Another Mainer has died as health officials on Tuesday reported 37 new coronavirus cases across the state.
There have now been 5,337 coronavirus cases reported in Maine since the outbreak began here in March, according to the Maine Center for Disease Control and Prevention. Thats up from 5,300 on Monday.
Of those, 4,777 have been confirmed positive, while 560 were classified as probable cases, the Maine CDC reports.
New cases were reported in Androscoggin (7), Cumberland (8), Oxford (1), Sagadahoc (1), Waldo (1) and York (19) counties, state data show.
The seven-day average for new coronavirus cases has fallen to 30.4, down from 34.1 a week ago but up from 23.6 a month ago.
The latest death involved a woman in her 80s from York County, bringing the statewide death toll to 141. It was the first coronavirus-related death reported in Maine in more than a week. Nearly all deaths have been in Mainers over age 60.
So far, 447 Mainers have been hospitalized at some point with COVID-19, the illness caused by the coronavirus. Of those, eight people are currently hospitalized, with five in critical care and one on a ventilator.
Meanwhile, 30 more people have recovered from the coronavirus, bringing total recoveries to 4,629. That means there are 567 active confirmed and probable cases in the state, which is down from 561 on Monday.
A majority of the cases 3,095 have been in Mainers under age 50, while more cases have been reported in women than men, according to the Maine CDC.
As of Tuesday, there have been 430,445 negative test results out of 437,878 overall. About 1.5 percent of all tests have come back positive, the most recently available Maine CDC data show.
The coronavirus has hit hardest in Cumberland County, where 2,316 cases have been reported and where the bulk of virus deaths 70 have been concentrated. It is one of four counties the others are Androscoggin, Penobscot and York, with 723, 254 and 1,188 cases, respectively where community transmission has been confirmed, according to the Maine CDC.
There are two criteria for establishing community transmission: at least 10 confirmed cases and that at least 25 percent of those are not connected to either known cases or travel. That second condition has not yet been satisfied in other counties.
Other cases have been reported in Aroostook (43), Franklin (62), Hancock (54), Kennebec (215), Knox (39), Lincoln (42), Oxford (149), Piscataquis (9), Sagadahoc (67), Somerset (86), Waldo (74) and Washington (16) counties.
As of Tuesday afternoon, the coronavirus had sickened 7,168,048 people in all 50 states, the District of Columbia, Puerto Rico, Guam, the Northern Mariana Islands and the U.S. Virgin Islands, as well as caused 205,547 deaths, according to Johns Hopkins University of Medicine.
Also, outside a lab, infection depends mainly on breathing in viral particles from an infected person and normal contact doesnt necessarily translate into infection for animals. Ferrets have been shown in the laboratory to be susceptible to infection with the virus, and to spread it to other ferrets.
But scientists at Tufts reported, in a paper that has yet to be peer- reviewed, that in one house with 29 pet ferrets and two humans with Covid not one ferret became infected with the virus.
The 29 ferrets roamed freely in the house, and both human adults were ill enough with Covid to show symptoms, so there was ample opportunity for infection. Kaitlin Sawatzki, a virologist at Tufts University and one of the authors of the ferret paper, said, Isnt that incredible? It was a beautiful natural experiment.
The researchers concluded that there could be genetic barriers to infection that are overcome in a lab with concentrated doses of virus. Minks, which are in the same family as ferrets, appear to be very easily infected, and to get sick from the disease. Researchers have also reported transmission from animals to humans at mink farms in the Netherlands in a paper not yet peer-reviewed. Dr. Sawatzki said the paper showed very strong evidence of multiple, independent mink-to-human transmission events.
The Colorado State researchers advise keeping cats indoors, particularly if a human in a household has become infected, because they could spread it to other cats. Also, if a person with Covid needs to be admitted to a hospital and has pet cats, Dr. Porter suggested, the cats caretakers should know to observe social distancing as they would with a person.
The infected cats that showed immunity, Dr. Bosco-Lauth said, were animals that were infected by contact with other cats, not by pipette. And, she said, the immune response was stronger than in some other laboratory animals, although how long that protection might last is completely unknown.
BARRE, Vermont On the first Friday in June, Jefrey Cameron, 29, left his home around midnight to buy heroin. He had been struggling with addiction for seven years but had seemingly turned a corner, holding down a job that he loved at Basils Pizzeria, driving his teenage sister to the mall to go shopping and sharing a home with his grandmother. But then the coronavirus pandemic hit.
When he returned home that night and tried the product, it was so potent that he fell and hit his head in the bathroom. Mr. Cameron texted a friend soon after, saying that he had messed up and would go to a 12-step meeting with a friend that weekend.
I promise Im good and I cant get in any more trouble tonight, he wrote. Sweet dreams, if you wake up before you hear from me definitely call me. The sooner I get up and into town the better. When Mr. Cameron woke up, he used the rest of the powder largely fentanyl, not heroin, his family would later learn from a small bag with a bunny stamped on it. Less than five hours after he sent the text, his grandmother found him dead.
