On Thursday, Politico reported that the Senate has confirmed Justin Walker, long considered a protege of Senate Majority Leader Mitch McConnell (R-KY), to the powerful D.C. Court of Appeals.
"In a 51-42 vote, Walker was confirmed to the U.S. Court of Appeals for the D.C. Circuit," reported Marianne Levine. "Sen. Susan Collins (R-Maine) was the only Republican to join Senate Democrats in voting against his nomination."
Walker, a far-right lawyer, previously served in a Kentucky district court, a position to which President Donald Trump had nominated him despite at the time never having tried a case.
One of Walker's most notable actions on that court was to strike down an order from the mayor of Louisville restricting Easter church services amid the coronavirus pandemic, in a scathing opinion that claimed the mayor "criminalized" Easter and called the order something out of the "pages of a dystopian novel."
McConnell's devotion to continuing to appoint judges comes as the coronavirus stimulus funds and unemployment benefits dry up, and Senate Republicans are resisting calls to authorize another round. McConnell has indicated he will not take up the issue until late July at the earliest.
Trump supporter Brandon Straka, a self-described former liberal who has spent the last several years urging minorities to "walk away" from the Democratic Party, caused a major incident this week when he refused to wear a face mask on an American Airlines flight.
Forbes reports that Straka refused to wear a mask on a Wednesday flight from New York to Seattle even after being asked to do so by customer service agents, flight attendants, and even the plane's captain.
In fact, Straka even refused to wear a mask when a flight attendant offered to give him one.
In an interview with Forbes, Straka says that he then got yelled at by his fellow passengers after his refusal to wear a mask caused a delay in the flight.
"It became uncomfortable," he said. "People were shouting. One said, ‘There is always one... person.’ Another guy said, 'You’re selfish.'"
A crew member then told Straka that he would have to get off the flight if he refused to wear a mask, and the Trump-supporting passenger decided to disembark.
"I felt that, ‘I’m not somebody who succumbs to peer pressure, [but] I wasn’t going to sit on plane and get arrested,'" he explained to Forbes.
Straka also tells Forbes that he believes wearing a mask is "inhibiting" and "extremely uncomfortable."
The Ventura County Board of Supervisors in California voted 4-3 this Monday to require that people wear masks inside businesses and government offices and other public venues and services. This prompted an impassioned speech from a local Trump supporter who saw the vote as a vicious assault on her civil rights, Towerload reports.
“I am a healthy American. I used to be free. I am not a terrorist. I am not antifa," the woman declared while addressing the Board. "I am not a sex slave that wears masks. I am not into sado-masochism and bondage. I am not a burglar. I am not a pandering politician like we see here, and here, and here, and here.”
After her rant, the woman then launched into her own rendition of God Bless America.
President Donald Trump's supporters in Tulsa, Oklahoma are already lining up outside the BOK Center ready to see him. When it comes to fears of the coronavirus, they're not worried.
When interviewing Trump supporters outside the BOK Center, MSNBC found that they're just not worried.
Former Rick Santorum supporters who make folk songs about their candidates of choice have been waiting since early in the week for the Saturday rally.
"If protesters are immune from it maybe Trump supporters are too," said one of the singers. Neither group is immune.
"365 times in the Bible it tells us not to live in fear," said another man. "That's a daily reminder not to live in fear."
When asked if he would put a mask on, another Trump supporter said that he doesn't know until he gets into the arena, but as of right now he's not wearing a mask.
"I'm not saying that it isn't real, OK?" said another woman wearing a MAGA Women hat. "The numbers do not add up. It is not as bad as people say."
CNN senior medical correspondent Elizabeth Cohen, however, warned that the president's happy spin on the state of the COVID-19 pandemic in the United States does not match reality.
"Hundreds of Americans are dying every day because of coronavirus!" she said. "Can you imagine if this was happening under President Obama, President Trump would be saying this is a national travesty and he'd be right."
CNN correspondent Rosa Flores then explained how Florida, which is once again shaping up to be a key swing state in the 2020 presidential election, could soon become a new epicenter in the United States.
"This is a model out of the University of Pennsylvania that says... that Florida has all of the ingredients for disaster," she said. "Really, all you have to do is really look at the numbers. Last week we were talking about a thousand cases a day. That changed over the weekend to more than 2,000, and the latest number that we have is 2,600 in one day with a 10.3 percent positivity rate. That is the biggest positivity rate in the past two weeks."
Writing in the Washington Post this Thursday, columnist Jennifer Rubin argues Republicans are clueless as to the problem gripping the nation.
"What don’t Republicans understand?" she writes. "Hundreds of thousands of Americans have taken to the streets. Within weeks, two police officers — one in Minnesota and another in Georgia — have been charged with murdering African American men who posed no threat to them. And still Republicans serve up crumbs."
"It is no different on the coronavirus front — another example of grave racial inequality in America as people of color are hospitalized and dying at much higher rates than whites. Republicans don’t seem to care," she adds.
According to Rubin, the lights are on at the White House and in the office of Senate Majority Leader Mitch McConnell, but "no one is home."
"More African Americans will be killed by police, and more covid-19 hot spots will develop. But do not expect Republicans to do much about either."
Rural areas seemed immune as the coronavirus spread through cities earlier this year. Few rural cases were reported, and attention focused on the surge of illnesses and deaths in the big metro areas. But that false sense of safety is now falling apart as infection rates explode in rural areas across the country.
