Category: Covid-19 Vaccine

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Howland woman taking part in experimental COVID-19 vaccine study says she wanted to contribute – WKBN.com

August 3, 2020

Her friends think she's crazy, but she said she wants to be part of something that could work to protect people from the virus

by: Dave Sess

HOWLAND, Ohio (WKBN) How do you know if a vaccine is going to work against the coronavirus if you dont test it? Americans are rolling up their sleeves to be part of the experimental vaccine. One woman we talked to believes her help is vital.

Linda Cator, of Howland, took her shot Wednesday.

If I think about it, yeah, its a little sore but it was no different than getting a flu shot, really, she said.

The 75-year-old is part of a Moderna study testing a vaccine to find out if it can help the immune system produce effective antibodies against the virus.

Her friends think shes crazy.

Well, because they dont believe whats in it. They keep thinking theyre going to give you the live virus, Cator said.

This vaccine is not made from a weakened or inactive virus. Rather, its made from a protein thought to help the bodys immune system fight COVID-19.

Like a typical study, its being compared to a placebo. Cator doesnt know which group shes in.

I feel anytime we can get something thats going to protect everybody and theres a chance its going to work, I want to be part of it, she said.

Her only hesitation was if another vaccine came out, she doesnt know if she could get it. The answer is yes, she could.

Cator was part of an ibuprofen study years ago. That company called her to see if she wanted to be part of the vaccine test.

They do give you some money for being in the study but thats not a concern for me becauseI felt that I wanted to contribute, she said.

She gets $90 per shot and roughly $25 a day for taking her temperature and responding to questions. Her second shot is next month.

Cator is being tested and does not have the coronavirus.

When they stick that up your nose, its not very fun to do, or draw blood but the thing is, its the purpose of it, she said.

The company doing this testing, Rapid Medical Research in Beachwood, is enrolling for at least nine studies right now.

You can apply to be a participant in these studies on its website.

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Howland woman taking part in experimental COVID-19 vaccine study says she wanted to contribute - WKBN.com

Merck, via its Themis buy, to move first COVID-19 vaccine into clinical development in Q3 – FierceBiotech

August 3, 2020

Merck was purposely cautious during the start of the pandemic when it came to vaccine development but is now slowly but surely ramping up its efforts into the clinic.

The U.S. Big Pharma, which has good form in creating a new vaccine against a sweeping threat after gaining approval for its Ebola vaccine, said in its second-quarter update that, via its recent buyout of Themis, its plotting a third-quarter start for human testing of its thus preclinical V591.

While behind the likes of AstraZeneca, Moderna, Pfizer/BioNTech and CureVac, Merck hopes its expertise and slightly different MOA may prove a tortoise over the hare victory.

The Themis/Merck vaccine works by tapping a measles virus vector platform based on a vector originally developed by scientists at the Institut Pasteur, a world-leading European vaccine research institute, and licensed exclusively to Themis.

And this is not the only shot on goal, as Merck has also teamed up with IAVI for another vaccine candidate,V590, that uses a recombinant vesicular stomatitis virus platform.

This is the same platform that was used for Mercks approved Ebola vaccine, making it more of a known entity; human studies are planned to start this year. This also dovetails with a series of antivirals the company is working on, already in clinical testing.

Mercks CEO Ken Frazier said: This pandemic underscores the essential role of Merck and the biopharmaceutical industry in addressing the worlds greatest health challenges and underscores the importance of a health care ecosystem that incentivizes risk-taking and innovation. Ultimately, scientific and medical knowledge will help overcome this ongoing global pandemic, and that is why we must continue to trust and invest in breakthrough science.

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Merck, via its Themis buy, to move first COVID-19 vaccine into clinical development in Q3 - FierceBiotech

What a post-vaccine world looks like for seniors: It’s time to learn telemed. Oh, and how you travel will change. – USA TODAY

August 3, 2020

Bruce Horovitz, Kaiser Health News Published 6:00 a.m. ET Aug. 1, 2020 | Updated 11:27 a.m. ET Aug. 2, 2020

The US recently topped 4 million confirmed COVID-19 cases and now has reached another unenviable milestone. USA TODAY

Imagine this scenario, perhaps a year or two in the future: An effective COVID-19 vaccine is routinely available and the world is moving forward. Life, however, will likely never be the same particularly for people over 60.

