Stanford Medicine begins enrolling for COVID-19 vaccine trial | News Center

Stanford Medicine has joined a large, Phase 3 clinical trial of an experimental vaccine against COVID-19.

The trial will test whether the vaccine, which is produced by the Janssen Pharmaceutical Companies of Johnson & Johnson, protects people from the disease. It will enroll some 60,000 people at about 180 sites around the world. The Stanford site is expected to enroll about 1,000 participants.  

Participants will receive either the vaccine or a placebo, and their health and immune responses will be monitored for about one year after their initial visits. If any participants become ill with symptoms of COVID-19, a health care provider will go to their homes to assess their health and collect a nasal sample to test for the presence of the novel coronavirus. If they are infected, Stanford physicians will monitor their disease progression. 

“We’re enrolling a wide variety of participants, but we are particularly interested in those who feel like their home or workplace exposure puts them at risk,” said Philip Grant, MD, assistant professor of medicine and the trial’s principal investigator at Stanford. “Teachers, grocery store workers, people who live in multigenerational households, health care workers and students on campus would all be good candidates for participation.”

Participants will be followed for two years and one month. They are expected to visit the trial site eight times: six in the first year and two in the second year. The initial visit will last about two hours; subsequent visits will consist of a short blood draw and symptom screening. If a participant develops COVID-19 during the study period, additional visits may be required.

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New COVID-19 Vaccine Unit Opens at Montefiore and Albert Einstein College of Medicine

The vaccine unit opening comes as global coronavirus infections are rising sharply, with nearly 200,000 cases reported daily in the United States. Montefiore’s goal is to ensure more than half of all trial participants are adults most affected by COVID-19 with a focus on people older than 65. Across the country, older individuals and communities of color have been disproportionately impacted by the pandemic.

“Montefiore and Einstein have a legacy of providing inclusive access to cutting edge care,” said Andrew D. Racine, M.D., Ph.D., system senior vice president and chief medical officer at Montefiore and professor of pediatrics at Einstein. “By ensuring that historically underrepresented patients are included in COVID-19 vaccination research, this effort will help ensure the efficacy and safety of vaccines for these underrepresented patient groups.”

The new vaccine unit builds on Montefiore and Einstein’s leadership conducting COVID-19 trials and providing lifesaving clinical care to thousands of people in the community and has already started enrolling people in the AstraZeneca-Oxford vaccine AZD1222 trial. Dr. Zingman is the principal investigator at Montefiore for the vaccine, which is one of 13 COVID-19 vaccines in phase III trials and the first to be evaluated at Montefiore and Einstein. He was also the principal investigator at Montefiore and Einstein for the ACTT-1 and ACTT-2 National Institutes of Health trials, which evaluated remdesivir (now FDA-approved as a treatment for people hospitalized with COVID-19) and remdesivir plus baricitinib, respectively. 

Since March, physician-scientists at Montefiore and Einstein have studied COVID-19’s impact on almost every major health condition, ranging from asthma to cancer; examined health inequities in local communities; and helped determine which treatments work best against COVID-19.

Among its notable research, Montefiore and Einstein faculty:

–  Published the first major U.S. study on the use of steroids, which confirmed the findings of the large-scale British RECOVERY trial showing that steroids are effective in treating COVID-19; the study also revealed which patients can be harmed by steroids

–  Led the first-ever study comparing the immune responses of adults and children with COVID-19 and detected key differences that may explain why children have milder disease than adults

–  Led the development of a monoclonal antibody therapy to neutralize COVID-19—and potentially other emerging coronaviruses—clinical trials will begin in December

–  Created a blood test for detecting COVID-19 antibodies, used clinically and for research

–  Launched the first randomized, placebo-controlled, double-blind trial of convalescent plasma with NYU Langone Medicine Center, which has expanded to include the University of Miami and the University of Texas-Houston, among other locations across the country

–  Was the first New York City medical center to enroll participants in the ACTT-1 remdesivir trial and the second highest enrolling site worldwide

–  Will offer the first randomized controlled trial of dexamethasone versus baricitinib (NIAID ACTT-4 study) for the hyperinflammatory state in COVID-19

“Words cannot express my appreciation for the many people who worked so hard to establish the new COVID-19 vaccine unit, making sure underrepresented communities will have access to the most promising

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Oxford Vaccine Demonstrates 70% Protection Against SARS-CoV-2

The Sars-CoV-2 vaccine developed by the University of Oxford demonstrated average efficacy of 70.4%, according to results of clinical trials.