As a professor of rural sociology, I have been studying the challenges rural America faces in responding to this pandemic to improve how communities prepare and respond.
Being able to identify communities that are susceptible to the pandemic before people become ill would allow officials to target public health interventions to slow the spread of the infection and avoid deaths. To do this, I developed a COVID-19 susceptibility scale to assess every county in the Lower 48 states. Susceptibility does not mean an outbreak of COVID-19 will happen, but it means conditions are right for one to occur if the virus is carried in and takes hold.
Why rural populations are at high risk
When you look at the factors that make a population more susceptible to the coronavirus, small communities and rural areas have higher risk factors, as a share of the population, than major cities do.
Rural areas tend to have older populations than the national average, with more chronic health conditions that raise the risk of developing more severe cases of COVID-19. They havefewerhealth care providers and more uninsured residents, meaning residents often wait longer before seeking medical help. They also tend to be home to large group facilities, such as prisons, meatpacking plants and nursing homes, where the virus can quickly spread to residents and employees can carry it back into the community.
In Iowa, for example, the Tyson plant in Storm Lake drove a 68% increase in confirmed coronavirus cases during the past two weeks. In New Mexico, where new cases rose 42% in the first week of June, about half the new cases were at the rural Otero County Prison. Anderson County, Texas, posted a 10-fold increase in cases when state officials counted infections in five prisons there.
The COVID-19 susceptibility scale uses 11 indicators of the disease based on initial reports from the Centers for Disease Control and Prevention. Those fall into seven distinct risk components: population density; people aged 65 and older; people living in group quarters such as colleges, prisons and military bases; employment in nursing homes; employment in meat processing facilities; people with compromised health; and the prevalence of diabetes. Among people hospitalized with COVID-19, more than 70% have some underlying medical condition, often diabetes or lung or cardiovascular diseases.
Where the high-risk populations are
Looking across the rural-urban continuum, the scale shows that populations in non-metropolitan counties are more susceptible to COVID-19 than in metropolitan ones. That susceptibility increases when going from big cities to rural areas.
Why were big cities overrun with COVID-19 cases? While only 6% of metropolitan counties are at high risk according to my scale, they tend to be our nation’s very large global cities. A small number of COVID-19 cases in densely populated cities can spread rapidly causing numerically large outbreaks. This can quickly overwhelm the health care system, even in large cities. This is what happened in New York City, causing cases to spread across the northeastern U.S.
About one-third of the most rural counties have susceptibility scores in the 80th percentile or higher, as do 29% of semi-rural counties and 19% of micropolitan counties, those with a city of 50,000 people or less. A map of these susceptibility scores shows high-risk communities are concentrated in the Great Plains, Midwest, around the Great Lakes and in some parts of the South.
Some counties are at high risk on just one factor, but have low overall susceptibility. Apache County in northeast Arizona, home to the Navajo Nation, is one example. High rates of diabetes mortality make this group highly susceptible to COVID-19. However, the lower percentage of senior citizens and other risk factors lowers the overall score.
In analyzing the data, some trends stand out.
Rural counties are primarily susceptible due to their large senior populations. COVID-19 outbreaks are likely to originate in care facilities for the elderly, posing risks for residents and workers alike.
In semi-rural places, institutions like prisons and military bases add to the risk, as do high numbers of residents who are older or whose health is already compromised.
Micropolitans are at above average susceptibility due to residents’ health issues, large numbers of meat processing plant workers and care facilities. Semi-rural and micropolitan counties typically provide employment and social services for a region, likely attracting higher-risk populations.
By contrast, the populations of metropolitan counties have lower susceptibility, though the largest ones face a risk of community spread of the virus because of their high population densities. Cities have lower percentages of older residents and people living in institutional settings. However, a small number of cases in densely populated cities can trigger large outbreaks, driving national cases and deaths.
Researchers at Princeton came to similar conclusions about the high susceptibility of rural counties in a study published June 16 that modeled the impact if 20% of the population in every U.S. county became infected.
Tailoring responses to a pandemic
By knowing how populations are susceptible to severe outbreaks, communities can tailor their responses.
In large metropolitan cities, susceptibility is clearly driven by high population densities, making business closures and shelter-in-place orders essential to slow community spread of COVID-19.
But since rural areas are more sparsely populated, general shelter-in-place orders may be less effective. Instead, rural and micropolitan communities will need to isolate members of specific vulnerable populations quickly. This includes people in poor health, older residents, people living in institutional settings and workers in large meat processing facilities.
To accomplish this, local agencies and providers will need to provide essential services, including food and health care. In many areas, the monumental task of providing these services to a dispersed population will require volunteers and civic groups.
Lack of health care and social services makes rural communities particularly vulnerable. Any state or national response will be hindered by logistical barriers to deploying health providers and supplies over a large geographic area. Limited broadband access means health planners cannot rely solely on telemedicine to fill the gaps in rural areas.
Communities may also see social issues surface. In micropolitan and small metro communities, susceptibility is linked to large meat packing plants whose workforces are predominately Hispanic. Outbreaks may lead to people being treated as coronavirus carriers based solely on their ethnicity and may worsen the marginalization of people based on race.
Different communities have different vulnerabilities to COVID-19, requiring distinctly different strategies to respond effectively to the pandemic across the rural-urban continuum. Such strategies should be developed now to prepare for the next COVID-19 wave.
