FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19 – FDA.gov

FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19 – FDA.gov

funded COVID-19 testing initiative aims to safely return children to in-person school – National Institutes of Health

funded COVID-19 testing initiative aims to safely return children to in-person school – National Institutes of Health

April 16, 2021

News Release

Thursday, April 15, 2021

New RADx-UP research effort combines testing and safety measures in underserved populations.

The National Institutes of Health is awarding up to $33 million over two years to fund projects at 10 institutions across eight states to build evidence on safely returning students, teachers and support staff to in-person school in areas with vulnerable and underserved populations. This funding was made availableby the American Rescue Plan. Known as the Safe Return to School Diagnostic Testing Initiative, the awards are part of the NIH Rapid Acceleration of Diagnostics Underserved Populations (RADx-UP) program, which aims to increase COVID-19 testing access and uptake for vulnerable and underserved populations.Projects will combine frequent COVID-19 testing with proven safety measures to reduce the spread of the SARS-CoV-2 virus.

Many children have inequitable access to reliable virtual learning, and it is important they are able to participate safely in person while also maintaining the health and safety of the of the school and general communities, said Eliseo J. Prez-Stable, M.D., director of NIHs National Institute on Minority Health and Health Disparities and co-chair of the RADx-UP program. Establishing frequent COVID-19 testing protocols for schools in vulnerable and underserved communities is essential to the safe return to school effort, and these projects will inform decision makers on the best strategies to accomplish this.

Although many schools are offering both in-person and virtual learning options, some students face barriers to attending school remotely. For example, children may lack access to computer equipment and internet connectivity or may not have family members who can assist them with virtual learning. Moreover, without in-person schooling, many children forego school-based meals, speech or occupational therapy and after school programs. These barriers often disproportionately affect minorities, socially and economically disadvantaged children, and children with medical complexities and/or developmental disabilities.

Participating early childhood education and kindergarten through 12 schools include public, chartered, special education, and pediatric complex care that serve children in urban, rural and tribal communities. Attendance ranges from 50 to 3,500 children and populations are racially and ethnically diverse, including African Americans, American Indians/Alaska Natives, Latinos/Latinas, and Asian Americans. Schools were also selected for being in a school district with at least 50% of students receiving free or reduced-price lunch.

Some projects will involve at-home COVID-19 testing, while others will use pooled, in-school testing approaches. Study participants will receive either molecular or antigen tests, which can detect SARS-CoV-2 infection in samples from nasal swabs or saliva. Researchers will obtain parental consent prior to administering the diagnostic tests to children.

These awards will foster the development of comprehensive programs to meet the challenge of safely returning children to in-person schooling, particularly for children who are vulnerable to COVID-19 or who are at risk for significant disparities in access to testing, said Diana W. Bianchi, M.D., director of NIHs Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which is managing the initiative.

In the coming months, the RADx-UP program will make additional awards,pending availability of funds, to expand the initiative across more locations.

RADx-UPSM is a registered service mark of the Department of Health and Human Services.

About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD leads research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. For more information, visit https://www.nichd.nih.gov.

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.

NIHTurning Discovery Into Health

###


Continued here:
funded COVID-19 testing initiative aims to safely return children to in-person school - National Institutes of Health
COVID-19 reflection & healing at the San Antonio VA – VAntage Point – VAntage Point Blog

COVID-19 reflection & healing at the San Antonio VA – VAntage Point – VAntage Point Blog

April 16, 2021

Employees at the Audie L. Murphy Memorial Veterans Hospital gathered on a cool Friday morning in the Polytrauma Courtyard to reflect on the last year of the COVID pandemic and begin to bring about the healing as we recover.

Since receiving its first COVID patient on March 26, 2020, the South Texas Veterans Health Care System has experienced several losses, both Veterans and employees alike.

But on a morning like this one, as employees quietly gathered and warmly greeted each other before the ceremony began, a calming breeze brought in a heightened sense of renewal, with gently swaying trees overhead and softly chirping birds soothed even the most fragile of spirits.