That is the conclusion of geriatric medical doctors, experts on aging, futurists and industry specialists. Experts say that in the aftermath of the pandemic, everything will change, from the way older folks receive health care to how they travel and shop. Also overturned: their work life and relationships with one another.

In the past few months, the entire world has had a near-death experience, said Ken Dychtwald, CEO of Age Wave, a think tank on aging around the world. Weve been forced to stop and think: I could die or someone I love could die. When those events happen, people think about what matters and what they will do differently.

At-home testing?FDA opens door to rapid, at-home testing for COVID-19

Older adults are uniquely vulnerable because their immune systems tend to deteriorate with age, making it much harder for them to battle not just COVID-19 but all infectious diseases. They are also more likely to suffer other health conditions, like heart and respiratory diseases, that make it tougher to fight or recover from illness. So its no surprise that even in the future, when a COVID-19 vaccine is widely available and widely used most seniors will be taking additional precautions.

Residents of the Dr. Sarphati House nursing home in Amsterdam, The Netherlands, sit in front of a same size version of the famous painting 'The Night Watch' by Dutch painter Rembrandt van Rijn, in Amsterdam on July 20, 2020. - This summer, the Rijksmuseum brings a version of the world-famous painting by Rembrandt to thirty nursing and care homes and senior complexes. Outings to cultural institutions are not possible for many elderly people due to the coronavirus crisis.(Photo: ROBIN VAN LONKHUIJSEN, ANP/AFP via Getty Images)

Before COVID-19, baby boomers those born after 1945 but before 1965 felt reassured that with all the benefits of modern medicine, they could live for years and years, said Dr. Mehrdad Ayati, who teaches geriatric medicine at Stanford University School of Medicine and advises the U.S. Senate Special Committee on Aging. What we never calculated was that a pandemic could totally change the dialogue.

It has. Hereare predictions for what a post-vaccine life looks like for older Americans:

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation) that is not affiliated with Kaiser Permanente.

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What a post-vaccine world looks like for seniors: It's time to learn telemed. Oh, and how you travel will change. - USA TODAY

Dozens of scientists and others took a DIY COVID-19 vaccine with no proof that it works – Live Science

July 31, 2020

The ingredients arrive by mail, to be prepared by recipients in their homes or labs. No, this isn't a DIY meal kit it's an unproven COVID-19 vaccine distributed by a group called the Rapid Deployment Vaccine Collaborative, or RADVAC, and no one knows if it actually works, MIT Technology Review reported.

The collaborative, composed of more than 20 scientists, technologists and "science enthusiasts," some affiliated with Harvard University and MIT, did not seek authorization from the U.S. Food and Drug Administration (FDA) before designing their vaccine, or before spraying it up their own noses. Nor did the group seek approval from any ethics board before launching the project and volunteering as their own test subjects in what could potentially be seen as an unofficial clinical trial, according to MIT Technology Review. They have also distributed materials for the vaccines to dozens in their social circles.

The FDA did not immediately respond to questions from MIT Technology Review as to whether the initiative can be considered legal. However, geneticist Preston Estep, who founded RADVAC and serves as its chief scientist, said that the FDA does not have jurisdiction over the project because participants mix and administer the vaccine themselves, without paying the collaborative any fees in exchange. It remains to be seen whether the FDA might step in to regulate the project, particularly as more people learn about, and take, the experimental vaccine.

Related: Here are the most promising coronavirus vaccine candidates out there

"We don't suggest people change their behavior if they are wearing masks, but [the vaccine] does provide potentially multiple layers of protection," Estep told MIT Technology Review. However, RADVAC does not yet have evidence that the vaccine prompts an adequate immune response to be protective at all. The group has begun conducting studies to answer that question, some of which are being conducted in the Harvard lab of geneticist George Church, who has already taken two doses of the vaccine. (Estep is a former graduate student and current collaborator in Church's lab.)

"I think we are at much bigger risk from COVID [than from the experimental vaccine], considering how many ways you can get it, and how highly variable the consequences are," Church told MIT Technology Review. Church added that, while he believes the vaccine is safe (in the absence of data proving that's the case), he thinks the "bigger risk is that it is ineffective."(Church is also head of Harvard's Woolly Mammoth Revival team, whose aim is to insert genes from the extinct mammoth into DNA of Asian elephants.)

