EAST GREENBUSH Regeneron has teamed up with Swiss biotechnology giant Roche for development and distribution of the COVID-19 treatment that Regeneron is producing in its East Greenbush facility.
The deal is expected to more than triple the supply of REGN-COV2, an antibody cocktail now in clinical trials. Regeneron, which earlier this year landed a $450 million contract with the U.S. government for production of the compound, will distribute the treatment in the United States. Roche will distribute it abroad.
The deal commits both companies to dedicate portions of their resource capacity to manufacturing, and theyve already begun transferring the needed technology. Roche will be responsible for obtaining regulatory approvals outside the United States and for conducting any further research required to accomplish that.
The $450 million contract Regeneron announced in July is part of Operation Warp Speed, the public-private partnership created by the U.S. government in response to the pandemic, which has hit the United States harder than any other country.
The ultimate goal of Warp Speed is to create a vaccine, which would offer long-term infection prevention benefits. REGN-COV2 is not a vaccine but would offer shorter-term benefits with antibodies. The bodys immune system produces antibodies to fight infections; REGN-COV2 is designed to block COVID-19s ability to infect a person by usinga targeted and engineered mix of antibodies.
The cocktail is currently in the second of three phases of clinical trials for treatment of infection and the third phase of a trial for infection prevention.
Regeneron has progressed the REGN-COV2 research and development program at record speed and worked tirelessly to maximize our in-house manufacturing capacity, Dr. Leonard S. Schleifer, president and CEO of Regeneron, said in a news release Wednesday. This major collaboration with Roche provides important scale and global expertise to bring REGN-COV2 to many more patients in the United States and around the globe.
Regeneron is headquartered in Westchester County and has a large and growing production facility in East Greenbush.
One additional HSU student resident has tested positive for COVID-19.
As of today, Humboldt State University has conducted more than 600 tests for nearly all students moving into campus residence halls. A small number of students have not yet arrived and are moving in over the next two days.
All five of the students with positive tests were asymptomatic. They had not shown symptoms or felt ill prior to traveling to this community.
The affected students have been moved to rooms on campus that are set aside for isolation. The University is providing ongoing support including health and wellness checks with the students, as well as delivery of meals and other necessities.
Comprehensive testing is continuing for all students living on campus this year. Campus residents will be tested multiple times during the course of a 14-day quarantine period. This enhanced level of testing is intended to identify those who may be asymptomatic and isolate them quickly, and was implemented late last week with the help of additional resources provided from the state and county.
In addition to the required testing for students living on campus, all other HSU students may opt to be tested at the Student Health Center and all students showing symptoms will be tested. Student-athletes are also being tested periodically per state requirements.
This advisory provides all the information the University will share about the cases.
The campus community is encouraged to stay safe and healthy, and to help protect the health of the community, by adhering to theSocial Responsibility Commitment. This includes wearing a face covering, maintaining social distancing, and staying at home if you are sick or have a fever.
The ongoing challenges of the pandemic can lead to increased stress and anxiety. Any students who would like to talk with a counselor can contact Counseling & Psychological Services at 707.826.3236. Staff or faculty needing additional support may call the Employee Assistance Program at 707.443.7358.
For more information about COVID-19, visit theCalifornia Department of Public Health website.
For more information about HSUs plans for the fall semester, visit theHSU Campus Ready website.
The North Dakota Department of Health Saturday morning has confirmed 262 new cases of COVID-19 in the state during testing August 21, bringing the total positives since testing began to 9,736.
The number of currently active COVID-19 cases in the state stands at 1,633 as of August 21.
Of the new positives, 48 were in Burleigh County and 12 were in Morton County. Both counties accounted for 22 percent of the new cases.
Williams County had 6, Stark County had 22 and Ward County had 19.
Three new deaths were reported: A woman in her 60s from Walsh County, A man in his 70s from Rolette County and a man in his 80s from Burleigh County.
All had underlying health conditions.
A total of 135 people have died so far in North Dakota as a result of COVID-19.
Of those, 108 are directly attributable to COVID-19 according to official death records. Another 15 deaths are where COVID-19 is not the primary cause of death. Nine death records are pending.
The health department reports 7,968 people are considered recovered from the 9,736 positive cases, an increase of 127 people from August 20.
This means there are actually 1,633 active COVID-19 cases in the state as of August 21.
Burleigh County has 403 active cases as of August 21, the most in the state and triple the number of active cases in Cass County (135). Morton County has 115 active cases.
Burleigh and Morton counties together account for 32 percent of all active COVID-19 cases as of August 20.
