They involve thousands, or even tens of thousands, of participants, and typically go on for years. The chances that one or more of these study volunteers will develop a health issue is quite high.
Most of the time, that health problem is not related to the vaccine being investigated, and the trial can continue. But sometimes there is a chance that the issue — called an “adverse event” in medical parlance — could be related to the vaccine.
In that case, the trial is paused so the incident can be investigated.
On Wednesday, it came to light that pharmaceutical giant AstraZeneca had paused its coronavirus vaccine trial not once but twice because of adverse events. The second pause is still in effect while researchers look into one volunteer’s “unexplained illness.”
While Dr. Robert Redfield, director of the US Centers for Disease Control and Prevention, on Wednesday implied that pausing a Phase 3 trial was a somewhat common occurrence, vaccine trial experts interviewed by CNN say it is not common.
“It’s unusual to pause a Phase 3 trial on a safety basis,” said Dr. Carl Fichtenbaum, an infectious disease expert at the University of Cincinnati College of Medicine. “It’s uncommon.”
One trial, two pauses
AstraZeneca is one of three companies in the US currently in Phase 3 trials for a coronavirus vaccine. Each trial is aiming to enroll 30,000 people; half will get the vaccine and half will get a placebo, which is a shot of saline that does nothing.
“With that many people, it’s inevitable that someone, at some point, will get sick,” said Dr. Robert Frenck, director of the Vaccine Research Center at Cincinnati Children’s Hospital.
Carrie Wolinetz, associate director for science policy at the National Institutes of Health, agrees. “Adverse events happen in the normal course of very large trials. It’s really a matter of determining whether it’s a coincidental event or was it really something linked to the trial itself,” she said.
The coronavirus vaccine trials are what’s called “double blind,” so when someone gets sick, neither the participants nor the doctors know if they received the vaccine or the placebo.
The only people who know are members of the trial’s Data Safety and Monitoring Board — an external group of experts that monitors the trial.
Each trial has its own protocol, but when an illness arises that causes concern, the DSMB will see if the volunteer received the vaccine or a placebo.
If the volunteer received the vaccine, then the questions begin. If it’s believed that the illness might possibly be related to the vaccine, the DSMB might recommend that the trial pause while the illness is investigated.
After investigating, the DSMB might recommend that the trial continue as before, or it might suggest a change in the trial protocol, or it could recommend that the trial be shut down.
“It’s unfortunate that it happened. Hopefully they’ll work it out and be able to proceed along with the remainder of the trial, but you don’t know. They need to investigate it further,” Fauci said.
Hitting the pause button
Redfield said Wednesday that in his research, he at times had to put trials on hold.
“I’ve conducted a number of clinical trials in my days, both at Walter Reed [National Military Medical Center] and University of Maryland, of which I had the trial put on hold because of adverse reactions until we could evaluate whether that adverse reaction was something that was associated with the investigational product, and if so, was it serious enough that we then had to stop the trial,” Redfield said at an online forum held by Research!America.
Redfield did not specify whether he meant vaccine trials, nor did he specify whether he meant Phase 3 trials or trials in earlier phases, which can be more prone to adverse events because the vaccine hasn’t been as well tested.
CNN reached out to a spokesperson for Redfield for clarification, but they did not provide a comment.
Illnesses that necessitate a pause don’t occur very often, according to three vaccinologists — Frenck, Fichtenbaum and Dr. Saad Omer — who, combined, have worked on more than 100 vaccine trials.
“In Phase 3, it’s uncommon to have a pause,” Frenck said. “I’ve seen it happen a few times.”
He estimates that pauses in Phase 3 trials due to a study subject becoming ill happens “in under 10% of trials — probably under 5%.”
According to Fichtenbaum, “Phase 3 trials don’t typically pause. I’ve only seen it handful of times in my experience.”
Both Fichtenbaum and Frenck have served on DSMBs. Additionally, Frenck is a researcher in both the AstraZeneca and Pfizer coronavirus vaccine trials, and Fichtenbaum is an investigator in the Moderna coronavirus vaccine trial.
Omer is director of the Yale Institute for Global Health and has been the principal investigator in several vaccine trials.
“It’s not unheard of that a trial has paused. It’s a very real possibility,” he said. “But I wouldn’t call it common.”
