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Rios Beaches Wont Fully Reopen Until Theres a COVID-19 Vaccine
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Rios Beaches Wont Fully Reopen Until Theres a COVID-19 Vaccine - Travel + Leisure
We might be one step closer to get COVID-19 vaccine on the market WKRC TV Cincinnati
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We might be one step closer to get COVID-19 vaccine on the market - WKRC TV Cincinnati
The website will handle registration for the four large vaccine studies that are expected to start this summer and fall, and any others that follow.
The US Department of Health and Human Services announced the website Wednesday, along with the appointment of the Fred Hutchinson Cancer Research Center in Seattle as the coordinating center for vaccine clinical trials run by the Covid-19 Prevention Network, which is funded by the National Institutes of Health.
"That's the target, but those target dates move up and down. They won't let a site start until they're absolutely ready. Some could start on July 27, and others on August 8," del Rio said.
Despite the delay, the Covid-19 vaccine trials are moving at an unprecedented speed, as researchers try to accomplish in months what usually takes years.
Del Rio said he enrolls six or seven study subjects a week in a typical clinical trial, but for the Covid vaccine trial he'll try to enroll that number in a day. Eventually, he aims to have a total of 750 study subjects at three Atlanta-area sites.
He noted that he still has not yet received approval from Emory's Institutional Review Board to begin the trial, a requirement before moving forward.
"This is the most complicated research study I've ever done, and we need to do it in record time," del Rio said, noting that he is still hiring staff and securing facilities for the trial.
Dr. Richard Novak, another clinical trial veteran agrees.
"I've been doing vaccine trials for 25 years, but this is the largest I've ever committed to and I just don't have enough staff and I don't have enough space," said Novak, who will be leading the Moderna trial at the University of Illinois at Chicago.
What researchers are looking for
On the new website, anyone interested in joining a vaccine study can fill out a quick questionnaire.
There will be more than 100 sites in the United States and abroad, and after registering on the website, your information will be sent to the study site closest to you.
Several of the questions are designed to assess how likely you are to become infected and sick with Covid-19, including your race, what kind of work you do and how many people you come into contact with on a daily basis.
Based on those answers, you might be rejected. People who don't get out much, and who wear a mask when they do leave home, would not make the best study subjects.
That's because the point of the study is to see if the vaccine protects people from getting sick with Covid-19. If people who mostly stay home get vaccinated, and they don't get sick with Covid-19, it's hard to know if the vaccine protected them or if their lifestyle kept them away from the virus in the first place.
That's why researchers are looking for people in communities that have been hardest hit by coronavirus.
"We need people who are black and brown and representative of harder hit communities by the pandemic," said Dr. Carl Fichtenbaum, medical director of the Moderna trial at University of Cincinnati Health.
The doctors say they'll recruit at churches and other organizations in those communities, as well as in workplaces such as factories and meatpacking plants where workers are at high risk of getting sick with Covid-19.
The researchers are also aiming to have 40% of the study subjects over age 65 or with underlying conditions, such as hypertension, lung disease, diabetes and morbid obesity, since they're more likely to become ill with Covid-19, Novak said.
Tens of thousands of volunteers needed
Moderna has finished a safety trial with more than 100 study subjects, but it has not yet published the results. These later phase trials monitor safety and focus on whether the vaccine protects against becoming ill from the coronavirus.
Novak said volunteers for the Moderna trial will receive two injections spaced a month apart. About half the study volunteers will receive two doses of the vaccine, and the other half will receive placebos -- a shot that has no therapeutic value. Neither the doctors nor the volunteers will know who's getting which shot.
The volunteers will have appointments seven times throughout the two-year course of the study, where they will have blood drawn and their noses swabbed to check for Covid-19 infection.
Volunteers will keep a weekly diary of their symptoms and will speak on the phone with study staff to discuss how they're feeling.
"It has to be done really meticulously, because that's a key part of clinical research," Novak said. "The data has to be impeccable."
Either way, tens of thousands of volunteers will need to step up for the studies.
"I want to emphasize to people that you will be part of something special, even if the answer is that this does not work," Fichtenbaum said. "That's a very important scientific answer because we need to know what works [and] what won't work."
CNN's John Bonifield and Dana Vigue contributed to this story.
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Will you get the COVID-19 vaccine when it's available? - Norfolk Daily News
On June 26, Dr. Anthony Fauci announced it's "unlikely" that a COVID-19 vaccine with 70-75% efficacy taken by two-thirds of Americans can provide herd immunity to the SARS-CoV-2 coronavirus.
