The West Virginia Department of Health and Human Resources (DHHR) reports as of February 19, 2021, there have been 2,099,685 total confirmatory laboratory results received for COVID-19, with 129,055 total cases and 2,248 total deaths.
DHHR has confirmed the deaths of a 51-year old male from Jefferson County, an 89-year old female from Mercer County, a 76-year old male from Kanawha County, a 92-year old male from Fayette County, an 87-year old male from Jackson County, an 85-year old male from Berkeley County, a 63-year old male from Wood County, an 88-year old male from Wayne County, a 91-year old female from Mercer County, a 92-year old female from Mercer County, an 87-year old male from Jackson County, and a 54-year old female from Marion County.
“It is with great sadness that we announce more lives lost to this pandemic,” said Bill J. Crouch, DHHR Cabinet Secretary. “Our sympathies and thoughts go out to these families, and we ask that all West Virginians do their part to prevent further spread of this virus.”
CASES PER COUNTY: Barbour (1,163), Berkeley (9,532), Boone (1,538), Braxton (769), Brooke (1,983), Cabell (7,646), Calhoun (218), Clay (370), Doddridge (460), Fayette (2,587), Gilmer (699), Grant (1,044), Greenbrier (2,371), Hampshire (1,491), Hancock (2,565), Hardy (1,257), Harrison (4,788), Jackson (1,638), Jefferson (3,560), Kanawha (11,795), Lewis (1,012), Lincoln (1,198), Logan (2,643), Marion (3,601), Marshall (2,967), Mason (1,746), McDowell (1,334), Mercer (4,138), Mineral (2,567), Mingo (2,082), Monongalia (7,716), Monroe (930), Morgan (909), Nicholas (1,154), Ohio (3,567), Pendleton (617), Pleasants (794), Pocahontas (580), Preston (2,499), Putnam (4,116), Raleigh (4,561), Randolph (2,356), Ritchie (604), Roane (488), Summers (696), Taylor (1,072), Tucker (495), Tyler (607), Upshur (1,640), Wayne (2,576), Webster (289), Wetzel (1,062), Wirt (341), Wood (6,908), Wyoming (1,716).
Delays may be experienced with the reporting of information from the local health department to DHHR. As case surveillance continues at the local health department level, it may reveal that those tested in a certain county may not be a resident of that county, or even the state as an individual in question may have crossed the state border to be tested. Such is the case of Cabell and Marshall counties in this report.
West Virginians may now pre-register for their COVID-19 vaccination at vaccinate.wv.gov. The COVID-19 dashboard located at www.coronavirus.wv.gov shows the total number of vaccines administered. Please see the vaccine summary tab for more detailed information.
Hospital admissions, new cases and active caseloads look good
Deaths averaging fewer than 10 per day for the first time since October
Modest improvement in vaccination pace; weather may change that
Updated: 11:35 a.m.
Minnesota’s COVID-19 numbers show the state on a steady, positive path, with key pandemic metrics continuing to improve.
Known, active cases have stayed below 7,000 for three straight days this week, the first time that’s happened since late September.
The seven-day hospital admissions trend for people with COVID-19 has also receded to September levels. There were 287 people with COVID-19 in Minnesota hospitals as of Wednesday — the first time since September hospitalization were below 300.
Fifty-four people currently need an intensive care bed, the lowest point since the spring.
If there’s frustration, it’s with the speed of vaccinations. Even as the state approaches 1 million vaccinations, the pace seems unable to take off after falling and then flattening following a late January surge.
While it’s ticked up since then, the overall trend line isn’t yet showing a sustained upswing. The current seven-day average is running at about 28,300 vaccinations per day. While it’s trending in the right direction now, it’s not back to the levels seen in late January and early February.
Officials have been emphasizing over the past weeks that the relatively low flow of vaccine supplies from the federal government is the main problem holding back the pace of vaccinations. There’s data to back that up.
They’ve also cautioned that the cold snap now gripping the nation will likely delay vaccine shipments to Minnesota, potentially depressing vaccination counts in the short-term.
The state is ranked 25th among states currently in doses administered per 100,000 people, according to data collected by the federal Centers for Disease Control and Prevention.