Confusion about the cause of AstraZeneca’s most recent pause
“Reports claiming to be based on comments made earlier today by our CEO stating that we have confirmed that a participant in our clinical trial suffered from transverse myelitis are incorrect. He stated that there is no final diagnosis and that there will not be one until more tests are carried out,” a spokesperson for the pharmaceutical giant said in a statement emailed to CNN.
“Those tests will be delivered to an independent safety committee that will review the event and establish a final diagnosis,” the spokesperson added.
While AstraZeneca didn’t specify what the issue was, at a Congressional hearing Wednesday, NIH Director Dr. Francis Collins said the AstraZeneca hold was due to a “spinal cord problem.”
“With an abundance of caution, at a time like this, you put a clinical hold. You investigate carefully to see if anybody else who received that vaccine or any of the other vaccines might have had a similar finding of a spinal cord problem,” Collins explained.
He added that “this ought to be reassuring to everybody listening,” as this shows the “focus first on safety.”
Coronavirus may disrupt lives until next year, Fauci says
“If you’re talking about getting back to a degree of normality which resembles where we were prior to Covid, it’s going to be well into 2021, maybe even towards the end of 2021,” Fauci said Friday.
A vaccine will help, but there are caveats, Fauci said in a series of interviews Friday.
Fauci has said repeatedly that it’s possible at least one of the vaccines being tested could get emergency authorization from the US Food and Drug Administration by the end of this year or early next year. But it won’t be available to everyone immediately.
“By the time you mobilize the distribution of the vaccinations, and you get the majority, or more, of the population vaccinated and protected, that’s likely not going to happen to the mid or end of 2021,” he told MSNBC’s Andrea Mitchell.
One stumbling block — keeping the vaccines cold. Most of the experimental coronavirus vaccines must be kept frozen.
Speaking during a Friends of the Global Fight webinar earlier on Friday, Fauci said, “One of the things that’s always an issue is the cold storage issue, and the ‘cold chain’ that is so often required.”
Plus, people are not always doing what they should do to control the spread of the virus, even now, Fauci said.
“When you’re dealing with a situation that requires behavioral change, we in the United States have a significant issue that I’m very disappointed in,” Fauci said during the webinar.
“It was stunning to me … that in some states and cities and counties, you would see television clips of people crowded indoors at bars, which is a superspreading event if you ever saw it.”
Young people may think they are not going to get dangerously ill, and get careless, Fauci said.
“But what they forget is their societal responsibility to not propagate the outbreak because if they get infected, they’re likely going to infect someone else who then might infect someone who really is vulnerable and will have a serious severe consequence.”
And people are spreading misinformation, making the virus even harder to fight.
“The one thing that bothers me is the amount of things that aren’t evidence-based, and we’ve seen examples of that in the United States like claims that certain drugs have a great positive effect when there’s no scientific evidence whatsoever that they have a positive effect,” Fauci said.
“And yet it gets ingrained and I and my colleagues have to spend a lot of time trying to debunk that. And you’re in the middle of a pandemic and you’re trying hard to address all the appropriate issues, it is truly a waste of time to have to debunk nonsense.”
Fauci also cautioned that just because coronaviruses are in the spotlight, people should not forget the flu.
“The one thing I’ve learned throughout the years is don’t put anything past the flu — don’t take anything for granted,” he said during the MSNBC interview.
There “a hint of potential good news” when it comes to flu season. In Australia, where the flu season just ended, “They have had the lightest flu season in memory — which most people think is because they’re doing things to prevent SARS-CoV2 infection with masks, distancing, avoiding crowds, outdoor more than indoor. That what they’ve done as a secondary offshoot of that is they brought down the level of influenza cases, very, very low,” he said.
He added that if Americans can do this, he’s optimistic the country will have a light flu season too.
Wildfire smoke and your health: Do you need to worry?
Firefighters look out over a burning hillside as they fight the Blue Ridge Fire in Yorba Linda, California, on Monday, October 26.
A man evacuates his home as flames from the Blue Ridge Fire approach in Chino Hills, California, on Tuesday, October 27.
Firefighters conduct a backfire operation in Chino Hills on October 27.
A firefighter uses a hose as the Silverado Fire approaches near Irvine, California.
