Here are some of the top stories we're following for Tuesday, June 30, 2020. Wochit
Gov. John Carney announced Tuesday afternoon that bars in Delaware beach towns will be ordered toclose Friday ahead of the holiday weekend, as the state has seen a spike in COVID-19 cases in the area.
Customers will nolonger be able to sit or stand at a bar, according to the new guidance. Instead, beachgoers will have to sit at a table and be served by a server.
This will affect taprooms and bar service in the following towns: Lewes, Rehoboth Beach, Dewey Beach, Long Neck, Bethany Beach, South Bethany, Fenwick Island, West Fenwick Island, Ocean View and Millville, according to the order.
This begins at8 a.m. on July 3 and lasts indefinitely, Carney said during his weekly press briefing.Restaurants will need to close their bar serviceand continue to follow the current phase two guidelines.
The city of Rehoboth Beach announced Tuesday that it will require people over the age of 12 to wear a face covering in all public places. Face coverings are not required when in the ocean. This order goes into effect 5 p.m. on July 1.
In recent weeks, tourists have poured into the beach towns of Rehoboth and Dewey, and even more crowds were expected for theFourth of July weekend. State health officials said they have identified at least 100 cases related to the beaches and warned about thepotential forwidespread infection in the state's coastal communities.
On Monday, the Rehoboth Beach Police Department announced that threelifeguards have tested positive for the coronavirus.
LEARN YOUR RISK: Delaware beach towns balance risks, economics during COVID-19
Some Delaware beach restaurants have closed their businesses due to the uptick in cases. The state has also significantly increased its testing capacity in these resort areas.
Autoplay
Show Thumbnails
Show Captions
State health officials attribute the recent increase in cases to a lack of social distancing and wearing of face coverings of those who go to the beach. Officials also noted that some restaurant servers have not been wearing face masks.
There's also a culture issue: Many of these workers are young people who live and socialize together, which can increase the likelihood of the infection spreading.
"Clearly we've had an outbreak among bars, restaurants, social activity in Delaware beaches," Carney said. "We've also witnessed throughout our statebut in particularly in beach communitiescomplacency with respect to mask wearing and social distancing."
As the country continues to see a rise in COVID-19 infections, many states have paused or reversed their reopening efforts. Carney announced last week that Delaware will delay the third phase of its reopening.
Gov. Phil Murphy of New Jersey announced Monday that indoor restaurant dining will be postponed indefinitely.In Florida, some counties have closed their beaches ahead of the holiday weekend.
Carney said during his Tuesday press briefing that the state does not plan to close the beaches orhalt indoor dining.But he said the state will become will be more aggressive in enforcing these guidelines.
This means some bars could face significant fines or even closure.
Carrie Leishman, president and CEO of the Delaware Restaurant Association, said she understands why Carney is imposing new restrictions, due to the spike in coronavirus cases among visitors and employees at businesses in the beach towns.
It's a setback for the bar and restaurant industry in that area, said Leishman, adding she is glad the new restrictions arent statewide. Ninety-nine percent of our industry are doing [things] the right way.
Steve"Monty"Montgomery, co-owner of the Starboard in Dewey Beach, said he found the announcement "disappointing" but not"totally shocking."
Early into the second phase, the Starboard staff "learned quickly that it was difficult to enforce folks to keep their masks on after 11 p.m." This led to the business to close before that time.
Montgomery said he wishes bars could have remained opened yet ordered to close at an earlier time. At Starboard, a lot of customers eat at the bars, he said.
"To lose that much seating is a real heartbreak, but we will continue on with table service for everyone and make the best of this situation,"Montgomery said.
"The amount of stress and pressure on everyone in the hospitality industry these days is totally over the top," he continued, "most every restaurant and bar that I know is working so hard to do the right thing, but there is still so much uncertainty."
As of June 30, Delaware has confirmed11,474 COVID-19 cases and 509related deaths.Since June 21, Delaware has seen a significantincrease in cases in the Rehoboth-Dewey Beach ZIP code. Many of these cases are in young people and beach residents.
Of about 1,081tests conducted at Rehoboth Beach site on June 25, about 9.5% of people were positive COVID-19, Karyl Rattay, director of the Delaware Division of Public Health, said. The average age was about 29 years old.
At a Dewey Beach testing site for restaurant employees, almost 15% of people tested positive for the virus, according to state data. Of the 93 tests conducted, 12 came back positive.