About 12.8 percent of Minnesotans had received at least one dose as of Tuesday, with about 4.7 percent completely vaccinated. About 38 percent of Minnesotans 65 and older have received at least one shot. At the current rate, it would take until September or October to vaccinate 80 percent of the state’s adults.
Fourteen reported deaths on Thursday raised Minnesota’s toll to 6,404. Among those who’ve died, about 63 percent had been living in long-term care or assisted living facilities; most had underlying health problems.
Minnesota COVID-19 deaths are averaging fewer than 10 per day for the first time since October.
The state’s recorded 476,292 total confirmed or probable cases so far in the pandemic, including 928 reported Thursday. About 97 percent of Minnesotans known to be infected with COVID-19 in the pandemic have recovered to the point they no longer need to be isolated.
Overall, the trends offer reasons to feel encouraged, enough so that Gov. Tim Walz on Wednesday proclaimed “we’re on our way to ending the pandemic” as he OK’d reopening secondary schools, starting Monday. “We’re beating this thing.”
Still, state health officials continue to monitor new virus strains circulating in the United States, which may be more contagious. Walz and other officials have warned that they could lead to an increase in cases.
Kris Ehresmann, the state’s infectious disease director, reaffirmed those concerns on Tuesday, noting that Minnesota’s now confirmed 40 cases of the U.K. strain here. “We want to make sure we’re not giving a foothold to these variants.”
Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told MPR News on Thursday that the variants are very concerning and it’s unclear whether they evade immunity from vaccination or natural protection.
Cases spread across age groups, regions
People in their 20s still make up the age bracket with the state’s largest number of confirmed cases — more than 90,000 since the pandemic began, including more than 47,000 among people ages 20 to 24.
The number of high school-age youth confirmed with the disease has also grown, with nearly 37,000 total cases among those ages 15 to 19 since the pandemic began.
Although less likely to feel the worst effects of the disease and end up hospitalized, experts worry youth and young adults will spread it unknowingly to older relatives and members of other vulnerable populations.
People can have the coronavirus and spread COVID-19 when they don’t have symptoms.
Regionally, most parts of Minnesota are down significantly from the late November, early December spike as well as a January blip.
There has been an uptick in cases in northwestern Minnesota recently, though it’s unclear why just yet.
Even as new case counts continue to fall from their late November, early December peaks, the data shows Latino people continue to be hit hard.
Distrust of the government, together with deeply rooted health and economic disparities, have hampered efforts to boost testing among communities of color, officials say, especially among unauthorized immigrants who fear their personal information may be used to deport them.
Malcolm on Thursday also acknowledged the need to ensure that vaccination opportunities be spread equitably.
Malcolm said the state will release data soon regarding vaccinations, race and ethnicity. Officials say they’re trying to improve the quality of data. Per state law, it’s been shared voluntarily, and so may be inconsistent.
Data in these graphs are based on the Minnesota Department of Health’s cumulative totals released at 11 a.m. daily. You can find more detailed statistics on COVID-19 at the Health Department website.
Latest developments
Fargo, N.D., extends mask mandate into late March
The Fargo City Commission extended a mask mandate Wednesday that was set to expire on Thursday.
Local public health officials asked the city to extend the mask mandate, which was first enacted in October. The first cases of the more contagious U.K. variant of the virus were reported this week in North Dakota.
Fargo police say checks of businesses in recent weeks found high rates of compliance with the mask mandate. The City Commission will review the mask requirement again on March 22.
— Dan Gunderson | MPR News
Top headlines
New vaccine tool will tell Minnesotans when they can get COVID-19 shots: The tool will alert Minnesotans of their eligibility, connect them to resources to schedule an appointment and provide information on nearby vaccination opportunities. Minnesotans will still have to make their own appointment to get a shot through a vaccine provider.
EMS workers adapt and persist, amid stress of pandemic:The pandemic has brought new challenges to already strained emergency medical services in Minnesota. Even the most routine calls carry higher risk — and require more preparation — than before the pandemic. Any call could involve a COVID-19 case.
COVID-19 causes surge in food shelf visits among older Minnesotans: The state’s largest increases in food shelf use over the last year happened in the Twin Cities metro areas. But in some rural places, there has been a more than five-fold increase in visits among people who are 65 or older.