Firefighter Raymond Vasquez battles the Silverado Fire in Irvine on Monday, October 26.
Flames rise from mountain ridges near a farmstead as a wildfire burns near Granby, Colorado, on Thursday, October 22.
Evacuees drive through a traffic jam exiting Big Thompson Canyon as the East Troublesome Fire forced residents out of Estes Park, Colorado, on October 22.
Structures burned by the Cal-Wood Fire are seen in Boulder County, Colorado, on October 18.
Flames from the Cameron Peak Fire, the largest wildfire in Colorado history, work their way along a ridge outside Estes Park on October 16.
An airplane drops fire retardant on the Bruder Fire in Redlands, California, on October 15.
A firefighter walks along a path as the Glass Fire burns in Calistoga, California, on October 1.
Vehicles burned in the Glass Fire sit outside of a home that survived in Calistoga on September 30.
The remains of guest houses smolder at Calistoga Ranch after the Glass Fire passed through on September 30.
Firefighter Abraham Garcia signals a water truck in Angwin, California, on September 29.
Firefighters watch the Glass Fire slowly creep across a clearing near Calistoga on September 29.
Damaged wine barrels sit stacked at the Fairwinds Estate Winery in Calistoga on September 29.
The Glass Fire burns in the background as Josh Asbury, an employee of CableCom, installs fiber-optic cable in Calistoga on September 28.
Residents of the Oakmont Gardens senior home are transported to safety as the Shady Fire approaches in Santa Rosa on September 28.
Cellar worker Jose Juan Perez extinguishes hotspots at Castello di Amorosa, a Calistoga winery that was damaged in the Glass Fire.
An officer with Napa County Animal Control rescues a cat after the Glass Fire passed through Napa Valley, California, on September 28.
The Glass Fire burns on a Napa County mountainside on September 28.
Flames from the Glass Fire consume the Black Rock Inn in St. Helena, California, on September 27.
Embers fly from a tree as the Glass Fire burns in St. Helena on September 27.
An air tanker drops fire retardant on the Glass Fire, which was burning near the Davis Estates winery in Calistoga on September 27.
Cal Fire Capt. Jesse Campbell works to save the Louis Stralla Water Treatment Plant as the Glass Fire burns in St. Helena.
A photograph of Charles Morton, a firefighter killed battling the El Dorado Fire, is displayed at a memorial service in San Bernardino, California, on September 25. Morton, 39, was a 14-year veteran of the US Forest Service and a squad boss with the Big Bear Hotshot Crew of the San Bernardino National Forest.
An inmate firefighter takes a break while working to contain the Bear Fire in Oroville, California, on September 24.
Inmate firefighters extinguish hot spots while working to contain the Bear Fire on September 24.
The Bobcat Fire burns near Cedar Springs, California, on September 21.
Wildfire smoke rises in Medicine Bow National Forest in southeastern Wyoming on September 21.
A deer looks for food in an area burned by the Bobcat Fire in Pearblossom, California.
A woman takes photos as the Bobcat Fire burns in Juniper Hills, California, on September 18.
Wind whips embers from Joshua trees burned by the Bobcat Fire in Juniper Hills on September 18.
Firefighter Kirk McDusky walks past smoke rising from the Brattain Fire in Paisley, Oregon, on September 18.
A Juniper Hills home burns during the Bobcat Fire on September 18.
A firefighter battles the Bobcat Fire while defending the Mount Wilson observatory in Los Angeles on September 17.
Stacey Kahny fixes her hair inside her tent at the evacuation center at the Jackson County Fairgrounds in Central Point, Oregon, on September 16. Kahny lived with her parents at a trailer park in Phoenix, Oregon, that was destroyed by fire.
A charred yearbook lies in the debris as Fred Skaff and his son Thomas clean up their home in Phoenix, Oregon, on September 16.
In this aerial photo taken with a drone, red fire retardant sits on leveled homes in Talent, Oregon, on September 15.
A firefighter works at the scene of the Bobcat Fire burning on hillsides near Monrovia, California, on September 15.
President Donald Trump listens as California Gov. Gavin Newsom speaks about the wildfires during a briefing on September 14.
George Coble walks through his destroyed property in Mill City, Oregon, on September 12.
The Bobcat Fire burns in Angeles National Forest, north of Monrovia, California, on September 11.