His statement has since stirred discussion about America's anti-vaccine movement.
A crucial question remains unanswered, however: Is COVID-19 even subject to herd immunity? From universities to sports teams, top experts are still debating this issue.
While the world anxiously awaits a vaccine, the length and durability of the protective immunity it would provide is far more in doubt than one might think.
A new study from China shows that antibodies can disappear in two to three months. The study further found that immunity is shorter for asymptomatic patients than symptomatic ones: The less symptomatic a person is, the weaker the immune response and antibody strength. "Young people who have mild disease or asymptomatic disease, their antibodies may never rise very high," said Sankar Swaminathan, chief of infectious diseases at the University of Utah. "We don't even know if those antibodies are protective."
How does herd immunity work?
Herd immunity occurs when a sufficient proportion of a population is immune to an infectious disease -- either through prior illness or vaccination -- so that contagion from person to person is unlikely.
According to Johns Hopkins, 70%-90% of the population (230-300 million Americans) needs to develop protective antibodies to COVID-19 to achieve herd immunity.
Approximately 2.74 million Americans have tested positive for the coronavirus, over 130,000 of which have died (case fatality of 4.74%). By contrast, the case fatality of the flu in the U.S. is roughly 0.1%.
Absent the existence of a COVID-19 vaccine, any reasonable extrapolation of the data -- even at half the current case fatality rate, means we will see a seven-figure body count that exceeds 5 million deaths before we can attain herd immunity.
How does a COVID-19 vaccine impact herd immunity?
There are three factors that determine if and how well a vaccine can safely bring us along to herd immunity without exposing individuals to the life-threatening consequences of the disease itself.
First is the vaccine's efficacy -- for example, the measles vaccine is 97-98% effective. Dr. Fauci believes that for COVID-19, we are unlikely to get a vaccine that is more than 75% effective.
Second is the vaccine's prevalence of use -- this is where Dr. Fauci's concern about the anti-vaccine movement comes into play.
Fauci noted that "there is a general anti-science, anti-authority, anti-vaccine feeling among some people in this country -- an alarmingly large percentage of people, relatively speaking."He said given the power of the anti-vaccine movement, "we have a lot of work to do" to educate people on the truth about vaccines.
Third is the durability and longevity of the vaccine's induced antibody immuno-response. This is where the two-month to three-month life span of antibodies becomes a concern.
An executive at AstraZeneca, one of the companies working to develop an effective vaccine,told a radio stationthat he thinks his vaccine might only offer protection for one year.
What do we know about COVID-19 antibodies?
Antibodies are proteins that specifically bind to invading pathogens to neutralize them so they cannot infect the host cell. They trigger a mechanism known as phagocytosis which destroys the virus. IgG antibodies are the most common and can protect us against bacterial and viral infections.
IgG antibody immunity to COVID-19 occurs through contracting SARS-CoV-2, or through a vaccine that produces an immuno-protective response.
Here's where things get dicey. In a scientific brief from April 24, the World Health Organization said, "there is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection." They described the notion of an acquired immunity from further infections of the disease for those who had already contracted the coronavirus an unproven and unreliable theory.
"It isn't a uniformly robust antibody response, which may be a reason why, when you look at the history of the common coronaviruses that cause the common cold, the reports in the literature are that the durability of immunity that's protective ranges from three to six months, to almost always less than a year," Fauci said in an interview with JAMA Editor-in-Chief Howard Bauchner.
The first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, receives an injection, May 4, 2020. The first of four experimental COVID-19 vaccines being tested by Pfizer and its German partner BioNTech showed encouraging results in very early testing of 45 people, the companies said Wednesday, July 1, 2020.
Consequences
The United Kingdom, Sweden and Brazil have each allowed herd immunity to inform their approaches to COVID-19 in one way or another -- with severe consequences.
In mid-March, Patrick Vallance, the British government's chief scientific adviser, announced they were taking an approach to COVID-19 that would "build up some kind of herd immunity," but quickly reversed course due to fatal risks.
Similarly, Sweden attempted to attain herd immunity through an approach that ultimately yielded among the highest per capita death rates from COVID-19 in the world, with no measurable associated economic gain, according to the European Commission. Only 6.1% of Sweden's population developed coronavirus antibodies by late May -- a number much lower than predicted.
For reference, a large-scale study out of Spain indicates that just5% of its population has developed antibodies. This study shows that even thoughSpainwas one of the countries hardest hit by the virus, the presence of antibodies is still only around 5%, which is not high enough to achieve herd immunity.