It’s been six months since researchers in China said they had identified a novel coronavirus spreading in the city of Wuhan. Hope and desire for a vaccine to end the global devastation is growing with each passing week.
Almost every day, I hear people making plans around the eventual arrival of a coronavirus vaccine — office reopenings, rescheduled weddings, family reunions and international travel. In recent weeks, colleagues and friends have asked me with growing urgency: “When will we have a vaccine? Will it be any good?”
At the same time, other friends have been telling me, “When I hear that this is going to be the fastest vaccine developed ever, that doesn’t make me feel good — it makes me feel nervous that they’re going to cut corners.”
These questions and concerns resonate with me. I, too, want a vaccine, but I want reassurance that it’s truly safe and effective. So I talked to a dozen people in the vaccine world: scientists, pediatricians, pharmaceutical manufacturers, as well as staff at the National Institutes of Health and the Food and Drug Administration.
Let me tell you this up front: If you’re imagining there’ll be one golden day when a vaccine is approved and the pandemic will be over — Finally! We can all crowd into one another’s living rooms and resume choir practice again — I’m afraid it won’t be quite like that. But it will be the beginning of the end.
There’s much to be hopeful about, and enormous challenges lie ahead. Let’s dig in.
Scientists Are Optimistic About a COVID-19 Vaccine
Everyone I spoke to was optimistic that manufacturers would eventually develop a COVID-19 vaccine. This isn’t just because there are so many scientists and pharmaceutical companies working on the endeavor, and so much money being poured into it, though that also raises the chance of success.
The goal of vaccine developers is to mimic a natural infection as closely as possible without getting a healthy individual sick. There are many ways to do this. You can give a person a weakened virus or a dead virus. You can also show the immune system just part of the virus. Many manufacturers are creating vaccines involving only the “spike protein,” the part on the surface of the coronavirus that attaches to the human cell it is trying to enter. Once the immune system has learned what the spike protein looks like, when it encounters it again, as part of a real coronavirus, it should know how to defend itself.
A transmission electron microscope image shows coronavirus particles. Spike proteins on the outer edge of the virus attach to human cells. (Image Point FR - LPN/BSIP/Universal Images Group via Getty Images)
Dr. John Mascola, director of the Vaccine Research Center at the NIH’s National Institute of Allergy and Infectious Diseases, said he is hopeful because our natural immune system, when healthy, is capable of handling the infection. “Most of the time, people recover from COVID-19, because their immune system eventually clears the virus,” he said. He contrasted the coronavirus to HIV, for which scientists so far have struggled to create an effective vaccine: “In HIV, the natural immune system is not effective and people get AIDS.” In this virus’s case, if we can mimic a natural infection closely enough, it’s likely that a vaccine will work.
The Coronavirus Is Not the Flu. In This Case, That’s Good News.
There are some vaccines that are extremely effective, like the MMR vaccine: One dose is about 93% effective at preventing measles; two doses (which is what’s recommended) are about 97% effective.
Other vaccines aren’t as perfect. The flu shot’s effectiveness varies year to year. During the 2019-20 flu season, it was about 45% effective at preventing infections, according to the CDC. The year before, it was just 29% effective.
The experts I talked to said that the flu shot was an outlier because of the rapidly shifting nature of the influenza virus. Because of its frequent mutations, developers have to make each year’s vaccine based on educated guesses on what strains of the flu virus will be circulating next year. Sometimes, they misjudge, resulting in a vaccine that doesn’t exactly match up with the flu strains that are most prevalent the following season.
“Influenza changes year in, year out, and the people who get it tend to be extremes in age — elderly and children — so you don’t tend to have as good an immune response,” said Dr. Nicholas Kartsonis, infectious disease and vaccines clinical research lead for Merck, which has two COVID-19 vaccine candidates that it plans to start in human trials this year.
One lucky break COVID-19 vaccine developers have had is that this coronavirus hasn’t mutated in any significant way so far, including, crucially, the part that is most visible to the immune system, that spike protein. So long as that remains true, the vaccine they make should match up with the virus that our bodies will encounter in the real world, meaning it’ll likely work as intended. Given the stability seen so far in the coronavirus’s genetic sequence, “I am hopeful that when we do develop a vaccine, it will provide long-term protection,” Kartsonis said.
Even a Vaccine That’s Not 100% Effective Could Be Good Enough
When vaccine manufacturers talk about “effective,” there are two common definitions. One is preventing people from getting sick. The other is preventing people from getting infected at all. In the case of COVID-19, this could be a nontrivial difference.
We know now that many people infected with the coronavirus may be asymptomatic carriers, which means that they never feel sick or get symptoms like a cough or fever, even if they are, in fact, infected with the virus. So you can have a vaccine that is effective in that it prevents symptomatic COVID-19, but that doesn’t mean it’ll stop everyone from being infected.
Vaccine candidates developed by Novavax, an American company. (Andrew Caballero-Reynolds/AFP via Getty Images)
Let’s be clear: A vaccine that can significantly reduce sickness would be fantastic. If a vaccine can reduce the severity of COVID-19 so that it’s far less deadly, decrease hospitalizations and minimize symptoms even for those who catch it, that’s a win.