Dr. Marcos Restrepo witnessed much of what transpired throughout the COVID units at the Audie L. Murphy Memorial Veterans Hospital and honored not only those who weve lost, but also saved.

We pray and we remember all their loved ones who have suffered so much, but today we also remember those losses and those sad moments, Restrepo said. We also remember those positive things that all of you have done for their services, for our Veterans, for our nation and for our community.

Employees reflected on the efforts of coworkers during the pandemic and how they never lost hope, even in the most difficult of times.

Valerie Rodriguez-Yu is the associate director for Patient Care Services. She saw employees demonstrate compassion and empathy for one another. Even with the burden of knowing that loved ones have been lost, they will not be forgotten.

You have gone above and beyond to care for our Veterans in an environment that has been extremely turbulent over the last year, Rodriguez-Yu said. We asked so much of you. Listened to your concerns. We shifted priorities more than once but always in the best interest of our Veterans. We may not have gotten it right every time, but we were in your corner every step of the way.

Memories were shared by employees who reflected on the efforts of coworkers during the pandemic. They expressed hope never lost, even in the most difficult of times.

When employee Eli Nieves-Perez performed His Eye Is On the Sparrow, there wasnt a dry eye in the crowd. Such powerful words reminded everyone of where we were, where we are and where we hope to be.

Christopher R. Sandles is the medical center director. He reflected on the hardships faced over the last year, telling the crowd he understood the importance of sharing his gratefulness for not only a vaccine that is now being offered to all Veterans but also knowing that we have each other to put the pieces back together again.

But after all of this, I am thankful, Sandles said. Im thankful for our incomparable soul. Im thankful that because of our amazing staff, clinical and non-clinical alike, lives were saved that would have otherwise been lost. Tell your story, please tell your story and lets begin to heal.

Dr. Julianne Flynn is the chief of staff. She reminded everyone we have kept to our true north and continue to provide the best care possible in the face of many challenges.

This is a day of reflection and remembrance, but do not forget our resilience, Flynn said. The path we have been on has demanded candor and humility from all of us. Many of us have shed tears and incredible support was the response.

To learn more of South Texas Veterans Health Care Systems efforts throughout COVID-19, visit https://www.southtexas.va.gov/features/index.asp.

Justin Saucier is a public affairs intern for the South Texas VA Health Care System.


Excerpt from: COVID-19 reflection & healing at the San Antonio VA - VAntage Point - VAntage Point Blog
Thailand to close schools, bars after surge in COVID-19 cases – Reuters

Thailand to close schools, bars after surge in COVID-19 cases – Reuters

April 16, 2021

A kindergarten student from Wichuthit school stands next to the mark during a rehearsal social distancing and measures to prevent the spread of the coronavirus disease (COVID-19) ahead of schoold reopening in Bangkok, Thailand, June 23, 2020. REUTERS/Athit Perawongmetha

Thailand will close close schools, bars and massage parlours, as well as ban alcohol sales in restaurants, for at least two weeks starting from Sunday after a jump in COVID-19 cases, a senior official said.

Activities involving more than 50 people will also be prohibited, Thailand's coronavirus taskforce spokesman, Taweesin Wisanuyothin, said, adding that 18 provinces including Bangkok had been labelled as red zones with the rest of the country categorised as orange zones.

Our Standards: The Thomson Reuters Trust Principles.


Visit link:
Thailand to close schools, bars after surge in COVID-19 cases - Reuters
COVID-19 hospital admissions on the rise in Southwest Florida – Wink News

COVID-19 hospital admissions on the rise in Southwest Florida – Wink News

April 16, 2021

FORT MYERS

Snowbirds may be leaving Southwest Florida but the number of COVID-19 admissions in some hospitals continues to increase.

Lee Health has watched admissions rise from 89 to 109 people over the last few days.

Little things over the last few weeks feel almost normal. There are more smiles and less fear as people continue to get vaccinated.

We just ate at a restaurant for the very first time the other day, inside, and I dont know it was still kind of awkward, said Amy Jones, who was visiting FGCU with her daughter.