Stark County has 189, Ward County has 127 and Williams County has 35 active cases.
According to state health department numbers (which have been revised several times for specific dates), the statewide active cases first peaked on May 21 at 672 active cases, then began falling until they hit a low of 213 on June 22.
After that, the statewide active cases have once again been trending upward.
According to the numbers, 83 percent of those who have tested positive for COVID-19 in North Dakota to date have recovered from the virus.
The number of people reported recovered from COVID-19 on August 21 (127) is lower than the number of new COVID-19 cases reported that day (262).
53 people are currently hospitalized due to COVID-19 as of August 21, a decrease of 1 from August 20. A total of 499 hospitalizations have been reported since data tracking began.
COVID-19 cases have been reported in all 53 of North Dakotas counties.
Cass County (3,250 cases) and Grand Forks County (980 cases) account for 43 percent of all positive North Dakota COVID-19 cases to date. Cass County alone accounts for 34 percent of all positive cases.
Burleigh County (1,673 cases) and Morton County (529 cases) together account for 23 percent of all positive COVID-19 cases to date.
Williams County has 325 positive cases to date, Stark County has 513, Ward County has 381 and Mountrail County has 159.
Other county numbers are availablehere.
A total of 189,038 unique individual tests have been conducted to date, with 179,302 coming back negative for COVID-19, or roughly a 5 percent cumulative positive rate.
How is COVID-19 being spread in the state? Community spread (3,952 cases), close contact with exposed individuals (3,262 cases) and household contact (1,584 cases) are the top three reported.
While COVID-19 is seen as a virus that mostly impacts older people, in North Dakota, 58 percent of those testing positive for the virus are under 40.
Those in the 20 to 29 year age range have the most positive cases among those tested to date.
The health department is releasing test results daily around 11:00 a.m. The results cover all testing performed the previous day.
You can read more on the daily statistics as well as other COVID-19 information and resources at the North Dakota Department of Health websitehere.
Smoke rises from a wildfire burning in the Santa Cruz Mountains in California. Getty Images photo
Wildfires are again raging in California, but this years season began in a perfect storm of smoke from the blazes, a scorching heat wave, and the ongoing COVID-19 pandemic.
During a typical wildfire season, hospitals see more people coming in for respiratory issues, said Stephanie Christenson, MD, assistant professor of pulmonology at UC San Francisco. The worry this year is that the smoke from wildfires could increase the severity of COVID-19 symptoms.
Though there have yet to be studies looking specifically at the effect of wildfire smoke on COVID-19, there is preliminary research linking air pollution to increased COVID-19 susceptibility, severity and death, said Christenson.
With wildfire smoke, and air pollution generally, the most concerning are the microscopic particles that are about 2.5 microns in size (about 30 times smaller than the width of a human hair), which can be inhaled deep into the lungs, said John Balmes, MD, professor of medicine. There, these tiny toxins can injure the lining of the lungs, in a process known as oxidative stress, and cause airway inflammation.
People with certain chronic respiratory conditions, such as asthma, already have airway inflammation, and the added inflammation from wildfire smoke would be particularly harmful, said Balmes. There is no question that wildfire smoke can exacerbate these pre-existing conditions.
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Research also has shown that wildfire smoke raises the risk of lower respiratory tract infections such as acute bronchitis and pneumonia, by impairing the immune response, said Balmes. The immune cells, known as alveolar macrophages, that patrol our lower lungs are adept at engulfing and digesting foreign particles, such as bacteria. But when these macrophages engulf the combustion particles in wildfire smoke, they cannot digest them, and essentially are disabled from performing their role in the immune response.
Wildfire smoke, like COVID-19, can affect more than the lungs. A study from the 2015 wildfire season found that emergency room visits in areas most affected by smoke increased not only for respiratory complaints, but also cardiovascular and neurological complaints, such as stroke, said Jahan Fahimi, MD, PhD, an emergency care physician.
My advice to the public is that people should be sheltering in place as much as possible, said Balmes. Stay home with windows closed, ventilation turned to recirculate, and if possible, have a clean air room with a HEPA air purifying appliance.
To avoid COVID-19 exposure, its safest to stay home with the people you already live with, added Fahimi.
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As for masks, Balmes noted that N95 masks fitted tightly over the face offer the best protection against wildfire smoke particles, but that N95 masks with exhalation valves do not provide COVID-19 protection. He recommends covering the valve with tape or wearing a surgical mask over the N95.
Because N95 masks (without valves) should be reserved for health care workers treating COVID-19, experts do not suggest buying new N95 masks unless you need to be outside for an extended period of time.