“In terms of what you’d expect for approval, it should at least be 50% efficacy against symptoms and 70% against moderate to severe disease, to keep you out of the hospital,” said Dr. Paul Offit, director of the vaccine education center at the Children’s Hospital of Philadelphia.
Even so, it’s important not only to measure what the vaccine does, but also for politicians, health officials and journalists to clearly explain to the public exactly what it is that the vaccine is capable of doing. If it ends up that the first vaccine to go to market is “70% effective,” we should be clear on whether it is 70% effective at reducing sickness or infection, so members of the public have the appropriate context and don’t feel let down if they are vaccinated and still get a mild case of COVID-19.
Large Scale Trials Will Tell Us if the Vaccine Works
When experimental vaccines are tested, they usually go through three phases of clinical trials. The first phase is the smallest and focuses on safety, making sure that the product doesn’t have any dangerous health effects. The second is a little larger, continuing to gather safety data while testing if the vaccine can induce an immune response, producing antibodies in participants. The third trial is the largest, and it needs to be big enough to confirm that the vaccine is actually effective in the real world.
Moderna Therapeutics is currently expected to be the first U.S. manufacturer to start a phase 3 trial. Candidates by AstraZeneca and Johnson & Johnson will follow, according to The Wall Street Journal. Moderna’s trial is planned to begin in July and will enroll about 30,000 participants. Half will get the vaccine and half will get a placebo, according to Moderna’s chief medical officer Dr. Tal Zaks. (I should disclose: Paul Sagan, chairman of ProPublica’s board, is also one of Moderna’s board members. That said, ProPublica’s board members have no say in what reporters write about, nor do they know about articles before they are published.)
The participants will be tracked carefully throughout the study. If they have any symptoms related to COVID-19, they’ll get tested to see if they have contracted the virus. The participants will also get blood drawn at regular intervals to get tested for antibodies, which will determine if they got infected but perhaps didn’t know because they didn’t develop symptoms.
A participant receives a shot in the first phase of Moderna Therapeutics’ clinical trial in March. (Ted S. Warren/AP Photo)
“But wait!” you say. “Doesn’t a vaccine also create antibodies? How can you tell by looking in a participant’s blood whether the antibodies come from the vaccine or from an infection that the vaccine failed to prevent?” Excellent question.
At least for Moderna’s vaccine trial, here’s how they’re going to tell the difference: Moderna’s vaccine is what’s known as an mRNA vaccine. Instead of using the actual virus or even a little bit of the virus, it uses a piece of genetic code, kind of like a recipe, that gives instructions for making the spike protein. Once injected into the arm and introduced into human cells, the cell’s protein-making factories read the recipe and manufacture the spike protein, churning out copies for the immune system to check out. The immune system should then create antibodies that correspond to the spike protein, like a matching puzzle piece.
When you get infected by an actual coronavirus, however, there are more parts to it than just the spike protein. Your body will produce other antibodies that match up with other parts of the virus, including what’s called the nucleoprotein, found inside the virus. We can also measure for those antibodies in a trial participant’s blood, the NIH’s Mascola explained. So if we find so-called NP antibodies, that means you’ve been infected for real, because there’s no way you could induce NP antibodies from the vaccine alone.
The Moderna trial is designed to end when a predetermined number of people have gotten sick, according to Zaks. Then, the study investigators will count up the number of people that have gotten sick in the placebo arm and compare it with the vaccine arm. Hopefully, there will be far fewer in the vaccinated cohort.
There’s one more question that a phase 3 trial cannot answer: How long will protection last? Right now, we don’t even know if people who have gotten sick via natural infection have lifelong immunity. The only way to find out how long a vaccine’s protection lasts will be to keep tracking study participants and whether their antibody levels drop over time. We may end up needing periodic booster shots. Truly, only time will tell.
Shortcuts Involve Trade-Offs
To give you a sense of what a blistering pace we are attempting to move at, consider that under normal circumstances, it typically takes 10 to 15 years to develop a vaccine. Creating the HPV vaccine was a 15-year journey from key research findings in 1991 until the vaccine was approved, initially for the prevention of cervical, vulvar and vaginal cancers, in 2006. Merck’s Ebola vaccine, one of the fastest ever to be approved, still took about four years from start to finish, according to Kartsonis.
The speed of the phase 3 trials depends on the rate of infection wherever people are enrolled. If there is a huge outbreak going on, people in the placebo group will get sick at a high rate, and the trial may be over in a matter of a few months. If infection rates are very low, however, the trial could drag on for months on end. Moderna hasn’t announced its trial sites yet, but it will have sites “well dispersed” in the U.S. and is considering international trials as well, according to a spokesman.
Among the many ways to shorten the vaccine development timeline, approving a treatment based on antibody data — without completing a phase 3 trial — could be contentious. This is why.
“There have been some European countries that wanted to be part of our trial, and we said: ‘Look at your epidemiology, you’re a victim of your own success — there’s just not enough cases happening. It would take five years!’” Moderna’s Zaks said. “So speed here is going to be enabled by what we anticipate is ongoing attack rates. We expect there will be infections amongst the participants on our trial.”
Still, there have been discussions of some potential ways to speed up trials even more. One common proposal is to conduct what are known as challenge trials, in which vaccinated participants are deliberately “challenged” with the coronavirus to see if they get sick.
