Pfizer’s COVID-19 vaccine prevents 90% of infections, interim trial analysis finds

Katie Adams

Clinical trial data for the COVID-19 vaccine Pfizer is developing  with BioNTech shows the candidate can prevent more than 90 percent of infections, the drugmaker said Nov. 9.

The results are based on an interim analysis of a trial in which 94 participants, half of whom received a placebo and half of whom received a vaccine, contracted COVID-19. Pfizer will continue the trial until 164 COVID-19 cases occur in order to gather more data and determine the candidate’s performance against other study endpoints.

Pfizer plans to collect two months of safety follow-up data, a key requirement laid out by the FDA before it grants emergency use authorization. That data is expected to be gathered by the third week of November, and if it raises no concerns, the drugmaker could apply for emergency use authorization by the end of the month. An accelerated review of the vaccine is underway in the U.K.

“This is about the best the news could possibly be for the world and for the United States and for public health,” William Gruber, Pfizer’s senior vice president for vaccine clinical research and development, told Bloomberg, saying the findings were better than even the best result he had wished for.

Analysis has not yet been conducted on the vaccine’s efficacy among key subgroups, such as older patients. Pfizer also has not yet studied how the vaccine  prevents severe cases of COVID-19.

HHS unveils plan to get coronavirus vaccines to nursing homes

Associated Press

WASHINGTON (AP)  Federal health officials on Friday unveiled a plan to get approved coronavirus vaccines to nursing home residents free of cost, with the aid of two national pharmacy chains.

No vaccine has yet been approved by the Food and Drug Administration, and the distribution program is contingent on that happening first.

Under the plan, trained staff from CVS and Walgreens will deliver the vaccines to each nursing home and administer shots. Assisted-living facilities and residential group homes can also participate in the voluntary program. Nursing home staffers can be vaccinated too, if they have not already received their shots. Needles, syringes and other necessary equipment will be included.

The idea is to give hard-pressed states an all-inclusive system for vaccinating their most vulnerable residents, said Paul Mango, a senior policy adviser at the Department of Health and Human Services. “We are trying to eliminate all potential barriers to getting folks safe and effective vaccines,” Mango said.

People in nursing homes and other long-term care facilities account for less than 1% of the U.S. population, but they account for about 40% of the deaths from COVID-19, with more than 83,600 fatalities logged by the COVID Tracking Project.

The Trump administration’s initial attempts to promote coronavirus testing in nursing homes and to ensure sufficient supplies of protective gear were hampered by missteps and led to widespread complaints from nursing home operators and advocates for older people. The vaccine program seems designed to prevent a repeat at a time when President Donald Trump is battling to hang on to support from older voters.

Vaccines will be on their way to nursing homes within 24 to 48 hours after the FDA approves their use, Mango said.

The effort is taking place under the auspices of Operation Warp Speed, a White House-backed effort to quickly produce and distribute hundreds of millions of doses of approved vaccines, enough for every American.

Mango said he anticipates that if a vaccine is approved this year, initial supplies would be limited. Availability will improve markedly in the first three months of 2021, he said.

HHS is fielding an online survey for nursing homes to assess their interest in the program, but the allocation of vaccines will be done through state and territorial governments.

Nursing homes and long-term care facilities will not be charged for the program. CVS and Walgreens will be reimbursed for administering the shots at standard Medicare rates, officials said.

Texas hospital seeks critical access status as break with Baylor Scott & White looms

Morgan Haefner, Becker’s Healthcare

Llano (Texas) County Memorial Hospital is applying for a critical access designation that would allow the rural hospital to reduce its financial vulnerability through increased Medicare reimbursement, according to DailyTrib.com.

The application comes as Llano County Memorial prepares to part ways with Dallas-based Baylor Scott & White. An operating agreement between the two organizations expires at the end of 2020, with no renewal planned. Baylor Scott & White has managed Llano County Memorial for the past 10 years, according to the news site.

Part of the reason the contract isn’t being renewed is due to the rural hospital’s finances, according to the news site. El Campo, Texas-based MidCoast Health System is vying to take over management of Llano County Memorial.

Llano County Memorial is working with a tight deadline for its critical access application as the operating contract deadline approaches. Under the designation process, a third-party contractor helping the hospital has up to 45 days to review the application, followed by an up to 45-day state review and another up to 60-day review from CMS.

“We’re still pressing against that December 31 deadline. Hopefully, we can have some sort of determination before that,” Brett Fuller, an accountant working with LCHA, told DailyTrib.com. “I do know that at least the communications with CMS have been positive at least in expediting their review.”

Read the full report here.