Most experts say that herd immunity requires at least 60-70% of the population to have antibodies, though this number varies depending on the virus.Because of the toll that this degree of infection would take on the health care system and on the population, the safest way to achieve herd immunity would be through a widely available, widely utilized, effective vaccine.
The poor results from Sweden's controversial approach have led to a formal investigation into the government's actions in response to the public health crisis.
Brazil has fared no better with the second highest number of coronavirus cases in the world.
Conclusions
Surgeon General Dr. Jerome Adams recently advised a leading national physicians' organization that the U.S. is far from reaching the 70%+ infection rate needed to begin having a real discussion about herd immunity. For reference, Adams mentioned his home state of Indiana was currently at an approximate 3% infection rate.
Dr. Adams further reiterated Dr. Fauci's concerns that antibodies appear to be limited in robustness, so it is unknown how significant or effective acquired immunity to COVID-19 may be. While it's still unclear whether or not a person can get infected with COVID-19 more than once, the limited durability of immuno-protective IgG antibodies may suggest an answer the world does not want to hear.
Dr. Jay Bhatt is an internist, Aspen Health innovator fellow and ABC News contributor.
Parag Deven Parikh is an epidemiologist and graduate of the University of Illinois at Chicago School of Public Health.
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Circling the Kaaba at the end of his Hajj pilgrimage, Hadi Yassine had a hacking cough and other symptoms of a respiratory illness.
Dr Yassine had come to the holy city of Makkah to spiritually recharge, but the physically draining journey and persistent flu-like sickness had already put one member of his party in hospital.
The Lebanese-American virologist completed his seventh revolution around the sacred courtyard in the Great Mosque of Makkah and climbed the hill back to his hotel.
As he passed through the throngs of the faithful in their white robes - about 2.5 million people perform the Hajj annually, the majority of them coming from outside the country - Dr Yassine was aware that others would leave the pilgrimage spiritually richer but poorer in health.
Research has shown that about a third of pilgrims catch a respiratory illness, including colds and flu.
But what he could not have known then was that the devotional voyage he had taken to Saudi Arabia in 2013 would set in motion a series of crucial discoveries on his return home to Maryland in the United States.
A few worshippers performing the fajr prayer at the Grand Mosque in Makkah. Saudi Arabia has announced it will hold a "very limited" Hajj this year. AFP
Saudi Arabia's authorities said only a limited number of people, who are already in Saudi Arabia, will be able to perform the Hajj amid a spike of cases and deaths in the kingdom. AFP
Arab countries have expressed their support for Saudi Arabia's decision to ban pilgrims from abroad attending the Hajj pilgrimage this year to stem the spread of the coronavirus pandemic. AFP
Arafat mountain in Saudi Arabia's holy city of Makkah. Egypt, home of Al Azhar, one of the Muslim worlds main centres of learning, quickly came out in support of the decision. AFP
Egyptan Religious Affairs Minister Mukhtar Jumah described the downsizing as practical and conforming with jurisprudence regarding the pandemic. AFP
Hundreds of thousands usually perform Hajj every year. AFP
Bahraini Justice and Islamic Affairs Minister Khaled Bin Khalifa said the ban conforms with the core values of Islam and that Bahrain appreciates what he described as Saudi Arabias quest to save lives. AFP
The Emirates Hajj Affairs Office said Saudi Arabia's move preserves the health of the people and their lives, which is one of the main purposes of our honoured religion. AFP
Part of the Grand Mosque complex in Saudi Arabia's holy city of Makkah. AFP
The symptoms he was experiencing were the result of a coronavirus that was relatively unknown at the time. Seven years later, it would provide a vital key in helping to unlock a vaccine to beat a deadly, global pandemic.
In 2020, the world has learned many grim truths about coronaviruses as SARS-Cov-2 has spread across the world leaving a trail of destruction in its wake.
According to John Hopkins University, nearly 12 million cases of the disease it causes - Covid-19 - have been confirmed globally and almost 550,000 people have died. The figures are shocking but do not come close to painting a proper picture of the profound and irrevocable changes that the disease has forced on country after country.
Even the best prepared governments have had to scramble to adapt to the outbreak. But if anyone was ready for what was to come it was experts such as Dr Yassine, now 42, and his then boss at the National Institutes of Health (NIH), Dr Barney Graham.
The irony that now, after more than four decades of work on viruses, people around the world are looking to teams like his to urgently provide a vaccine is not lost on the deputy director of the NIHs Vaccine Research Centre.