This idea was dismissed as unethical by some experts I interviewed. “We don’t have a treatment — we can’t guarantee to any volunteer that if we gave them a challenge with the actual virus, that it wouldn’t make them very, very sick,” said Dr. William Schaffner, professor of preventive medicine and infectious diseases at Vanderbilt Medicine. “That would make a lot of people very uneasy.”
The other shortcoming of approving a vaccine via a challenge trial is that because of the inherently risky nature of giving participants a live virus, challenge trials are typically very small. “That diminishes the safety database, and you need a large safety database to give us comfort to communicate to the public that we think that this is a safe vaccine,” Schaffner said.
Another potential would be to green light use of a vaccine based on expected benefit, if manufacturers can show it reliably generates levels of antibodies in study participants that are similar to those found in people who have been naturally infected. Not everyone is a fan of that idea — some experts I interviewed told me that immune responses aren’t always predictive of a vaccine’s real-world capabilities. (Read more about this discussion.)
Children and Pregnant Women Won’t Be First in Line
In the phase 3 trials currently being planned, the vaccines will be tested in adults. People over the age of 55 are being specifically recruited, and it’s important to include them because the need for the vaccine in that demographic is particularly high.
One group that won’t be in the initial set of phase 3 trials: children.
This is for two reasons. First, as a safety precaution, the NIH’s Mascola explained. Traditionally, when running trials with an experimental vaccine or drug, developers make sure it’s safe in adults before moving on to children. Second, for the COVID-19 vaccine specifically, the most acute need isn’t in children.
This means that when the vaccine is first approved, it likely won’t be available for those under 18, because it hasn’t yet been studied in that population. However, Mascola said there are already discussions for how to run future trials for children. Moderna will eventually run trials in children, Zaks confirmed.
Another special population is pregnant women. They are also not going to be enrolled in the initial phase 3 trial for the Moderna vaccine, according to Zaks. But Mascola said that it’s essential that that population eventually be studied. “If we’re not able to immunize women of childbearing age, that excludes a large proportion of the population. There’s a strong interest in getting those studies done,” he said. “The FDA is encouraging companies/sponsors to include in their development plans studies that would provide data to support use of COVID-19 vaccines during pregnancy,” the agency said in a statement.
The FDA added that it “strongly encourages the enrollment of populations most affected by COVID-19, specifically racial and ethnic minorities.” African Americans have been disproportionately affected by the pandemic, contracting the virus and dying at higher rates.
Manufacturing “At Risk” Is a Safe Time-Saver
One strategy that everyone agreed was a safe way to save a whole lot of time without any risk to human health is what’s known as “manufacturing at risk.” This is one of the key components of the U.S. government’s Operation Warp Speed, which is supporting five candidates with billions of dollars of federal funding.
Typically, drugmakers will manufacture only enough doses for clinical trials and make sure the trials are successful before starting mass production. Manufacturing at risk means that developers will instead begin mass production at the same time as clinical trials, which means that if a vaccine fails in human trials, they’ll have to throw away all the product they’ve made, wasting money and materials. But if a product is successful, it means that the minute its trial is completed, there’ll be millions of doses ready to go.
Manufacturing at a massive scale is no simple task. “If we’re going to immunize 300 million people in the U.S. — we don’t even do that with the flu vaccine every year — we need a lot of glass vials, we have to make sure we have printing supplies and paper to make the labels and package inserts, we need stoppers for the vials, and they all need to be made to a very high standard. All this in addition to the raw materials to the vaccine itself,” Schaffner said.
Mass production of H1N1 flu vaccines at Sinovac in 2009. (China Photos/Getty Images)
Pfizer and its partner, German company BioNTech, are planning to have a few million doses ready by the end of the year, and hundreds of millions of doses available in 2021, even though the first of their four vaccine candidates just began its first early-stage human trials in May. The companies are currently preparing manufacturing facilities in St. Louis, Andover, Massachusetts, and Kalamazoo, Michigan, as well as in Europe, according to Dr. Philip Dormitzer, Pfizer’s vice president and chief scientific officer for viral vaccines.
Development Is the First Hurdle, Distribution Is the Next Challenge
On the day that a vaccine is approved, you’ll find me jumping up and down in my apartment, cheering loudly enough to startle my neighbors. And then … I’ll keep on washing my hands, wearing a mask and maintaining social distancing.
Why? Because I know that when a vaccine is first approved by the FDA, there won’t be enough available for everyone who wants it. There will need to be a prioritization, with the vaccine given first to those who need it most: essential workers and the elderly. As a healthy adult who is fortunate to be able to work from home, I’ll be nowhere near the front of the inoculation line.
Distribution is going to be a massive challenge. “There’s a need to have in place a mechanism to ensure people who should get the vaccine get it,” Dr. Walter Orenstein, associate director of Emory University’s vaccine center, said. “We won’t have 8 billion vaccines. So who should get priority, and how should it get delivered? We will need to remove barriers to access, including cost and distance.”
In all likelihood, we’ll have several vaccines that come to market and are in use at the same time, because of the unprecedented need to vaccinate so many people around the globe. No one company has the manufacturing capability to make it all.
There may also be differences in what works best for different countries and populations. Some of the vaccines will require cold shipping or storage. Some will require two doses (Moderna’s is a two-dose vaccine, taken a month apart). All these variations will add to the complexity of delivery and distribution.
