COVID-19 vaccine will likely arrive in December, state's top health official says krcgtv.com
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COVID-19 vaccine will likely arrive in December, state's top health official says - krcgtv.com
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In late March, officials in the United States were still talking about the coronavirus lockdown in terms of weeks instead of months. People were wiping down their groceries with disinfectant spray and basically scared to step outside.
It was then that biologist Preston Estep sat alone in a Boston lab with a coronavirus vaccine his team had developed over just a few weeks.
I took a small dose first, he said. You know, I usually do this even with pharmaceutical therapeutics, I always take a small dose first just in case there was some sort of negative reaction.
Estep took maybe a tenth of the total dose, waited a few hours, and then took the rest.
I just felt really good, really positive about taking that first step, taking that first shot of vaccine, he said. And when I say shot, I mean a nasal spritz up the nose. So less dramatic than sticking a needle in oneself.
What drove Estep here, sniffing his home-made vaccine?
It was the way people were dying. He was devastated by the thought of people dying alone.
Basically, older people were being quarantined away from their families, and they were being left to die alone in sealed rooms, Estep said.
Couple that with the rosiest vaccine estimates coming from the government at the time: If everything went right, wed have a vaccine, and a way out of this, in 12 to 18 months.
These were people suffering and dying alone, hundreds, and then thousands of them. And I just couldnt stand the idea that we were gonna wait a year and a half while these sorts of scenarios played out, he said.
Estep is a geneticist by training, not an infectious-disease specialist. But hes Harvard-trained and highly connected in scientific circles. A world renowned geneticist, George Church, was one of the first to take a version of his vaccine.
I had studied with some of the smartest and most capable and amazing scientists in the world, and Id seen people do some pretty amazing things, he said. Ive been up close and personal to some radical breakthroughs and important scientific work thats happened very quickly.
The way he explained it, its not so much that he was convinced he could do something about the coronavirus. More like, he just wasnt convinced he would be totally useless.
He assembled the Rapid Deployment Vaccine Collaborative, RadVac, essentially a posse of scientists that hed known from previous work. Estep said they werent only brilliant, they had a healthy conception of risk calculation. He needed risk takers because, in his mind, self-experimentation was the only way to move faster than the virus.
I knew that we were on uncharted territory. This was previously only sort of a theoretical challenge that was going to hit civilization at some point that there would be a worldwide pandemic, he said. But I knew that my colleagues that I originally reached out to had thought about these kinds of things.
Estep found it wasnt all that hard to get the band back together. Scientists like many of the rest of us had their careers upended by March of this year. A lot of them were out of work or at least cut off from whatever they were researching at the time, thanks to coronavirus restrictions. One of his collaborators had a lab space.
So we had a fully stocked professional biotech lab basically ready to go, that had sufficient equipment, he said.
And they were off.
Look into vaccine development in general and you discover that its not all that hard to create one from a technical standpoint. Its not of the same engineering order as, say, making a nuclear reactor.
Estep found there was already decades-old technology that had been tested in humans that he could use to deliver the vaccine in a nasal spray.
You can form gel nanoparticles that are about the size of a virus that cross the mucous membrane because of both the size and the chemical properties, he said. And it acts as an ideal intranasal delivery vehicle.
There are basically five ingredients to form those particles that are readily available. To elicit an immune response, Esteps team used little bits of artificially synthesized protein that mimic bits of the coronavirus.
It basically all came together very quickly within a week or two, he said. I had a basic design that used these synthetic pieces, these little tiny non-infectious pieces of the virus, that I could order, you know, online.
So if creating a vaccine is the easy part, its testing it that gets tricky. You have to figure out if its safe and effective before distributing it to literally every living human being on the planet.
The only ethical test subject, he figured, was himself.
Since taking that first dose in March, Estep and his collaborators have developed seven more versions of the vaccine, and have tried them all.