But regardless of whether or not the vaccine grants protection against the coronavirus, vaccines always carry some risk of side effects. The more than 30 candidate COVID-19 vaccines being tested in sanctioned clinical trials must undergo several rounds of efficacy and safety tests to be approved, Live Science previously reported. In early trials, vaccine developers watch for acute side effects that occur shortly after vaccine administration, which may include swelling, redness and soreness at the administration site, or potentially fever. In advanced clinical trials, they can monitor for side effects that may emerge when a vaccinated person becomes exposed to the virus in a real-world scenario.

Related: 5 dangerous myths about vaccines

One side effect that could occur upon exposure is known as antibody dependent enhancement (ADE); this rare phenomenon paradoxically leaves the body more vulnerable to severe infection after vaccination, and was previously observed in animal studies of vaccines for coronaviruses related to SARS-CoV-2, the virus that causes COVID-19, Live Science previously reported.

Self-experimenting with the RADVAC vaccine is "not the best idea especially in this case, you could make things worse" by triggering ADE, George Siber, the former head of vaccines at the pharmaceutical company Wyeth, told MIT Technology Review. "You really need to know what you are doing here."

Siber added that, given the vaccine's ingredients and its route of administration through the nose, he's not sure that the vaccine would be potent enough to be protective, even if it is safe.

RADVAC published a white paper detailing the recipe for the vaccine in July, with a disclaimer that states that anyone using the information must be a consenting adult, based in the U.S., who agrees to "take full responsibility" for their use of the information, vaccine and materials required for production and administration. In addition, anyone accessing the site must first "acknowledge and agree that any use of that information to develop and self-administer a substance is an act of self-experimentation," the legality of which may differ depending on where you live.

Below the disclaimers in the paper, the group describes the formulation of the vaccine, which contains short protein fragments, called peptides, found on the coronavirus. These peptides cannot cause COVID-19 on their own, but should in theory be recognized by the immune system and prompt the construction of antibodies that can target and deactivate the virus. That said, Estep called Siber about the vaccine earlier this year and Siber told him that short peptides don't consistently prompt a strong immune response, according to MIT Technology Review.

In addition to peptides, the RADVAC vaccine contains chitosan, a substance found in the shells of crustaceans like shrimp, according to the white paper. The chitosan is intended to coat the peptides and ease their delivery through mucosal tissue in the nose, MIT Technology Review reported. The RADVAC developers chose to deliver their vaccine in a nasal spray, rather than through an injection, in an attempt to trigger a strong, localized immune response in the nose, where COVID-19 infection often takes hold.

Related: 20 of the worst epidemics and pandemics in history

Mucosal tissues, like that of the nose, have their own specialized fleet of immune cells that help guard the somewhat-permeable tissues against debris and pathogens, Live Science previously reported. Ideally, an effective COVID-19 vaccine would trigger both this localized immune response and a systemic immune response throughout the body. Some experts share the view of RADVAC, in that they think COVID-19 vaccines delivered through the nose would be more protective than injectable ones, The New York Times reported. However, Siber told MIT Technology Review that he's not aware of any existing vaccines that are both based on peptides and delivered through the nose; studies would be needed to confirm that such vaccines could reliably trigger a robust immune response.

While the underlying theory may prove true, the efficacy of individual vaccines can only be shown through rigorous analysis of the body's immune response. RADVAC has not completed such studies.

Having presented no evidence that the vaccine provides protection against COVID-19, or that it's safe to administer, the researchers have already distributed materials for the vaccine to others in their social circles.

"We have delivered material to 70 people," Estep told MIT Technology Review. "They have to mix it themselves, but we haven't had a full reporting on how many have taken it."

Originally published on Live Science.

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Dozens of scientists and others took a DIY COVID-19 vaccine with no proof that it works - Live Science

Pfizer executive says COVID-19 vaccine could be approved by end of 2020 – WPRI.com

July 31, 2020

ANDOVER, Mass. (WPRI) Pfizer could file for approval for its potential COVID-19 vaccine as early as October, according to Dr. Meg Ruesch, the pharmaceutical companys vice president of worldwide research and development.