Fahimi drew a parallel between wildfire smoke and the coronavirus that in both cases, the duration and dose of exposure determines risk. If youre only going to be out for 10 to 15 minutes, even no mask is fine for a short duration, he said. But people working outdoors, thats when you want a mask.
Surgical masks are more readily available and will provide some protection against wildfire smoke, said Balmes. Cloth masks likely provide little protection against PM2.5 particles, but are still essential for COVID-19 protection.
If you cant get a surgical or a N95 mask, wear a cloth mask because the most important thing is to protect others from the virus, said Balmes.
The Grays Harbor County COVID-19 rate grew by 31 Wednesday and Thursday to 184, Grays Harbor Public Health reported Friday.
There were 16 news cases reported Friday, after 15 reported Thursday. The new case count Wednesday was three. Since Sunday, Aug. 16, there have been 48 positive COVID-19 tests reported in the county.
Public Health is now reporting five COVID-19-related deaths in the county, one in July and four in August, two of those reported Wednesday. No further details about the most recent deaths have been released by Public Health.
There are 56 active cases as of Friday, with six new contacts identified. Active cases are those those still under isolation or quarantine. Public Health said cases with improved symptoms are no longer active 10 days after their first symptoms began, or from their test date if they did not develop symptoms.
Contacts who do not develop symptoms are no longer active 14 days after their last exposure to a person confirmed to have a COVID-19 infection.
The 56 active cases are still under investigation. There have been 483 total contact investigations to date.
Of the total cases so far, the majority, 71, were reported in the 20-39-year-old age group, followed by 43 in the 40-59-year age range, 27 age 60-79 years, 17 in ages 1-19, and 10 in those aged 80 and older.
Confirmed cases include 87 females and 81 males.
In cases by race, there have been 123 among whites, 27 among Hispanics, six American Indian/Alaska Native, four Asian, four bi-racial, three black, and one Native Hawaiian or Pacific Islander. The county update by zip code map had not been updated by press time.
According to state Department of Health data, which Friday still had the case count at 165 and death count at 3, there are 18 current hospitalizations in Grays Harbor County.
Westport testing
Friday, Grays Harbor Public Health conducted two mass COVID-19 testing operations in Westport. Tests were conducted at the Alaskan Hotel and Washington Crab parking lot.
These tests are closed to the public and are for continual surveillance as part of COVID-19 outbreak investigations, said Public Health on its Facebook page Thursday. Calls to Public Health for more details about this mass testing effort were not immediately returned Friday.
Pacific County
There were a total of 58 COVID-19 cases in Pacific County as of Aug. 19, an increase of three cases from the previous weeks total of 55.
This is a sharp drop in the weekly number; the week of Aug. 5-12 saw an increase of a dozen cases.
For the week of Aug. 13-19, there were three active cases in the county being monitored by Public Health staff, and eight hospitalizations. Of the 58 cases, 54 were confirmed to be current residents of the county. According to Wednesdays numbers, there are 55 closed cases in the county.
One previous case was removed, according to Pacific County Emergency Management Director Scott McDougall: The individual being removed is incarcerated in a correctional facility and has not been in Pacific County during their illness.
The county is still reporting two deaths related to the virus, with one case still pending further investigation. As of Friday the county had eight hospitalizations related to the virus.
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Approving a vaccine in the U.S. usually takes years, but COVID-19 vaccines are moving through in record time. What does that mean? USA TODAY
BOSTON Dianne Wilkerson wants Black Bostonians to volunteer for trials testing potential COVID-19 vaccines.
She understands why they're hesitant.Black Americans have a long history of being treated poorly by the medical establishment; many faced discrimination in medical care themselves.
Still, if they don'tparticipate in the trials meant to establish vaccine safety and effectiveness, they'll never know whether the vaccines will work for them.
"The risks for not being involved are so great," said Wilkerson, a founding member of Boston's Black COVID-19 Coalition.
About 25% of the city's populationis Black, yet Blacks have made up more than 35% of those infected and killed by COVID-19.
Nationally, the figures are even worse.Just over 80 Black Americans have died of COVID-19 out of every 100,000, compared with 46 Latino Americans and 36 white Americans, according to the American Public Media Research Lab.
The first two large-scale vaccine trials began nationwide in late July, and at least three more will start before early fall. Each one will need 30,000 volunteers, half of whom will get an active vaccine and half a placebo.
Federal officials including the heads of the National Institutes of Health, the Food and Drug Administration, and the Centers for Disease Control and Prevention have called for these trials to include a large number of people of color.