So we volunteered ourselves as the designers of the vaccine, Estep said. We decided that the only way to create that rapid feedback loop of design iterations and testing was to use it on ourselves.
Design, test, look for the immune response, improve, design and then repeat. Estep said this model makes him more nimble than the big pharmaceutical groups, able to incorporate more of what is learned about the virus into designs in real time instead of being locked into a vaccine thats months old and that has to go through months-long regulatory and safety hurdles.
What the world calls warp speed the way pharmaceutical giants and governments are working together to create a vaccine in 18 months rather than the usual span of several years to Estep is slow motion.
I think we do need to get a vaccine out as quickly as possible, said Paul Offit, vaccine researcher and director of the Vaccine Education Center at Childrens Hospital of Philadelphia. That said, we need to make sure that the vaccine works and that its safe.
Offit said much of todays vaccine regulation architecture stems from a 1955 disaster known as the Cutter Incident.
Jonas Salk made his polio vaccine in 1955 by taking the virus and inactivating it with a chemical, [and] five companies stepped forward to make it. One company made it badly, Cutter Laboratories of Berkeley, California, he said. They had failed to fully inactivate the polio virus that was in that vaccine. As a consequence, about 120,000 children were inoculated with live, fully virulent polio virus, Offit said. Investigations later showed that the contaminated vaccine had caused about 40,000 cases of polio, in which, about 200 children were paralyzed and 10 children were killed. I think it was probably the worst biological disaster in this countrys history.
Offit said its an unfortunate part of cutting-edge medicine, especially medicine distributed to hundreds of millions of people.
The history of, frankly, medical breakthroughs is littered with those kinds of stories, he said.
The Cutter Incident harmed far more people than others, but Offit mentioned another vaccine from the 60s that looked like a real winner initially. It was from the National Institutes of Health and had great results in animal models, with good initial data all around.
[But] when they put it into a Phase Three [trial], they found the children who got that vaccine were more likely to develop pneumonia, more likely to be hospitalized and, in the case of two children, more likely to die than children who didnt get that vaccine, he said.
All this serves to explain why the safety protocols exist in the first place, Offit said, adding that warp speed doesnt really touch the safety and efficacy hurdles that slow down vaccine development.
Instead, it simply removes much of the financial risk facing vaccine makers.
Theyve said, Look, well pay for the Phase Three trials, which cost hundreds of millions of dollars; well pay for the mass production, even not knowing whether or not the vaccine is safe, not knowing whether the vaccine is effective. Well take the risk for that, he said, with we meaning the federal government. Well make hundreds of millions of doses not knowing whether this vaccine works and is safe, and if it doesnt work and isnt safe, then well just throw those millions of doses away. No pharmaceutical company would ever do that, Offit said.
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'Warp speed' is too slow for scientists testing COVID-19 vaccine on themselves - WHYY
FILE PHOTO: A small bottle labeled with a "Vaccine COVID-19" sticker and a medical syringe in this illustration taken April 10, 2020. REUTERS/Dado Ruvic
SAO PAULO (Reuters) - Brazilian health regulator Anvisa has authorized resumption of a clinical trial of Johnson & Johnsons experimental COVID-19 vaccine, according to a statement from the government agency on Tuesday.
The J&J vaccine is one of four being tested in Brazil, which has the worlds third worst outbreak behind the United States and India, and the second-highest COVID-19 death toll.
J&Js trial in Brazil had been suspended since Oct. 12, so a safety panel could evaluate an unexplained illness of a participant in its planned 60,000-person Phase III study. Testing of the vaccine in the United States resumed last month.
Anvisa said when the trial was interrupted, 12 volunteers in Brazil, all from Rio de Janeiro, had either received a dose of the vaccine or a placebo.
The study in the South American country is being conducted in 11 states, and is expected to involve up to 7,560 people over the age of 18, Anvisa said.
