Wayne County health officials are expected to issue COVID-19guidance to schools on Friday.
The health and safety of the students in Wayne County is our top priority as we welcome them back to school this year," saidDaveda Colbert, superintendent at the Wayne Regional Educational Service Agencies, or RESA,in a statement.
RESA, which provides services and support to more than 30 districts in the county, has been in ongoing conversations with the county health division throughout the pandemic about safety mitigation measures, she said.
Colbert saidthe health department was expected to offer additional direction on mitigation measures and safety procedures on Friday.
"The work of our educators across the county in preparation for this school year has been extraordinary, especially given the ongoing challenges presented by the pandemic," she said. "I know they are all eager to welcome students back to school in a safe and secure learning environment that protects the health and wellbeing of their students."
The county has not formally decided on a mask policy as of Thursday night.
Tiffani Jackson, a spokeswoman for Wayne County Executive Warren Evans, said Wednesday that we are in discussions with school districts and communities and heavily considering the implementation of a mask mandate for in-person learning.
On Thursday night, she told The Detroit News in an email that county officials would "have something solidified tomorrow."
Others were weighing in, meanwhile, to urge the county to issue a mask order. Seven state Democratic senators sent a letter to the Wayne County Health Department, citing "serious and severe cases" of young children contracting the virus and "potential long-term side effects." They calledfor a county-wide mask requirement in schools, Sen. Dayna Polehanki, 7th District, said Thursday on Twitter.
"We write to you today to respectully request that the Wayne County Department of Health, Human and Veterans Sevices issue an emergency health order, with immediate effect, requiring masks to be worn by every student, teacher, and staff memmber in all Wayne County public shcools regardless of vaccination status," the lettter said.
"... School districts, in large measure, wanted the ability to make COVID-related decisions at the local level, but becaue they are not public health experts, they need bold, science-based guidance from you and your team of medical experts."
A mask mandate for the state's largestcounty would be the latestas the delta variant of COVID-19 surges through Michigan and has pushed most counties in the state into a high transmission rate for the variant.
It would also affect the most students, following Oakland County's decision this week for 210,000 students. According to RESA, there are 33 school districts in 43 Wayne County communities serving approximately 226,000 students.There also are 108 public school academies serving 64,000 students.
Other counties have issued mask mandates, including Oakland, Genesee, Kalamazoo, Allegan, Kent and Ottawa, although some, like Genesee, only require masks for students in grades K-6.
The list is likely to grow. COVID-19 transmission is high enough inMichigan's 83 counties, where 72 arelisted as high for transmission of the delta variant and 11 others listed as substantial, that an overwhelming majority of stateresidents should be wearing masks while in public under federal guidelines, according to the latest data from the Centers for Disease Control and Prevention.
On Wednesday, Michigan added 4,326 new COVID-19 cases and 38 deaths from the virus. The figures brought overall totals to 937,720 cases and 20,161 deaths since the pandemic began in March 2020.
Last week, the state reported 10,807 new cases, up 14% from the 9,467 cases disclosed over the previous seven-day period.
Michigan's COVID-19 hospitalizations havesurpassed1,100 inpatients, and new infection numbers have been climbing for a month.
Through Wednesday, 65.3% of Michigan residents age 16 or older had received at least one COVID-19 vaccine dose, according to the state health department.
The Oakland County Health Division issued an emergency health order Tuesday that affects about 210,000 students across 28 publicschool districts and 22 charter schools academies.The order also applies to daycare centers and vocational schools.
The move sparked a protest outside county health division offices in Pontiac on Wednesday. About 150 parents railed against the mandate decision that applies regardless of vaccination status.Some said they would sendtheir children to schoolwithout masks, turnto home-schooling or try to overturn the emergency health order in the courts.
Hours later, parents and community members demonstratedoutside the Macomb County Health Department in Mount Clemens to urge the county to institute amask mandate this school year.
Gov. Gretchen Whitmer has defended her decision not to issue a statewide mask mandate despite advice from the state's chief medical executive as well as urging from federal officials and the White House.
She told reporters Monday there are mitigating measures such as vaccines. "We now have tools so that we can take action to protect ourselves and those around us," she said.
Whitmer added that nearly 35% of Michigan students were in districts that have implemented mask requirements.
In response to the COVID-19 public health emergency, states and the federal government took a range of actions in Medicaid to enhance capacity to respond to the public health and economic crises. The COVID-19 pandemic had wide ranging effects across Medicaid, impacting providers, beneficiaries, and long-term services and supports (LTSS). States were able to use Medicaid emergency authorities to address specific challenges and make necessary changes as circumstances evolved and new challenges emerged.
Although the federal public health emergency (PHE) remains in place, as vaccine rates increased and COVID-19 cases declined earlier this year, many state-level emergency declarations expired and states started to terminate some Medicaid flexibilities beginning in late Spring and early Summer of 2021. However, the Delta variant and low vaccination rates in some areas may present additional challenges. The Biden Administration has indicated it intends to extend the public health emergency until at least the end of calendar year 2021, but a continued wave of infections, hospitalizations, and deaths could lead to further extensions and continued emergency authorities in Medicaid.
This brief summarizes how states have used Medicaid emergency authorities related to the COVID-19 PHE, providing potential lessons for future public health and economic crises.
The declarations of a national disaster and a public health emergency allow for the use of a range of Medicaid emergency authorities. These authorities include Disaster-Relief state plan amendments (SPAs), Section 1135 waivers, Section 1915(c) Appendix K waivers, and Section 1115 waivers. States can also make Medicaid program changes during a PHE using existing administrative authorities and traditional SPAs. In addition, Congress enacted major federal legislation to respond to the COVID-19 emergency, including funding to support Medicaid and increase access to Medicaid coverage. The PHE began on January 27, 2020, and the most recent declaration extended the PHE through October 18, 2021, however; the Biden administration has indicated it will continue to renew the PHE through the end of 2021 and that states will receive 60 days notice prior to its expiration or termination.