FTC urges Texas regulators to block CHS’ divestiture of 2 hospitals

Alia Paavola Becker’s Healthcare

The Federal Trade Commission is urging Texas regulators to block Franklin, Tenn.-based Community Health Systems’ planned divestiture of two hospitals in the state.

In April, CHS announced its intent to sell the 231-bed Abilene (Texas) Regional Medical Center to Abilene-based Hendrick Health System and its 171-bed San Angelo (Texas) Community Medical Center to Shannon Health System in San Angelo. 

The Texas Health and Human Services Commission ultimately will approve or block the proposed transactions as Texas implemented a law that shields the deals from federal oversight in exchange for state oversight.

In a letter to the Texas commission, the FTC argues that if the deals are allowed to move forward, the combinations would remove competition in the markets, resulting in higher prices and harming consumers.

Particularly, if Hendrick Health System is allowed to purchase Abilene Regional, the combined organization would have an 85 percent market share of inpatient services in the region, the FTC said. 

“Hendrick competes vigorously with Abilene Regional to be included in health plan networks and to attract patients. The proposed Hendrick merger would eliminate this competition and would likely lead to increased prices and reduced quality and availability of healthcare services in Midwest Texas,” the FTC wrote in the letter. 

In addition, the FTC argues that if the divestiture of San Angelo Community Medical Center to Shannon Health moves forward, the combined organization will have a 62.3 percent market share of inpatient hospital services and would have concentration numbers that “approach monopoly levels.”

Read the full letter here

States ranked by COVID-19 test positivity rates: Sept. 2

Molly Gamble (Twitter) – Tuesday, July 14th, 2020 Print  | EmailShare  

Here are the rates of positive COVID-19 tests in each state, along with the number of new cases most recently reported and number of tests conducted per 1,000 people. 

Data points were last updated Sept. 2. Data for positivity rates and tests are seven-day moving averages; new cases are daily counts as reported by state and the District of Columbia. The information cited is from the Johns Hopkins Coronavirus Resource Center. States are arranged in descending order of test positivity rates. 

Editor’s note: A jurisdiction might report a negative number of probable cases on a given day if more probable cases were disproven than were initially reported on that day. Furthermore, some states modify their reporting to include both confirmed cases and probable cases, which may cause new case data to spike. Due to limited reporting on Sundays, some data is unavailable until later hours Monday, including new daily cases.