“Since I have gray hair, I’m trying to remind my colleagues that in previous distribution and prioritization schemes, flexibility is very important,” Schaffner warned me. He has long worked with the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practice, which reviews data on vaccines and gives recommendations on which populations they should be used for. He is now on the COVID-19 vaccine working group. “Adverse events will come up that have to become investigated. There will be bumps in the road. War plans are great, until the war starts. Then you will have to be flexible.”
Safety Monitoring Doesn’t End After Trials Are Over
Vaccinating 15,000 to 20,000 people before approval should give regulators a large pool of data to help them understand what side effects are to be expected and help ensure that the vaccines that go to market don’t have any major safety issues.
But of course, 20,000 people isn’t 20 million or 200 million or 2 billion people.
“When we have tens of thousands of people being evaluated, we can at least pick up safety signals for serious adverse events for the more frequent adverse events,” Orenstein said. “Now for very rare events, if it’s 1 per million, you’re not going to catch that in clinical trials.”
What everyone wants to avoid is a repeat of the mass immunization program following the swine flu outbreak at Fort Dix in 1976. After 45 million doses were distributed, the vaccine was found to be associated with increased cases of Guillain-Barré syndrome, which can cause paralysis and sometimes death. Even worse, there wasn’t actually a pandemic — the program had been launched in fears that the swine flu virus circulating among recruits at Fort Dix would cause a catastrophic outbreak. In the end, there was no transmission across the U.S., and the vaccination program was canceled.
So there will need to be some sort of mechanism to track and monitor for rare safety events even after the vaccine goes on the market. There is already a program to do so, which is the Vaccine Adverse Event Reporting System, run by the CDC.
While it may be impossible for a phase 3 trial to catch a very rare potential side effect, Offit, of the Children’s Hospital of Philadelphia, points out that “it’s not a risk-free choice to not get the vaccine, if the virus is still circulating.”
He added, “If the data were clear that in 20,000 people it appears to be safe and highly efficacious, then you should get the vaccine, because if you’re choosing not to get a vaccine, you’re choosing to risk getting a natural infection, which could be fatal.”
When Will a Coronavirus Vaccine Be Ready? Let Data Determine the Timeline.
The Trump administration’s Operation Warp Speed has said it “aims to have substantial quantities of a safe and effective vaccine available for Americans by January 2021.”
Experts I’ve spoken to have ranged in their optimism about that timeline. The NIH’s Mascola said, “If a study is started in the summertime, it’s possible that by the end of the year we’ll have an answer.”
Dr. Luciana Borio, former FDA acting chief scientist and current vice president at In-Q-Tel, a nonprofit strategic investment firm, concurred. “Depending on the results of the clinical trials, I think we might see some vaccine become available before the end of the year, but most people will have to wait for 2021.”
Others were more cautious. Orenstein said he thinks there is a “real possibility” that we will have a vaccine by summer next year, “if everything goes well.”
Vanderbilt’s Schaffner said he prefers to avoid timelines altogether. “We’re making the same mistake we made back in 2009 when we developed the H1N1 vaccine. We made the same statements and then it took more time than people anticipated, and when it finally came out, the media all said, ‘It’s a late vaccine!’
“So we overpromised and underdelivered in 2009, and we haven’t learned that lesson. We are overpromising now, and I wish we wouldn’t do that. I wish we would just say, ‘We’re working as hard as we can and we’ll get it to you whenever it’s finished, but we’ve got to do it right.’ And that would be a much more solid message.”
ProPublica deputy managing editor Charles Ornstein wanted to know why experts were wrong when they said U.S. hospitals would be overwhelmed by COVID-19 patients. Here’s what he learned, including what hospitals can do before the next wave.
Many of the experts I talked to stressed that they wanted to see the phase 3 trials run to completion, however long they took.
Dr. Brit Trogen, a pediatrics resident at NYU Langone, said she worries about political pressures on developers. “I consider vaccines to be one of the greatest public health achievements of the past few centuries, and I know the consequences of undervaccinating, because I treat kids who are seriously ill with preventable illness,” she said. “But I worry that at the first hint of something positive, politicians will swoop in and push for an early release beyond what the science allows.”
Some also noted that vaccine hesitancy has been growing in the United States, thanks to a fervent anti-vaccination movement.
Dr. Peter Hotez, a vaccine scientist, professor and dean of the National School of Tropical Medicine at Baylor College of Medicine, said communication that focuses solely on speed “is very tone deaf to the fact that there’s an aggressive anti-vax lobby that says that vaccines are rushed and aren’t adequately tested for safety.”
I brought these concerns to the FDA, as the agency will ultimately be the one to make the call on when there is sufficient data to approve a vaccine.
“We recognize that there are some that are concerned that ‘rapid development’ means that vaccine development steps are being skipped, but the FDA scientists will not cut corners in order to approve a vaccine,” the agency responded. “The FDA will thoroughly evaluate the data submitted in support of a vaccine’s safety and effectiveness, and will approve a vaccine for the prevention of COVID-19 only if the FDA determines that it is safe and effective for its intended use.”
When I pause to really think about it, I am staggered by what an enormous undertaking is underway around the globe — and what lies ahead — to develop and distribute a COVID-19 vaccine to billions of people. There is so much at stake, both to give the world a vaccine as soon as possible, and also to not make any critical mistakes in the process. As I cheer on all of the developers, I hope that every country’s leaders will let science and evidence guide decisions every step of the way.