Of those who tested positive, many of the people had mild symptoms or were asymptomatic, Rattay said.
Carney said Delaware is in a much better position to fight the virus than it was in mid-March. The state is also in "much better shape" compared withplaces like Texas and California.
"If we get complacent, if we listen to the naysayers, then we're going to end up like some of those other states," Carney said."I don't want to be in that place, and I know Delawareans across our state don't want to be in that place."
Reporters Ryan Cormier and Patricia Talorico contributed to this article.
Contact Meredith Newman at (302) 324-2386 or at mnewman@delawareonline.com. Follow her on Twitter at @merenewman.
Read or Share this story: https://www.delawareonline.com/story/news/health/2020/06/30/bars-delaware-beaches-covid/5348619002/
The Sardar Patel COVID Care Centre, the largest facility of its kind in India, became partly operational on Sunday, with 2,000 of its 10,000 beds available, according to the Delhi government.
India's Home Minister Amit Shah and Delhi's Chief Minister Arvind Kejriwal visited the care center on Saturday ahead of its launch.
In a message posted on Twitter that day, Kejriwal described the center as being "among the largest hospitals in the world."
Meanwhile, the Home Minister tweeted that the 10,000-bed facility "would provide huge relief to the people of Delhi."
The administration and operations of the facility will be run by the Indo-Tiberan Border Police (ITBP), Shah confirmed.
"I applaud our courageous ITBP personnel, who would be operating this COVID Care facility during these trying times. Their commitment to serve the nation and people of Delhi is unparalleled," he added in a tweet.
The opening of the hospital coincided with the release of India health ministry data on Sunday which showed the largest rise in the daily number of new Covid-19 cases.
The country reported 19,906 new infections and 410 new deaths from the virus, bringing the total to 528,859 positive cases and 16,095 fatalities.
Delhi became the country's worst-hit city on Wednesday, surpassing Mumbai's coronavirus tally. Only the west India state of Maharashtra with 159,133 cases has had more infections than the capital.
The antiviral drug remdesivir has been approved for emergency use among hospitalized COVID-19 patients, and in recent studies, has shown promise as a treatment for the pandemic disease.
How exactly does remdesivir counter SARS-CoV-2 -- the coronavirus strain responsible for COVID-19?
With hat tips to virologist Jan Carette, PhD, geneticist Judith Frydman, PhD, and infectious-disease expert Bob Shafer, MD, let's follow the coronavirus downstream as it courses through its agenda within the infected cell.
Toward the end, we'll zero in on one of the virus's several Achilles heels, and we'll see how remdesivir could help -- and alas, why it may not be able to save the day on its own.
Previously, I tracked the novel coronavirus's invasion of a susceptible cell. When we left off, SARS-CoV-2 had come riding into the cell like a Lilliputian aquanaut, stealthily stowed inside a little membrane-bound bubble called an endosome.
Within that endosome, the virus remains clad in its own membrane coat, or envelope, which (when things go right for the virus) fuses with the membrane of the surrounding endosome. The viral envelope's contents spill into the (relatively) vast surrounding cellular ocean, or cytosol, that occupies the space between the cell's nucleus and its outer membrane.
Chief among those contents is the virus's genome, which wriggles out of its self-imposed prison to pursue its destiny: It aspires to generate thousands of identical progeny that will eventually burst out through the cell's enclosing membrane and fan out to infect more cells.
That lonely single strand of RNA that is the virus's genome has a big job to do -- two, in fact, Frydman and Carette told me --- in order to bootstrap itself into parenting a pack of progeny. For one thing, it must replicate itself in entirety and in bulk, with each copy the potential seed of a new viral particle. For another, it must generate multiple partial copies of itself -- sawed-off snippets that serve as instruction guides telling the cell's protein-making machines, called ribosomes, how to manufacture the virus's more than two dozen proteins.
To do both of those things, the virus needs its own special kind of polymerase: a protein that acts as a copy machine for genetic material. Every living cell uses polymerases to copy its DNA-based genome, as well as to transcribe the resident genes along that genome into RNA-based instructions that ribosomes can read.
The SARS-CoV2 genome, unlike ours, is made of RNA, so it's already ribosome-friendly; but replicating itself means making RNA copies of RNA. Our cells never need to do this, and they lack polymerases that can.
SARS-CoV2's genome, though, does carry a gene coding for an RNA-to-RNA polymerase. If that lone RNA strand can find and latch onto a ribosome, the latter can translate the viral polymerase's genetic blueprint into a working polymerase. Fortunately for the virus, there can be as many as 10 million ribosomes in a single cell.