The unprecedented nature of the COVID-19 pandemic resulted in wide adoption by states of available Medicaid emergency authorities to expand Medicaid capacity and target services, providers, and enrollees that were impacted by the coronavirus emergency. Based on our tracking between March 2020 and July 2021, all 50 states and DC received approval to make changes through Disaster-Relief state plan amendments (SPAs), Section 1135 waivers and Section 1915(c) Appendix K waivers. Additionally, twelve states received approval for changes through a Section 1115 waiver and six states made changes through regular SPAs. States adopted many policies through these existing authorities similar to previous disasters, including to connect individuals to coverage more quickly and to address needs of affected populations.
States used Medicaid emergency authorities to make changes across a number of policy areas during the COVID-19 PHE to address the effects of the emergency. We analyzed specific state actions in more detail in a series of briefs, linked below. State actions included:
Use of Medicaid emergency Section 1115 authority differed from previous emergencies. Historically, states have used Section 1115 authority to expand coverage and/or provide uncompensated care to address the direct impact of natural disasters and public health emergencies (likeNew York City after 9/11,Hurricane Katrina, andFlint Michigan) on state Medicaid and Childrens Health Insurance Program (CHIP) programs. In response to the COVID-19 PHE, however, CMS targeted the emergency Section 1115 waiver demonstration opportunity to HCBS flexibilities. While states initially submitted Section 1115 waivers with a broader approach, CMS approved few waivers and mostly limited the scope to authorities in the application template.
Medicaid emergency authorities related to the PHE expire at different times, but states can choose to continue some of these changes even after the PHE ends (Table 1). The PHE ends when the Secretary declares that the emergency no longer exists, or after 90 days from the last PHE extension, whichever happens first. As noted above, the Biden Administration has indicated the PHE will last at least through 2021. Policy changes such as streamlining eligibility and enrollment, adding benefits and increasing provider rates that were made through Disaster-Relief SPAs can be continued after the emergency through regular SPA authority. Similarly, states may submit 1915(c) waiver amendment requests to continue some Appendix K options (such as expanded telehealth, new services, and increased ability to pay family caregivers) after the PHE. States may also submit Section 1115 requests to continue some emergency flexibilities.
Lessons learned from Medicaids response to the COVID-19 PHE can inform continued pandemic response and recovery as well as future emergencies. To facilitate states adoption of emergency authorities during the COVID-19 PHE, the federal government issued templates, guidance documents and held state calls to communicate with states. These weekly state calls helped to provide timely guidance and to answer emerging questions as the federal government and states were moving quickly to implement new legislative provisions as well as emergency authorities designed to facilitate enrollment, access to care and reimbursement for providers. Preprint templates allowed states to quickly apply for and adopt flexibilities specifically addressed to COVID-19 challenges, especially given that states faced staffing shortages due to social distancing and illness. Once adopted, states and the federal government communicated with providers and enrollees to inform those impacted by the policy changes and to ensure that additional resources were utilized. Policy flexibilities during the COVID-19 PHE strengthened Medicaids ability to serve as a safety net during the pandemic and economic downturn by providing coverage to individuals who lost their jobs and supporting providers who experienced reduced income. The Biden Administration has indicated a continued focus on Medicaid as a key part of the social safety net during the COVID-19 recovery and beyond, including increasing support for HCBS services and increasing adoption of the Medicaid expansion. Going forward, understanding how the process of adopting and implementing changes during the pandemic worked and what could be improved will be important in continuing to respond to the current emergency and the Delta variant as well as future emergencies.
Looking ahead, some states had begun to unwind emergency authorities and were planning for a return to normal operations; however, they may face challenges due to rising cases as a result of the Delta variant and low vaccination rates in some areas. The Biden Administration recently updated previous guidance to states on the end of the PHE on transitioning to normal operations, allowing additional time for states to complete renewals and redeterminations once the PHE ends. States began to roll back emergency authorities and plan for normal operations beginning in late Spring and early Summer of 2021 as vaccination levels increased and cases declined. More recently, however, states are again seeing increased cases due to the Delta variant. States with areas of low vaccination rates in particular may face challenges and disruptions similar to those experienced earlier in the pandemic. If states have terminated emergency Medicaid flexibilities that increased access to coverage and care, they may have reduced ability to address the effects of the Delta variant on providers and individuals. Increased case levels due to coronavirus variants may result in the Biden Administration continuing to extend the PHE into 2022, which would also have implications for maintenance of effort requirements for states, further extending the time which they must provide continuous Medicaid coverage and keeping many emergency authorities in place longer.
The ultrastructural morphology exhibited by the 2019 Novel Coronavirus (2019-nCoV), which was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China, is seen in an illustration released by the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, U.S. January 29, 2020. Alissa Eckert, MS; Dan Higgins, MAM/CDC/Handout via REUTERS
MEXICO CITY, Aug 26 (Reuters) - Researchers at the National Autonomous University of Mexico (UNAM) have created a facemask using silver and copper nanolayers that neutralizes SARS-CoV-2, the virus that causes COVID-19, the university's official gazette said on Thursday.
UNAM is calling the triple-layered antimicrobial facemask SakCu; Sak means silver in Mayan and Cu is the chemical symbol for copper.
To test the mask, researchers took drops with the virus from COVID-19-positive patients at the Hospital Juarez in Mexico and placed them on the silver-copper film deposited in polypropylene.
UNAM said that if the viral concentration was high, the virus disappeared by more than 80% in about eight hours and if the viral load was low, in two hours none of the virus RNA was detected.
"Upon contact with the silver-copper nanolayer, the SARS-CoV-2 membrane breaks and its RNA is damaged," the gazette said. "Thus, even if SakCu is disposed of improperly, it will not be a problem as it does not remain contaminated, like many of the masks that are thrown away."