In the six months since Covid-19 brought the nation to a standstill, the opioid epidemic has taken a sharp turn for the worse. More than 40 states have recorded increases in opioid-related deaths since the pandemic began, according to the American Medical Association. In Arkansas, the use of Narcan, an overdose-reversing drug, has tripled. Jacksonville, Fla., has seen a 40 percent increase in overdose-related calls. In March alone, York County in Pennsylvania recorded three times more overdose deaths than normal.
For Mr. Cameron, the shutdown of daily life in the spring not only led him back to drugs, but led him to use alone an especially dangerous proposition.
Usually he would use with somebody, especially if its a different dealer or different batch, said his mother, Tara Reil. I dont think he had that person to use with, to have that safety net.
Mr. Cameron lived in East Barre, a tiny town about 20 minutes outside of the state capital, Montpelier. He drove a red Subaru Legacy, had a pet snake named Lucy and was passionate about making food for others. For two days after he died, the pizza shop he worked for closed its doors; now his pictures plaster the windows and customers can buy car decals, T-shirts and bracelets made in his memory.
When Vermont shut down in March, so did Mr. Camerons job, which provided his biggest support network. He was lonely and had money to spare: the $600 per week he received in extra unemployment benefits from the federal government was more than he earned from his job.
Jefrey hated being alone. And the last couple of weeks, he was, said Ms. Reil, who is 47. His grandmother had gone to Atlanta to visit her other children and had delayed flying home for fear of catching Covid-19. In her absence, Mr. Cameron started keeping the television tuned to her favorite channel, blaring Western movies and Bonanza reruns.
He was home alone a lot more, Ms. Reil said. And I think the drug became his friend.
Mr. Cameron had stopped taking Suboxone, a medication that helps suppress the cravings and withdrawal symptoms that plague people addicted to opioids, last fall; it has been found to sharply reduce the risk of dying from an overdose, but he had grown tired of taking it after three years, his mother said.
Opioid addiction has been a scourge in Vermont for more than two decades. When dealers and illegal drug organizations realized they could charge more for narcotics here than they could in nearby cities such as Boston, New York or Montreal, the market was flooded. As the painkillers that many young Vermonters became addicted to in the early 2000s grew harder to get starting about a decade ago, heroin moved in. Then came fentanyl, which is far more potent and has driven up deaths in almost every corner of the country.
Last year, after aggressive efforts to expand access to treatment, Vermont saw its first decrease in opioid-related deaths since 2014; that year, then-Gov. Peter Shumlin devoted his entire State of the State Message to what he called a full-blown heroin crisis gripping Vermont. But Vermont saw 82 opioid overdoses through July of this year, up from 60 during the same period last year.
Nowhere in the state is as hard hit as Windham County, which borders New Hampshire and Massachusetts and typically has the highest yearly number of opioid-related deaths. In the first three months of this year, emergency workers in Brattleboro, the county seat, responded to 10 overdose calls, none of them fatal. But by August they had responded to a total of 53 overdoses, including seven that were fatal.
When this all initiated, it shot up, said Lt. Adam Petlock of the Brattleboro Police Department.
Before the pandemic, Lieutenant Petlock and a trained civilian addiction counselor would bring Narcan and information packets to drug users and homeless people every two weeks through a program called Project CARE. Health and safety concerns prevented them from conducting the wellness checks during the peak of the shutdown, but they recently restarted the program.
While most businesses in the county closed in March, the Brattleboro Retreat, a psychiatric and addiction treatment hospital, remained open. It was able to stockpile hand sanitizer and protective gear, and even created a 22-bed, negative-pressure unit so it could accommodate coronavirus patients in the event of an outbreak.
But in order to be admitted, patients have to test negative for Covid-19 a potentially deadly setback for some who are unable or unwilling to wait several days for results.
Far more common than inpatient addiction care is treatment with three medications that help suppress the cravings and withdrawal symptoms that plague people addicted to opioids. Vermont has gone further than most states in expanding access to medication-assisted treatment, as it is known; at least 8,960 residents about 1.5 percent of the states population were taking one of the three medications, buprenorphine, methadone and naltrexone, during the first quarter of this year.
Once the pandemic began, the federal government tried to make it easier for patients to stay on these medications while doctors offices and clinics were generally closed and people were being asked to stay home. Nik Rowley, 37, has been taking a daily dose of Suboxone a brand name for buprenorphine for about eight years.
Typically, Mr. Rowley has to go see a doctor every two weeks to get 38 doses of Suboxone two per day. What they started doing was emergency exemption doses. So you were getting a months worth of emergency doses, he said.
Mr. Rowley was getting back on his feet after being hospitalized for pneumonia when the pandemic hit. With nowhere else to go, he found housing in a hotel through a state-funded program to keep residents off the streets. The extra supply of medication helped him avoid drugs, but in his hotel room, he relapsed on alcohol. I had a few beers at the hotel because youre stuck in a room all by yourself, he said. You have nothing to do. So all you do is sit there and ruminate and your depression gets worse.