You make MPR News possible. Individual donations are behind the clarity in coverage from our reporters across the state, stories that connect us, and conversations that provide perspectives. Help ensure MPR remains a resource that brings Minnesotans together.
New York Attorney General Letitia James sued Amazon on Tuesday over workplace safety concerns at two of the company’s distribution and fulfillment centers in Queens and Staten Island. Jim Watson/AFP via Getty Images hide caption
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Jim Watson/AFP via Getty Images
New York Attorney General Letitia James sued Amazon on Tuesday over workplace safety concerns at two of the company’s distribution and fulfillment centers in Queens and Staten Island.
Jim Watson/AFP via Getty Images
Updated at 9:07 a.m. ET
New York Attorney General Letitia James sued Amazon on Tuesday, claiming the massive e-commerce company’s “flagrant disregard for health and safety requirements” during the coronavirus pandemic put the lives of workers and the general public at risk.
She accused the company of shoddy contact tracing and poor cleaning — both designed to prevent the spread of the virus — at two New York facilities: a Staten Island fulfillment center and a Queens distribution center. A worker at the State Island plant warehouse died of COVID-19.
The Staten Island facility employs about 5,000 workers, and the Queens distribution center employs several hundred workers — most of whom were deemed essential during the pandemic, the filing says.
New York’s lawsuit follows one filed by Amazon — in a Brooklyn federal court — trying to prevent James from filing her own. The company argues that federal labor and safety laws take precedence over New York’s laws, meaning James would not have the legal authority to sue Amazon for workplace safety violations.
In response to James’ suit, Amazon spokesperson Kelly Nantel said in a statement, “We care deeply about the health and safety of our employees, as demonstrated in our filing last week, and we don’t believe the Attorney General’s filing presents an accurate picture of Amazon’s industry-leading response to the pandemic.”
James began investigating Amazon in March 2020 after receiving several complaints from current and former Amazon employees.
The company “failed to follow health and safety requirements” at its massive distribution hubs in violation of New York’s labor laws, James said. Under state guidelines, employers are required to provide “reasonable and adequate protection” to their employees.
Amazon received written notification of at least 250 employees at the Staten Island facility who had positive COVID-19 tests or diagnoses, of which more than 90 workers had worked in the facility within seven days of notifying Amazon.
The complaint says, “In more than 80 of these instances, Amazon failed to close any portion” of the Staten Island facility even after receiving documentation from workers of their positive coronavirus tests.
The attorney general said in her court filing, “Amazon has cut corners in complying with the particular requirements that would most jeopardize its sales volume and productivity rates, thereby ensuring outsize profits at an unprecedented rate of growth for the company and its shareholders.”
The complaint notes Amazon’s financial success during the pandemic — with profits of $130 billion.
James also accused Amazon of illegally retaliating against employees who publicly complained about inadequate safety measures. Last March, Amazon fired worker activist Christian Smalls after he led a protest over conditions at the Staten Island warehouse. The company said Smalls had violated a mandatory quarantine order.
Amazon also issued a final written warning to employee Derrick Palmer, another worker who demanded stronger safety protections. Palmer and two other workers sued Amazon, claiming it failed to follow guidelines set by public health agencies. The lawsuit was thrown out.
This lawsuit comes as nearly 6,000 Amazon employees at a Bessemer, Ala., warehouse are voting on whether to unionize — an effort spawned in part over workplace safety concerns during the pandemic. If the workers are successful, it would be the first unionized Amazon warehouse in the U.S.
Editor’s note: Amazon is among NPR’s recent financial supporters.
A highway on-ramp in Houston is closed due to snow and ice on Monday. Frigid temperatures, icy roads and power outages caused by a major winter storm have interfered with COVID-19 vaccine distribution in Texas and several other states. Chengyue Lao/Xinhua News Agency/Getty Images hide caption
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Chengyue Lao/Xinhua News Agency/Getty Images
A highway on-ramp in Houston is closed due to snow and ice on Monday. Frigid temperatures, icy roads and power outages caused by a major winter storm have interfered with COVID-19 vaccine distribution in Texas and several other states.