This May 4, 2020 photo from the University of Maryland School of Medicine, the first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, receives an injection.(Photo: AP)
"We must make sure there is appropriate diversity in the clinical trials," FDA Commissioner Dr. Stephen Hahn said in an recent interview with the editor of the scientific journal JAMA.
Even if everyone's immune system reacts the same way to the virus, differences in care and underlying health may mean people of color respond differently to infection, Hahn said:"We need to make sure those folks are in these trials so that we understand what the immunological effects are, but also the clinical effects."
In addition to racial and ethnic diversity, most of the trials also are looking for people over 65. Older immune systems don't work as well as they used to, and older people have been disproportionately sickened and killed by the virus that causes COVID-19.
Early trials haven't been diverse.
In the two small clinical trials that have published their results, one in The New England Journal of Medicine, one in The Lancet, only eight of 1,100 participants were Black.In both studies, participant age averaged in the mid-30s.
It's not for lack of enthusiasm in the trials. More than 300,000 people have already expressed interest in volunteering to participate.
The Fred Hutchinson Cancer Centerin Seattle, which is managing a registry of volunteers, is not breaking them down by demographic group. But Hahn said 19% of those who had volunteered so far were Black and nearly the same percentage were Latino.
And although 300,000 sounds like a lot of volunteers, it's not nearly enough, said Claire Hudson, a spokesperson for the center.
"Its important to note that we need millions of interested volunteers to join the online registry," coronaviruspreventionnetwork.org, she said via email.
Not all the people who express interest in volunteering will make it into one of the trials, Dr. FrancisCollins, director of the National Institutes of Health,explained at a teleconference announcing the start of the first trial.Some volunteers might not live near testing sites, for instance.
"The more the better," Collins said of volunteers. "This is going to be a big American opportunity for people to come on board as our partners to try to take part in what has been a historic effort to bring to an end the worst pandemic our world has seen in over 100 years."
Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time. USA TODAY
Dr. Barbara Pahud has a plan:If not enough people of color will come to major medical centers to volunteer for clinical trials, she'll bring the clinical trials to them.
As a medical student in Mexico, Pahud was given a cooler of shots to deliver to the community. Now, she's has outfitted a van that she plans to park perhaps at a health center or church to take vaccine trials where Americans of color spend their time.
Pahud, research director of pediatric infectious diseases at Childrens Mercy Kansas City, said she's also making an effort to hire people who speak Spanish, and to have all printed material available in two languages.
"The usual stuff that should always be done is actually being done this time, which is fantastic," she said.
Dr. Barbara Pahud, MD, MPH and Research Director of Pediatric Infectious Diseases at Childrens Mercy Kansas City.(Photo: Children's Mercy Kansas City)
Researchers and community members will both need to take a risk.
"If we really want to do research that reflects the community that we live in, that is being impacted by this disease, we (researchers)need to change our mindset," Pahud said. On the flip side, "communities need to understand that if they want to benefit from the vaccine, they need to let their people volunteer, or we won't be able to know if the vaccine works in their population."
Others are making similar efforts.
At the University of Colorado, Thomas Campbell said his medical practice has used its electronic medical records to identify and reach out to everyone at high risk for COVID-19.
"I've already had over 100 people email me personally and said 'sign me up,'" said Campbell, also aninfectious disease physician at UCHealth.
Pfizer, which has launched its own 30,000-person trial, is locating its trials in diverse communities, including some with large Hispanic and Black populations, spokesperson Sharon Castillo said.
"We're making sure that the demographics of our trial population reflects the demographics of the states and communities that have been most impacted," she said.
Pfizer also is working with partners, such as grassroots organizations and local and Spanish media, to raise awareness and encourage participation. And the company is reducing barriers to participation, Castillo said, by printing materials in five languages.
"We're learning a lot on how to go above and beyond to make sure minorities are represented," she said, promising that Pfizer would continue this approach in all its clinical trials going forward.
Butgood intentions may not be enough.
Wilkerson said a recent meeting with officials at Brigham and Women's Hospital did not end where she wanted it to.
The hospital has reached out to Black leaders, including Wilkerson, for help in encouraging minority participation in these trials. Hospital officials said that meeting and others with local people of color have gone well.
But Wilkerson said a few listening sessions and dropping flyers at local communities centers won't be enough to redress decades of mistrust, or to get Black Bostonians to participate.
"We have an opportunity to reset how (hospitals)relate to Black and brown people," she said, adding that her group plans to seize that opportunity:"We intend to get their attention."
Contact Karen Weintraub at kweintraub@usatoday.com
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
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