Crystal Sparks kisses her 4-year-old twins, Chance and Ryder Sutton, as they escape the Obenchain Fire in Butte Falls, Oregon, on September 11.
North Valley Disaster Group member Kari Zeitler and Butte County Animal Control officer Linda Newman bridle up two donkeys wandering along a roadside in Berry Creek, California, on September 11. The donkeys were displaced by the Bear Fire.
A firefighter shoots an incendiary device during a back burn to help control the Dolan Fire in Big Sur, California, on September 11.
Dora Negrete is consoled by her son Hector Rocha after seeing their destroyed mobile home in Talent, Oregon, on September 10.
This aerial photo shows a destroyed mobile-home park in Phoenix, Oregon, on September 10.
A street is shrouded by smoke from wildfires in West Linn, Oregon, on September 10.
A tanker jet drops fire retardant to slow the Bobcat Fire in the Angeles National Forest north of Monrovia, California, on September 10.
Looking up San Francisco’s Columbus Avenue, the Transamerica Pyramid and Salesforce Tower are covered with smoke from nearby wildfires on September 9. This photo was taken in the late morning.
Wildfire smoke hangs over the San Francisco-Oakland Bay Bridge on September 9.
Bejhan Razi, a senior building inspector in Mill Valley, California, checks out repairs on a lamp-post clock as the sky is illuminated by nearby wildfires.
People stand in Alamo Square Park as smoke hangs over San Francisco on September 9.
People stop to take pictures of the Golden Gate Bridge as it is affected from smoke by nearby wildfires on September 9.
Firefighters cut defensive lines and light backfires to protect structures in Butte County, California, on September 9.
Flames shoot from a home in Butte County.
A Pacific Gas and Electric worker looks up at the advancing Creek Fire near Alder Springs, California, on September 8.
Lisa Theis unloads the last of her 44 alpacas after she evacuated her ranch in North Fork, California.
Flames burn at a home leveled by the Creek Fire in Fresno County, California.
A slide is melted at a school playground in Fresno County.
Firefighter Nick Grinstead battles the Creek Fire in Shaver Lake, California, on September 7.
A firefighter in Jamul, California, battles the Valley Fire on September 6.
A fire encroaches Japatul Road in Jamul on September 6.
Little League baseball players warm up for a game near Dehesa, California, as the Valley Fire burns on September 6.
A firefighter watches the advancing Creek Fire in Shaver Lake.
A business owner in Shaver Lake walks next to kayaks he rents as smoke from the Creek Fire fills the sky on September 6.
Family members comfort each other as the El Dorado Fire moves closer to their home in Yucaipa, California, on September 6.
A firefighter sets a controlled burn with a drip torch while fighting the Creek Fire in Shaver Lake.
Dozens of evacuees are airlifted to safety on a California National Guard helicopter on September 5. The Creek Fire had left them stranded in a popular camping area in the Sierra National Forest.
Firefighters walk in a line in Yucaipa on September 5.
Haze and smoke blanket the sky near Naches, Washington, as the Evans Canyon Fire burns on September 3.
California Gov. Gavin Newsom, right, listens as Santa Cruz State Park Superintendent Chris Spohrer talks about the fire damage to the Big Basin Redwoods State Park.
Randy Hunt packs up his belongings, including his daughter Natasha’s first Pooh bear, left, in case he and his wife Sheli had to evacuate the home they rent in Middletown, California, on August 26.
Firefighter Juan Chavarin pulls down a burning tree trunk in Guerneville, California, on August 25.
A sign reading “Vaca Strong” adorns a charred hillside in Vacaville, California, on August 24.
Austin Giannuzzi cries while embracing relatives at the burned remains of their Vacaville home on August 23.
A firefighter looks out from a helicopter while battling the LNU Lightning Complex fires in Lake County, California.
Flames from the LNU Lightning Complex fires leap above Butts Canyon Road in Lake County on August 23.
Karol Markowski of the South Pasadena Fire Department hoses down hot spots while battling the CZU Lightning Complex fires in Boulder Creek, California, on August 22.
A burned-out vehicle is left in front of a destroyed residence as smoke fills the sky in Boulder Creek on August 22.
Smoke hangs low in the air at the Big Basin Redwoods State Park as some redwoods burn in Boulder Creek on August 22.