Brattleboro has several hotels that the state helped convert into temporary housing units for homeless and other at-risk people. Groundworks, a year-round housing service in Windham County, typically places 33 people in hotels during the winter months; in the spring, the number swelled to 150.
Many of the recent lethal overdoses in the town have taken place at those hotels. We immediately saw a skyrocket in the amount of substances that people were using, says Rhianna Kendrick, director of operations for Groundworks.
Nick Luoma, a heroin user who has been living in one of the hotels, said several people who had overdosed during the pandemic had relapsed after it began. I get it like, what are you going to do? said Mr. Luoma, who is 35.
When he got housed at a hotel in late March he was using less than a bag of heroin a day, but his use has gone up. Despite efforts to stop he briefly tried medication-assisted treatment he accidentally overdosed twice in July. I am not honoring some of the parts of myself that have so much potential, Mr. Luoma wrote in a text message that month.
Last night I almost died again, he wrote. I may have to wait 2-3 weeks to get into rehab. Im fortunate to have the folks from Groundworks willing to find ways to help me through this waiting period, but the nagging urge, the beast inside that sits waiting for a moment of weakness could kill me before I am able to get in.
Not all drug-related deaths during the pandemic have been from overdoses. Jessie-Mae DeCosta, 32, died from sepsis, an infection she got from injecting drugs. Covid kind of sealed Jessies fate, said her mother, LaNell DeCosta, 62, of Bristol, Vt.
Ms. DeCosta had struggled with drug use for a decade and was living with her mother, and three cats she had rescued, until the shutdown began. Afraid that she might expose her mother to the virus, she moved into a house with some friends where they all were using drugs. Already in poor health, with abscesses covering much of her body, she started feeling worse than usual in May and assumed she had Covid-19. But past experiences in hospitals, including one long stay when she was treated poorly by doctors and nurses because of her addiction, made her avoid seeking care.
She was petrified, LaNell DeCosta said. Imagine being trapped in an environment where you have nobody on your side, you dont have your mother, you dont have a boyfriend, you dont have any friends. You just have people that you think could be judging you.
Ms. DeCosta, like so many other grieving family members and friends of people who have died during the pandemic, grapples with how to say goodbye to her only daughter. Because of the pandemic, she has put off holding a funeral or memorial service. Its denied me closure, and I think it denied her boyfriend closure, denied her dad closure, denied everyone who loved her, Ms. DeCosta said. Because no one could say or show their last respects to her.
The Reil family decided to wait over a month after Mr. Cameron died to hold a service. On a bright and humid afternoon in July, more than 80 friends and family members came together at St. Sylvesters Catholic Cemetery in Barre to mourn him.
Our hearts break, our heads shake at the injustice of yet another young life extinguished by the disease of addiction, Pastor Rachel Fraumann said after beginning her service with a strong warning for mourners to stay as distant from one another as possible. I dont want to do a bunch of funerals on the heels of this one.
Tara Reil and her four surviving children sat in white folding chairs with masks, tissues and water bottles handy. Two of Mr. Camerons brothers had flown in from out of state, taking leave from their posts in the Marine Corps and Navy.
Six family members spoke, including Mr. Camerons stepfather, Terry Reil. Let Jefs purpose empower you to make a difference in yours or someone elses life, he said, to do good things in this world or just let someone you know, know you care about them.
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A sign is posted on the campus of Marquette University at the corner of 15th and Wells street for COVID-19 awareness and testing on Monday, Sept. 29, 2020.(Photo: Angela Peterson / Milwaukee Journal Sentinel)
Milwaukee and Madison are no longer Wisconsin's coronavirus hotspots.
As the state's outbreak balloons to one of the nation's worst, the surge of cases and hospitalizationsin Northeast Wisconsin is unlike anything the region has experienced since the pandemic began.
Green Bay and Fox Valley-area hospitals are near capacity, and local resources are strained as cases rise at a nearly exponential rate. While growth has slowed among college-aged people, that gain has been lost torapid increases among other age groups.
"We can't blame it all on college campuses," said Jeff Pothof, chief quality officer at University of Wisconsin Health.
Pothof believes that the early-September surge among young people and the outbreaks at University of Wisconsin campuses may have given people in other parts of the state a false sense of security.
"People started to think that, 'as long as I'm not in a college town and I'm not a college student, things are OK,'" he said.
Young people in college townsdo continue to report high case numbers, but the outbreak has spread beyond campus communities, according to a Milwaukee Journal Sentinel analysis.
Two weeks ago, people ages 10 to 29accounted for nearly half of new cases in the state. But last week, they made up a little more than a third.
And that age group actually reported fewer cases last week than the week prior, while middle-aged adults saw 45% to 55% more casesweek over week.
The state Department of Health Services on Monday reported 1,726 new cases and 6,159 negative tests for a positivity rate of 21.9%.
The average daily new case count over the last seven days is 2,155.On March 25, when Gov. Tony Evers' Safer at Home order went into effect, Wisconsin reported 192 new cases.