Chengyue Lao/Xinhua News Agency/Getty Images
The massive storm sweeping across the country isn’t only bringing subzero temperatures and widespread power outages to much of the U.S., it’s also putting a freeze on COVID-19 vaccine distribution in several states and cities.
In Missouri, Gov. Mike Parson announced on Monday that all state-run mass vaccination events scheduled for this week are canceled, citing safety concerns brought on by the extreme weather.
“Missouri is experiencing severe winter weather that makes driving dangerous and threatens the health and safety of anyone exposed to the cold. These conditions will also likely delay some vaccine shipments,” Parson said. “We want to protect the safety of everyone involved in the mass vaccination events, from the patients being vaccinated to the volunteers who generously support these events.”
He emphasized that the cancellations will not change Missouri’s weekly regional vaccine allocations. All arriving vaccine shipments intended for this week’s events will be stored in Missouri State Highway Patrol regions across the state and redistributed to community hospitals with emergency generators, which can administer the vaccine according to the state’s tiers of eligibility.
The disruption also means those who were scheduled to receive their second dose of the Pfizer vaccine at this week’s events will have to wait. Citing the Centers for Disease Control and Prevention, Parson said the “slight delay” will not decrease the booster’s efficacy.
The CDC says the second dose can be administered up to six weeks, or 42 days, after the first.
Officials in New Hampshire said that all state-run vaccination sites will be closed on Tuesday as the storm heads north.
Vaccine candidates in Alabama are similarly facing delays, as many county health departments are closed on Tuesday or reducing their operating hours. The state’s public health department said it will “assure the opportunity” for people affected to get their second dose in the next two weeks, including by extending clinic hours as staffing permits.
And in Texas, where some 4.4 million customers remain without power, several cities have canceled vaccination appointments because of the winter weather.
They include San Antonio, which rescheduled all Monday and Tuesday appointments at the Alamodome, and Dallas, which suspended all vaccine operations at Fair Park through Wednesday.
And in Harris County, home to Houston, officials scrambled early Monday to administer some 5,000 vaccine doses after the facility storing them lost power.
Harris County Judge Lina Hidalgo explained at a Monday evening news conference that the health department building had been storing 8,430 Moderna vaccines when the power went out and its backup generator failed, meaning they could not be maintained at the proper temperature.
“We all know those vaccines need to be kept in cold storage, so we got to work under the mission to avoid losing those vaccines with the loss of power,” she said.
Hidalgo said officials quickly put together a plan to “allocate and salvage” the doses before they went bad, by getting them to locations where there were already large numbers of people, including trained medical professionals who could administer the vaccines, and without requiring people to drive in dangerous conditions.
They were ultimately able to administer a total of 5,410 doses to three hospitals, the Harris County Jail and Rice University. The remaining doses were saved, Hidalgo said, after Moderna told officials directly that they could be safely re-refrigerated and distributed later.
Icy roads and frigid temperatures are also interfering with the transportation of vaccine shipments to different parts of the country, according to officials in several states.
Officials in Corpus Christi, Texas, said that the Corpus Christi-Nueces County Public Health District was notified by the state that it would not receive its allocated first dose vaccines until Wednesday at the earliest, and that the week’s vaccination clinics are “being contemplated” for Saturday and Sunday.
The director of the Florida Division of Emergency Management said the state had been informed that the storm was delaying its Monday-Tuesday shipment of vaccines, according to the Tallahassee Democrat.
Meanwhile, health officials in Nevada announced on Monday that the state had learned the arrival of some vaccine deliveries could be delayed this week because of the storm.
“Our team is monitoring closely & working with health districts & pharmacies that may be affected,” they tweeted. “We ask Nevadans to continue to be patient at this time.”
In Kentucky, where regional vaccination sites first closed last week in response to an ice storm, Gov. Andy Beshear called the delays “unfortunate” but said he was not concerned about their long-term impact on the state’s vaccine distribution efforts because he expects supply to increase, reports member station WFPL.
“We’re hoping what we’re getting right now is a trickle compared to what we will get late spring and moving into the summer,” Beshear said.