Once made, the viral polymerase whirls into action, cranking out not only multiple copies of the full-length viral genome -- replication -- but also smaller sections, representing individual viral genes or groups of them. These smaller sections can clamber aboard ribosomes and command that they produce all of the proteins needed to assemble numerous new viral offspring.
This repertoire of newly created proteins includes, notably, more polymerase molecules. Each copy of the SARS-CoV-2 genome can be fed repeatedly through prolific polymerase molecules, generating myriad faithful reproductions of the initial RNA strand.
Well, mostly faithful. We all make mistakes, and the viral polymerase is no exception; actually it's pretty sloppy as polymerases go -- much more so than our own cells' polymerases, Carette and Frydman told me. So the copies of the initial viral genome -- and their copies -- are at risk of being riddled with copying errors, aka mutations.
However, coronavirus polymerases, including SARS-CoV-2's, come uniquely equipped with a sidekick "proofreader protein" that catches most of those errors. It chops out the wrongly inserted chemical component and gives the polymerase another, generally successful, stab at inserting the proper chemical unit into the growing RNA sequence.
Here's where remdesivir could become important. It belongs to a class of antiviral drugs that work by posing as legitimate chemical building blocks of a DNA or RNA sequence. These poseurs get themselves stitched into the nascent strand and gum things up so badly that the polymerase stalls out or produces a defective product. Remdesivir has the virtue of not messing up our cells' own polymerases, said Shafer, who maintains a continuously updated database of results from trials of drugs targeting SARS-CoV-2.
"Now the virus is making a lot of rotten genomes that poison the viral replication process," Frydman told me. If its progeny are defective and unable to bust out and invade other cells throughout the body, the virus's mission is defeated -- and the patient gets better.
But while remdesivir is pretty good -- better than many other antivirals, anyway -- at faking out the viral polymerase's companion proofreader protein, it's far from perfect, Shafer said. Some intact viral-genome copies may still manage to get made, escape from the cell, and infect other cells -- mission accomplished.
Using remdesivir in combination with some still-sought, as-yet-undiscovered drug that could block the proofreader could turn out to be a more surefire strategy than remdesivir alone.
Barring that, it may well be that the most lethal aspect of SARS-CoV-2 is our own immune response to it.
Stay tuned.
Image of SARS-CoV-2 emerging from the surface of cells cultured in the lab, courtesy of National Institute of Allergy and Infectious Diseases-Rocky Mountain Laboratories, NIH
Gwen Darien is a three-time cancer survivor. When she was thirty-five, she was diagnosed with lymphoma; in her fifties, she was treated for breast cancer; two years ago, she learned that she had endometrial cancer. With curly black hair and an indomitable personality, she embodies vibrancy, courage, and resilience. Even so, last month, when she received a call from her doctors office about an upcoming visit, she decided to postpone it indefinitely. I was very unnerved, she told me. I thought about all the risks. First, Id have to get transportationUber or train or subway. Then Id have to walk into the doctors office, near a hospital with COVID-19 patients. Then Id have to be in the office with other people, even if they are socially distanced. Id much rather just wait.
During the pandemic, many patients and physicians have felt this kind of hesitation. Some people with chronic illnesses, fearful of entering a medical setting or even venturing outside, have stopped seeing doctors altogether. Others have tried to make appointments but found clinics closed and routine care suspended. At many hospitals, non-urgent or elective care has been postponed for months. Its difficult to say for sure what the effects of such postponements have been and will be. But statistics show that, across the United States, so-called excess deathsdeaths beyond those that are historically typicalhave surged. Although many of these deaths can be attributed to COVID-19, delayed or cancelled care is probably a contributing factor, too. An analysis of death certificates shows that a fifth of the twenty-four thousand excess deaths that occurred in New York City between March 11th and May 2nd were caused by factors other than COVID-19; according to a study currently in pre-publication review, hospitals saw a thirty-eight-per-cent drop in serious heart-attack cases in March alone, suggesting that even people with acute, life-threatening illnesses have been avoiding medical visits. (The American College of Cardiology has gone so far as to issue a statement urging people to seek medical attention if theyre having cardiac symptoms.) A nationwide survey conducted in April found that a quarter of cancer patients receiving active treatment had seen their care delayed. Ultimately, its not just people with COVID-19 who are suffering; those with other illnesses are affected by the pandemic, too.