The interim analysis of phase 2/3 trials in the UK and Brazil found efficacy of 62% following two full doses given at least one month apart.

However, vaccine efficacy was 90% when ChAdOx1 nCoV-19, also known as AZD1222, was given to a subset of participants as a half dose, followed by a full dose at least one month later.

No hospitalisations or severe cases of the disease were reported in participants who received the vaccine, Oxford’s partner AstraZeneca said in a press release this morning.

The data also suggested a half dose and full dose regime could help to prevent transmission of the virus, according to a press release from the University of Oxford.

Sarah Gilbert, professor of vaccinology at Oxford, said: “The announcement today takes us another step closer to the time when we can use vaccines to bring an end to the devastation caused by SARS-CoV-2.”

The announcement follows promising interim data from Pfizer-BioNTech and Moderna, which recently demonstrated protection of around 95% against developing COVID-19 with their messenger RNA (mRNA) vaccines

However, the Oxford vaccine is cheaper to produce, and unlike the other vaccines that require a demanding cold chain storage, can be kept at standard refrigerator temperatures of between 2C and 8C.

‘Exciting’ News

Prof Andrew Pollard, director of the Oxford Vaccine Group, said: “These findings show that we have an effective vaccine that will save many lives.

Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply.”

Asked why giving a half dose followed by a full dose appeared to be more effective, Prof Pollard told a briefing hosted by the Science Media Centre: “We think that by giving a smaller first dose that we’re priming the immune system differently, we’re setting it up better to respond.”

He added: “What we don’t know at this moment is whether that difference is in the quality or the quantity of the immune response, and that’s something we are doing to be digging into.”

Pascal Soriot, AstraZeneca’s chief executive Officer, said using a halved first dose and a standard second dose would mean “we can vaccinate more people, faster”.

AstraZeneca Prepares to Seek Regulatory Approval

The company said it would immediately prepare regulatory submission of the data to authorities around the world.

Trial results will be submitted to a scientific journal for peer review.

The pooled analysis included data from the COV002 Phase 2/3 trial in the UK and COV003 phase 3 trial in Brazil, and involved more than 23,000 participants.

Dr Zania Stamataki, viral immunologist at the University of Birmingham, commented: ” People will be tempted to compare efficacy between the different vaccines but we must remember that these are early data designed to achieve approval. Efficacy is not the same as effectiveness and the early numbers

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‘Half-measure’ Virus Vaccine Intrigues Experts

Evidence suggesting an initial half dose of the vaccine being developed by drugs firm AstraZeneca and the University of Oxford is more effective than a full dose is counterintuitive, and even took the researchers by surprise.

Why would less be better than more when it comes to triggering an immune response?

Andrew Pollard, the director of the Oxford Vaccine Group, described the findings from the Phase 3 clinical trial as “intriguing”.

They showed that the vaccine had an efficacy of 62 percent among the people given two full doses a month apart.

But this rose to 90 percent for another group who received a half-dose first and then a full dose after a month.

“I think all of us expected that the two high doses would be the best response,” said Pollard, who noted researchers had only seen the details of the results over the weekend and would now start digging into the data.

“We think that by giving a smaller first dose, that we’re priming the immune system differently. We’re setting it up better to respond,” he told a press briefing.

Sarah Gilbert, professor at Oxford’s Nuffield Department of Medicine, said the better result with a smaller initial dose could be because this better “mimics what happens in a real infection”.