The National Weather Service says this storm will bring ice and snow to the Northeast before exiting off the coast, while another major storm emerging in the Southern Plains is set to wallop the mid-South again on Wednesday.
Mónika Zsúnyi is 26 years old and lives in Temerin, Serbia. She holds a MSc degree in Applied Mathematics, she is engaged in 3D modeling and loves to read. Living with a cerebral palsy, she is also very active in promoting rights of people with disabilities in Serbia.
In Serbia, around 8 per cent of the total population — nearly 600,000 people, the majority of them women and girls — lives with some kind of disability. Yet they are far from being treated equally, especially when it comes to sexual and reproductive health.
One in five women and adolescent girls with disabilities in Serbia say they have difficulty accessing needed health services, according to a study carried out by UNFPA and Iz Kruga Vojvodina, an organization providing support to women with disabilities. One in four is unsatisfied with the sexual and reproductive health services they receive. One in seven has never had a gynaecological examination. And only one in four says they can freely and independently decide if they want children, or have their family’s support in doing so.
These multi-layered challenges are perpetuated by persistent negative stereotypes and prejudices in society, found even among health professionals. The COVID-19 pandemic has only exacerbated these difficulties. Women and young people with disabilities are nearly three times more likely than their non-disabled peers to experience sexual violence, and they are at risk of being left behind in the response to the COVID-19 crisis.
Mónika Zsúnyi
But women with disabilities in Serbia are leading the efforts to make the world more equitable and inclusive, by raising awareness about disability, setting standards for inclusivity and championing legislation to advance their rights.
“I am a woman with a disability. I live with cerebral palsy, I have difficulty speaking and moving. I try to be as independent as possible and live a full life. Sexual life is part of that,” says Monika, one of five women who are championing sexual and reproductive health.
With UNFPA support, women from the municipalities of Raska, Temerin, Uzice, Valjevo and Vranje are learning about reproductive rights, mapping barriers and creating local solutions. And the COVID-19 pandemic has not stopped them. They moved all of their activities online and joined forces with others in their communities to become advocates for change.
“Due to the COVID-19 pandemic we implemented almost the whole project online. I had to face the fear that no one in the online space would understand me because of my speech (it is easier to understand me when I speak face to face). At the same time, I had the opportunity to get acquainted with the technique and possibilities of online work, which has always been a challenge for me. I am very proud of the work of the women of our Association. They regularly got involved in trainings, regardless of the obligations they had beyond that. They were always present and open to talk about more sensitive topics,” shares Monika.
The women made great strides in less than a year marked with the COVID-19 pandemic worldwide: getting a hydraulic table for gynaecological check-ups back into service, made movies about the barriers they face and successfully engaged with local policy makers to offer and advocate for solutions to their problems during and after COVID-19 pandemics.
“These activities pushed me out of my comfort zone a bit, and broke down the prejudices I had about myself – that I am not capable of being a leader due to my difficulty in speaking,” Monika says. “Our life is not always easy, but it is always worth fighting for our rights.”
At 10 a.m. Saturday, the Iowa Department of Public Health reported 328,640 total positive cases since the pandemic began. That number rose to 329,098 by 10 a.m. Sunday.
The state’s dashboard says out of those who have tested positive, 301,773 have recovered, an increase of 599 since yesterday.
The state has reported no additional deaths connected to COVID-19 over the last 24 hours, keeping the state’s death toll to 5,236.
Subtracting the number of recoveries (301,773) and the number of deaths (5,236) from the total number of cases (329,098) shows there are currently 22,089 active virus cases in the state.
In Iowa, there were 2,802 new tests given in the last 24 hours, and a total of 1,511,675 people have been tested for COVID-19.
Iowa’s 14-day positivity rate is currently 8%.
According to the health department’s latest report, 240 Iowans are hospitalized due to the virus, which is up from 225 reported yesterday. Out of those hospitalizations, 57 are in the ICU with 29 on ventilators.
The IDPH is currently reporting 35 COVID-19 outbreaks in long-term care facilities across the state. So far, 2,136 virus-related deaths have been reported among long-term care residents.
Data from the state’s vaccine dashboard shows 439,944 Iowa residents have received doses of the COVID-19 vaccines. A total of 118,673 people have completed their vaccine series.