While authorization of the treatment is dependent on a review by the U.S. Food and Drug Administration (FDA) and clinical data, Pfizer hopes to win approval by the end of the year, Ruesch said Thursday during a news conference with Gov. Charlie Baker at the companys Andover, Mass., facility.

As we continue to fight against COVID-19, a vaccine and a treatment cant come soon enough, Baker said. Pfizer is developing one of the most advanced COVID-19 vaccines.

(Story continues below.)

Earlier this month, Pfizer reported positive findings from the preliminary trials and on Monday, announced the study would be moving ahead to the next phase.

Clinical data for the vaccine has been encouraging so far, Ruesch said.

The vaccine is manufactured in Andover, then purified and shipped as a frozen solution for further manufacturing and to be filled into vials, according to Ruesch.

She said they are working to manufacture as much of the vaccine as possible, so it will be ready if the clinical trials are successful and it wins FDA approval.

We have the potential, subject to technical success and regulatory authorization, to manufacture up to 100 million vaccine doses by the end of the year and up to 1.3 billion doses by the end of 2021, she said.

Reusch said scientists are also studying the production process in an effort to make larger batches and implement testing protocols, but reassured that the quality will not be compromised.

The review process will be rigorous and in collaboration with the FDA, she added.

Pfizer is seeking 30,000 people for their clinical trial, mostly in places that have seen high COVID-19 rates. People involved will receive two injections, three weeks apart.

More information on COVID-19 vaccine clinical trials

The Massachusetts Department of Public Health reported 304 new confirmed cases and 15 new deaths on Thursday.

Full breakdown of Thursdays COVID-19 data (Mass.gov)

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Pfizer executive says COVID-19 vaccine could be approved by end of 2020 - WPRI.com

Majority of people say they won’t take COVID-19 vaccine within first year – New York Post

July 31, 2020

Most people would like to see a coronavirus vaccine approved this year, but far fewer are willing to be the first in line, a new poll has revealed.

Recently, WebMD surveyed its readers to explore their sense of urgency and concern regarding a vaccine for COVID-19. Of the 1,000 respondents, less than half, 42%, said they would opt-in for treatment within the first 12 months of a vaccines release.

Alarmingly, nearly a third of participants, 28%, told the medical news and information website that they had no intention of getting any vaccine, ever.

This serves as a wake-up call, said Dr. John Whyte, chief medical officer of WebMD, in an article appearing on the website. If immunization rates are low, then were not going to achieve the level of herd immunity needed to protect us from this virus.

Whyte later told The Post in an e-mail statement that now is too early to make a call.

Its too early to know whether you should, or should not, be hesitant about getting the vaccine, he said. All we have now are the early results from a couple of major studies on a few hundred people.

Health experts have estimated that 70% of a population must be protected either with a vaccine or by having recovered from the virus to reach herd immunity status meaning COVID-19 will no longer be a pandemic-level threat and the worlds economies can safely reopen.

Unfortunately, many may be forced to achieve immunity the hard way by getting the virus as only 26% have said theyd step up within the first 90 days.

How are we going to reopen if people arent getting the vaccine? We need a Plan B, Whyte said.

Currently, there are more than five pre-eminent therapies being studied as part of Operation Warp Speed, a government-backed initiative to help scientists and drug companies fast-track a vaccine to market. Since its launch in May, the White House has ordered 500 million doses total from three such potential cures for SARS-CoV-2 for clinical trials. On Monday, a fourth option entered its third and final round of clinical testing on 30,000 US adult volunteers.

Around the world, there are more than 165 vaccines being developed, according to WebMD.

The poll suggests that Americans arent confident that expedited testing will be thorough enough to guarantee the vaccines safety. Three-quarters of respondents reported having concerns over potential side effects, while 15% didnt believe a vaccine would be effective.

The best way to build public trust, Whyte suggested, would be for the Food and Drug Administration to show Americans how the drugs are vetted.

I think it is critical that we have a transparent process when the FDA reviews the completed trial results, he said. The safety and efficacy must be publicly available and broadly disseminated.