Testing is up compared to the spring the state now regularly tests more than 10,000 people a day, compared to about 1,500 a day in late March but the percentage of positive testsrarely surmounted 10% then.
The positivity rate has climbed steadily since early September, and the average over thelast seven days was 18.2%.
The state also reported two deaths, bringing the total to 1,283.
It all comes as President Donald Trump plans to hold rallies Saturday at airports in Green Bay and La Crosse an areaexperiencing the second-highest rate of infection in the country, according to a New York Times analysis. The Green Bay area has the sixth-highest rate.
Trump's airport rallies around the country have been marked by little social distancing or mask-wearing.
The outbreaks in the Green Bay, Appleton and Oshkosh areas are driven by large gatherings like weddings andparties as well as varying levels of mask-wearing, local health officials said.
Wisconsin residents may have"COVID fatigue," tired of staying home, and are choosing to attend events and socialize as normal, health officials said.
Its not the time to throw in the towel and say, 'What the heck, Im just going to live my life,'" saidChris Woleske, chief executive officer of Bellin Health.
Bellin Hospital, 744 S. Webster Ave., in Green Bay.(Photo: Sarah Kloepping/USA TODAY NETWORK-Wisconsin)
Pothof said a few large gatherings can spread the virus to hundreds of people.
Even those who live in small towns are not immune to the virus, he said the rural, northern Kewaunee and Shawano counties are reporting the highestcase ratesin the state,several times greater than Milwaukee.
"The biggest thing that needs to shift is our behaviors," Pothof said. "We really are stuck with ... the same tools we've had since March, which is masking, social distancing, good hygiene."
Much of the Midwest is seeing a surge in cases,as Minnesota,North Dakota and South Dakota join Wisconsin in outsized case growth.
In recent days, Wisconsin has been reporting higher daily case counts than the state of New York, which is three times as populousand has been seeing about 800 to 900 new cases a day. Its positivity rate is about 1%.
And Florida, in the spotlight in recent months for widespread outbreaks, is reporting an average positivity rate of just under 5%.
Cases in Wisconsinhave been swelling since early September when colleges brought students back to campus, thought to be an early explanation for the surge.
UW-Madison halted in-person classes a week into the semester after more than 1,000 students were infected, and other schools including UW-La Crosse, UW-Eau Claire and Marquette University have quarantined dorms in hopes of preventing the virus from spreading further.
But campuses are no longer the only flash points.
For weeks, Fox Valley and northeastern Wisconsin communities have been setting records and filling hospitals Appleton, Green Bay and the Oshkosh-Neenah area all fall among the top 10 metro areas in the nation where outbreaks are the worst, according to the New York Times.
The Fox Valley is at a "critical burden" level of infection, Winnebago County health officials said. The county reports about 574 cases per 100,000 residents. Milwaukee County, in comparison, reports a rate of 182.
And the growth is rapid. In Winnebago County, the 778 cases reported last week were more than double the week prior and more than five times the cases three weeks ago, according to local health officials.
Winnebago County last Thursdayrecorded 194 new cases in a single day, the highest total since the pandemic began. The city of Appleton has set a new record for weekly case counts for the fifth straight week, reporting 340 cases from Sept. 21 through Saturday.
And Brown County on Friday reported nearly 30% of tests were returned positive.
Area hospitals have begun to sound the alarm. At a news conference Friday,Woleske said COVID patients occupy three-quarters of Bellin Hospital's ICU beds and two-thirds of medical unit beds roughly double the number two weeks prior.
In the past week, Bellin's emergency room was so overwhelmed that workers had to tend to patients on gurneys in the hallway.
Coronavirushospitalizations in the Fox Valley are more than five times as high as they were a month ago. ThedaCare, which throughout the pandemic has been able to house all coronavirus patients at its Appleton hospital, is now making plans to route patients to Neenah and its critical access hospitals in Berlin, Shawano and Waupaca.
"If we dont change something ... we are back to square one, where we were back in February and March, and actually probably even somewhat worse off than at that moment in time," CEO Imran Andrabi told the Appleton Post Crescent.
Hospitals in the spring made plans to expand their capacity to treat coronavirus patients, but since then many have restarted non-emergency procedures, compounding the space issue some hospitals are now facing, Pothof said.
If trends continue, the state's health care system will face the far reaches of its capacity, he said.
"None of those plans is infinite. At some point, they all have an end-point," he said."And if you get to those end-points, that's when bad things start to happen to patients."
And as cases accelerate, one of the main tools to stop the spread gets harder to accomplish.
Multiple health departments across the state have reported that contact tracers, tasked with reaching infected people and identifying and tracking down their close contacts, have become overwhelmed by the barrage of new cases to work through.
Our goal is to reach out to all confirmed cases within 24 hours of being reported to the health department, but due to the current surge in cases we are days behind this goal, the Winnebago County Health Department wrote in a Thursday release.
Tracers in Portage County, Outagamie County and Marathon County have also reported not being able to keep up.
