccine approval, but we wont stray from the vaccine requirements delineated in the guidance.Will an EUA carve out sub-populations?The potential exists that EUAs might be carved out for sub-populations in a clinical trial in whom high efficacy is seen, said Hahn. I cant pre-judge the data, he added, but one could imagine a situation where we had very robust safety and efficacy data and could make an EUA determination.The threshold of 50% reduction in COVID-19 cases established in the guidance, he said, should be seen in every subgroup in order to make this generalizable. Whether decisions would be made for individual subgroups, he said, is a complete unknown at this point, because we dont have the data in front of us.Regarding safety, Hahn said that current and projected Phase 3 trials will fall within the usual practice of requiring a patient pool of 3,000-5,000 for determining vaccine safety, since FDA foresees these trials enrolling 30,000 patients or more, with about half that number receiving active vaccines.However, Hahn and his colleagues noted in the JAMA piece that FDA recognizes that there could be rare adverse events not detected in a trial of 15,000 to 20,000 patients, so postmarketing surveillance will be critical. The officials said that a discussion will need to take place prior to authorization or licensure of a vaccine about postmarket surveillance, with an eye to building the proper pharmacovigilance framework.He emphasized that FDA is asking for clinical endpoints, not immunological endpoints, from the vaccine trials, since the presence of antibodies alone has not yet been shown to be protective of becoming ill with COVID-19.

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Hahn: COVID-19 vaccine decision will be "deliberative" | RAPS - Regulatory Focus

If and when a coronavirus vaccine is rolled out, there will be people who refuse to take it for various reasons, but a Stanford Law School professor says such refusal will have consequences.

Hank Greely will appear on "TMZ Live" Thursday ... he's an expert in public health law and says people who refuse to take the vaccine could -- repeat COULD -- be denied the right to enter their workplace or their school.

Fact is ... there will probably be 3 groups of people who will refuse the vaccine -- the anti-vaxxers, the people who want to turn the vaccine into a political issue, and people who are afraid to take the vaccine because they worry it was rushed and not properly tested.

If the FDA, NIH and others show the phase 3 studies were thorough and established both safety and efficacy, Professor Greely says it will be hard for people to make the case they can refuse the vaccine and not be barred from work or school.

It's dicier, the good professor says, if phase 3 studies are less than thorough.

Professor Greely, whose focus includes legal and social issues related to advances in biosciences ... couched everything with the preface good lawyers always use ... "It Depends."

Excerpt from:

People Who Refuse COVID-19 Vaccine Could Be Barred from Work and Schools - TMZ

TUCSON, Ariz. As part of the federal government's "Operation Warp Speed," the Tucson clinic conducting part of Moderna's COVID-19 vaccine trial is now accelerating the number of patients it is enrolling.

The person coordinating this groundbreaking study is Yvonne De Los Reyes.

In her 15th year with Quality of Life Medical & Research Centers, De Los Reyes calls it the most important study of her career.

"People are losing their life every day," said De Los Reyes. "People are losing loved ones. At some point, at the end of this trial, hopefully we'll make an impact on people's lives, the world."

RELATED: Moderna's promising COVID-19 vaccine, explained

In the past two weeks, she has set up the vaccine trial at QLMC on the east side of Tucson. It is a huge undertaking.

De Los Reyes is in charge of recruiting participants, coordinating staff, lab tests, collecting the data, plus lots of paperwork to document each patient.

"And it's got to be precise," said De Los Reyes.

Quality of Life continues to ask for volunteers, especially Latinos and Native Americans. Those are groups who have been hit hard by the coronavirus.

More than 3,000 people have already volunteered in Tucson.

De Los Reyes says if you haven't been contacted yet, have patience.

"We're going to eventually get to them," she said. "But we also want to make sure the integrity of the study is being conducted properly."

National news reports this week say enrolling participants in Moderna's trial at the nearly 90 clinics across the country, has been slower than expected.

But QLMC already has more than 200 people enrolled, including KGUN 9 Anchor Pat Parris. He received the first of two injections last week.

QLMC is enrolling an additional 25 participants each day.

They'll soon pass Moderna's goal of 300 participants screened and randomized into the Tucson portion of the clinic trial.

But Dr. Jack McGettigan, the owner of QLMC, wants a thousand participants. A goal shared by Yvonne.

"That's the overall goal," she said. "It's a lot of patients, a lot of work, but at the end of the day it'll be worth it."

De Los Reyes says participants are reporting very little in the way of reactions to the first dose. A second dose is given 28 days later.

Two other major pharmaceutical companies are about to begin clinical trials in the United States. De Los Reyes is hopeful Quality of Life Medical & Research will also run those trials in Tucson.

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Meet the coordinator running the Tucson COVID-19 vaccine trial - KGUN