Essentially a vaccine uses a safe method to trick the immune system into believing it is dealing with a dangerous infection, triggering an immune response and an immune memory that can activate if the body comes across the real pathogen.

“It could be that by giving a small amount of the vaccine to start with and following up with a big amount, that’s a better way of kicking the immune system into action and giving us the strongest immune response,” Gilbert told reporters.

Clinical trials suggested that an initial half-dose was better than a full one Clinical trials suggested that an initial half-dose was better than a full one Photo: AFP / JUAN MABROMATA

The Astra/Oxford vaccine employs what is known as a “viral vector”, using engineered viruses to deliver genetic cargo into cells, giving them instructions on how to fight SARS-CoV-2.

The strategy uses the transporting virus as a “Trojan Horse”, said Colin Butter, Associate Professor at the University of Lincoln.

It is “complex and usually achieved experimentally: a luxury not available in the present situation”.

The technology itself may be the reason why an initial half-dose could work better, according to several scientists commenting on the results, with the immune system acting against the virus being used as a delivery vehicle.

“It may seem confusing that a higher initial dose gives a less favourable response, but this may just be due to a residual response in some patients to the disabled ‘vehicle’,” a snippet of chimpanzee virus used to deliver the vaccine “payload”, said Stephen Griffin, Associate Professor in the School of Medicine, University of Leeds.

But he said this could be “easily fixed” by using the adjusted dose.

Pollard said researchers would be looking to find out if the issue was the quantity or quality of the immune

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AstraZeneca to seek FDA authorization for vaccine based on foreign trial data

The company also said it would work with the agency to adjust the design of its late-stage U.S. trial to test the half-dose regimen, rather than the higher dose that proved less effective in the U.S and Brazil studies. That U.S. trial has enrolled about 10,000 of a planned 40,000 participants, but the company has not released any data from that study.

The U.K. and Brazil studies have enrolled about 24,000 participants — fewer than the 30,000 participants that the FDA is requiring for late-stage coronavirus vaccine trials.

The initial findings were based on 131 infections among trial participants. The company did not break down how many cases were reported among those who got a placebo versus those who got the vaccine, and within that vaccine group, how cases split among the two doses tested.

AstraZeneca also said that none of the infected people had severe Covid-19 or were hospitalized, but offered no further safety information.

Promising logistics: The AstraZeneca vaccine is cheaper and easier to distribute than the other two shots that have proven effective. It can be transported and stored under refrigerated conditions for at least six months, and the company says it can make up to 3 billion doses next year.

Vaccines from Pfizer and Moderna, which have each proven about 95 percent effective, must be frozen during distribution and kept at very cold temperatures.

“AstraZeneca and Oxford have developed an affordable, scalable vaccine that crucially can be stored and shipped in a regular refrigerator,” said Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations, said in a statement. “This makes it appropriate for use and easy to deliver almost anywhere in the world, including in low-resource settings.”

But questions remain: Others doubt whether the FDA will authorize the vaccine.

“We believe that this product will never be licensed in the US,” investment bank SVB Leerink analyst Geoffrey Porges said in a note on Monday. “This belief is based on the design of the company’s pivotal trials (which does not appear to match the FDA’s requirements for representation of minorities, severe cases, previously infected individuals and elderly and other increase risk populations), and based on the occurrence of severe safety events (why take the risk) that resulted in the extended clinical hold on enrollment into the trials in the US.”

The company halted its U.S. trial in early September over safety concerns, after a trial participant reported neurological problems. The study resumed earlier this month after FDA concluded that no evidence linked the volunteer’s symptoms to the shot.

Background: The AstraZeneca vaccine was developed by scientists at Oxford University, and uses a different technology than the Moderna and Pfizer vaccines. It uses a weakened version of the common cold that contains some genetic material from the coronavirus.