The coronavirus crisis itself continues to deepen. Although the first peak has passed in a few major cities, cases have held steady in many parts of the country and are rising in twenty-six states. North Carolina saw its highest single-day increase in coronavirus cases on June 12th; Florida, Arizona, and Texas saw record spikes this week. Some of this growth reflects increased testing, but, in many places, deaths caused by the virus are also risinga sign that the spike is real and not a statistical artefact. The U.S. still records more than thirty thousand new cases each day; according to projections from the Centers for Disease Control and Prevention, the national death toll could reach a hundred and forty thousand by the Fourth of July; the countrys public-health response remains scattershot, with grossly inadequate testing and contact tracing; and mass protests and planned reopenings, which are continuing despite the risks, have given the virus new breathing room. America as a whole seems to have entered a long viral plateau. The pandemic is now a rolling collection of mini-epidemics that surge and subside as the virus bobs and weaves its way across the country. It will be a long time before life returns to normal.
The persistence of the pandemic is creating serious challenges, many of them unforeseen, for the health-care system. Even before the pandemic, many hospitals were in precarious financial condition: in 2018, the average hospital had a two-per-cent operating margin and less than two months of cash on hand; the situation was worse for rural hospitals, a fifth of which were already at risk of closing due to financial problems. Having lost billions of dollars in revenue, hospitals must now figure out how to reintroduce routine care while keeping patients safe and preparing for possible surges of COVID-19. (As my colleague Atul Gawande has written, it is possible for hospitals to reopen without becoming vectors for the virus; doing so, however, requires time, resources, and personnel.) Hospitals in Massachusetts are losing $1.4 billion in revenue per month, and project total losses of five billion dollars by the end of July. The Mayo Clinic alone, which runs twenty-three hospitals nationwide, is set to lose three billion dollars this year. The American Hospital Association estimates that, altogether, U.S. hospitals are bleeding fifty billion dollars a month during the pandemic. The hundreds of thousands of doctors in independent practice have more limited capital reserves, and many may be forced to shutter their operations or merge them with others.
In the context of the economy as a whole, these losses are substantial. According to the Department of Commerce, the American economy shrank by nearly five per cent in the first quarter of 2020. Nearly half of this changethe biggest single-quarter drop since the Great Recessionhad to do with reductions in health care. In a few months time, the coronavirus has accomplished what lawmakers have been trying to do for decades: by flattening the curve of infection, we have bent the curve of health-care spending. But its been bent haphazardly, by the hurried cancellation or postponement of colonoscopies and mammograms, hip replacements and cataract surgeries, stress tests and root canalsand those unsustainable choices will have real consequences for the health of patients. As the virus continues to spread, the clinical damage will almost certainly compound.
Its vitally important, thereforeboth for the health of individuals and of the system as a wholefor doctors to resume seeing patients who dont have COVID-19. In April, medical organizations, including the American Hospital Association, began releasing road maps for the resumption of regular care; since then, governors have announced various protocols in their own states. The details vary, but the basic principles are the same: wait for a sustained reduction in COVID-19 cases; insure an adequate supply of personal protective equipment (P.P.E.); test constantly; and plan to throttle back on the expansion of services if the virus surges again. The more fine-grained question, of exactly which procedures should be prioritized and which delayed, is usually left unanswered.
Vivek Prachand, a surgeon at the University of Chicago, has been thinking about this problem since early March, when hospitals first started grappling with how to rank procedures in terms of their clinical urgency. Often, he told me, the decisions were being made by individual physicians or small committees within hospitals. It was really just surgeons saying, O.K., go ahead, or, No, we need to hold off, he said. You can imagine the emotional and ethical challenges of being in that position. He and his colleagues have developed a rubric to help guide such decisions during the pandemic, which they call the Medically Necessary, Time-Sensitive System, or MENTS.
Prachand dislikes referring to care as elective, because the term suggests that procedures are optional or unnecessary; really, elective care is just care that can be scheduled. (Setting a broken arm is urgent care; brain surgery, most of the time, isnt.) To help set the schedule, the MENTS protocol asks three kinds of questions. First, it assesses procedural factors, such as how long the surgery will take, how many clinicians will be exposed, how much P.P.E. will be used, and how likely the patient is to be intubated or require a prolonged stay in the hospital. Second, it grades the dangers presented by the problems the surgery hopes to solve, asking how bad the condition will get if doctors wait, and whether there are any effective non-surgical remedies. Finally, it sizes up how much viral risk the operation poses to the patient. Is she immunosuppressed? Does she have an underlying lung disease? What are the chances that shes already been exposed to the virus? The answers to all of these questions are combined into a formula that yields a recommendation about when the team should proceed.