Reporting by Anthony Boadle and Ana Mano; Editing by Bill Berkrot
Excerpt from:
Brazil allows Johnson & Johnson to resume trial of COVID-19 vaccine - Reuters
ANNAPOLIS, Md. (WJZ) Nearly 40 Maryland companies are developing or manufacturing coronavirus vaccines and therapeutics, Gov. Larry Hogan said Thursday during a press conference.
The governor addressed residents after COVID-19 cases grew by at least 1,000 for the second consecutive day and the states positivity rate went up to 4.21% after dropping to below 3% several weeks ago.
Although he said the states health officials are prepared for the second wave of coronavirus and has enough hospital beds, PPE and testing supplies, Marylanders cannot let their guard down.
HOGAN NEWS CONFERENCE UPDATES:
Hogan said more than three dozen Maryland companies are working on vaccines and innovative therapies to treat COVID-19.
Novavax, which added 400 more jobs and was awarded $1.6 billion, is ahead of the group with the development of a coronavirus vaccine.
Hogan said the Maryland Department of Health has submitted a plan to the CDC for how they will order, distribute and administer a vaccine when its made available.
WATCH BELOW: Hogans Full News Conference
For the latest information on coronavirus go to the Maryland Health Departments website or call 211. You can find all of WJZs coverage on coronavirus in Maryland here.
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Nearly 40 Maryland Companies Working On COVID-19 Vaccines, Therapeutics - CBS Baltimore
Nov. 5 (UPI) -- Pharma company AstraZeneca said Thursday it is on track to deliver results from late-stage human trials for its COVID-19 vaccine candidate before the end of the year.
The announcement raised hopes that an effective vaccine against the coronavirus disease could become available before the start of 2021.
"Results from late-stage trials are anticipated later this year, depending on the rate of infection within the communities where the clinical trials are being conducted," AstraZeneca said Thursday in its third quarter earnings report.
The company is developing the AZD1222 vaccine in collaboration with the University of Oxford. It is in the final phase of trials in the United States, Britain, Brazil and South Africa with 23,000 volunteers.
The British and U.S. trials were temporarily placed on hold two months ago when two participants exhibited unexplained illnesses, and AstraZeneca has already missed an initial September target of delivering 30 million doses to the British government.
"In the fight against COVID-19, we advanced our vaccine collaboration with the University of Oxford and are launching Phase III trials for our long-acting antibody combination for the prophylaxis and treatment against COVID-19 for people who need an immediate defense or whose weaker immune systems mean they are less likely to benefit from a vaccine," said AstraZeneca CEO Pascal Soriot.
The drugmaker reported a 7% increase in global sales, to $6.5 billion, from July to October, which Soriot called "encouraging headway" despite "ongoing disruption from the COVID-19 pandemic."
AstraZeneca's COVID-19 vaccine is one of several candidates now in late-stage clinical trials worldwide, along with efforts from Johnson & Johnson, Pfizer-BioNTech, Novavax and Moderna.
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AstraZeneca COVID-19 vaccine results to be delivered by end of 2020 - UPI News
Dr. Joshua Liao explains why pinning a full return to normalcy solely on vaccines could alter our risk perceptions, encourage unsafe behaviors, and ultimately prolong suffering from the pandemic.
It can also be dangerous to pin our hopes on vaccines.
The world eagerly awaits a Covid-19 vaccine. In the United States, one quarter of Americans are inclined to delay resuming normal activities until a vaccine is available. Public officials have used promising news about vaccine candidates to rally their bases. Vaccine topicswhen the first one will arrive, how to ensure it is safe, and who will get it firstdominate the news cycle.
All of this attention reflects a widespread expectation that Covid-19 vaccines will accelerate a return to normalcy, ending the need for measures like social distancing and masking. This optimism is understandable given both the incredible suffering that Covid-19 has caused, and the massive amount of time and resources that the world has committed to ending it.
But it can also be dangerous to pin our hopes on vaccines. As behavioral science teaches us, humans are highly susceptible to optimism biasthe tendency to overestimate the likelihood of experiencing positive events and underestimate the risk of negative ones. In the case of Covid-19, over-optimism about vaccines could distort our risk perceptions, encourage unsafe behaviors, and ultimately prolong suffering from the pandemic.