Jones knows what its like to see family members get sick and become overwhelmed.

That was scary because we didnt know, thats when all of a sudden, youre like who has power of attorney, who has, its sort of like those questions that in your regular life maybe you didnt have to think about, Jones said.

A growing number of families are facing those questions, especially in the last two weeks due to hospitalization trending upward.

Hospitalizations are not nearly as high compared to Southwest Floridas peak in July when Lee Health had more than 300 hospitalizations.

This is the time of year when we have a lot of folks enjoying southern Florida for spring break, said Dr. Mary Beth Saunders, medical director for Infection Prevention and Epidemiology for Lee Health.

NCH said having more people around means more people will get sick.

The season used to end around Easter time but now its closer to Mothers Day. That and the fact that many are deciding to summer in Southwest Florida longer in order to avoid shutdowns up north is a perfect storm for COVID hospitalizations.

As for the increase in admissions, people are letting their guard down especially now that the vaccine is available.

Nancy Weatherly works in a hospital and knows some who has gotten sick post-vaccination.

Its very serious, Weatherly said. Should be taken seriously.


Go here to see the original:
COVID-19 hospital admissions on the rise in Southwest Florida - Wink News
Tracking COVID-19 in Alaska: 194 cases and 20 deaths reported Thursday after death certificate review – Anchorage Daily News

Tracking COVID-19 in Alaska: 194 cases and 20 deaths reported Thursday after death certificate review – Anchorage Daily News

April 16, 2021

We're making this important information available without a subscription as a public service. But we depend on reader support to do this work. Please consider supporting independent journalism in Alaska, at just $3.69 a week for an online subscription.

State data showed that eight of the newly reported deaths involved residents of Anchorage, along with three people from Fairbanks, one from Delta Junction, three from Wasilla, one from Sitka, one from a smaller community in the Yakutat plus Hoonah-Angoon region, one from the Kusilvak Census Area and one from the Dillingham Census Area. The 20th death involved a nonresident in Fairbanks, according to state data.

We had one (death) that occurred as far back as December. A fair number had occurred in February, and then some in March, said Louisa Castrodale, an epidemiologist with the state, during a call with members of the media on Thursday.

Reviewing death certificates to confirm cause of death is a lengthy process that involves a weekslong delay between when a death occurs and when its reported by the state. It takes around nine days for a death to be registered, and then up to three weeks for the federal Centers for Disease Control and Prevention to code and classify those deaths. CDC specialists rely on cause of death noted by a medical professional to certify each death.

This reporting process has been in place for decades and is considered the most accurate way COVID-19 deaths are tracked, health officials have said.

Some folks have a pretty complicated medical history and disease course, Castrodale said Thursday. Thats why for some of these deaths, we do wait for the death certificate review to have been completed before counting a death as a COVID-19 death, she explained.

Although case counts and hospitalizations in Alaska remain below what they were during a peak in November and December, the states average daily case rate has been increasing in recent weeks. Most regions in the state are still in the highest alert category based on their current per capita rate of infection.

Health officials continue to encourage Alaskans to wear face coverings in public, avoid large gatherings, wash their hands frequently and get vaccinated against COVID-19 to prevent further spread.

Alaska in March became the first state in the country to open vaccine eligibility to anyone 16 and older who lives or works in the state. You can visit covidvax.alaska.gov or call 907-646-3322 to sign up for a vaccine appointment; new appointments are added regularly. The phone line is staffed 9 a.m. to 6:30 p.m. on weekdays and 9 a.m. to 4:30 p.m. on weekends.

By Thursday, 288,731 people about 47% of Alaskans eligible for a shot had received at least their first dose. At least 232,392 people about 39% of Alaskans 16 and older were considered fully vaccinated, according to the states vaccine monitoring dashboard.

By Thursday, there were 39 people with confirmed or suspected cases of COVID-19 in hospitals throughout the state, far below a peak in late 2020 but part of a slight increase over the last few weeks.