U.S. vaccine and therapeutics accelerator Operation Warp Speed paid for some of the clinical development of the AstraZeneca vaccine and purchased 300 million doses for $1.2 billion.

Other clinical trials are ongoing in Japan, Russia, South Africa, Kenya

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What to Know About California’s Vaccine Rollout

What are the challenges to rolling out a vaccine?

The two vaccines announced last week shattered all records for speed of development. “We’d be lucky in normal circumstances if we were able to develop vaccines in three years,” said Brad Pollock, associate dean for public health sciences at the University of California, Davis, School of Medicine.

The vaccines work by using the host’s own immune system to form a defense against the virus.

Even with the historic development, there are some challenges ahead. The Moderna and Pfizer vaccines require two doses given weeks apart, meaning people will have to remember to get their second follow-up dose.

There’s also the matter of storage. Both of those vaccines must be stored at low temperatures, although Moderna said that its vaccine had a longer shelf life under refrigeration and at room temperature than previously reported. State health officials said they are working to improve their cold chain storage capacities.

The state also needs an adequate supply of needles and syringes, alcohol, pads, bandages, masks and personal protective equipment to safely administer the vaccine.

Once the vaccine is widely available, there might be some resistance to taking it, studies have shown. But there is now reason to believe that more people will be willing to take a vaccine than previously thought. A Gallup poll released on Tuesday showed that 58 percent of the adults who were surveyed were willing to be vaccinated, up from 50 percent in September.

[Read about California’s curfew.]

Is there a timeline?

Mr. Newsom said he expected the vaccine would be widely available in the middle of next year. A number of variables will become more clear in the coming months. Dr. Pollock said that people who participated in the Moderna and Pfizer trials will still need to be followed for a few more months in order to monitor potential side effects.

The Moderna trial did not include children but there are plans to include them in the coming months. However, since children seem to be spared from the harshest effects of the virus, it’s unlikely that they will be included in the first few phases.

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Moderna’s COVID-19 Vaccine Will Cost As Much As A Flu Shot, says CEO Stephane Bancel

KEY POINTS

  • The vaccine candidate will cost between $25 and $37, depending on orders: Moderna CEO
  • The vaccine needs to be administered in two doses
  • Trials of Moderna’s vaccine candidate showed 95% efficiency rates

Massachusetts-based biotechnology firm Moderna’s COVID-19 vaccine candidate, mRNA-1273, will cost governments between $25 and $37 per dose, depending on their orders, CEO Stephane Bancel told a German weekly paper.

“Our vaccine…costs about the same as a flu shot, which is between $10 and $50,” Bancel told Welt am Sonntag (WamS), according to Reuters.

Moderna is in discussion with the European Commission to finalize a deal on the supply of millions of doses of its vaccine at a price less than $25 per dose. “Nothing is signed yet but we are close to a deal with the EU Commission. We want to deliver to Europe and are in constructive talks,” Bancel told the paper. He said it would be a matter of days before an agreement is reached.

This would come up to at least $50 per patient, as the vaccine needs to be administered in two doses. Moderna received nearly $1 billion in funds from the Biomedical Advanced Research and Development Authority for the vaccine, as per Forbes.

The cost of this vaccine will be similar to the price of the annual flu vaccine in the U.S., which costs about $40 for people without insurance. It is interesting to note that flu shots have an efficacy rate of 40%-60%, whereas Moderna is claiming that its vaccine candidate showed an almost 95% efficacy rate in trials. The final Phase 3 trials will confirm these results.

When Moderna announced these results, Dr. Anthony Fauci, the nation’s top infectious disease expert, told NBC News, “These are obviously very exciting results. It’s just as good as it gets… 94.5% is truly outstanding.”

Vaccinations could begin in the second half of December, Fauci said. The vaccine will first be made available to high-risk groups, and for the rest of the population, it will be available next spring.

The government also wants to ensure that everyone can afford a COVID-19 vaccine. Centers for Medicare and Medicaid Services are discussing a rule that as soon as a vaccine is available for the virus and is approved by the Food and Drug Administration, it will be made available to seniors and low-income people in public health insurance programs for no cost.