The facemask is reusable and can be washed up to 10 times without losing its biocide properties.
UNAM is not mass-producing the facemask and said that it currently has the capacity to produce 200 of them per day.
The research was led by UNAM's Materials Research Institute. It has not been peer reviewed.
Reporting by Anthony Esposito; Editing by Leslie Adler
Our Standards: The Thomson Reuters Trust Principles.
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DHHR has confirmed the deaths of an 84-year old male from Marion County, a 50-year old male from Nicholas County, a 78-year old male from Raleigh County, a 92-year old female from Raleigh County, an 81-year old male from Cabell County, a 64-year old male from Upshur County, a 76-year old male from Marshall County, a 92-year old female from Berkeley County, a 50-year old male from Monroe County, a 68-year old male from Upshur County, an 81-year old female from Nicholas County, a 94-year old male from Marion County, and a 66-year old male from Pocahontas County.
This is another solemn day for West Virginia as we experience more deaths, said Bill J. Crouch, DHHR Cabinet Secretary. Our hearts go out to these families for their loss. Please take every precaution to slow the spread of this disease including vaccination.
CASES PER COUNTY: Barbour (1,839), Berkeley (14,191), Boone (2,358), Braxton (1,175), Brooke (2,381), Cabell (10,142), Calhoun (450), Clay (641), Doddridge (693), Fayette (4,020), Gilmer (983), Grant (1,393), Greenbrier (3,199), Hampshire (2,098), Hancock (2,999), Hardy (1,703), Harrison (6,879), Jackson (2,488), Jefferson (5,207), Kanawha (17,231), Lewis (1,640), Lincoln (1,809), Logan (3,658), Marion (5,151), Marshall (3,978), Mason (2,385), McDowell (1,856), Mercer (5,824), Mineral (3,207), Mingo (3,082), Monongalia (10,050), Monroe (1,404), Morgan (1,418), Nicholas (2,177), Ohio (4,775), Pendleton (785), Pleasants (1,029), Pocahontas (775), Preston (3,161), Putnam (5,974), Raleigh (7,949), Randolph (3,384), Ritchie (831), Roane (790), Summers (950), Taylor (1,480), Tucker (632), Tyler (884), Upshur (2,492), Wayne (3,649), Webster (693), Wetzel (1,689), Wirt (505), Wood (8,825), Wyoming (2,393).
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. Please visit www.coronavirus.wv.gov for more detailed information.
West Virginians 12 years and older are eligible for a COVID-19 vaccine. To learn more about the vaccine, or to find a vaccine site near you, visit vaccinate.wv.gov or call 1-833-734-0965. West Virginians ages 12 and older who have had at least one dose of the COVID-19 vaccine can register for the second Do it for Babydog: Save a life, Change your life vaccine sweepstakes by visiting doitforbabydog.wv.gov.
Free pop-up COVID-19 testing is available today in Barbour, Berkeley, Boone, Fayette, Hampshire, Jefferson, Lincoln, Mineral, Mingo, Monroe, Ohio, Taylor, and Wood counties.
Barbour County
9:00 AM 12:00 PM, Barbour County Health Department, 109 Wabash Avenue, Philippi, WV
3:00 PM 7:00 PM, Junior Volunteer Fire Department, 331 Row Avenue, Junior, WV
Berkeley County
1:00 PM 5:00 PM, Shenandoah Community Health, 99 Tavern Road, Martinsburg, WV
10:00 AM 5:00 PM, 891 Auto Parts Place, Martinsburg, WV
4:30 PM 8:00 PM, Dorothy McCormack Building, 2000 Foundation Way, Martinsburg, WV
Boone County
12:00 PM 4:00 PM, Boone County Health Department, 213 Kenmore Drive, Danville, WV (optional pre-registration: https://wv.getmycovidresult.com/)
Fayette County
3:00 PM 6:00 PM, Gateway Center, 1 Greyhound Lane, Smithers, WV
Hampshire County
10:00 AM 5:00 PM, Hampshire County Health Department, 16189 Northwestern Turnpike, Augusta, WV
Jefferson County
10:00 AM 6:00 PM, Hollywood Casino, 750 Hollywood Drive, Charles Town, WV
Lincoln County
9:00 AM 3:00 PM, Lincoln County Health Department, 8008 Court Avenue, Hamlin, WV (optional pre-registration: https://wv.getmycovidresult.com/)
Mineral County
10:00 AM 4:00 PM, Mineral County Health Department, 541 Harley O. Staggers Drive, Keyser, WV
Mingo County
10:00 AM 2:00 PM, Seven Eleven, 11 West Second Avenue, Williamson, WV
Monroe County
1:00 PM 3:00 PM, Monroe County Health Department, 200 Health Center Drive, Union, WV
Ohio County
9:00 AM 3:30 PM, Ohio Valley Medical Center (former main entrance/turning circle), 2000 Eoff Street, Wheeling, WV
Taylor County
2:00 PM 4:00 PM, Grafton-Taylor County Health Department, 718 West Main Street (parking lot at Operations Trailer), Grafton, WV
Wood County
12:00 PM 4:00 PM, New Hope Baptist Church, 1777 Rosemar Road, Vienna, WV
There have been more cases of students and staff catching COVID-19 during the first threeweeks of school this year than all of last school year inManatee County, and Sarasota County is not far behind.
As of Thursday, Manatee was reporting 1,156 positive cases among students and 200 among staff. Last year, the school district had 1,119 total cases among students and staff for the entire year.
In Sarasota, the district's COVID-19 numbers have been growing at an unprecedented rate.
As of Thursday, the district was reporting that 1,436 students and 232staff members have tested positive since July 1, for a total of 1,668 cases in just 13 days of school. (Some of those cases were over the summer, but the vast majority have been reported since school began Aug. 10.)