Of the 185 cases reported among Alaska residents, there were 54 in Anchorage, plus four in Chugiak, nine in Eagle River and one in Girdwood; 54 in Wasilla; 20 in Palmer; 12 in Fairbanks; eight in Soldotna; four in North Pole; three in Kenai; two in Willow; two in Big Lake; two in Seward; one in Valdez; one in Delta Junction; one in Sutton Alpine; one in Sitka; one in Wrangell; one in Dillingham; and one in Chevak.

Among communities smaller than 1,000 people that arent named to protect privacy, there was one in the northern Kenai Peninsula Borough and one in the Kusilvak Census Area.

There were also nine new cases among nonresidents: two in Anchorage, one in Wasilla, one in Juneau, four in the Bristol Bay plus Lake and Peninsula area and one in an unidentified region of the state.

While people might get tested more than once, each case reported by the state health department represents only one person.

The states data doesnt specify whether people testing positive for COVID-19 have symptoms. More than half of the nations infections are transmitted from asymptomatic people, according to CDC estimates.


See the rest here: Tracking COVID-19 in Alaska: 194 cases and 20 deaths reported Thursday after death certificate review - Anchorage Daily News
COVID-19 Daily Update 4-14-2021 – West Virginia Department of Health and Human Resources

COVID-19 Daily Update 4-14-2021 – West Virginia Department of Health and Human Resources

April 16, 2021

The West Virginia Department of Health and Human Resources (DHHR) reports as of April 14, 2021, there have been 2,571,122 total confirmatory laboratory results received for COVID-19, with 147,203 total cases and 2,756 total deaths.

DHHR has confirmed the deaths of a 73-year old female from Harrison County, a 53-year old male from Marshall County, a 94-year old female from Berkeley County, a 65-year old male from Wood County, an 89-year old male from Marshall County, a 56-year old female from Cabell County, a 90-year old male from Wayne County, a 59-year old female from Raleigh County, and a 68-year old male from Putnam County.

We mourn the loss of these West Virginians and send our deepest sympathies to their loved ones, said Bill J. Crouch, DHHR Cabinet Secretary.

CASES PER COUNTY: Barbour (1,337), Berkeley (11,391), Boone (1,849), Braxton (857), Brooke (2,104), Cabell (8,578), Calhoun (271), Clay (444), Doddridge (536), Fayette (3,210), Gilmer (734), Grant (1,234), Greenbrier (2,578), Hampshire (1,680), Hancock (2,686), Hardy (1,425), Harrison (5,336), Jackson (1,882), Jefferson (4,281), Kanawha (13,834), Lewis (1,126), Lincoln (1,388), Logan (2,987), Marion (4,091), Marshall (3,247), Mason (1,922), McDowell (1,455), Mercer (4,526), Mineral (2,742), Mingo (2,396), Monongalia (8,897), Monroe (1,061), Morgan (1,063), Nicholas (1,468), Ohio (3,993), Pendleton (677), Pleasants (830), Pocahontas (632), Preston (2,790), Putnam (4,744), Raleigh (6,017), Randolph (2,487), Ritchie (653), Roane (571), Summers (743), Taylor (1,194), Tucker (524), Tyler (671), Upshur (1,812), Wayne (2,803), Webster (453), Wetzel (1,177), Wirt (375), Wood (7,548), Wyoming (1,893).

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 Roane and Tucker counties in this report.

Free COVID-19 testing is available today in Barbour, Berkeley, Boone, Calhoun, Doddridge, Jefferson, Lincoln, Marshall, Morgan, Ohio, Putnam, Raleigh, Tyler/Wetzel, and Wayne counties:

Barbour County

9:00 AM 11:00 AM, Barbour County Health Department, 109 Wabash Avenue, Philippi, WV

1:00 PM 5:00 PM, Junior Volunteer Fire Department, 331 Row Avenue, Junior, WV

Berkeley County

10:00 AM 6:00 PM, 891 Auto Parts Place, Martinsburg, WV

10:00 AM 6:00 PM, Ambrose Park, 25404 Mall Drive, Martinsburg, WV

Boone County

Calhoun County

9:00 AM 11:00 AM, Minnie Hamilton Health Center, Annex Building, 186 Hospital Drive, Grantsville, WV