The key to turning around the current outbreak is getting the public to understand the severity of the virus and its widespread impact, Pothof said.
"The longer we go on, the gravity of those numbers and the historic nature of what we're going through is starting to get a little bit lost," he said, "and people are starting to go back to their normal behaviors, which unfortunately allowfor the continued spread and escalation (of the virus)."
Haley BeMiller of the Green Bay Press-Gazette contributed to this report.
Contact Sophie Carson at (414) 223-5512 or scarson@gannett.com. Follow heron Twitter at @SCarson_News.
Read or Share this story: https://www.jsonline.com/story/news/2020/09/28/wisconsin-coronavirus-green-bay-fox-valley-outbreaks-worsen/3562169001/
Overall frequency of alcohol consumption increased by about 14% from 2019, the researchers reported in the journal JAMA Network Open. That increase averages out to about one additional drinking day per month by 75% of adults.
RAND Corporation sociologist Michael Pollard and colleagues analyzed a nationally representative sample of 1,540 people ages 30 to 80. The participants completed a survey about their drinking habits between April 29 and June 9 of 2019 and then again between May 28 and June 16 of 2020.
The volunteers reported they drank alcohol on more days every week. They also reported increases in the number of drinks they had; the number of heavy drinking days; and the number of alcohol related problems over the last 30 days between 2019 and 2020.
Frequency of drinking increased by 17% among women, 19% among people aged 30 to 59 and by 10% among White people.
Heavy drinking among women increased by 41% -- about one additional day of heavy drinking for one in every five women. Nearly one in 10 women, or 39%, reported an increase in alcohol-related problems, the researchers found.
"At times of lockdown during the COVID-19 pandemic, alcohol consumption can exacerbate health vulnerability, risk-taking behaviors, mental health issues and violence," the World Health Organization said in April.
The researchers say it's important to watch for whether the increases in alcohol consumption persist over the pandemic, and whether there will be physical and mental health consequences as a result.
1. India could become the world's worst affected country
Global deaths from the pandemic have now reached more than 997,000 while global cases have risen to more than 33 million according to data from the Johns Hopkins University.
This tally of deaths is likely to rise to above 1 million shortly and the World Health Organization has warned that the pandemic may eventually cause 2 million deaths before an effective vaccine is rolled out.
Indias coronavirus cases have now topped 6 million after it reported 82,170 new infections in the last 24 hours. Infections are rising faster than anywhere else in the world.
Restrictions began to be lifted in June, despite the fact that cases have continued to rise.
Responding to the COVID-19 pandemic requires global cooperation among governments, international organizations and the business community, which is at the centre of the World Economic Forums mission as the International Organization for Public-Private Cooperation.
Since its launch on 11 March, the Forums COVID Action Platform has brought together 1,667 stakeholders from 1,106 businesses and organizations to mitigate the risk and impact of the unprecedented global health emergency that is COVID-19.
The platform is created with the support of the World Health Organization and is open to all businesses and industry groups, as well as other stakeholders, aiming to integrate and inform joint action.
As an organization, the Forum has a track record of supporting efforts to contain epidemics. In 2017, at our Annual Meeting, the Coalition for Epidemic Preparedness Innovations (CEPI) was launched bringing together experts from government, business, health, academia and civil society to accelerate the development of vaccines. CEPI is currently supporting the race to develop a vaccine against this strand of the coronavirus.
2. China acts to prevent future outbreaks
Beijing has said it will protect healthcare workers who warn of emerging health emergencies. The move comes after criticism of the treatment of medical staff in Wuhan when they first warned about a new and unknown disease at the end of 2019.
It now says it will offer a reward to health workers who alert the authorities to new threats, and will also ensure their safety and legal rights are protected.
China had reported no local infections of the coronavirus for more than a month
However, it has detected cases of the virus on imported seafood products, raising new fears that the virus could travel via refrigerated supply chains.
The rise and fall of confirmed cases.
Image: Our World in Data
3. Tighter restrictions in Europe
France, Spain and the UK are all seeing rising case numbers as winter approaches, and are imposing tighter restrictions as a result.
More than 1 million people in and around Madrid will not be able to leave their area except for school or work. And the Spanish government wants local officials to go further and impose a citywide lockdown, despite a backlash of protests against the new measures.
Nearly two-thirds of Wales population is now under lockdown, with households not allowed to mix. Elsewhere in the UK, much of the focus has been on the impact of students starting university, with thousands of students now confined to their halls of residence.
Also in Europe, the Czech Republic is becoming a new hotspot, reporting 1,305 new cases on Sunday, while Russia has reported 8,135 cases in the past 24 hours.
In a U.S. pandemic response dominated by missteps, the effort to develop vaccines to prevent Covid-19 has so far been a triumph. Vaccines against the coronavirus that causes the disease are now racing through giant clinical trials as a result.