In Sarasota: Sarasota School Board mandates masks in school; DeSantis says move is illegal
More: Manatee schools make masks mandatory, but parents can opt out
Last year, Sarasota had2,266 cases for the entire year, a number the district will likely surpass in the coming days if it keeps up the current pace.
The highest number of new cases Sarasota had in one week last year was 322, the week after Winter Break. This year, the district has beenaveraging roughly 128 new cases per day.
While the numbers are climbing steadily, at this point the vast majority of students are in school and not getting sick.
Manatee's total student cases amount to 2% of the total student enrollment. Sarasota's total student cases amounts to roughly 3% of enrollment.
On Tuesday, the Manatee County School Board voted to extend its optional mask mandate. Students in Manatee are required to wear masks unless their parents turn in an opt-out form, and the policy will be suspended if the seven-day positivity rate falls to 8%.
According to district spokesman Mike Barber, 5,336 students in traditional schoolshave turned in opt-out forms (charter schools keep their own numbers). That means roughly 15% of students in Manatee'straditional K-12 schoolshave opted out and 85% are expected to wear masks.
Administrators in both districts have said that makingmasks "mandatory" with an opportunity to opt out was no different than the existing mask-optional policy that Sarasota and Manatee began the year with.
While 85% of the district has, in theory, agreed to wear a mask in Manatee, there is no penalty if a student does not have an opt-out but still does not wear a mask.
Manatee School Board member Mary Foreman said that the lack of enforcement makes the policy far less effective.
"I am hearing from family members in the community that there may be three kids in a class of 20 that are wearing a mask...Obviously we arenot enforcing it," Foreman said.
Earlier this year: An unprecedented school year comes to an end in Sarasota
Also: Summer is here! School year comes to an end for the Manatee County School District
"We can only hold the superintendent accountable, but she needs to hold the schools and the principals accountable," she said.
Board Chairman Charlie Kennedy said to give the new policy time, and that as the case numbers rise kids will begin to see the importance of masking up so that events like homecoming or school plays don't get canceled.
"It is going to take some time," Kennedy said. "Anecdotally I'm hearing that (mask-wearing) is definitely higher now than it was the first week of school."
The Sarasota County School District is rolling out a mask-mandatory policy this week, with plans to begin enforcing mandatory masking at schools on Monday.
School officials have been developing rules for enforcement this week that wereexpected to go out to families Thursday evening, district spokesman Craig Maniglia said.
Sarasota's mask policy will remain in effect for the next 90 days, but it could be suspended earlier if the single-day positivity rate falls below 8% for three consecutive days.
The district has added a positivity rate tracker to its website. As of Thursday morning, the single-day positivity rate for the past three days had been 15.9% on Monday, 16% on Tuesday and 14.74% on Wednesday.
Ryan McKinnon covers schools for the Herald-Tribune. Connect with him at ryan.mckinnon@heraldtribune.com or on Twitter: @JRMcKinnon. Support the Sarasota Herald-Tribune by subscribing today.
10:03 AM ET
Marcel Louis-JacquesESPN
BUFFALO, N.Y. -- Buffalo Bills wide receivers Isaiah McKenzie and Cole Beasley on Thursday disclosed they were fined for violating the NFL's COVID-19 protocol.
McKenzie tweeted out a picture of the letter he was sent by the NFL detailing multiple documented violations of the protocol. He said in a subsequent tweet that he was fined $14,650.
"They got me!" McKenzie wrote. "@NFL you win!"
Beasley did not disclose how much he was fined, only saying on Twitter that he was disciplined for not wearing a mask for "literally 5 steps" from the entry door to the locker room after wearing it "that whole day."
"It's unfortunate when players get fined," Bills coach Sean McDermott said Thursday. "That being said, these rules have been agreed upon and in place and well-communicated for some time. And so it's important for us that we focus on being safe and healthy -- that's No. 1 and that's always been No. 1 -- and then No. 2 is doing our best to stay focused on the goal and the purpose of why we're here -- which is to win football games."
2 Related
According to the league's letter, McKenzie's discipline comes after he failed to wear a mask in the team facility on multiple occasions on Wednesday -- once while walking through the indoor fieldhouse into the training room and again in the meeting area of the weight room "while gathered near other players after the offensive meeting."
In addition to those violations, the league said it sent a written warning to him on July 27 saying that future violations would result in "increased discipline, including for conduct detrimental."
Under the NFL's COVID-19 policy, unvaccinated players are required to wear a mask throughout the team facility, which the league reminded McKenzie of in its letter Thursday.
"Your conduct is expressly prohibited by the Protocols," the NFL told McKenzie. "Again, your conduct potentially compromised not only your safety, but also the safety of others, as well as the league's ability to ensure that your club's training camp is conducted in a safe manner."
The violations come after the Bills sent six players home Tuesday who were deemed close contacts to a vaccinated staff member who tested positive for COVID-19. Beasley, Gabriel Davis, Star Lotulelei and Vernon Butler were all designated close contacts by the NFL and must remain away from the facility for five days, per NFL policy. The Bills also sent Matt Milano and A.J. Klein home for precautionary reasons, but neither were designated close contacts by the NFL and were allowed to return to practice Wednesday.
Beasley has been vocally opposed to the NFL's protocols for vaccinated and unvaccinated players and responded in support of McKenzie on Thursday.
"Don't worry they got me too," Beasley tweeted. "But I was wearing a mask when I was in close contact with fully vaxxed trainer who tested positive and still got sent home. So what's the point of the mask anyways?
"Meanwhile I'm here still testing negative and can't come back. Make it make sense."
McDermott said around 81% of the team is fully vaccinated. Buffalo has placed three players on the reserve/COVID-19 list due to positive tests this preseason, including starting left tackle Dion Dawkins -- who was hospitalized for four days as a result of the virus.