New York malls will need high quality air systems that can filter out the coronavirus before they will be allowed to reopen, Gov. Andrew Cuomo said on Monday.
"Any malls that will open in New York, large malls, we will make it mandatory that they have air filtration systems that can filter out the Covid virus," Cuomo said at a press briefing.
High efficiency particle air filters, or HEPA filters, have been shown to help reduce the presence of Covid-19 in the air, according to a presentation from Cuomo.
The U.S. Centers for Disease Control and Prevention says the coronavirus is thought to spread primarily through person-to-person contact, when an infected person produces respiratory droplets by coughing, sneezing or talking in close contact with other people. It's possible someone can become infected by touching a surface and then touching their mouth, nose or eyes, but that's not considered to be the main way the virus is transmitted, the CDC says.
Some epidemiologists say the virus also appears to spread through exhaled air when people talk or breathe, known as aerosols, according to Nature.
The coronavirus' particle has a diameter of about 0.125 micron, he said, pointing torecent studies. HEPA filters are designed to filter particles that are 0.01 micron and above, Cuomo said, a figure he based on a previousNASA studyon HEPA filtration.
The Lufthansa logo is visible through a HEPA filter (High Efficiency Particulate Air filter). During a press tour, the airport operator Fraport and the airline Lufthansa explain their hygiene concept under current corona conditions.
Andreas Arnold | picture alliance | Getty Images
. New York has not allowed malls to reopen in the state yet, Cuomo said. He said the state recommends all businesses and offices "explore the potential for their air conditioning air filtration system."
New Jersey allowed malls to reopen on Monday while following the same health precautions required of other stores but without advanced filtration systems, according to the state's guidelines.
Cuomo has allowed other businesses to reopen without installing high-end filtration systems. So far, indoor retail, except for malls, indoor and outdoor dining and some office spaces have reopened in different regions of the state with reduced capacity.
New York City is expected to begin on July 6 its next phase of reopening, which will allow for indoor dining and personal care services such as nail salons, spas, massage parlors, and tattoo and piercing facilities with limited occupancy.
Cuomo said on Monday, however, that he's concerned about the city's enforcement of previous reopenings and that it has experienced a lack of compliance when it comes to social distancing and mask wearing, he said.
"You can see it in pictures, you can see it if you walk down the street, you can see the crowds in front of bars, you can see the crowds on street corners. It is undeniable," Cuomo said.
Indoor dining has proven problematic in other states where cases are rising, Cuomo said. Meanwhile, outdoor dining has so far worked well across the state, including in New York City, he added.
Cuomo said the state is reviewing the data and talking with local business owners but could decide to postpone indoor dining at restaurants. The state will provide a final decision by Wednesday, he said.
"This is a real issue. Our reopenings have worked very well. We're not going backwards; we're going forwards," Cuomo said. "A lot of other states have actually had to go backwards."
Gov. Andrew Cuomo during a daily coronavirus briefing on June 29th, 2020.
Source: New York State
To illustrate the state's progress suppressing the coronavirus outbreak, Cuomo appeared in front of a sculpture of a mountain that represented the curve of the outbreak, saying it was "the mountain that New Yorkers climbed," reaching the peak in the first 42 days. On Sunday, the state reported 853 people currently hospitalized with Covid-19, down from a peak of more than 18,800.
"Do you know what this is? This is the mountain," Cuomo said while standing in front of the green sculpture.
He has previously called the state's outbreak a mountain, referring to the shape of newly reported Covid-19 cases on a chart. Earlier in June, Cuomo said he was going to declare the "Covid mountain" the highest mountain in the state of New York.
CLARIFICATION: This story has been updated to show that HEPA filters are designed to filter particles that are 0.01 micron and above, according to New York Gov. Andrew Cuomo. He based the figure on a previousNASA studyon HEPA filtration.
An intelligent take on global lifestyle, arts and culture
Choose your subscription
Not sure which package to choose?Try full access for 4 weeks
Read more
Be informed with the essentialnews and opinion
Read more
FT print edition delivered Monday - Saturday along with ePaper access
Premium FT.com access for multiple users, with integrations & admin tools
Read more
Learn more and compare subscriptions
Sign in
It's not an understatement to say that the entire nation's hopes are focused on what's happening in a Maryland laboratory step one in manufacturing a potential coronavirus vaccine.