Woodbury County
As of 9 a.m. Sunday, the Siouxland District Health Department reported five new positive cases in Woodbury County, bringing the county’s total to 13,460. To date, 12,809 of the county’s cases have recovered.
The SDHD has confirmed there were no additional virus-related deaths in Woodbury County, keeping its death toll to 205.
A total of five people are currently hospitalized with COVID-19 in Woodbury County. Of those hospitalized, two are county residents.
Buena Vista County
In Buena Vista County, the IDPH has reported three more positive cases, bringing the county’s total to 4,042. Of those cases, 3,893 have recovered.
The county has reported no new virus-related deaths, keeping its total to 36.
Clay County
In Clay County, 1,809 total positive cases have been reported by the IDPH. Of those cases, 1,642 have recovered.
Clay County has reported no additional virus-related deaths, keeping its death toll at 25.
Dickinson County
State health officials say in Dickinson County five new cases were reported, bringing the total to 1,968. Of those cases, 1,815 have recovered.
Dickinson County has reported no new virus-related deaths, keeping its death toll at 37.
Plymouth County
Plymouth County reported 3,610 total cases on Saturday, that number rose to 3,611 by Sunday morning. Of those cases, 3,428 have recovered.
There have been no additional virus-related deaths in Plymouth County, with its death toll remaining at 75.
Sioux County
State health officials say Sioux County has had three additional cases bringing its total to 4,692. Of those cases, 4,488 have recovered.
There was no additional virus-related deaths in Sioux County, keeping the COVID-19 toll to 67.
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
This week, the FDA posted the webpage, COVID-19 Vaccine Safety Surveillance, which provides an overview of our active and passive systems used to monitor the safety of authorized COVID-19 vaccines. The FDA’s Center for Biologics Evaluation and Research is conducting these surveillance efforts in collaboration with the Centers for Disease Control and Prevention, the Center for Medicare and Medicaid Services, the Department of Veterans Affairs, and other academic and large non-government healthcare data systems.
This week, the FDA issued an emergency use authorization (EUA) for a a monoclonal antibody combination for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19.
This week, FDA revised its guidance, Investigational COVID-19 Convalescent Plasma and associated web page, to reflect the reissued Emergency Use Authorization for COVID-19 convalescent plasma. Specifically, the guidance provides recommendations to blood establishments on the collection and labeling of high titer COVID-19 convalescent plasma under the EUA. In addition, the revisions address when individuals who have received an investigational COVID-19 monoclonal therapy as a participant in a clinical trial, or received an authorized or licensed COVID-19 monoclonal antibody therapy, qualify as convalescent plasma donors.
Testing updates:
As of today, 327 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 243 molecular tests and sample collection devices, 70 antibody tests, and 14 antigen tests. There are 35 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Enrollment has begun to test additional investigational drugs in the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. ACTIV is a public-private partnership program to create a coordinated research strategy that prioritizes and speeds development of promising COVID-19 treatments and vaccines. The new agents entering the randomized, placebo-controlled study are part of ACTIV-2, an adaptive trial designed to test investigational agents in non-hospitalized adult volunteers experiencing mild to moderate COVID-19 symptoms. ACTIV-2 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health, and is led by the NIAID-funded AIDS Clinical Trials Group (ACTG).
The added sub-studies will test four interventions for safety and efficacy: SNG001, an inhalable beta interferon delivered by nebulizer, (Synairgen); AZD7442, a long-acting monoclonal antibody combination that will be studied as both an infusion and an intramuscular injection (AstraZeneca); and Camostat mesilate, an orally administered serine protease inhibitor that may block SARS-CoV-2, the virus that causes COVID-19, from entering cells (Sagent Pharmaceuticals). The first volunteer enrolled in the SNG001 sub-study on February 10. The other agents under study are expected to begin enrolling participants soon.