The White Houses top health adviser, Dr. Anthony Fauci, has implored the public to get over their skepticism of a coronavirus vaccine. During a CNN broadcast on Monday, the director of the National Institute of Allergy and Infectious Diseases told viewers, If we get a widespread uptake of vaccine, we can put an end to the pandemic and we can create a veil of immunity that would prevent the infection coming back.

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Majority of people say they won't take COVID-19 vaccine within first year - New York Post

Pfizer closing in on COVID-19 vaccine – Fox17

July 31, 2020

PORTAGE, Mich. Pfizer, one of the worlds largest drug makers, is also one of a few companies closing in on a vaccine for COVID-19.

Recently, Pfizers vaccine candidate entered Phase 3 of the Food and Drug Administrations testing. The late-stage testing includes human trials, and Pfizer told FOX17 Thursday they hope to have the drug ready by the end of the year.

Were just going as fast as we can, said Chaz Calitri, the site leader at Pfizers Portage facility. We have a commitment this year up to 100-million doses, and then next year around a billion doses.

Pfizer couldnt say exactly when a vaccine would be ready to hit the market, only noting it would depend heavily on the trials. Last week, Pfizer reached a deal with the U.S. government worth $1.95 billion for those first 100-million doses by the years end.

Pfizers candidate differs from a traditional vaccine in that it uses the cells you already have in your body to fight the invading virus.

So its giving the cells instructions to make the antigens, versus a traditional vaccine which is an inactivated virus typically, said Calitri. The fact that this is a vaccine which is going to actually utilize your own cells to make an antigen could prove it very safe as well.

Pfizer would not say how much doses of the vaccine would cost once it hits the market, though reports have indicated different amounts.

Pfizer says its less about the money than the result. Theyve diverted almost 200 workers to the vaccine program, and say theyve invested almost a billion dollars at-risk to produce results at a rapidly faster pace than a traditional timeline for a vaccine.

Were throwing everything we have at this to get it done as soon as we can, said Calitri. Everyone would say that all of our lives have changedand a vaccine is really going to be the only solution.

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Pfizer closing in on COVID-19 vaccine - Fox17

The Infodemic: Does Russia Have a COVID-19 Vaccine? – Voice of America

July 31, 2020

Fake news about the coronavirus can do real harm. Polygraph.info is spotlighting fact-checks from other reliable sources here.

Claim:The West loses the race to develop a coronavirus vaccine. Russias vaccine against COVID-19 is ready.

Verdict:False

Read the full story at:EUvsDisinfo

"US social media users still mischaracterize Canadas COVID-19 aid,"Agence France-Presse, July 29.

Covid-19 infections leave an impact on the heart, raising concerns about lasting damageTwo new studies from Germany paint a sobering picture of the toll that Covid-19 takes on the heart.-- Stat, July 27

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The Infodemic: Does Russia Have a COVID-19 Vaccine? - Voice of America

Mississippi on the front lines as COVID-19 vaccine, treatment trials come to Hattiesburg – Clarion Ledger

July 31, 2020

The world's biggest COVID-19 vaccine test got underway Monday with the first of 30,000 planned volunteers. The experimental vaccine is made by the National Institutes of Health and Moderna Inc. It's one of several candidates in the vaccine race. (July 27) AP Domestic

Enrollment expected to begin in early August of patient referrals from local physicians.

Hattiesburg Clinic is packing a double punch in the fight againstthe coronavirus, which causes the disease COVID-19.

The clinic, with Forrest General Hospital, has joined two nationwide clinical trial programs one for treating seriously ill patientsthrough Mayo Clinic and the other for preventing infection through vaccination with Moderna and the National Institutes of Health.

Leading the treatment program for Hattiesburg Clinic is Dr. John "Bo" Hrom,clinical trial director for oncology for Hattiesburg Clinic and Forrest General.

"This is kind of my wheelhouse," he said. "Since I set up and help run clinical trials, I basically have the experience to do it."

Mississippi: Health experts, governor debunk 7 common COVID-19 myths

The other clinical trial, conducted by Dr. Rambod Rouhbakhsh, principal investigator for Hattiesburg Clinic's MediSync Clinical Research, will focus on testing patients who meet certain criteria as part of a larger study by Moderna and the NIHs National Institute of Allergy and Infectious Diseases.