Sean Kirk, executive vice president of Emergent BioSolutions, explained to correspondent Martha Teichner how a bioreactor is used to create the ingredients needed in the development and testing of a vaccine for clinical trials already underway in Australia. "This is where it begins, to produce the hundreds of millions of doses," he said.
Emergent BioSolutions is gearing up now, preparing 4,000-liter tanks, to have hundreds of millions of doses ready to go if and when any of its clients Novavax, Johnson & Johnson, Vaxart and AstraZenica make it to the finish line in the race to a vaccine.
Teichner asked, "What happens to all those vaccines that you're ramping up to have ready on Day One after approval, if it doesn't come?"
"Yeah, the federal government's made it clear that they're willing to invest a substantial amount of money," Kirk replied.
That's $628 million just to Emergent to manufacture them all anyway, before approval, whether they succeed or fail. "If they're deemed to be ultimately unusable, then it's quite possible that they could be discarded," Kirk said.
President Donald Trump announced Operation Warp Speed on May 15. "Its objective is to finish developing, and then to manufacture and distribute, a proven coronavirus vaccine as fast as possible," he said. "Again, we'd love to see if we could do it prior to the end of the year."
To try and meet that target, the federal government has already pumped more than $2 billion into what it's betting are the likeliest to win FDA approval fastest, out of more than 120 in development. Drug industry heavyweights are behind some of the frontrunners: Pfizer, Johnson & Johnson, Merck, AstraZenica. Not-so-well-known, the biotech firm Moderna touted promising early results for its vaccine, which uses an unconventional new approach to creating immunity.
"We are desperate for a vaccine," said Dr. Paul Offit, a member of the National Institutes of Health panel overseeing the accelerated development of a COVID vaccine. "As a consequence, we're looking for any sort of news that could be good. But I think what we should exercise here is humility."
Dr. Offit fears what he calls "an October surprise," and co-authored an op-ed in The New York Times: "Could Trump turn a vaccine into a campaign stunt?"
"I do worry that as we move to September and October and then Election Day, that there will be pressure to get a vaccine out there even if it hasn't been tested in the way it needs to be tested, which is a big phase 3 trial," he said.
What that means is giving a vaccine to at least 20,000 people, with another 10,000 getting a placebo, and then waiting ... to see who gets a disease and who doesn't.
Typically, those trials last years, not months. It took Offit more than a quarter of a century to get his own vaccine licensed for rotavirus, which killed half a million infants and young children each year around the world more than the total death toll from coronavirus.
Teichner said, "People are frantic. They're almost panicky about living in a world until there is a vaccine. How do you manage the public pressure to hurry up and get to the finish line?"
"Hopefully, there will be an understanding that in order for us to prove that a vaccine is safe and effective, that it needs to go through this process," Dr. Offit said. "I harken back to the polio days. We waited, despite the fact that every year in this country as many as 30,000 children would get polio and be permanently paralyzed or end up in iron lungs, and 1,500 died. And if you think that the terror of that was any different than the terror of this, you're wrong. So, we could even wait then, and we can wait now."
Abie Rohrig thinks he, and other people of his generation, can help speed up the process. "By my doing this, there is a very real, very immediate chance that a vaccine could be developed earlier," he said. "Lives'll be saved."
Teichner asked, "Even if the cost is getting very, very ill, or even dying?"
"Yes. That cost is real."
Rohrig is 20, a college student, and a member of 1 Day Sooner, an organization calling for controversial human challenge trials, in which healthy, young volunteers ages 18-25 would test vaccines by being exposed to the virus deliberately, no waiting. So far, more than 25,000 people worldwide say they'd do it.
Rohrig said, "I have some history taking on this sort of calculated medical risk, because I donated my kidney last summer. And so, I see this as a very similar situation. I am very willing to take this risk onto myself, because I know that COVID-19 is devastating the world. This is, I think, my generation's World War II, basically."
But with COVID, there are ethical and safety issues. According to Dr. Nadine Rouphael, an associate professor of medicine at Emory University, "We have multiple instances for many diseases, such as influenza, dengue, cholera, malaria, typhoid, where it has been shown that those human challenges actually were able to better understand the infection, but also test therapeutics and vaccines."
Dr. Rouphael has worked on four human challenge trials, which start out with deciding which strain of a virus to use and how big a dose to give.