Its a terrible irony, then, that the Trump administrations statements have resulted in an erosion of public trust, with the percent of Americans who tell pollsters they would take a Covid-19 vaccine dropping and experts worrying the president could compel the Food and Drug Administration to approve a vaccine before one is ready. (Spoiler: No vaccine will likely be ready by Election Day.)
When the the president comes out and says, by a very special day, we might have a vaccine, the whole thing blows up, Ashish Jha, the dean of the Brown School of Public Health, said at a session focused on Covid-19 at the STAT Health Tech Summit. In some ways, weve got to get the politicians to shut up and let the scientists talk about this and drive this process.
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The process of deciding when a vaccine appears to be safe and effective isnt as straightforward as the general public might believe. But its important to understand it if we are to have confidence in these critical tools for helping to curb the pandemic.
Here, then, is a rundown of the science that goes into the decision-making process, what it tells us about when results could realistically be available, and when vaccines could start to be administered. This story is based on interviews as well as on documents the drug makers have released detailing their clinical trial plans.
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A clinical trial is typically sponsored by a company making a vaccine candidate or an academic institution, or a partnership of both. But it is actually monitored by what is known as a data and safety monitoring board, or DSMB, a group of independent experts hired to make sure volunteers in the study are safe. In many studies, the DSMB has the ability to recommend stopping a study not only if a treatment is unsafe, but also if it is so clearly effective that continuing just wouldnt be ethical.
In the case of the vaccine trials, the studies being run by Moderna, AstraZeneca, and Johnson & Johnson with the National Institutes of Health share a common DSMB. The study being run by Pfizer and its partner BioNTech has its own.
The DSMBs will conduct whats called an interim analysis after a certain number of people have been infected with Covid-19 and shown symptoms. Each of these cases is considered an event, and each vaccine maker has set a different number of events as a threshold to conduct an interim analysis as part of their trial protocols.
The study being run by Pfizer and its partner BioNTech, frontrunners in the race for a vaccine, is conducting its first interim analysis after 32 events, and would consider the vaccine effective if 26 people in the placebo group and six in its vaccine group had Covid. A study of Modernas vaccine, another frontrunner, is waiting until there are 53 cases of Covid.
In the case of Pfizer and BioNTech, an interim analysis could happen in October.
Should a vaccine be approved, potentially for millions of people, after its efficacy has been shown based on 32 cases of Covid-19?
Some experts say no. Eric Topol, the director of the Scripps Research Translational Institute, has been fervently saying that all the trials should continue beyond even their designed ends when there are about 150 cases of Covid saying that even the 150 number may make statistical sense, but it defies common sense. This could be particularly true if efficacy is limited, given that all the vaccines frequently cause side effects like fever.
Others say that while making a decision based on an interim analysis is fine, the first Pfizer analysis, in particular, seems to set a relatively low bar for efficacy given the small number of events.
The numbers are in line with past vaccine studies. Prevnar 13 was approved to prevent pneumonia in adults based on a study of 84,000 people that detected 139 cases of pneumonia, 90 of them in the placebo group.
But theres also a precedent for keeping such studies going to collect more safety data. Researchers studying RotaTeq, a vaccine to prevent a virus that causes childhood diarrhea, collected data from 70,000 patients to rule out a potential side effect which had been seen with a previous vaccine.
If and when a company believes its vaccine is safe and effective, it will then submit its data to the Food and Drug Administration.
No Covid-19 vaccine is likely to be fully approved by the FDA in the near term, because of requirements for manufacturing and follow-up that could take years. The FDA is expected instead to use a different authority by granting what is known as an emergency use authorization, or EUA.
The bar for an EUA is low, and past EUAs have seemed unwise in hindsight. A drug, peramivir, was authorized on an emergency basis to treat hospitalized patients during the H1N1 swine flu in 2009; the drug later failed to be shown effective in a clinical trial of such patients. Hydroxychloroquine was given an EUA to treat Covid-19 in hospitalized patients; that authorization was later rescinded once further study showed the drug did not benefit them. The EUA for convalescent plasma involved data that would never pass muster for an approval. These later examples are precisely why many experts are so worried that the FDAs decision-making is politicized.
The challenge for the FDA will be to make sure that it brings its usual standards for a vaccine to the much more flexible emergency use authorization process.
Reviewing data on a drug candidate normally takes a year, six months if it is fast, and three months at the fastest. Even a truncated review should take weeks. So even if data on Pfizers vaccine are available in mid-October, an emergency authorization by Election Day is difficult to imagine. The same is true if data emerge from one of the studies of AstraZenecas vaccine being conducted outside the U.S.
That assumes, of course, that politics are not at play.
In the interim analyses that most people who follow medicine are used to, as soon as there is a clear result, the trial stops. But the plan for Covid-19 vaccines is different: Data from an interim analysis may be released if a vaccine is deemed inarguably effective but volunteers may not be immediately told whether they are receiving vaccine or placebo. In other words, the study will remain blinded. Participants receiving a placebo will not be switched immediately to the vaccine.