I asked Zaks, of Moderna, what kind of pressure he felt, and he answered me in two ways. He said: “Every day and every minute counts.” And then he told me this — that normally, when he works on vaccines, he never gets to meet the people that he’s making the vaccine for. But this pandemic has been different. His future daughter-in-law is a second-year internal medicine resident in New York City, where the coronavirus has hit hard. “This one’s personal,” he said. “This one cuts close to home.”
Dr. Jeanne Marrazzo, the director of the Division of Infectious Diseases at the University of Alabama at Birmingham, said that she's been watching with alarm as Florida's confirmed COVID-19 infections keep growing at a record-setting pace.
"Florida has already made the stuff of nightmares for me and many infectious disease people when it comes to COVID-19," she said. "Part of the reason I'm really concerned is that Florida has a lot of older people, right? And we know very, very well that age and coexisting conditions -- like cardiovascular disease, like lung disease, like diabetes -- are the prime predictors for hospitalization and for mortality with this virus."
She also said that the large number of nursing homes in Florida would leave the state highly vulnerable to a large-scale outbreak that could quickly spiral out of control.
"The potential for the virus to take off there is very, very nerve-racking and could have catastrophic consequences," she said.
The Eiffel Tower is preparing to welcome back visitors after the Covid-19 lockdown, but they will need to be fit: Because of lingering concerns about infection, the elevators will initially be off-limits.
Workers at the Parisian landmark, which looms 324 metres (1,062 feet) over the French capital, were on Wednesday making preparations to re-open on June 25, after three months of shutdown. It has been the site’s longest period out of action since World War Two.
Managers said they hoped to get operations fully back to normal later in the summer. In the meantime, a series of safety measures will be in place.
Visitors will not be able to go any higher than the second level of the tower, and until the start of July access will be only via the staircases. The elevators, with their confined space, represent a risk of disease transmission.
There will also be a one-way traffic system in force on the staircases, and all visitors over the age of 11 will be required to wear a face covering.
A stringent cleaning operation is in place and will continue daily from next week.
“There is a new protocol,” said Eiffel Tower hygiene consultant Alain Miralles. “The day cleaning teams will be able to clean all the points of contact every two hours, from the opening of the site to its closing.”
Tourists planning trips to the City of Light are advised to book tickets to visit the Eiffel Tower online once the ticket office reopens Thursday.
Paris tourism officials have expressed muted optimism about the city’s reemergence as a travel destination. Since confinement measures were imposed in March, tourism levels have dropped by around 80 percent compared to the same month in previous years, they say.
“To attract people, the most important thing is that security measures are taken, and that's why we're promoting safe distances,” said Patrick Branco Ruivo, director of the Eiffel Tower's operating company.
He said that with foreign travel yet to recover from restrictions put in place to slow the pandemic, most of the visitors would in the initial stage be domestic.
“For the French public, this is the moment to come to the Eiffel Tower,” he added.
President Donald Trump and Vice President Mike Pence were ripped to shreds by "Late Show" comedian Stephen Colbert during his Wednesday night show.
Colbert, who cracked jokes before interviewing Kamala Harris, said that Pence tried to blame the rising infection numbers on the increase in testing.
"Because for Pence, the real disease is knowledge," said Colbert. "And you can catch it through the eyes and the ears, so he's going to need a new mask."
The host addressed Pence's op-ed in the Wall Street Journal in which he tried desperately to claim, "There isn't a coronavirus second wave."
"Great news for all the thousands of people who checked into hospitals this week," said Colbert. "You can go home! It turns out you were faking it for all the free pudding!"
Pence's op-ed in the Journal claimed that the media is panicking about nothing and people should stay calm.
"Every time you've said something about COVID is overblown, you've been wrong," said Colbert. "I think the panic is perfectly blown. Like, in terms of how this panic is blown, let's just say the panic is having an amazing birthday. Now, keep in mind, Pence is the same medical genius who only 20 years ago wrote an article arguing that 'despite the hysteria from the political class and the media, smoking doesn't kill.' You do not want Mike Pence as your doctor."
As Pence, Colbert joked, "I am afraid I have bad news. I'm afraid your lung x-ray shows a rapidly growing mass of media hysteria. I'm going to write you a prescription for cool-menthol flavor. It'll relax your t-zone."
He went on to explain to Trump that his upcoming rally in Oklahoma probably isn't the best idea. Citing Dr. Anthony Fauci, Colbert said that an outside rally is better than inside, no crowd is better than a crowd, and a normal crowd is better than a large crowd. For the guidance of a small crowd of people outdoors, Colbert encouraged Trump to look at his inauguration.
He goes on to talk about John Bolton's new book, which you can see in the video below:
The novel coronavirus is twice as infectious within households than similar diseases such as SARS, with a substantial number of additional infections spreading before a COVID-19 sufferer shows any symptoms, according to modelling released Thursday.
Researchers based in China and the United States said their findings could have profound impacts on reducing the number of new infections as the pandemic progresses.
Using data on 350 COVID-19 patients and nearly 2,000 of their close contacts in the city of Guangzhou, China, the researchers estimated the virus' "secondary attack rate" -- that is, the probability that an infected person transmits the disease to someone else.
They found that while the average patient had just a 2.4 percent chance of infecting someone they did not live with, that figure jumped to 17.1 percent -- around one in six -- among cohabitants.