She noted, "For coronavirus human challenge, we don't have a strain; we don't have a dose. We also don't have a good drug against COVID."
Teichner asked, "Ordinarily, do diseases or viruses that have human challenge trials, do they have rescue drugs?"
"Typically they do," she said. And with no rescue therapy for coronavirus, the risk is intensified. It would take 3-6 months, she said, just to set up human challenge trials. But she's in favor of moving forward.
Teichner asked, "Is it brave, or is it crazy?"
"If it's done the right way, it's really a service to society," Dr. Rouphael replied.
"So, you're leaning toward brave?"
"I guess so."
For COVID vaccines, human challenge trials are still only in the discussion phase, while several of the frontrunners are expected to begin phase 3 trials next month.
At a House Energy & Commerce Committee hearing this past week about the administration's response to the pandemic, Dr. Anthony Fauci said, "I still think there is a reasonably good chance that by the very beginning fo 2021, that if we're gonna have a vaccine, that we will have it by then."
For all Dr. Fauci's optimism, will that first vaccine allow us to take off our masks and feel safe? Will it keep us from getting COVID-19, or just from getting really sick, or dying?
"We have to make sure that people know that it's likely going to protect against moderate-to-severe disease, but maybe not mild disease associated with re-exposure," Dr. Offit said. "So, I think we need to manage expectations."
He predicts the first across the finish line may not be the ultimate winner: "You don't want it to be necessarily the first vaccine. You want it to be the best vaccine," he said.
For more info:
Story produced by Mark Hudspeth. Editor: Ed Givnish.
Who would be the first to get a COVID-19 vaccine?
Probably people in the country where the first effective vaccine is developed.
About a dozen different vaccines are in various stages of testing worldwide, including in Britain, China and the U.S. This week, Dr. Anthony Fauci, the top U.S. infectious disease expert, said he is cautiously optimistic there will be a COVID-19 vaccine by the end of the year or early 2021.
Several wealthy countries have already ordered millions of doses of those experimental vaccines.
Britain and the U.S., for example, have invested in a vaccine candidate being developed by Oxford University and produced by AstraZeneca. If it works, U.K. politicians have said Britons will be vaccinated with it. The U.S. expects to start stockpiling it this fall and also has invested in other vaccine candidates.
Groups including the vaccine alliance GAVI are also working to buy doses for poor countries, and AstraZeneca has agreed to license its vaccine to Indias Serum Institute for the production of 1 billion doses. The World Health Organization is drafting guidelines for the ethical distribution of COVID-19 vaccines.
How vaccines are distributed within a country will vary. Last week, U.S. officials said they were developing a tiered system for that. The system would likely prioritize groups at greatest risk of severe complications from COVID-19 and key workers.
___
The AP is answering your questions about the coronavirus in this series. Submit them at: FactCheck@AP.org.
Read previous Viral Questions:
Is it safe to form a COVID-19 support bubble with friends?
Is it safe to stay in hotels as reopenings get underway?
What can a COVID-19 antibody test tell me?
The excitement and enthusiasm for a COVID-19 vaccine by the end of 2020 is both palpable and understandable. We all hope for a rapid end to the pandemic and an effective vaccine would be a surefire solution. But there are risks that come with a fast-tracked vaccine delivered end of this year, not the least of which are the risks related to the safety of the vaccine itself.
Telescoping testing timelines and approvals may expose all of us to unnecessary dangers related to the vaccine. While preclinical trials to evaluate the potential safety and efficacy of vaccine candidates are likely to include tens of thousands of patients, it is still unclear whether that number will be large enough and a trial will last long enough to evaluate safety for a drug that would be administered to so many. The US alone plans to vaccinate hundreds of millions of people with the first successful candidate.One serious adverse event per thousand of a vaccine given to 100 million people means harm to 100,000 otherwise healthy people.
Aside from questions of safety that attend any vaccine, there are good reasons to be especially cautious for COVID-19. Some vaccines worsen the consequences of infection rather than protect, a phenomenon called antibody-dependent enhancement (ADE). ADE has been observed in previous attempts to develop coronavirus vaccines. To add to the concern, antibodies typical of ADE are present in the blood of some COVID-19 patients. Such concerns are real. As recently as 2016, Dengavxia, intended to protect children from the dengue virus, increased hospitalizations for children who received the vaccine.