The protocol is designed in a way that even if we would be able to file after an interim analysis, the protocol is designed to move on, at least for a certain amount of time, said Kathrin Jansen, Pfizers head of vaccine research, on a recent call with reporters. The reason is that there is a need to assess efficacy in smaller groups, such as teenagers, the elderly, and people with HIV, she said. Jansen said that Pfizer and BioNTech hope to gather information about severe infection, too.
Keeping a trial going after an interim analysis can be difficult, so much so that Thomas Fleming, one of the top minds in clinical trial statistics, co-authored a 2008 paper on why it should be avoided.
In a conference call with reporters to discuss the start of the study for Johnson & Johnsons vaccine, Anthony Fauci, who heads research on infectious disease at the NIH, said that the other trials will continue in a blinded fashion until half the volunteers in the study have been followed for at least two months, in order to collect more data on efficacy and safety.
The J&J study requires only 20 cases of Covid-19 before an interim analysis is conducted. But Paul Stoffels, Johnson & Johnsons chief scientific officer, told STAT that his company will wait to even conduct an interim analysis until after half the participants in its 60,000-volunteer study, started this month, have been followed for two months. Such an analysis will also require enough data in other populations, including the elderly. After the data are interpreted, the DSMB might recommend stopping the study.
Generating enough data is also where we take our responsibility, because in the end we will be liable for the product getting into the market, Stoffels said.
You know, we go from a thousand people, to 60,000, to probably 100 million to 500 million people, Stoffels said. The information we generate has to be very solid.
Thats the point that regulators and, especially, politicians need to remember no matter how eager they are to have a vaccine in hand.
Scientist Drew Weissman's research is the basis for several vaccines being developed to fight the pandemic.
It is no exaggeration to say that Drew Weissman '81, MS '81, is among a handful of scientists whose research may save the world from COVID-19.
Now his findings and the system he developed for delivering mRNA into cells underpin two of the most promising candidates for a coronavirus vaccine, one being developed by Pfizer and BioNTech and the other by Moderna.
Drew Weissman
Weissman, a professor of medicine at the Perelman School of Medicine at the University of Pennsylvania, is also working with the government of Thailand on a COVID-19 vaccine for the developing world. It is expected to be more affordable and easier-to-produce than the vaccines being created by drug companies.
A biochemistry major at Brandeis, Weissman worked in professor Gerald Fasmans lab.
"He definitely gave me insights on how to develop hypotheses how to think about them, how to develop new lines of research," said Weissman, who wrote his master's thesis on acetylation of DNA, part of the process of gene regulation.
Messenger molecules, mRNA transport instructions from DNA to the ribosomes in our cells for the production of proteins.
In a traditional chickenpox, polio, flu or rabies vaccine, a weakened or killed version of the virus is injected, fooling the immune system into fighting the disease.
But manufacturing a virus is a lot more expensive than synthesizing mRNA. And it isnt necessary to create an entirely new vaccine for each disease using mRNA since the mRNA can be reprogrammed to fight the target illness.
Many researchers gave up on mRNA, but Weissman and Karik persisted. "We were getting interesting results, so they just kept leading us on," Weissman said.
They replaced one of mRNAs four chemical building blocks, a nucleoside called uridine, with a slightly modified nucleoside called pseudouridine. This enabled the mRNA to skirt the body's immune system.
In the late 2010s came several more major breakthroughs. The researchers used mRNA to immunize mice against genital herpes (which is caused by the herpes simplex virus), influenza, Zika and HIV.
If it works, a COVID-19 mRNA vaccine will spur human cells to produce the spike-shaped protein found on SARS-CoV-2, the virus that causes the illness, and will trigger the immune system to produce protective antibodies.
Weissman is now focusing on an even more ambitious project developing a vaccine for all coronaviruses. Besides SARS-CoV-2, two other lethal varieties of coronavirus SARS and MERS have spread among humans in recent years.
At least one late-stage clinical trial will likely provide data to support the safety and efficacy of an emerging coronavirus disease 2019 (COVID-19) vaccine candidate by the end of this year, but there are concerns that the lack of long-term safety data and the rush to approve a vaccine before November could pose potential health risks to the public.
This is according to Barry Bloom, Ph.D., research professor of public health and former dean at the Harvard T.H. Chan School of Public Health, who participated in an online forum titled The Coronavirus Pandemic: Global Race for a Vaccine held September 15.
Even if results are able to support an emergency use authorization (EUA) for a COVID-19 vaccine by the end of 2020, Bloom noted, there will be a limited supply. Manufacturers, he argued, do not currently have the capacity to produce all the vaccines necessary for the U.S and the world at large.
By January 2nd, there will not be enough vaccines to protect everybody, and that leads to some critical decisions of who will be prioritized to get the first vaccines, Bloom said.
Forum moderator Michele Gershberg, the U.S. health editor for Reuters, asked Bloom whether it was realistic for a potential COVID-19 vaccine, once proven safe and effective in Phase III trials, could be considered or authorized for some people by as early as October 2020. Bloom responded that the decision as to whether a vaccine is protective and safe will depend on the studys statistical data.