Doddridge County

10:00 AM 2:00 PM, Crimson River Church Parking Lot, 1623 Doe Run Road, West Union, WV

Jefferson County

10:00 AM 6:00 PM, Hollywood Casino, 750 Hollywood Drive, Charles Town, WV

10:00 AM 6:00 PM, Shepherd University Wellness Center Parking Lot, 164 University Drive, Shepherdstown, WV

Lincoln County

Marshall County

Morgan County

10:00 AM 6:00 PM, Valley Health War Memorial Hospital, 1 Health Way, Berkeley Springs, WV

Ohio County

11:00 AM 4:00 PM, Wheeling Island Fire Station (Station #5), 11 North Wabash Street, Wheeling, WV

Putnam County

9:00 AM 4:00 PM, Liberty Square, 613 Putnam Village, Hurricane, WV

Raleigh County

Tyler/Wetzel Counties

Wayne County

10:00 AM 2:00 PM, Kenova Police Department, 1501 Pine Street, Kenova, WV


See the rest here:
COVID-19 Daily Update 4-14-2021 - West Virginia Department of Health and Human Resources
Pine Rest opens adult foster care COVID-19 unit – MLive.com

Pine Rest opens adult foster care COVID-19 unit – MLive.com

April 16, 2021

GRAND RAPIDS, MI Pine Rest Christian Mental Health Services has opened a 10-bed unit for people living in and adult foster care home and have been diagnosed with COVID-19.

The behavioral health care provider says the unit addresses a gap in care and treats both psychiatric and COVID-19 concerns. The unit was created in partnership with the state of Michigan, and comes online at time when coronavirus cases in Michigan are surging.

The special unit features a negative air pressure system to limit the spread of COVID-19, according to a news release from Pine Rest. Thats in addition to enhanced employee training, specialized cleaning protocols, and use of personal protective equipment, Pine Rest said.

Throughout our 111-year history, Pine Rest has brought hope and healing to those most in need of care, Pine Rest President and CEO Mark Eastburg said in a statement.

We are rooted in West Michigan and accountable to the many individuals who turn to us for care and support. This commitment drives development of programs tailored to meet the needs most acutely felt in our community. I am proud Pine Rest has continued this tradition by first opening our inpatient Special Care Unit in December, and now, by opening our residential AFC Special Care Unit.

Pine Rest says its 30-bed COVID-19 special care unit opened in December 2020, and has been operating at or near capacity since that time. Pine Rest says patient referrals for space within the unit have come from across the state.

Our mission is to create a service network for Michigan residents who need behavioral health care particularly during the COVID-19 pandemic, Allen Jansen, deputy director of the Behavioral Health and Developmental Disabilities Administration within the Michigan Department of Health and Human Services, said in a statement.

After growing evidence that this need could be better met, we reached out to a number of providers and are appreciative that Pine Rest responded to our request. They prioritized space and resources to address this clinical need. This service is urgently needed and will be well-used for a very vulnerable group of our residents.

Read more:

Perrigo breaks ground on new Grand Rapids headquarters

COVID-19 claims younger lives in Muskegon as surge spreads through community

Cracked sewer pump system causes 400-gallon sewage leak in Jackson County


See the article here: Pine Rest opens adult foster care COVID-19 unit - MLive.com
COVID-19 prevalence in England drops sharply in latest week – ONS – Reuters

COVID-19 prevalence in England drops sharply in latest week – ONS – Reuters

April 16, 2021

The prevalence of COVID-19 infections in England dropped sharply to its lowest level since September, the Office for National Statistics (ONS) said on Friday.

There were 1 in 480 people infected in the week ending April 10, according to the latest figures, down from 1 in 340 infected the week before.

The estimated 0.21% of the population that had the coronavirus was the lowest level since the week ending September 24, 2020.

"Our modelling suggests that the percentage of people testing positive in England decreased in the week ending 10 April 2021," the ONS said.