If an investigational agent shows promise by demonstrating safety and reducing COVD-19 symptoms through 28 days following administration, the ACTIV-2 trial is designed to expand seamlessly from a Phase 2 to a Phase 3 study to gather additional critical data from a larger pool of volunteers without delay. Phase 2 studies in ACTIV-2 enroll up to 220 volunteers, while exact enrollment size of Phase 3 studies will vary depending on mode of administration of the investigational agent. The adaptive nature of the ACTIV-2 trial allows for comparison of multiple interventions with a shared group of placebo recipients. In addition to assessing safety and effect on COVID-19 symptoms, ACTIV-2 studies also assess whether an investigational agent can reduce the amount of SARS-CoV-2 virus detectable in the nasopharynx.
To qualify for ACTIV-2, participants must have tested positive for SARS-CoV-2 in the outpatient setting within 10 days and started experiencing symptoms within eight days of enrolling. Participants eligible for the AZD7442 infusion study must have a risk factor that puts them at higher probability of progressing to severe COVID-19. These include being age 60 or older, a current smoker, or having one of the following conditions: chronic lung, kidney, or liver disease; obesity, hypertension, cardiovascular disease, diabetes, current cancer or immunosuppression. Participants eligible for the other agents may be at higher or lower risk for progressing to severe COVID-19.
On Aug. 4, 2020, NIAID announced the launch of ACTIV-2, which initially tested LY-CoV555, a monoclonal antibody made by Eli Lilly and Company. On Nov. 10, 2020, LY-CoV555, also known as bamlanivimab, was granted Emergency Use Authorization by the U.S. Food and Drug Administration for treating mild-to-moderate COVID-19 in adults and children over 12 years old who are at high risk for progressing to severe COVID-19 and/or hospitalization. An ACTIV-2 study testing BRII-196 and BRII-198, investigational neutralizing monoclonal antibodies manufactured by Brii Biosciences (Durham, North Carolina, and Beijing), was announced by NIAID on Jan. 5, 2021, and is continuing to enroll volunteers.
To ensure that the trial is being conducted in a safe and effective manner, an independent data and safety monitoring board oversees the trial and periodically reviews the accumulating data.
The study team is led by protocol co-chairs Davey Smith, M.D., of the University of California, San Diego, and Kara W. Chew, M.D., M.S., of the University of California, Los Angeles (UCLA). David Alain Wohl, M.D., of the University of North Carolina at Chapel Hill (UNC), and Eric S. Daar, M.D., UCLA, serve as protocol vice-chairs. The ACTG network is led by chair Judith Currier, M.D., M.Sc., (UCLA) and co-chair Joseph Eron, M.D. (UNC).
For more information on this study, please visit www.riseabovecovid.org, or visit ClinicalTrials.gov and search identifier NCT04518410.
NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH):
NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
Austin, Texas – Yesterday, Feb. 9, Austin Public Health (APH) received the second dose shipment for people who got their first dose through APH the week of Jan. 11.
APH has started contacting those people by email or phone with information on second dose appointments. Staff will work through the weekend to continue scheduling. Appointments are required for both doses and walk-ups will not be accepted.
“We want to address the anxiety and frustration about second doses by assuring everyone that we are working diligently to get booster shots scheduled and administered as soon as we have them delivered,” said APH Director Stephanie Hayden-Howard. “We have staff who have been tirelessly working the emergency response, keeping our cases comparatively lower than other metropolitan areas.”
“When a physician prescribes medication, it typically requires you to take it on a stringent timeline, that is not the case with the COVID-19 booster shots,” said Dr. Mark Escott, Interim Austin-Travis County Health Authority. “There is some flexibility allowed between doses without diminishing efficacy.”
Escott added: “Studies of both the Pfizer and Moderna vaccines indicate that immunity following the first dose is approximately 50% when evaluated up to 14 days following the first dose of the vaccine. For Moderna, which is what APH is administering, the efficacy for the single-dose when evaluated more than 14 days after the first dose was 92.1%. While this represents a small group of 2,000 individuals studied, it does provide reassurance that the effectiveness of the first dose improves with time.”
Additional Information:
As of Feb. 9, more than 580,000 have created accounts in APH’s online portal, with 286,000 people pre-registered for the vaccine. Of those who are pre-registered, there are 217,000 people eligible to receive the vaccine, and 181,000 eligible without a first dose appointment.