"I go back to the personal decision on this thing. I respect our players' positions," McDermott said Thursday. "In my personal opinion, it's right to get vaccinated."
McDermott said there's a fine line between the personal and competitive reasons surrounding players' choices to be vaccinated or not, but he stressed that final roster cuts will not based on players' decisions regarding the matter.
"That [choice of being vaccinated or not vaccinated] will not be a factor in deciding who stays and who goes," McDermott said.
On top of it, many are infected with a second virus at the same time -- usually respiratory syncytial virus, or RSV.
A fresh surge of Covid-19 is colliding with an unseasonable epidemic of RSV, and it's landing kids in hospitals across the country.
"The past few days, the past week, we've been seeing high numbers of children coming in," said Dr. Sarah Combs, a pediatric emergency medicine physician at Children's National Hospital in Washington, DC.
"You name it -- anything from the common cold to pneumonia to having respiratory distress, meaning we need to get some support breathing, and they're just coming in in higher and higher numbers," Combs told CNN. "In the summer, typically RSV is a non-issue. It's just not there."
It's the same in Texas.
"This Delta surge has been coupled with the re-emergence of other respiratory viruses," said Dr. Jim Versalovic, interim pediatrician in chief at Texas Children's Hospital in Houston.
And in Ohio.
"We are definitely seeing more RSV," Dr. Joshua Schaffzin, director of infection prevention and control at Cincinnati Children's Hospital, told CNN.
'Christmas in July' -- without the joy
"It's not seasonal. I have been calling it Christmas in July, because we usually see it around Christmas," he added.
"It's not exactly a gift. We are just seeing it at a time we typically don't."
The three hospitals, among others, are also seeing high numbers of other respiratory viruses such as parainfluenza 3, rhinoviruses and enteroviruses that cause hand, foot and mouth disease and other conditions.
"The interesting thing with rhinovirus is that normally it would cause just the common cold," Combs said.
"It's normally a very mild virus. It's the most common cause of the common cold, so it is unusual that we're seeing children get sicker than we'd expect. And really what we see is that children are just getting that much sicker, you know, they may be requiring things like BiPap to breathe." Bilevel positive airway pressure devices are a non-invasive type of ventilator that help ensure the lungs keep filling up with oxygenated air.
It's all new for 2021.
In 2020, Versalovic told CNN, "it was really mainly about Covid."
Now, hospitals are not only seeing more kids with Covid-19, and sicker than they were with Covid-19, but they're sicker with viruses that normally do not land most children in the hospital.
"We are working with other children's hospitals and the Centers for Disease Control and Prevention and the Children's Hospital Association to share data to explore this further," Versalovic said.
"The cases are there. The cases are rising. The children are getting sick. And so we need to be prepared to take care of them," Combs said.
The pediatricians see some clear reasons for what's causing the surges, and equally clear ways forward for preventing them.
Back to school for kids, and germs, too
"I think it's clear over the summer months we had children mingling playing out and about," Versalovic said. "Many children are now congregating in preschool and obviously grade school environments -- high schools too. So we also know they're involved in extracurricular activities and getting together socially and playing," he added.
"And we want children to develop and to be in class in person, but we have to continue to emphasize the importance of masking. Because masking doesn't just protect one from Covid but could also prevent these co-infections."
There's another factor. Kids have not been exposed to seasonal viruses for more than a year.
"I think one thing is that we essentially sheltered a lot of these children during Covid," Combs said.
"So there's a theory that their immune systems didn't have the normal low-lying, routine level of exposure to the normal routine viruses like rhinovirus, so they weren't able to mount those kind of micro-responses to viruses and keep themselves ticking over," she added.
"Essentially it was like a bubble child, right? You've had them contained. You've had them quarantined ... and then all of a sudden we released these children. They're often in summer camps and we're even looking at going back to school. So all of a sudden these relatively naive immune systems that have kind of been resting on their laurels for the past 18 months are forced to confront the normal load of viruses and it's just that much harder to fight them."
On top of that, said Schaffzin, people got tired of wearing masks, of washing hands, of keeping apart. The heat of summer drove many people back indoors.
"We can't say for sure whether the unmasking and people wanting to spend time with each other is causing more of an increase, but we're certainly seeing a lot more infections and for RSV, not at the typical time of year," he said.
The benefits of all that masking and social distancing earlier in the pandemic was made clear by the lack of a flu season in 2020-2021, Schaffzin said.
"On average, 125 children die of flu in the United States every year, but the range is between 40 to closer to 200," he said.
"Last year, there was one. And that's why masking, again, seems to be the answer."
The CDC did indeed report just a single pediatric flu death last season.
"I think this statistic of a single flu death last season in the United States was really striking, and there were many, many school systems that were open and functioning, many daycares that were open and functioning," Schaffzin said.
"And I think that really proves, the real-world data shows us, that masking is an inexpensive and effective intervention," he added.
Masks won't hurt you. Really
People don't like masks, but the pediatricians agreed that parents and governors making a fuss over mask mandates are wrongheaded.
"I'm not going to lie -- you're outside and there's 100% humidity, a high heat index, it doesn't feel great," Combs said.
But it's not dangerous to anyone to wear a mask.
"When people are uncomfortable from the mask it's because they feel overheated and they're either getting a little anxious, or the mask is uncomfortable. It's close up against their mouth. Sometimes they breathe in and they can feel it against their lips and it's not something they're accustomed to. And it makes people feel out of breath," Schaffzin said.
"It is a sensation. It is not an increase of carbon dioxide. It is not anything internal that's dangerous."
And children don't mind masks unless their parents tell them they should.
"Kids tolerate masks really well. Kids tolerate masks a lot more than adults give them credit for," Schaffzin said.
"Especially if you make it fun, if you make it colorful or something that they enjoy, kids will not only have no problem but they'll want to wear the masks," he added.