While vaccines can play a role in controlling the pandemic, they are not silver bullets.
The reason to worry is that optimism bias pervades life. College students can overestimate their test performance and post-graduation starting salaries. People tend to be unreasonably optimistic about marriage, underestimating the likelihood that they will experience a divorce. Small business owners are prone to unrealistic optimism about the chances of their new ventures succeeding. Financial advisors can be too positive in their forecasts, and clients in their willingness to take that advice.
This bias is not confined to pure self-assessment; it also occurs when people compare themselves to others. Nearly three-quarters of college students rate themselves as above-average in leadership ability compared to their peers, while only 6% consider themselves below average in athletic ability. In healthcare, we have observed comparative over-optimism for a number of different health conditions and behaviors. Hundreds of studies done in different settings affirm the same point: humans frequently view themselves through disproportionately rose-colored glasses.
It would be dangerous to view Covid-19 vaccination this way. While vaccines can play a role in controlling the pandemic, they are not silver bullets. But optimism bias can create a mismatch between belief and reality, causing people to overestimate vaccine effectiveness and the protection it gives them. Under a false sense of security, people who are vaccinated could be emboldened to stop masking, social distancing, and limiting the size of their gatheringsmeasures that would be burdensome and unnecessary under the assumption of immunity.
Premature choices would be even more alarming for several reasons. We still dont know how long immunity from a Covid-19 vaccine will last; if anything, coronavirus antibodies seem to wane rapidly after infection. We also dont know what exactly vaccines will prevent (getting infected versus our ability to infect others) and how effectively (partial versus full prevention). Given the time required to manufacture and distribute vaccines at scale, we also dont know exactly when vaccines will be available to everyone. These factors all increase the harm that could occur if those who get vaccinated prematurely abandon safe behaviors and precautions.
We can frame masking and social distancing as necessary behaviors even after Covid-19 vaccines ... [+] arrive.
How can we combat over-optimism about Covid vaccines? In both our public health messaging and social interactions, we can leverage framing effectsthe fact that peoples decisions are affected by how information about an issue is presentedand change how we talk about social distancing and masking.
So far, even if implicitly, these behaviors have been framed as stop-gap measures, things to tolerate until we get an effective vaccine. The problem is that this framing itself could increase the risk of over-optimism: months of pent-up anticipation about vaccines obviating social distancing and masking could further predispose people to overconfidence.
Instead, we can frame these behaviors as necessary parts of life, even after Covid-19 vaccines arrive. Because of optimism bias and gaps in vaccine knowledge, public officials could use this framing to convey a clear, even if unintuitive, message: that the arrival of Covid-19 vaccines should prompt us to make even greater commitments to behaviors like social distancing and maskingnot less.
To be fair, other factors can affect how individuals view Covid-19 vaccines. As a psychological phenomenon, optimism can also be protective, preserving self-esteem and building resilience in the face of adversity. Nonetheless, the problem with over-optimism about Covid-19 vaccines is that it can expose us to unnecessary risks at a time when we should be doing everything in our power to mitigate them.
Resisting optimism bias will help us meet that mark and use vaccines as a tool for achieving our ultimate goal: ending the pandemic as quickly as possible.
Full coverage and live updates on the Coronavirus
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Why We Should Resist Over-Optimism About Covid-19 Vaccines - Forbes
Medical assistant Debbie Turrise assists drive-thru patients with self administered COVID-19 tests at a 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)
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University of Chicago Medicine to begin testing another COVID-19 vaccine - Chicago Tribune
The company recently announced it was in a phase 1 trial.
For those patients who might have anxiety about needles or hesitancy to take a vaccine, an oral COVID-19 tablet vaccine has been developed and is in a phase 1 trial.