Moderna is the second company to develop a vaccine, following Pfizer and its partner BioNTech, which proved to be 90% effective in its initial trials.

US biotech firm Moderna says its experimental vaccine is almost 95 percent effective in protecting people from the novel coronavirus US biotech firm Moderna says its experimental vaccine is almost 95 percent effective in protecting people from the novel coronavirus Photo: AFP / Joseph Prezioso

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How Parents Feel About Their Kids in COVID-19 Vaccine Trials

Katelyn Evans, 16, has never met Randy Kerr—and there’s no reason she should have. It was 66 years ago that Kerr, then 6, became briefly famous, receiving the first injection of Jonas Salk’s experimental polio vaccine during the massive field trial of hundreds of thousands of children in the spring of 1954. History notes that the vaccine worked, and the children who stepped forward to receive either the actual shot or a placebo were heroically dubbed the Polio Pioneers.

Evans is a pioneer of the modern age, one of an eventual group of 600 children in the 16-to-17 year-old age group (along with 2,000 more between 12 and 15) to volunteer to be part of a Phase 3 trial to test an experimental COVID-19 vaccine made by the multinational pharmaceutical giant Pfizer. The company had already enrolled 42,113 adult volunteers in its Phase 2 and 3 trials, but only recently did the U.S. Food and Drug Administration (FDA) give approval to include children. And Evans, a high school junior in Cincinnati, was among the earliest, receiving her first of two injections on Oct. 14, at Cincinnati Children’s Hospital.

“She was the youngest one to receive the vaccine at that point in time,” says her mother, Laurie Evans, an elementary school teacher. In the spring, the family saw a news report that Pfizer was looking for volunteers and Evans and both of her children signed up. “Katelyn was the only one who got the call,” Laurie says. “I know from the response we’ve gotten that there are some people out there who don’t think this is the smartest thing for us to have done. But I’m more afraid of COVID than the vaccine.”

With good reason. The 8.8 million Americans who have contracted the disease include about 800,000 children, with the American Academy of Pediatrics (AAP) reporting a 13% increase in total pediatric cases in just the first two weeks of October. Children with COVID-19 may typically fare better than adults who catch the virus, but they can still become severely ill: some 3.6% of total U.S. COVID-19 patients who have had to be hospitalized have been children, according to the AAP. That reality makes volunteering for the Pfizer field trial more than an act of public-service heroism; it is also a potential act of preventive medicine.

Certainly, that’s the way Sharat Chandra saw things. Sharat was already part of the Pfizer adult trial and when word first went around that children would soon be included too, he and his wife discussed the possibility of enrolling their 12-year-old son Abhinav, and then posed the question to him.

“I raised it to my son and we felt that it might be a good thing for him because if he got the vaccine, it could protect him from getting the virus himself,” Sharat says. “Because he was attending school in person, we felt that it would be good to minimize his risk for infection, if we can.”

Abhinav Chandra participating in Pfizer's COVID-19 vaccine trial.

Abhinav Chandra participating in Pfizer’s

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University of Chicago Medicine looking for 2,000 participants for COVID-19 vaccine trial

University of Chicago Medicine will soon begin testing another potential COVID-19 vaccine, and is looking for up to 2,000 people to enroll in the phase three clinical trial.



Medical assistant Debbie Turrise assists patients driving thru with self administered COVID-19 tests at a COVID-19 drive-thru testing site at Rush University Medical Center in Chicago, Tuesday, Oct. 20, 2020. University of Chicago Medicine will soon begin testing another potential COVID-19 vaccine, and is looking for up to 2,000 people to enroll in the phase three clinical trial.