For those 181,000 who are currently eligible and waiting to receive a first dose appointment, we have received your vaccine pre-registration. However, due to the limited supply of vaccine, APH is not able to immediately provide appointments for everyone eligible. Please continue to check the registration portal.
For those who are currently not eligible in the system, we have received your vaccine pre-registration. APH will notify you when you are eligible to receive the vaccine.
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions.
In a clinical trial of patients with COVID-19 at high risk for disease progression, a single intravenous infusion of bamlanivimab and etesevimab administered together significantly reduced COVID-19-related hospitalization and death during 29 days of follow-up compared to placebo. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continue to be evaluated.
Bamlanivimab and etesevimab are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
“Today’s action, which provides another treatment for COVID-19, reflects the FDA’s strong commitment to working with sponsors to expand potential treatment options health care providers can use to fight this pandemic,” said Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research. “The data supporting this emergency authorization add to emerging evidence that points to the clinical utility of neutralizing antibodies for the treatment of COVID-19 in certain patients. As part of our Coronavirus Treatment Acceleration Program, the FDA uses every resource at our disposal to make treatments such as these monoclonal antibodies available while continuing to study their safety and effectiveness.”
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. Bamlanivimab and etesevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells. Bamlanivimab and etesevimab bind to different but overlapping sites on the spike protein of the virus.
The issuance of an EUA is different than an FDA approval. In determining whether to issue an EUA, the FDA evaluates the totality of available scientific evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency. Based on the FDA’s review of the totality of the scientific evidence available, the agency has determined that it is reasonable to believe that bamlanivimab and etesevimab administered together may be effective in treating certain patients with mild or moderate COVID-19. When used to treat COVID-19 for the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks. There are no adequate, approved and available alternative treatments to bamlanivimab and etesevimab administered together for the authorized population.
The data supporting this EUA for bamlanivimab and etesevimab are based on a randomized, double-blind, placebo-controlled clinical trial in 1,035 non-hospitalized adults with mild to moderate COVID-19 symptoms who were at high risk for progressing to severe COVID-19. Of these patients, 518 received a single infusion of bamlanivimab 2,800 milligrams and etesevimab 2,800 milligrams together, and 517 received placebo. The primary endpoint was COVID-19 related hospitalizations or death by any cause during 29 days of follow-up. Hospitalization or death occurred in 36 (7%) patients who received placebo compared to 11 (2%) patients treated with bamlanivimab 2,800 milligrams and etesevimab 2,800 milligrams administered together, a 70% reduction. All 10 deaths (2%) deaths occurred in the placebo group. Thus, all-cause death was significantly lower in the bamlanivimab 2,800-milligram and etesevimab 2,800-milligram group than the placebo group.
The authorized dosage of 700 milligrams bamlanivimab and 1400 milligrams etesevimab administered together is based on analyses of available preclinical, clinical, and virologic data, as well as pharmacokinetic and pharmacodynamic modeling, which, in totality, support that the authorized dosage is expected to have a similar clinical and virologic effect to 2,800 milligrams bamlanivimab and 2,800 milligrams etesevimab administered together.
On Nov. 9, 2020, the FDA issued an EUA for a single infusion of 700 mg bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and certain pediatric patients. While bamlanivimab and etesevimab administered together resulted in a lower risk of resistant viruses developing during treatment compared with bamlanivimab administered alone, both treatments are expected to benefit patients at high risk of disease progression. At present, both 700 milligrams bamlanivimab alone as well as 700 milligrams bamlanivimab and 1,400 milligrams etesevimab administered together will be available under an EUA.
Under the EUA, fact sheets that provide important information about using bamlanivimab and etesevimab administered together in treating COVID-19 as authorized must be made available to health care providers and to patients and caregivers. These fact sheets include dosing instructions, potential side effects and drug interactions. Serious and unexpected adverse events including hypersensitivity, anaphylaxis, and infusion-related reactions have been observed with bamlanivimab with and without coadministration of etesevimab. In addition, clinical worsening following bamlanivimab administration has been reported, although it is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Possible side effects of bamlanivimab and etesevimab administered together include nausea, dizziness, pruritus, and rash.
The EUA was issued to Eli Lilly and Co.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