Bonnie Hill, a nurse at a southwest Florida hospital, transfers convalescent plasma from a patient in this Tuesday, April 21, 2020, file photo. The plasma is used to treat seriously ill COVID-19 patients who are participating in the Mayo Clinic's study of convalescent plasma. Hattiesburg Clinic joined the Mayo Clinic program and is treating similar patients in Mississippi.(Photo: Andrew West, The News-Press)

The study is in its third stage, which meansthere has been positive results in the earlier stages and it is time toopen the trial to a larger group of participants who will randomly be given either the vaccine or a placebo to accurately measure the effects of the vaccine and make sure it is safe.

Rouhbakhsh said Hattiesburg Clinic is one of 89 sites in the country taking part in this phase of the vaccine study. He said Hattiesburg Clinic is expected to begin the trial soon.

Hromsaid Mississippi south Mississippi in particular saw an influx of cases early in the pandemic, with many people requiring hospitalization. Medical professionals knew something needed to be done quickly to help patients, but there was no known treatment at the time.

"When the pandemic first started in March, we didn't have any available therapies," Hrom said. "We still have very limited therapies as far as treatment for COVID-19."

Dr. John "Bo" Hrom(Photo: Courtesy of Hattiesburg Clinic)

One of the first programs Hattiesburg Clinic and Forrest General consideredwas Mayo Clinic's convalescent plasma treatment. While the treatment is not FDA approved, the protocol for the program met FDA approval.

"Hattiesburg Clinic was one of the early adopters of the treatment," Hrom said. "When (the pandemic) first started, the hospital and Hattiesburg Clinic administrationtalked about we needed to do something so that we would have a treatment that was available in the hospital.

"This basically came out of the need for treatment. We wanted to do something to have treatment available."

Motherhood: Caring for COVID-19 positive moms presents unique challenges at Mississippi hospital

They joined Mayo Clinic's Expanded Access Program, which allows Hattiesburg Clinic and Forrest General to treat seriously ill COVID-19 patients with convalescent plasma collected from those who have recovered from the coronavirus.

Plasma is the liquid part of blood, Hrom said. A recovered person's plasma contains coronavirus antibodies, which could help neutralize and kill the virus when given to a person who is fighting COVID-19.

So far, Hrom said, more than 100 patients have been treated, with encouraging results. Nationwide there are nearly 2,700 sites participating in the trial with more than 40,000 people treated.

Hrom said the clinic and hospital hope to treat many more patients, but needs plasma donations from those who have recovered from COVID-19 and meet certain criteria.

"It's slow going," he said. "There's not enough recovered patients who have donated."

While Hattiesburg physicians, educators and others worked quickly on creating personal protection equipment, rapid-response testing and other innovations since the onset of the pandemic, treatment and prevention have been slowly evolving but are now gaining steam.

We are very pleased to be involved in the latest phase 3 trial (for the Moderna vaccine), which means our community will have access to this as early as any other community in the world,Rouhbakhsh said.

He said enrollment is expected to begin in early August from patient referrals by Hattiesburg Clinic physicians who know the inclusion and exclusion criteria. A website also will be available for those interested in learning more ormay want to volunteer for the trial.

"But we are going to rely on our doctors to help refer patients,"Rouhbakhsh said.

Mississippi: Hundreds sick with COVID-19 at George County correctional facility

Those being considered for the study are people who are at high risk, such as older patients and those who haveco-morbid illnesses, he said.

If it proves to be efficacious with lower side effects, production could be ramped up quickly "to get billions of doses out in the world."

Rouhbakhsh said other doctors at Hattiesburg Clinic will be called on to help him and sub-investigator Dr. Elizabeth Danfordwith the trial on a volunteer basis

"This is such a large trial that is going to rapidly enroll patients, so we are essentially asking doctors to volunteer their off time to participate in this,"Rouhbakhsh said. "Many faculty colleagues have volunteered to be sub-investigators."

He said the goal is to vaccinate around 420, but could getclose to 500 people locally in the next six to seven weeks. Moderna is hoping to have around 30,000 participants nationwide.