Six months ago, there were probably only half a dozen people on earth who really would care about what we were doing, Dr Graham said.
His team, in partnership with the commercial biotech company Moderna, was joint-first in the world to launch experimental vaccine trials for Covid-19. Chinese trials also began on the same day in mid-March.
The breakneck speed at which the US team was able to roll out a vaccine candidate the shot was given to the first volunteer during trials after just 63 days is owing to groundbreaking work that Dr Graham did in 2013 with Dr Yassine and the common coronavirus that returned with him from Makkah.
Creating vaccines is a complicated business. Dr Grahams team has made inroads with a consortium of academic laboratories around the US in studying the structures of different viruses and the tell-tale spikes that make the distinctive shape of coronavirus molecules.
Defining those structures and recreating stable spikes is critical in creating certain types of vaccines for diseases like Covid-19.
In 2013, however, as Dr Graham and Dr Yassine grappled with Middle East Respiratory Syndrome (Mers), a coronavirus first reported in Saudi Arabia in 2012, and Severe Acute Respiratory Syndrome (Sars), which emerged in 2003, they were repeatedly hitting a brick wall.
We couldn't get the structure stabilised enough to really understand or to get the structure solved, Dr Graham explained. We couldn't figure it out.
That changed when Dr Yassine returned from Saudi Arabia. Concerned that he may have contracted MERS, and hoping that the blood cells of a MERS-positive patient might hold a clue to the diseases structure, the immunologist was tested in the NIH labs. The results showed that he had contracted a number of viruses, among them the common cold coronavirus, HKU1.
The more severe coronaviruses like Sars, Mers and Covid-19 are now well known to the public, but there are also a handful of others, such as HKU1, that are less often referred to because their symptoms are more mild.
A lab technician holds a PCR plate to perform Covid-19 tests at Hermes Pardini Lab amid the pandemic in Vespasiano, Brazil. Getty Images
Brazilian President Jair Bolsonaro speaks to media at Planalto Palace in Brasilia. AFP
New South Wales police officers speak to drivers trying to cross from the state of Victoria into NSW at a checkpoint after the border was closed, in Albury, Australia. Reuters
Security forces use shields during a protest against a lockdown planned for the capital this weekend in Belgrade, Serbia. Reuters
A Reuters photographer holds a picture of revellers at the running of the bulls at the San Fermin festival, taken in July 2019, in front of the bullring, as a Spanish apprentice bullfighter trains at the arena during what would be the second day of the cancelled event, in Pamplona, Spain. Reuters
Nuria Bosch, 29, and Dria Abramson, 29, eat lunch in a social-distancing greenhouse dining pod, in the former car parking of the Lady Byrd Cafe in Los Angeles, California. Reuters
A woman who is suspected of having Covid-19 sits outside El Norte Hospital, La Paz, Bolivia. Reuters
Circus performers of the Association of Circus Proprietors outside Downing Street, London. The association handed a petition to Prime Minister Boris Johnson urging him to allow circuses to reopen. EPA
I did some research, Dr Yassine said, and I realised that this virus emerged in 2005. So it is a relatively new virus which appeared even after the SARS1 coronavirus.
The Lebanese virologist had trained in Beirut before travelling to do his PhD in the United States, where he studied the transmission of flu between animals. He had originally joined the NIH to research a possible influenza vaccine and used his experience in those areas to create a stable spike of HKU1.
We were so focused on Sars and Mers, the real pathogens, that honestly I hadn't really paused to think maybe we should work on one of the other coronaviruses, Dr Graham explained.
It was really that event that made me think: 'Let's work on another coronavirus, it may be easier to get some of the basic biology figured out. So it was really very lucky.
The work done by the NIH in 2013 through to 2017 has directly informed the progress that the institutes have made on pandemic preparedness in the run-up to the coronavirus outbreak.
Dr Yassines discovery has not only led to the lightning-fast roll out of the Moderna vaccine trials but the science behind roughly half the other vaccine candidates now in the race to stop Covid-19.
Though the two men are now separated by eight time zones, they are both effusive when it comes to talking about the impact their work is likely to have, providing a potential silver bullet to the worlds most pressing crisis.
I don't like to talk about it that much but I know one time Barney told me I had contributed really significantly to this thing, Dr Yassine said. He told me, You might not realise it but your contribution was very significant'.
Dr Graham said he was pleased that the breakthrough in 2013 had gone on to have many applications, not confined to the Covid-19 vaccine candidates.