"If you normalize masking, which is normal in many countries around the world, the controversy goes away."
The same goes for hand hygiene.
"You know there are lots of things that we do that we do for our own health that may not impact others' health. We brush our teeth. Some of us floss, exercise and whatnot, and what we do is we build those methods and those events into our daily routine, so that it feels weird if we don't do them," Schaffzin said.
"We're more likely to notice that we haven't brushed our teeth than we are to remember brushing our teeth on a given day. And what I would like to see is Covid prevention methods to be similar to that."
The pediatricians note that it's true masks can interfere with communication, especially in classrooms, where seeing someone's mouth or expression might be important.
"We need more data in terms of the social effects of masks and we can't dismiss that outright," Schaffzin said.
There are work-arounds. For instance, clear masks, sometimes used at children's hospitals, can help, he said.
"There's always a way around it. Humans innovate. It's what they do," he added.
'We can control a pandemic'
"We have not found a way to prevent every respiratory disease, but we do have mechanisms, including hand hygiene and including masking and including avoiding people who are sick, that when we do them together, reliably, we actually can prevent transmission," Schaffzin said. "We can control a pandemic."
Combs echoed this.
"What we know, numbers wise, is that we were successful when we put all the measures in place," she said. But people have started letting down their guard.
"There's a lot of fatigue around with doing the same things over and over, especially with seeing these peaks come and go and come and go. But what we do know is that when we mask appropriately, especially if you have a well-fitting mask or even a double mask technique, if everyone in a certain area is wearing that appropriate masking, that's going to be about 95% effective at preventing transmission or spread," she said.
And that will be the same whether the virus being kept at bay is Covid-19, or RSV, or rhinovirus or parainfluenza virus.
Since Covid-19 patients started showing up at clinics and hospitals a year and a half ago, doctors and researchers have been hard at work trying to figure out how to treat them. Most drugs and treatments havent panned out, producing either no results or small ones in large-scale clinical trials. Many of the few that work are expensive and difficult to administer.
Hydroxychloroquine, enthusiastically endorsed by President Trump last year, has been shown to have no measurable benefits. New drugs like monoclonal antibodies proteins meant to imitate the immune systems response to the disease have been approved by regulators but must be administered by a doctor through an IV or series of injections.
But scientists havent stopped searching, and the results of a new massive clinical trial suggest theyre getting somewhere. In a large, randomized clinical trial conducted with thousands of patients over the past six months, researchers at McMaster University tested eight different Covid-19 treatments against a control group to figure out what works.
One drug stood out: fluvoxamine, an antidepressant that the Food and Drug Administration has already found to be safe and thats cheap to produce as a generic drug.
These new results follow some promising findings in small-scale trials last year. In those smaller studies, researchers found that fluvoxamine was strikingly good at reducing hospitalization for Covid-19 patients but small-scale trials can sometimes turn up spurious good results, so those findings were obviously tempered by a lot of caveats.
This study, called the TOGETHER study, is a lot bigger more than 3,000 patients across the whole study, with 800 in the fluvoxamine group and supports the promising results from those previous studies. The authors released it this week as a preprint, meaning that it is still under peer review.
Patients given fluvoxamine within a few days after testing positive for Covid-19 were 31 percent less likely to end up hospitalized and similarly less likely to end up on a ventilator. (Death from Covid-19 is rare enough that the study has wide error bars when it comes to how much fluvoxamine reduces death, meaning its much harder to draw conclusions.) Its a much larger effect than any that has been found for an outpatient Covid-19 treatment so far.
This is a huge finding, study co-author Ed Mills, a professor of health sciences at McMaster University, told me. The game changers are things we already had in the cupboards.
What makes this result potentially such a big deal is that fluvoxamine is inexpensive and has already been FDA approved for obsessive-compulsive disorder (OCD), so any doctor can prescribe it for Covid-19 using their clinical judgment (whats called off-label prescribing). Its a pill, which means it doesnt need to be administered in a hospital or by a medical professional.
To be clear, these results have just been released, and clinicians around the world will want to take a close look at them as they decide whether or not to prescribe fluvoxamine. Future research could also moderate this exciting result.
Heres what we know: This is a large and well-designed study that affirms previous studies that pointed in the same direction. More research is needed, but the results from this trial might already start changing how we treat Covid-19. And the way researchers stumbled upon the drug as a potential treatment is a worthwhile story in itself about the scientific process and the unseen and often unheralded work thats helping humanity fight the pandemic.
Covid-19 treatments fall into two categories: treatment for severe illness, generally administered in the hospital to reduce the risk of death; and treatment for the onset of illness, which hopefully reduces the odds that a patient will need to be hospitalized at all.
The FDA has granted emergency authorization to a variety of Covid-19 treatments, but the evidence base for many is limited and the effect sizes have tended to be small. Hopes were high for repurposed antiviral drugs, for instance. Many of them are routinely administered and at least one was shown to reduce the length of hospital stays, but some studies have found no effect on mortality.
The same is true of convalescent plasma, transfusions of blood proteins from people who recovered from Covid-19. After more than a year of research, it mostly looks like these treatments arent effective, though theres still lots we dont know.
The FDA has issued emergency use authorization for monoclonal antibody treatments proteins that mimic the ones the immune system would produce to fight off the virus for those at severe risk from Covid-19. Monoclonal antibodies are also infused intravenously or as a series of four injections. They cost $2,100 a dose, which in the US is paid by the federal government so they are free to patients. They seem to work best when given early, pre-hospitalization, and while under those conditions they appear to be highly effective. However, getting people who recently tested positive for Covid-19 and still have mild symptoms to a medical setting for an intravenous infusion or four injections is a logistical challenge and the cost and the difficulty of delivery mean monoclonal antibodies will never be an option in much of the world.