The drop in prevalence in England followed a slight rise in estimated infections last week, as a sharp fall in cases which followed the start of England's third lockdown in January had levelled off in recent weeks. read more

The latest reported drop in infection levels did not capture the impact of the reopening of pub gardens and shops in England on April 12. The ONS Infection Survey is a widely watched estimate of the COVID-19 infection levels in the community populations of the United Kingdom.

The ONS said it estimated infections had fallen in Scotland, Wales and Northern Ireland as well as England.

Our Standards: The Thomson Reuters Trust Principles.


Read the original: COVID-19 prevalence in England drops sharply in latest week - ONS - Reuters
Can your workplace make the COVID-19 vaccine mandatory? – Wink News – Wink News

Can your workplace make the COVID-19 vaccine mandatory? – Wink News – Wink News

April 16, 2021

FORT MYERS

If your workplace required you to be vaccinated against COVID-19 before returning, would you do it? Perhaps more importantly, is it legal for employers to make such a mandate?

According to Ben Yormak, an attorney based in Bonita Springs specializing in employment law, the answer is yes.

Yeah, weve been getting a lot of phone calls from employees asking exactly that question, Yormak said. Unfortunately, the answer is that your employer generally can require the vaccine. There are certain exceptions, though, to it: The employer cant be inquiring, you know, about medical related questions or anything like that. But there are potential exceptions for mandatory vaccines given any religious belief or disability that would prevent or put you at risk.

Gov. Ron DeSantis recently signed an executive action that prohibited businesses from requiring the vaccine. But Yormak and other experts say private businesses can essentially do what they want. Businesses can decide who to welcome as long as it does not discriminate, and that includes incentivizing the vaccine.

If you put yourself in the position of somebody that, you know, say, is undergoing chemotherapy, and theyre saying, Why didnt I get a $2,500 bonus for getting the vaccine? And everybody else in the office is? I would have gotten it if I could, but I cant. Therefore, because Im a person with a disability, Im being treated less favorably than everybody else. That would be a valid claim, Yormak said.

Yormak said most of the calls he has received have been from people with strong political beliefs, not a medical or religious exemption. When it comes to state-operated or state-funded facilities like public universities, however, that is when the governor could have a stronger case in court.


See original here:
Can your workplace make the COVID-19 vaccine mandatory? - Wink News - Wink News
Twins’ Andrelton Simmons tests positive for COVID-19 after declining vaccine offered to team – Yahoo Sports

Twins’ Andrelton Simmons tests positive for COVID-19 after declining vaccine offered to team – Yahoo Sports

April 16, 2021

Minnesota Twins shortstop Andrelton Simmons tested positive for COVID-19 and was placed on the COVID-19 injured list on Wednesday.

Twins president of baseball operations Derek Falvey told reporters that Simmons was experiencing "very mild" symptoms and resting at home.

Simmons has expressed skepticism of COVID-19 vaccines and declined to take one last week when it was offered to the team. Simmons tweeted in March that he would not take a COVID-19 vaccine or advocate for vaccines.

He confirmed on Sunday that he didn't take the vaccine when it was offered and said that he didn't know if he would take one in the future, according to the Associated Press. The Twins, meanwhile, promoted the team's vaccine campaign on social media.

At the time, Falvey addressed skepticism among players and offered the team as a resource for information on vaccines.

If you have very specific reasons as to why you dont want to get it, thats a total individual choice," Falvey said last week, per the Twin Cities Pioneer Press. "But if youre someone whos just hesitant because you lack a little bit of information about it, then I think its our responsibility to some degree to help them get that information and ultimately make whatever informed decision theyre going to make going forward.

The Twins conducted contact tracing after Simmons' positive test and did not place any other players or staff members in quarantine.

Andrelton Simmons previously said that he would not take or advocate for COVID-19 vaccines. (Brace Hemmelgarn/Minnesota Twins/Getty Images)

More from Yahoo Sports:


Continue reading here: Twins' Andrelton Simmons tests positive for COVID-19 after declining vaccine offered to team - Yahoo Sports