That is gratifying, he said. Thats what we do.
At the start of July, it was announced that Moderna would delay its Phase II vaccine testing. The trials have reportedly become the subject of infighting between the US government, the Food and Drug Administration and the biotech company.
I hope that our world can get to a point where we can exert the political will to work on things that have not yet happened
Dr Barney Graham
Dr Graham acknowledges that multiple vaccines will ultimately be necessary to meet global demand. He is in the process of publishing an interim report on Phase I of the trial and wrapping up the data needed by the FDA to continue testing.
Both immunologists are confident that a viable vaccine for Covid-19 can be found but their optimism is qualified. They believe that the lack of impetus to develop vaccines for Mers and Sars before the onset of the current pandemic has prevented scientists from progressing faster. Such vaccines would have been invaluable to putting an end to the coronavirus crisis, and they hope that the delay serves as a warning in the future.
If we had developed this concept or these approaches with [Sars and Mers] and done Phase I, III and III clinical trials and had these things implemented, could we have saved time to produce the SARS2 corona vaccine? Dr Yassine asks rhetorically.
Dr Graham says that as humans continue to have a dramatic ecological impact on the world around them, such as the destruction of the Amazon rainforest, there will be greater transition transmission of diseases.
It is no coincidence, he said, that over the past decade there have been outbreaks every year or two of new diseases like Mers, Chikungunya, Zika, Ebola and now Covid-19.
I hope that our world can get to a point where we can exert the political will to work on things that have not yet happened, Dr Graham said.
Waiting for things to happen is the wrong time to act. The investment in doing this work is relatively small compared to what we are losing right now.
Updated: July 9, 2020 09:06 AM
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Makkah to Moderna: How the journey to a Covid-19 vaccine began on the Hajj - The National
An update on COVID-19 vaccine research and treatment
Scientists across the globe are racing to develop an effective coronavirus vaccine, and local researchers are at the forefront of that effort. Rochester is one of four sites in the nation selected to test a coronavirus vaccine developed by Pfizer and BioNTech. The trial began last month, and the vaccine is one of few in the world to have advanced to clinical trials. A separate vaccine study is set to launch in Rochester in August.
We talk with scientists leading these studies at the University of Rochester Medical Center and Rochester Regional Health. They discuss the state and timeline of vaccine development, the latest research on the drug Remdesivir, and what it means for controlling the virus. Our guests:
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Connections: An update on COVID-19 vaccine research and treatment - WXXI News
]]> BD will deliver 50 million needles and syringes by the end of this year to support the Covid-19 vaccination effort in the US. Credit: BD.
Sign up here for GlobalData's free bi-weekly Covid-19 report on the latest information your industry needs to know.
Becton, Dickinson and Company (BD) has formed a strategic partnership with the Biomedical Advanced Research and Development Authority (BARDA) in the US to establish new manufacturing lines for injection devices.
BARDA is part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response.
The companys additional manufacturing lines will provide the US Government with priority access to huge volumes of syringes and needles to support its ongoing and future pandemic vaccination efforts.
As part of the partnership, BARDA will invest an estimated $42m into a $70m capital project to expand BDs operations and manufacturing capacity in Nebraska within 12 months.
Once completed, BARDA will have priority access to injection devices from the new manufacturing lines to support mass vaccination efforts for Covid-19 and future pandemics in the US.
In addition, BD also finalised an initial pandemic order for 50 million needles and syringes to be delivered by the end of this year to support the countrys Covid-19 vaccination effort.
The order will be fulfilled using the companys existing manufacturing capacity. BD noted the initial order will not affect the ability to fulfil existing customer requirements for needles and syringes.
BD Medication Delivery Solutions president Rick Byrd said: BDs commitment to produce 50 million vaccine injection devices by the end of this year to support the US Covid-19 vaccination campaign is the latest effort in the companys multifaceted global response to this virus, and the new, strategic public-private partnership will help ensure the US is prepared for future pandemic vaccination efforts.
We are extremely proud of our talented and dedicated workforce in Nebraska and our longstanding partnership with the state, and we look forward to building on our strong presence and track record in Nebraska as we move forward.
Meanwhile, BD is also working to expand access to diagnostic testing and support treatment of Covid-19 patients in the US.
The company has supplied approximately 48 million swabs for flu and Covid-19 testing and over 2.85 million Covid-19 rapid molecular diagnostic tests on the BD MAX System globally.
See more here:
BD to manufacture injection devices for Covid-19 vaccination in US - Medical Device Network