Corticosteroids, which are powerful anti-inflammatory medicines, have a solid track record. Studies have found that administering the cheap steroid dexamethasone, which can be given as a pill or an infusion, to patients hospitalized with Covid-19 reduces their risk of death. But because it can constrain the immune system, it isnt recommended early in the course of the disease, when the main concern is the direct damage from the virus.
That leaves a glaring hole: Where are cheap, outpatient treatments that can reduce the risk of hospitalization in the first place and dont require a medical professional to administer in a medical setting? Fluvoxamine could hopefully fill that gap.
Fluvoxamine is an antidepressant, and in the US, its mostly prescribed for treating OCD. It is what is known as an SSRI, short for selective serotonin reuptake inhibitor the same class of drugs as popular antidepressants like Zoloft, Prozac, and Lexapro.
Through an unusual journey, it ended up on scientists radars as a potential Covid-19 treatment and subsequent research seems to bear that out.
Years ago, before the novel coronavirus had infected its first patient, Angela Reiersen, a psychiatrist at Washington University in St. Louis, was studying patients with a rare genetic disorder called Wolfram syndrome, which affects cellular stress responses. She noticed that they seemed to tolerate some SSRIs well and others poorly and dove into the differences in SSRI chemistry to figure out why.
It turned out that one of the SSRIs that worked well, fluvoxamine, binds to a receptor in cells that regulates cellular stress response and the production of cytokines, proteins that tell the body something is wrong and cause inflammation. Researchers at the University of Virginia found that fluvoxamine reduced inflammation in animals. Reiersen wondered if that was why it worked well for her patients.
Then the pandemic hit. One leading theory of what happens when patients suffer through Covid-19 is that cells damaged by the disease release tons of cytokines, which then causes inflammation in the lungs that can make it hard to breathe and cause lasting tissue damage. Early in the pandemic, Reiersen went to her colleagues at the Washington University School of Medicine in St. Louis with a wild idea: Fluvoxamine might help Covid-19 patients.
Eric Lenze, a leading clinical researcher, agreed they should test it with a randomized controlled trial. I emailed him on March 25, 2020. We got the trial started by April 10, Reiersen told me.
They spent the spring and summer recruiting and treating Covid-19 patients. By the fall, they had results: Of the 152 participants, half in the placebo group (receiving a sugar pill rather than active medication) and half in the fluvoxamine group, six patients in the placebo group had met their studys threshold for respiratory difficulties. None in the fluvoxamine group had.
The results were published in the Journal of the American Medical Association. What I think is the most supported mechanism is an anti-inflammatory effect, Reiersen told me. Fluvoxamine can reduce the level of these chemicals called cytokines, which are involved in inflammation, so youd get less damage in the lungs.
The results were promising, but 152 patients isnt that many. Reiersen and Lenze started recruiting for a larger-scale trial, looking for more evidence that fluvoxamine could be a first-line Covid-19 treatment.
In the meantime, evidence was coming in from other angles, too. After a mass outbreak in California, researchers gave affected people the option to take fluvoxamine; 65 people opted to take it and 48 declined. None of those who took it required hospitalization, while six did among those who declined it.
In France, Nicolas Hoertel, a psychiatry researcher at the University of Paris who is not affiliated with the TOGETHER study, had conducted and published an observational study finding that patients on certain antidepressants were less likely to have severe Covid-19. This effect is not just fluvoxamine, but its not all antidepressants, he told me.
Observational studies dont assign patients a specific treatment but just record what treatment they receive and how well they do. They dont involve randomization, so they can be misleading if, say, people on antidepressants are systemically different from people not on antidepressants or if people who agree to try an experimental medication are healthier than people who refuse. So the results from these studies couldnt be taken as definitive but it was additional data.
The limited, promising literature around fluvoxamine prompted its inclusion in the large-scale study of treatments for Covid-19 run by Ed Mills at McMaster University and primarily conducted in Brazil. Dubbed the TOGETHER study after other prominent mega-clinical trials like RECOVERY and SOLIDARITY by other organizations, it randomized patients across eight prospective treatments, including metformin (a diabetes medication), hydroxychloroquine (an antimalarial), and ivermectin (an antiparasite).
The team announced their results at an August 6 symposium that was sponsored by the National Institutes of Health. Most of the treatments failed: Their study couldnt detect an effect. A lot of drugs against Covid just dont work very well, Mills told me. Two other treatments were still in progress, and it was too early to rule out the chance that theyll work.
But fluvoxamine was a different story. In the trial, it improved patient outcomes substantially and while its not the first drug to do that, ease of delivery and price give it the potential to have an outsized impact on patient care, especially outside the rich world.
In the research conducted so far, fluvoxamine was prescribed to patients who started experiencing Covid-19 symptoms.
In the TOGETHER study, they typically visited a doctor to enroll in the trial and start taking medication or a placebo three days after their symptoms began.
The results of the study are strong enough that researchers are suggesting changing clinical practice to recommend fluvoxamine to people with symptomatic Covid-19.
We have now growing evidence from different kinds of research technical, clinical indicating that [treatment with certain antidepressants] is very likely to be effective in Covid, Hoertel said. The likelihood of benefits is very high.
Critical to changing clinical recommendations is having enough information about the risks and benefits of a treatment. Since fluvoxamine is decades old, its risks are already well understood.
We know a great deal about the safety and tolerability of fluvoxamine, Lenze told me. It can cause in about one-quarter of people some nausea, which is usually mild. Its not fatal even in overdose, its been around for over a quarter of a century so theres not going to be any unpleasant surprises about safety issues, and its really easy to use its just a pill. I dont see anything that should stop people from taking it.
There are still things scientists want to know about fluvoxamine, including exactly how it works within the body. And pinning down precisely how much the drug reduces hospitalization and death will definitely take more evidence though from the 31 percent reduction in hospitalizations in the McMaster study, the researchers who spoke to Vox think its likely that the effect is real and sizable.