A firefighter watches the LNU Lightning Complex fires spread through the Berryessa Estates neighborhood in Napa County on August 21.
Veterinary technician Brianna Jeter comforts a llama injured by a fire in Vacaville on August 21. At right, animal control officer Dae Kim prepares to euthanize the llama.
Smoke from nearby wildfires hangs over San Francisco on August 21.
A firefighter monitors the advance of a fire in Boulder Creek on August 21.
Members of the US Forest Service discuss their next moves to battle the Grizzly Creek Fire near Dotsero, Colorado, on August 21.
People pack brown-bag lunches at an evacuation center in Santa Cruz, California, on August 21.
A smoke plume from the LNU Lightning Complex fires billows over Healdsburg, California, on August 20.
A firefighter battles flames in Santa Cruz County, California, on August 20.
Only scorched homes and vehicles remain in the Spanish Flat Mobile Villa in Napa County, California, on August 20.
Peter Koleckar reacts after seeing multiple homes burned in his neighborhood in Bonny Doon, California, on August 20.
A forest burns in Bonny Doon on August 20.
A man looks at a tree blocking his way after a fire ravaged Vacaville, California, on August 20.
A melted plastic fence lies on the charred ground after fire swept through Vacaville on August 20.
Sarah Hawkins searches through rubble after her Vacaville home was destroyed on August 20.
Fire crews maintain a backburn to control the River Fire near the Las Palmas neighborhood in Salinas, California, on August 19.
Gina Santos cries in her car after evacuating Vacaville on August 19.
People herd cows down Pleasants Valley Road in Vacaville on August 19.
Flames consume a home in Napa County, California, on August 19.
Embers burn along a hillside above Lake Berryessa as the LNU Lightning Complex fires tear through Napa County on August 18. This image was taken with a long exposure.
A resident runs into a home to save a dog while flames from the Hennessy Fire close in near Lake Berryessa on August 18.
A home burns as the LNU Lightning Complex fires tear through the Spanish Flat community in Napa County on August 18.
An air tanker drops retardant on fires in the Spanish Flat community of Napa County on August 18.
Flames from the Hennessy Fire consume a cabin at the Nichelini Family Winery in Napa County on August 18.
Tony Leonardini works on a spot fire as thunderstorm winds fan the Hennessy Fire in Napa County on August 17.
Smoke from the Grizzly Creek Fire is thick in Glenwood Canyon, near Glenwood Springs, Colorado, on August 16.
Kathy Mathison looks at the still-smoldering wildfire on August 16 that, just a day before, came within several feet of her home in Bend, Oregon.
Firefighters look at smoke and flames rising from the Ranch2 Fire in the San Gabriel Mountains, east of Los Angeles, on August 14.
A helicopter makes a water drop over the Ranch2 Fire in Azusa, California, on August 13.
A car is charred by the Lake Fire near Lake Hughes, 60 miles north of Los Angeles, on August 13.
A couple watches the Ranch2 Fire from a distance on August 13.
A firefighter crew works in Lake Hughes on August 13.
The Lake Fire burns a home in Angeles National Forest on August 13.
Flames and smoke from the Lake Fire rise on Wednesday, August 12.
A firefighter works against the Lake Fire on August 12.
Firefighters make an escape plan as the Lake Fire burns a hillside on August 12.
A tanker makes a drop on the Lake Fire on August 12.
A plume of smoke rises from the Lake Fire on August 12.
Fire crews battle the Grizzly Creek Fire near Glenwood Springs, Colorado, on August 11.
US coronavirus: Nation could see a ‘very deadly December’ with tens of thousands of coronavirus death to come, model predicts
A possible scenario sees 415,090 Covid-19 deaths by January, the Institute for Health Metrics and Evaluation (IHME) at the University of Washington says in its latest forecast. The worst-case scenario is 600,000 deaths by January 1.
“When we look ahead into the winter with seasonality kicking in, people becoming clearly less vigilant, you know mask use is down, mobility is up in the nation, you put all those together and we look like we’re going to have a very deadly December ahead of us in terms of toll of coronavirus,” IHME director Dr. Christopher Murray told CNN’s Anderson Cooper.
“I really do believe we’re rounding the corner and the vaccines are right there, but not even discussing vaccines and not discussing therapeutics, we’re rounding the corner,” Trump said.