South San Francisco-based Vaxart recently announced they had entered into a phase 1 trial for their VXA-CoV2-1 vaccine. Vaxartis a biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform.
The trial is an open-label, dose-ranging study and is expected to finish this month. The trial is going to examine the safety and immunogenicity of 2 doses of VXA-CoV2-1 in up to 48 healthy adult volunteers aged 18 to 54 years old.
All participants will be receiving the low or high dose of the VXA-CoV2-1 oral tablet at days 1 and 29. Safety, reactogenicity, and immunogenicity assessments will be performed at set times during the active phase.
Contagion recently spoke to Sean Tucker, PhD, chief scientific officer and founder of Vaxart.
I think one of the key things we are excited about is what is happening on the mucosal surface, Tucker said. We think having a mucosal vaccine at the site of infection could be extremely beneficial from a standpoint of efficacy. Imagine if you could block infection entirely?
Tucker also spoke about the vaccines platform, the advantages of taking a tablet as opposed to injecting a vaccine, and its potential place in the market.
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Vaxart Has Developed the First Oral Investigational COVID-19 Vaccine - Contagionlive.com
Paul Pettit, public health director for Genesee and Orleans counties, is determined to look beyond the rumors and posturing to make sure his department is ready when federal and state governments roll out the first phase of a COVID-19 vaccine.
Theres a lot of chatter out there locally, well have our plan ready, Pettit said on Monday afternoon as he advised the Genesee County Legislatures Human Services Committee of the importance of three resolutions pertaining to the health departments readiness to administer a vaccine.
The first resolution renews the countys agreement with Genesee Community College to use the campus at no charge -- as a Point of Dispensing Clinic during an emergency for the period of Jan. 1, 2021 through Dec. 31, 2023.
Pettit said GCC (possibly the new athletic facility) is an ideal site for distributing the vaccine, which he said likely will be made available in phases first to elder care facilities such as nursing homes and then to healthier adults and children.
He mentioned that there could be up to 30 million doses by the end of the year, but didnt know how many the county would get, speculating maybe 50 to 100 doses of the initial outlay. He noted that as the number of public vaccinations increase, private providers and pharmacies would be enlisted to support the health departments efforts.
For smaller clinics, Pettit said the county already has the use of the fairgrounds and County Building II.
Pettit also responded to Legislator John Deleos comments about New York State wanting to review any federallyapproved vaccine before allowing it to be dispensed to its residents and about talk that the proposed vaccines are not sufficient for minorities.
Thats when he said he and his staff are focused not on the chatter but on making sure they are prepared when the time comes.
A second resolution was an agreement with the Centers for Disease Control and Prevention in Atlanta for the CDC to provide vaccine to the Genesee County Health Department at no cost to the county.
This is the first step for us to receive the vaccine when it becomes available, Pettit said, adding that he hasnt heard of any vaccines that have cleared phase three of their trials yet.
A third resolution was a request to create a full-time COVID-19 Response Specialist, a Civil Service position, effective Nov. 12, 2020. The position would befunded by COVID-19 monies until June 30, 2022, at no cost to the county.
Pettit said coronavirus funding previously created one job and now the department needs this one, borrowing the title from a similar position in Wyoming County.
He said he wasnt sure of the pay rate, thinking it was around $17 to $18 per hour, and noted that the jobis tied to Orleans County and could lead to a full-time position.
Responsibilities of the Response Specialist would be to assist with contact tracing, testing and eventually vaccination. Pettit said the county continues to utilize the services of contact tracers employed by the state.
The Human Services Committee approved all three resolutions, which now will be forwarded to the Ways & Means Committee on Wednesday.
In a related development, the committee approved a contract renewal with Mary Younge of Rochester to provide nursing services on an as-needed basis for 2021. Pettit said Younge provided support to the countyat the outset of the coronavirus outbreak in March, April and May.
Excerpt from:
Health department takes steps to be prepared when COVID-19 vaccine is rolled out - The Batavian