Questions also arise around the efficacy of a potential vaccine. The little we know of the current generation of COVID-19 vaccines raises serious questions regarding their ability to protect people from infection. We know all the candidates tested to date in non-human primates failed to protect any of the monkeys from infection of the nasal passages, the primary route of human infection. Failure to protect entirely from infection fits with all we know about attempts to protect monkeys from two other deadly coronaviruses, those that cause SARS and MERS.
On a brighter note, at least some of the candidate vaccines did raise significant immune responses. How that translates to protection of humans is uncertain though as monkeys do not become noticeably ill or exhibit many of the life-threatening consequences of COVID-19, even when exposed to high doses of the virus via the nose, lung, and rectum simultaneously. As many of the most serious COVID symptoms do not appear until late in the disease course, sometimes four to five weeks following exposure, there is a possibility that we will not have sufficient time to judge efficacy of a new vaccine, even by the lower standard of symptom amelioration.
An effective COVID-19 vaccine also faces several hurdles beyond our control. The older we get the poorer our ability to respond to vaccines. Resistance to vaccination begins early at age 30 and becomes progressively more profound with time. That is especially troubling as those over 60 are the population most at risk. Vaccination of the elderly may sometimes succeed by administering repeated doses and by increasing the potency of the vaccine with powerful adjuvants. But these adjuvants can be especially risky for the very old.
It seems a folly then to rush our way towards a vaccine in 2020 if it is likely to have only limited benefit to the population most in need and may put otherwise healthy people at risk. The risk goes far beyond the dangers a COVID vaccine alone may hold. Public support for vaccines in general is already an issue. Trust in other lifesaving vaccines will be eroded even further if a COVID vaccine goes wrong and many more peoplechildren especiallywill be at risk if vaccination rates fall.
Yes, we are all increasingly longing for an end to the outbreak. But a safe vaccine, effective for all those at risk, is worth the wait, especially when we have other solutions in hand. We already know from the experience of countries in Asia that the epidemic can be stopped in its tracks with basic public health measures: widespread testing, contact tracing, and mandatory controlled quarantinenot necessarily in a dismal public health facility as many imagine, but in our own homes with virtual supervision or in a hotel environment. These efforts alone could bring new infections down to almost zero within just weeks.
In addition, I believe it will be possible before the end of this year to protect those most at risk from exposure with combinations of monoclonal antibodies or with truly effective antiviral drugs. These drugs could treat those who were ill and prevent further infection. In addition to pursuing a vaccine within a realistic timeframe, we should also be throwing our weight behind these other types of medical solutions which have historically been much quicker to bring to market safely.
There is no doubt we need an urgent end to the pandemic. Economies around the world are crashing. Governments are piling up trillions of dollars in debt. And, in the US alone, tens of millions are without work or income. But there are still costs that are too great, even when compared to such numbers. When we have solutions to the pandemic in hand we cannot risk the potential lives lost of rushing a COVID vaccine to market. We must hold dear the central dictum of the medical community, first, do no harm. Trust that given the time science will deliver a medical solution in the form of a vaccine or a chemoprophylactic drug treatment, and in the meantime let us immediately implement the public health strategies that we know will work today to drive new infections down to nothing.
Read more about the coronavirus outbreak from Scientific American here. And read coverage from our international network of magazines here.
Scientists around the world have been working on developing a vaccine to cure the coronavirus since the virus was first detected late last year. By 28 June, there have been almost 10 million confirmed cases around the world with the death toll about to reach 500,000. The United States is the epicenter of the pandemic.
A number of Covid-19 vaccines are currently being trialled in humans, with companies committing to manufacture them on a large scale. The University of Oxford and Imperial College London are two of the multiple research institutes working day and night to produce a vaccine. They hope to have results by the end of the year with secured deals for mass manufacturing.
There are four separate studies which form the main contenders for a coronavirus vaccine, two from China, one in the United States and one in the United Kingdom. Some of these studies have reached the third and final phase of clinical testing.
The vaccine developed by the Vaccine Research Centre of the USA and Modern company has already started human trialswith their vaccine candidate; unfortunately, a 29-year-old volunteer named Ian Haydon suffered a severe reaction to the dose. According to the STAT medical journey, 12 hours after being administered a dose, he developed a high fever of over 39.5 C. His fever was so high that he was admitted to accidents and emergencies where hefainted and passed out.
In the UK, more than 4,000 participants are already enrolled, with enrolment of a further 10,000 people planned as researchers test the vaccine known as ChAdOx1 nCoV-19. The phase one in healthy adult volunteers began in April.