According to their models, which rely on data collated in January and February but have been updated to reflect the latest developments, the likelihood of household infection was highest among over-60s, and lowest among under-20s.
The overall chances of infecting a family member or live-in partner with COVID-19 are twice as high as with SARS, and three times higher than MERS, another coronavirus, they found.
Significantly, the researchers found that the probability of a COVID-19 carrier infecting a family member or flatmate was significantly higher -- 39 percent -- before they started showing symptoms than afterwards.
This suggests that the virus is easily transmissible within its incubation period and may be passed on by individuals who don't know they are infected.
The team said that isolation within households cut the total number of COVID-19 cases among the study cohort by 20-50 percent compared with no quarantine.
"Although the effect of case isolation seems moderate, the high infectivity of the virus during the incubation period suggests quarantine of asymptomatic contacts could have prevented more onward transmissions," said Qin-Long Jing from the Guangzhou Center for Disease Control and Prevention.
Many European nations, before implementing weeks-long lockdowns, issued public health advice only to stay at home if an individual was sick -- that is, showing symptoms typical to the virus.
The research suggests that may have already been too late to prevent COVID-19 circulating widely.
Writing in a linked comment, Virginia Pitzer from the Yale School of Public Health said that a "key difference" between COVID-19 and other coronaviruses was its "substantially higher" probability of transmission in its incubation period.
She said the research, published in The Lancet, "confirms the relative importance of pre-symptomatic transmission and the relationship between older age and susceptibility, key insights which should inform design of intervention strategies."
Florida is reporting record daily totals of new coronavirus cases, but you'd never know it looking at the Sunshine State's increasingly busy beaches and hotels.
Republican Governor Ron DeSantis wants tourists to return en masse to help bolster the local economy -- and in so doing, help his ally President Donald Trump win over voters.
But many of those visitors are not wearing masks and ignoring social distancing guidelines, and striking a balance between protecting public health and saving people's jobs is tricky.
On both Monday and Tuesday, Florida confirmed more than 2,500 new virus cases, bringing the state's total caseload to more than 82,000, with more than 3,000 deaths.
While the number of deaths per day is not rising, the percentage of positive tests is, hitting 10.3 percent on Wednesday, compared to 5.5 percent the week before, according to the state health department.
Despite the worrying data, Floridians seem to have hit peak quarantine fatigue -- they are fed up with the pandemic and the measures suggested to help keep it in check.
That means tempers are flaring between people who wear masks and those who refuse to do so.
"It's not easy," said Kathia Joseph, the owner of a French bakery in Miami Beach, a barrier island off the city itself.
"We really have to be after them, ask them to wear a mask, ask them to stay away. Some people, they're not happy when you ask them to do that."
Out in the street, a mask-free man trying to get into an Uber car argues with the driver.
On the beach, a so-called safe distancing ambassador is taunted by a group of people who are drinking and dancing.
Joseph says only about half of her customers obey guidelines designed to contain the spread of the virus.
That proportion sounds about right, says Diane, a 60-year-old woman who drove from Texas to relax in Miami Beach.
"It seems that some people just want to get on with their lives, and they're going to take the chance," said Diane, who declined to give her last name.
Then she went for a swim wearing her mask.
- Controlling risk -
Miami Beach Mayor Dan Gelber is certainly aware of all the friction, and is trying to adopt a conciliatory tone.
"We realize that this is not about eliminating risk -- it's about managing the risk," Gelber told AFP.
"So even if we don't get 100 percent compliance, if most people follow the rules, we're going to reduce the virus tremendously and save lives."
The two and a half months of lockdown dealt a severe economic blow to Miami Beach, home to 93,000 people.
Before the pandemic, it would welcome seven million visitors a year. Now, some businesses are shutting down for good.
Therein lies the problem, as the city needs tourists desperately.
Interacting with customers safely is "a big challenge for us," Joseph says. "But we are really happy to be back to work because it's been two and a half months."
Nevertheless, she is closing her bakery and opening a Cuban-style cafe near Ocean Drive, the waterfront main drag that is home to what is left of Miami Beach's commercial buzz.
Officials note that hospitalization and death rates from the coronavirus have remained stable, and partly attribute the overall rise in case numbers to an increase in testing.
But the increase in the percentage of positive tests is worrying and many people are alarmed.
They fear the reopening of businesses and huge protests over the death in police custody of George Floyd are to blame.
- Backfire -
"We are not shutting down. We are going to go forward," DeSantis said Tuesday.
Florida is crucial to Trump's reelection hopes, and DeSantis wants to help him over the finish line.
Last week, the governor offered up Jacksonville as a new host city for Trump's nomination acceptance speech at the Republican convention, after North Carolina balked at allowing the president to address a packed arena.
Florida started to reopen its economy slowly in May and most businesses are open -- albeit with limited occupancy and with instructions on social distancing.
But in recent days, several bars and restaurants in Tampa, which began to reopen before Miami, were forced to close after some workers were infected with the virus.
In Jacksonville Beach, at least 12 friends tested positive for coronavirus after a night out for a birthday celebration, one of the group members told US media.
DeSantis is "shooting himself in the foot," Aileen Marty, a Florida International University pandemic expert, told Politico.
"He thinks in downplaying the threat of the virus that's going to help the economy," Marty said.
"It's going to backfire because if people fail to understand how dangerous this particular virus is, they're going to act in irresponsible ways."