Gershberg also asked Bloom about pauses in COVID-19 trials, for which he responded: It is unlikely that I think a vaccine will be so spectacular that there would be reason to stop the trial, but I would point out the pause in one of the vaccine trials from AstraZeneca was because of two patients that had potential serious adverse effects.
This response was in reference to AstraZenecas decision earlier this month to pause a U.K. trial studying COVID-19 vaccine candidate AZD1222. While the company has since resumed the trial, it hasnt yet released specifics on the adverse effects the two patients experienced.
Now we know generally in clinical trials [that] this information does not have to be disclosed to the public, but I'm wondering under these circumstances, with everybody watching this race so closely, do you think that vaccine developers should think a little bit more differently about how quickly they disclose issues like this for the sake of transparency? Gershberg asked.
Bloom responded that most late-stage trials, including those which enroll up to 30,000 people or more, expect to see at least one adverse event during the study period. Likewise, making interim data available during a non-pandemic era isnt mandatory or always considered. This is a very special situation, he added, in which every country in the world (and their political parties) are involved in the COVID-19 vaccine race.
I think your point is well-taken that the companies and the government should be as transparent as possible, [while] still protecting individual personal privacy and rights, to tell what they know at the earliest possible point, he said.
When asked about the lack of U.S. involvement in a World Health Organization (WHO) initiative to raise money to create an equitable distribution network of vaccines around the world, Bloom noted that it is very sad to see the U.S. withdraw from the WHO at exactly the time in the middle of a unique pandemic [and] when developing countries that do not have the capacity for the science or developing industrial production of vaccines are increasingly vulnerable and not willing to have us participate in a formal way.
The U.S. has been seen as the leader in global health, the leader in science, the leader in the commitment of science for the benefit of people around the world, Bloom added. We have withdrawn from that role, and I think that's bad for the U.S. and certainly not good for the people in low- and middle-income countries.
Gershberg proceeded to ask Bloom about the potential of a government granting an EUA for a COVID-19 vaccine in children prior to adequate testing being conducted. Bloom responded that this will be highly unlikely considering most trials are restricted to adults and people with the highest risk of COVID-19-related mortality are over the age of 60.
I would hope if the results [of adult COVID-19 studies] are so spectacularly clear that the injuries are minor that there will be studies immediately after approvals to show that it's safe in children, he said. We're lucky with COVID-19 in that children seem to be the most resistant to the adverse, serious consequences of hospitalization and death of any age group, so they're not the most vulnerable which they would be for many other infectious diseases.
Bloom added that COVID-19 vaccines will likely face opposition by some groups of people.
The first anti-vaccine organized society was in 1886, and it has persisted in many, many vaccines that were developed after smallpox, he said. There's always been a small group who preserve and fight for their independence to make decisions, rather than believe it's worth the public good to have everybody protected.
Whats different now, he suggested, is that social media has provided these groups a pervasive platform capable of spreading disinformation and misinformation on a more massive scale.
And we now know from other countries [that] misinformationmakes it only more difficult for people to get the information they need to make a decision, he added.
Despite the possible backlash, Bloom stated he and his colleagues in the scientific community are optimistic that several of these vaccines, and there are many more behind them, are going to be found to be safe and effective and be made available. He estimated that approximately 5.6 billion doses will be required for the world population, or 200 to 250 million for the U.S.
As scientists around the world race to find a vaccine for COVID-19 and even a cure, a drug heavily pushed by the president doesnt seem to be a front runner.
Back in March, we met an infectious disease doctor from North Dakota on the frontlines looking for a cure to coronavirus, studying the drug hydroxychloroquine and its effects on people that contract the virus.
Since March we completed two randomized controlled trials. One was hydroxychloroquine being able to treat COVID-19 disease and the other was looking at hydroxychloroquine as post-exposure prophylaxis, meaning trying to prevent developing disease after getting exposed, said Dr. Caleb Skipper, University of Minnesota.
President Donald Trump has been a long time supporter of the drug, even after some of the countries top health experts said otherwise, like Dr. Anthony Fauci.
Hydroxy has tremendous support, but politically its toxic because I supported it. If I would have said, Do not use hydroxychloroquine under any circumstances, they would have come out and they would have said, Its a great its a great thing,' said Trump.
Dr. Fauci recently shared that a study using hydroxychloroquine at The Henry Ford Hospital, and many others have not shown success. The same is for Dr. Skipper and his team at the University of Minnesota.
Dr. Skipper added, Both trials found essentially the same thing. Hydroxychloroquine was not able to effectively either prevent the progression of the disease, compared to placebo or prevent disease after exposure.
Dr. Skipper says that doesnt mean the drug cant be used to fight the virus at all, just not on a universal scale. Instead, it may be effective in certain populations, like healthcare workers who could take the drug and it would prevent them from ever getting it.
He says although they werent able to find a cure, others are working hard for vaccines to end the pandemic.
Dr. Skipper says other medications are being looked at that could cure COVID-19.