Speaking with MSNBC’s Andrea Mitchell on Friday, Dr. Anthony Fauci said he does not agree with the President’s statements.
“We’re plateauing at around 40,000 cases a day, and the deaths of around 1,000,” said Fauci, the director of the National Institute of Allergy and Infectious Diseases.
He said test positivity is increasing in some regions of the country and people are spending more time indoors because of cooler weather.
“That’s not good for a respiratory-borne virus,” he said. “You don’t want to start off already with a baseline that’s so high.”
“We’re in a very politically-charged atmosphere now and whenever you’re trying to get people all together singing from the same tune and doing the same things as a society, unified against this common enemy — this virus — it’s very difficult to do that when you have such a charged atmosphere that we have right now,” Fauci told CNN’s Wolf Blitzer Friday. “And that really is truly unfortunate.”
Fauci warned that the country needs to get the levels down lower “so that when you go into a more precarious situation, like the fall and the winter, you won’t have a situation where you really are at a disadvantage right from the very beginning.”
US may not return to normal until 2021, Fauci says
The US might not return to pre-coronavirus life until the end of next year, Fauci said, but he is cautiously optimistic the US will have a vaccine by the end of this year.
“But it’s not going to be turning a switch off and turning the switch on. It’s going to be gradual and I think it’s going to take several months before we get to the point where we can really feel something that approximates how it was normally before Covid-19,” he said.
There’s also the issue of how many doses of the vaccine will be available and how long it takes to distribute the vaccine.
“It’s going to take several months to get the country safe and vaccinated,” Fauci said.
“We need to hunker down and get through this fall and winter because it’s not going to be easy,” Fauci said.
“I keep looking at that curve and I get more depressed and more depressed about the fact that we never really get down to the baseline that I’d like,” he said.
As the weather gets colder, Americans will move indoors more, where the virus spreads more easily.
Where we stand now
Across the US, 28 states are reporting downward trends — including Florida and California — compared to the previous week, and 14 are steady.
An ensemble forecast from the CDC now projects that between 205,000 and 217,000 people in the US will die by October 3.
Medical experts also worry about the upcoming flu season. Fauci told CNN Friday the CDC recommended people getting their flu vaccines by October 31.
“What we’re hoping for — and I hope this happens — is that a combination of people getting vaccinated against the flu and the fact that the very public health measures that they implement to avoid coronavirus will actually help them avoid influenza,” Fauci said.
Fauci also recommended people “hunker down” for the fall and winter, but he says that does not mean shutting down the country again.
“We don’t need to shut down, we can do this if we pull together and abide by relatively simple and understandable public health measures,” Fauci said, adding that the measures include social distancing, wearing masks and avoiding crowds.
Non-symptomatic children can transmit virus, data show
Even children with mild or no symptoms can transmit Covid-19, according to contact tracing data from three Utah child care facilities released Friday.
Researchers said 12 children got Covid-19 in a child care location and transmitted it to at least 12 people outside, including household members.
They analyzed contact tracing data from 184 people with links to three child care centers in Salt Lake County from this April to July.
They found at least two children who had no symptoms not only had caught the virus but passed it to other people, including one mother who was hospitalized. One 8-month-old child spread the virus to both parents.
The researchers say that two of the facility outbreaks began with staff members who had household contacts with the virus.
Overall, children accounted for 13 of the 31 confirmed Covid-19 case linked to the facility, and all of the children had mild or no symptoms.
Infected college students shouldn’t be sent home
The University of Texas at Austin announced this week three confirmed clusters on campus which collectively account for about 100 cases. San Diego State University confirmed almost 400 infections among students, after announcing a halt on in-person instruction.
And more than 1,300 Arizona State University students have tested positive since August 1.
Colleges and universities should try to isolate infected students instead of sending them home, Fauci has said.
“You send them back to their community, you will in essence be reseeding with individuals who are capable of transmitting infection, many communities throughout the country,” he said earlier this week.
“So it’s much, much better to have the capability to put them in a place where they could comfortably recover.”
CNN’s Ben Tinker, Maggie Fox, Haley Brink, Jen Christensen, Amanda Watts, Lauren Mascarenhas and Shelby Lin Erdman contributed to this report.
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