The TOGETHER trial hasnt yet been peer-reviewed, though I spoke with numerous unaffiliated researchers whod seen the results and found them convincing.
Bottom line, in my opinion at least, Ed [Mills]s finding proves that the drug works, Lenze told me.
Weve all been burned by promising studies of these repurposed drugs, and its quite reasonable to reserve final judgment until we see the complete data, and even other studies. ... But this already feels different from hydroxychloroquine and company given the high quality of the research, Paul Sax argued in NEJM Journal Watch Infectious Diseases. We might finally be onto something.
Another possibility to account for when looking at clinical trial data is publication bias studies that find results get published, while those that find null results often dont. Lenze is attempting a large-scale replication of his small-scale fluvoxamine study from last year, and so far hasnt been able to validate the huge reduction in hospitalizations he found the first time around mainly because recruiting for Covid-19 clinical trials in the US has gotten increasingly difficult as most high-risk people are vaccinated and not at risk of hospitalization, and unvaccinated people are less likely to enroll in clinical trials or adhere to a recommended course of medication. (The TOGETHER study got around this problem by recruiting in Brazil.)
Another worry is that variants will make our understanding of Covid-19 treatments obsolete as soon as we develop one. The TOGETHER study was mostly conducted before the delta variant predominated in Brazil. Theres no strong reason to think fluvoxamine wouldnt work against delta, but well need additional research to see if the effect size remains the same.
But crucially, we dont have to answer every unanswered question for doctors to prescribe fluvoxamine to patients. Researchers do have answers to the questions of Is the drug safe? and Does the balance of evidence suggest significant improvement in patient outcomes? The evidence on those two points looks convincing, so even though theres lots more to learn, the researchers and clinicians studying fluvoxamine feel ready to say that the drug is a good idea.
One question lots of doctors and patients have about a Covid-19 treatment, of course, is: Is it FDA-approved? Fluvoxamine is FDA-approved but for OCD, not for Covid-19. In fact, Lenze told me, I dont think the FDA ever will approve it for Covid. The reason the FDA will never approve it for Covid is exactly the reason its so useful for Covid, namely its cheap and its widely available. No one can make any money off it, so no one is going to spend the money to appeal to the FDA to approve it.
Doctors can prescribe drugs the FDA has approved as a treatment for one condition to treat another condition off-label, using their clinical judgment. Doctors may vary in how comfortable they feel with it, but it is common and fully permitted by US regulations.
One other thing about the emergence of fluvoxamine worth discussing is the process by which it happened: a new approach to clinical trials that is changing how we find new treatments.
Conducting clinical trials takes a long time. Most people will not be eligible to join a given trial. Finding the eligible ones and recruiting and enrolling them is time- and labor-intensive.
In order to find moderate-effect sizes and be confident in the results, a clinical trial needs to enlist thousands of patients, but that also means it will take much longer to recruit for and conduct and with Covid-19, delays have costs in human lives. Clinical trials on this scale are expensive, too. TOGETHER is funded by private philanthropists, including Fast Grants, an initiative by Silicon Valley billionaire Patrick Collison and economist Tyler Cowen to speed pandemic response by getting grant money out rapidly.
For the past year, Mills has been using a new approach to clinical trials in order to test potential Covid-19 treatments faster. The key thing was to conduct them in parallel using whats called an adaptive platform trial. Theyre multi-armed, so youre testing lots of substances at a time, which allows you to only have one control group, Mills told me. What all of the useful trials in Covid have in common is that theyre an adaptive platform trial.
Running, say, eight clinical trials, with eight control groups, requires many thousands of patients to get an informative sample, which can take a long time. Having eight experimental groups sharing a single control group cuts the number of patients required nearly in half.
This study model reallocates patients among treatment groups once a given treatment has been demonstrated not to work. That leads them to have larger, more convincing sample sizes for the most promising treatments. You make decisions based on the data that emerges early, Mills said. After you have randomized 200 patients to the drug, if you cant tell that its working, its probably not a very good drug. Every drug thats not showing effects is a waste of patients.
Fluvoxamine was one of eight treatments Mills and colleagues tested. Over time, as other treatments showed no effect, more patients got randomized to the fluvoxamine arm of the trial letting the researchers learn more about the drug that seemed the most promising.
Mills says that played a huge role in their ability to quickly figure out what worked and what didnt. Prior to Covid, it was really just MD Anderson [the cancer hospital in Houston] doing this design. I think its going to be how almost all clinical trials happen going forward.
Now that there are Covid-19 vaccines, the race for a treatment might seem less urgent than it was last year. But researchers say that mindset would be a mistake.
Vaccine uptake has stalled in most rich countries around 60 to 70 percent, and the delta variant means that the virus is still spreading. Effective treatments could mean dramatically fewer people hospitalized in places where hospitals are overwhelmed.
In poor countries, the situation is starker. Vaccines are not yet widely available, and the prospects for mass vaccinations are grim. And many existing treatments for Covid-19 are unaffordable for the global poor. Thats where fluvoxamines promise really comes in.
Its $2,000 for a dose for a monoclonal antibody, Mills told me. Our drug costs $4. The supply chain, too, is simpler. Fluvoxamine doesnt need to be kept in a freezer, doesnt expire quickly, and can be mass-manufactured cheaply. If it continues to show health benefits for Covid-19 patients, making it widely available in poor countries could help them weather delta.
The fight to discover new treatments isnt over, either. When I talked with Mills, he was excited about research in the UK finding that steroid inhalers another cheap, widely available medication reduced Covid-19 hospitalizations. Mills is also in the process of enrolling patients for a study of both steroids and fluvoxamine, to see whether the benefits are greater when patients take both drugs. We go from having no drugs for early treatment that are cheap and widely available to having two, he told me. What does it look like if we use them together?
The world is still months of research away from an answer to that question. But even the partial answers available today might make all the difference for some patients.