In this March 16, 2020, file photo, a person at a Seattle hospital receives a shot in the first-stage safety study clinical trial of a potential vaccine by Moderna for COVID-19, the disease caused by the new coronavirus. Hattiesburg Clinic is joining the study, now in its third stage. According to results released on Tuesday, July 14, 2020, early-stage testing showed the first COVID-19 vaccine tested in the U.S. revved up peoples immune systems the way scientists had hoped. The vaccine is made by the National Institutes of Health and Moderna Inc.(Photo: Ted S. Warren, AP)

Participants would not know if they are receiving theinvestigational medication or a placebo.

The doctors won't either.

Rouhbakhsh said the doctors will follow the patients during length of trial and send the responses to Moderna, along with the other participating sites, so results won't be skewed. A review board also will examine the findings.

If that data is so compelling and it shows that it is so effective, we could potentially end this trial early because it would be unethical to continue with it and deny the placebo group of patients the access to this investigational trial,"Rouhbakhsh said.

That likely wont happen until the early part of 2021 at best,Rouhbakhsh said.

Dr. Rambod Rouhbakhsh(Photo: Courtesy of Hattiesburg Clinic)

Participants who are given the vaccine or placebo will be asked to conduct their lives as usual using the same coronavirus precautions they did before the trial, such as wearing a mask, social distancing and regular hand washing.

"Participants will still need to continue using the same protocols,"Rouhbakhsh said. "Dont go out and be careless and reckless. As scientists,we presume the trial is not going to work and treat participants accordingly."

While the vaccine has already been proven to work, seeing its effectiveness in a larger group of people is another matter. And anumber of participants with the placebo could get COVID-19 during the trial.

"In the United States there are a lot of cases, so the likelihood of getting the illness is quite high,"Rouhbakhsh said.

He said most research is done in bigger cities and in academic settings. The vaccination trial will focus on different size communities

Rouhbakhsh said it is important for the trial to be conducted in communities of all sizes, so Hattiesburg is a prime location since it has qualified experts to conduct the trials.

"We punch above our weight," he said. "We have resources here that are far beyond a city of our size."

To donate, a person must have had a formal COVID-19 diagnosis,be recovered and have no symptoms for 14 days and have a negative COVID-19 RNA swab.

If the person meets the criteria, he or she may go to a blood donation center, such as Vitalant or American Red Cross, where they are hooked up to a machine similar to ones used in traditional blood donations. Donors can give once per week.

"We can get anywhere from two to six units of convalescent plasma at a time," Hrom said."One unit of convalescent plasma is used to treat one patient, so potentially, two to six patients can be treated from one persons donation.

LSUHS will be using serology testing to support the convalescent plasma therapy clinical trial and help identify ideal plasma donors. Shreveport Times

The goal of the trial is to determine if the antibodies developed in a patient who has recovered from the virus will effectively treat those who are currently affected by the disease, Hrom said in a news release.

Only patients in serious, critical condition currently are able to receive convalescent plasma treatment.

While the study is in its infancy, risks associated with receiving treatment are the same as any other blood transfusion. Since plasma is takenat a blood donation center, it meets FDA requirements. Every unit that is donated undergoes various system checks to ensure it is safe.

We needed access to something that would help critically ill patients," Hrom said."If this treatment proves to be beneficial, I want to be able to offer patients the same treatment as those services provided by the Mayo Clinic or Mount Sinai Hospital in New York.

"We want to be able to provide the same level of care as some of these major medical institutions.

Anyone interested in participating in the Convalescent Plasma Clinic Trial may visit hattiesburgclinic.com/convalescent-plasma-trial and fill out the information form provided.

For more information on the COVID-19 Expanded Access Program, visit uscovidplasma.org.

To learn more about the enrollment process for the Coronavirus EfficacyStudy, visit hattiesburgclinic.com/medisync-study-opportunitiesor call 601-544-1866.

To learn more about Moderna and the COVE study, visitinvestors.modernatx.com/news-releases/news-release-details/moderna-announces-phase-3-cove-study-mrna-vaccine-against-covid.

Contact Lici Beveridgeat 601-584-3104 orlbeveridge@gannett.com. Follow her onTwitter@licibevor Facebook atfacebook.com/licibeveridge.

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Mississippi on the front lines as COVID-19 vaccine, treatment trials come to Hattiesburg - Clarion Ledger

US Studies Hold The Key To COVID-19 Vaccines Race – Scrip

July 31, 2020

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US Studies Hold The Key To COVID-19 Vaccines Race - Scrip

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