© Antonio Perez / Chicago Tribune/Chicago Tribune/TNS
Medical assistant Debbie Turrise assists patients driving thru with self administered COVID-19 tests at a COVID-19 drive-thru testing site at Rush University Medical Center in Chicago, Tuesday, Oct. 20, 2020. University of Chicago Medicine will soon begin testing another potential COVID-19 vaccine, and is looking for up to 2,000 people to enroll in the phase three clinical trial.

The trial is designed to evaluate the safety and efficacy of a single dose of a vaccine produced by Janssen Pharmaceutical Companies of Johnson & Johnson. The trial began enrolling 60,000 adults across the world in September.

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It’s one of a handful of potential vaccines now in advanced clinical trials in the U.S.

The international trial of the Janssen vaccine was temporarily paused in October after one participant developed an unexplained illness.

“Such pauses are not uncommon in vaccine trials, and late last week the FDA approved the resumption of the trial after an independent committee found the vaccine did not cause the illness,” University of Chicago Medicine leaders wrote in an email sent Monday to faculty, staff and students.

This is the second COVID-19 vaccine trial University of Chicago Medicine has offered. Since mid-September, the system has also been enrolling subjects in the Moderna COVE trial.

To participate in the Janssen trial and future research, people can join UChicago Medicine’s registry.

Other large hospital systems in Chicago are also participating in COVID-19 vaccine trials, including the University of Illinois at Chicago, which is part of the Moderna trial, and Northwestern Medicine, which is part of a trial of the AstraZeneca Oxford vaccine.

———

©2020 the Chicago Tribune

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As rich countries hoard potential coronavirus vaccine doses, rest of world could go without

As a result, relatively wealthy nations will likely be able to vaccinate their entire populations, with billions of others relegated to the back of the line. People in low-income countries could be waiting until 2024.

These deals between countries and drug manufacturers, known as advance purchase agreements, are undermining a World Health Organization-linked initiative to equitably distribute vaccines, the study suggests.

“Where we are headed is a situation where high-income countries have enough, and low-income countries just don’t,” said Andrea Taylor, the lead researcher.

Since the vaccine race got underway, experts have warned of the dangers of “vaccine nationalism” and calling for a cooperative approach to vaccine development and distribution.

More than 150 countries, representing a large share of the world’s population, have signed on to participate in the Covid-19 Vaccines Global Access Facility, or Covax, which aims to develop and equitably distribute $2 billion in doses of a vaccine by the end of next year.

Under the plan, both rich and poor countries pool money to offer manufacturers volume guarantees for potential vaccines. The idea is to discourage hoarding and focus on vaccinating high-risk people in every participating country first.

Many wealthy players, including the European Union, Canada and Japan, joined the initiative. But most are backing Covax while also cutting deals directly with manufacturers.

The researchers found that Canada and the United Kingdom have already reserved more than enough potential vaccines to cover their entire populations. The E.U. has also secured hundreds of millions of doses.

These deals make sense from a country perspective, but they undermine cooperative efforts to secure enough doses, particularly for low-income countries, experts said.

“The more that countries hedge their bets and work outside of Covax, the harder it is for Covax to actually deliver on its promises,” said Suerie Moon, co-director of the Global Health Center at the Graduate Institute of International and Development Studies in Geneva.

Rich countries, she said, “are eating up all the supply before Covax can take a nibble.”

The United States did not join Covax, in part because the Trump administration did not want to work with the WHO. The Duke analysis found that the U.S. already has agreements to buy enough doses to cover 139 percent of its population — and could eventually control 1.8 billion doses, or roughly a quarter of the world’s “near-term” supply.

Middle-income countries are also reserving doses. Brazil and India already have secured the rights to enough vaccines to cover about half of their populations, the study noted.

Most low-income countries, by contrast, have little choice but to rely on Covax, which must compete with big players to secure access to vaccines.

Taylor, the lead researcher, stressed that the study offers a “snapshot” of where things stand, not a definitive prediction. Access to vaccines depends in large part on which vaccines prove safe and effective — and that is still very much up in the air.

Another critical question is capacity: How many coronavirus vaccines can the world make in a

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