Alabama: 32.8 percent positive

New daily cases: 1,558

Tests per 1,000: 0.9

South Dakota: 22.2 

New daily cases: 240

Tests per 1,000: 1.6

North Dakota: 20.1

New daily cases: 184

Tests per 1,000: 1.7

Iowa: 18.5

New daily cases: 708

Tests per 1,000: 1.6

Kansas: 16

New daily cases: 363

Tests per 1,000: 1.3

Nevada: 15.3

New daily cases: 405

Tests per 1,000: 1

Mississippi: 14.5

New daily cases: 634

Tests per 1,000: 1.5

Missouri: 13.6

New daily cases: 1,103

Tests per 1,000: 1.6

South Carolina: 13.2

New daily cases: 854

Tests per 1,000: 1.3

Florida: 12.2

New daily cases: 7,569

Tests per 1,000: 1.4

Idaho: 11.5

New daily cases: 272

Tests per 1,000: 1.4

Georgia: 10.4

New daily cases: 2,226

Tests per 1,000: 1.9

Nebraska: 9.9

New daily cases: 287

Tests per 1,000: 1.7

Texas: 9.9

New daily cases: 4,982

Tests per 1,000: 1.5

Minnesota: 9.4

New daily cases: 491

Tests per 1,000: 1.5

Oklahoma: 9.3

New daily cases: 665

Tests per 1,000: 2.0

Indiana: 8.9

New daily cases: 695

Tests per 1,000: 1.5

Wisconsin: 8.8

New daily cases: 981

Tests per 1,000: 1.5

Hawaii: 8.6

New daily cases: 181

Tests per 1,000: 1.7

Kentucky: 8.4

New daily cases: 789

Tests per 1,000: 1.8

Utah: 7.8

New daily cases: 296

Tests per 1,000: 1.5

Tennessee: 7.6

New daily cases: 1,396

Tests per 1,000: 3

Arkansas: 7.3

New daily cases: 273

Tests per 1,000: 2.7

Virginia: 7.1

New daily cases: 1,018

Tests per 1,000: 1.7

Arizona: 6.6

New daily cases: 507

Tests per 1,000: 0.9

North Carolina: 6

New daily cases: 2,115

Tests per 1,000: 2.6

Montana: 5.6

New daily cases: 88

Tests per 1,000: 2.1

Louisiana: 5

New daily cases: 689

Tests per 1,000: 2.9

California: 4.9

New daily cases: 3,142

Tests per 1,000: 2.6

Pennsylvania: 4.8

New daily cases: 753

Tests per 1,000: 1.1

Oregon: 4.6

New daily cases: 233

Tests per 1,000: 1.1

Maryland: 4.6

New daily cases: 614

Tests per 1,000: 2

Delaware: 4.4

New daily cases: 106

Tests per 1,000: 1.9

Illinois: 4.4

New daily cases: 1,492

Tests per 1,000: 3.5

Wyoming: 3.8

New daily cases: 24

Tests per 1,000: 1.5

Ohio: 3.4

New daily cases: 1,451

Tests per 1,000: 3

Colorado: 3.3

New daily cases: 351

Tests per 1,000: 1.5

West Virginia: 3.2

New daily cases: 264

Tests per 1,000: 2.8

Washington: 3.2

New daily cases: 304

Tests per 1,000: 1.7

Michigan: 2.5

New daily cases: 795

Tests per 1,000: 3

New Mexico: 2.4

New daily cases: 108

Tests per 1,000: 2.5

Washington, D.C.: 1.7

New daily cases: 57

Tests per 1,000: 4.3

Massachusetts: 1.6

New daily cases: 355

Tests per 1,000: 3.1

New Jersey: 1.4

New daily cases: 330

Tests per 1,000: 2.6

Rhode Island: 1.2

New daily cases: 53

Tests per 1,000: 6.9

Alaska: 1.2

New daily cases: 34

Tests per 1,000: 7.9

New Hampshire: 1.1

New daily cases: 22

Tests per 1,000: 1.2

Connecticut: 0.9

New daily cases: 127

Tests per 1,000: 4.4

New York: 0.8

New daily cases: 754

Tests per 1,000: 4.3

Maine: 0.6

New daily cases: 20

Tests per 1,000: 3.3

Vermont: 0.4

New daily cases: 11

Tests per 1,000: 3.7

Henry Ford researchers defend hydroxychloroquine study, slam politics surrounding drug

Gabrielle Masson 

The persisting political climate has made any objective discussion about hydroxychloroquine “impossible,” two Henry Ford Health System executives wrote in an open letter dated Aug. 3.

Adnan Munkarah, MD, executive vice president and chief clinical officer at the Detroit-based system, along with Steven Kalkanis, MD, senior vice president and chief academic officer for Henry Ford, penned the letter in response to comments by Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, that their study on hydroxychloroquine was “flawed.” 

The situation is a bellwether for the kind of tension other systems may face when their clinical research overlaps with commentary from the White House. 

Four things to know:

1. Addressing friends and colleagues around the world, Dr. Munkarah and Dr. Kalkanis said the most accepted and definitive way to determine treatment efficacy is a double-blind, randomized clinical trial. But this type of study takes a long time to design, execute and analyze, so observational research is used to get as best an answer as soon as possible.

2. Observational research can never completely account for biases inherent in how physicians make different decisions to treat different patients, the leaders said. It’s not unusual that results vary in different studies, and no one study should be considered on its own.

3. The Henry Ford treatment study should be considered as another important contribution to hydroxychloroquine research, Drs. Munkarah and Kalkanis wrote in a letter to the editor published in the International Journal of Infectious Diseases July 31. Based on their findings, the authors believe the drug can have a role in reducing mortality for COVID-19.

4. Scientific debate is common, and can, in part, fuel the advancement of knowledge, the leaders write. They said their only goal was to report validated findings and allow the science to speak for itself, regardless of political considerations. In light of the recent events, Drs. Munkarah and Kalkanis said they have decided to no longer comment about the topic outside of the medical community and will stay focused on their patients, community and commitment to clinical and academic integrity

https://www.beckershospitalreview.com/hospital-management-administration/henry-ford-researchers-defend-hydroxychloroquine-study-slam-politics-surrounding-drug.html

Coronavirus or West Nile? CDC reports 17 cases of mosquito disease that present symptoms similarly to COVID-19

By Amy McGorry | Fox News

‘Mosquitoes do not carry COVID, but because the symptoms are so similar you’ll need to talk with your doctor ‘

While the United States deals with the coronavirus, the West Nile virus is on the rise and can show similar features to COVID-19, creating some confusion. Seventeen human cases of West Nile virus have been reported so far in Texas, Los Angeles County, and Fla., according to the Centers for Disease Control and Prevention (CDC).

In Georgia, Fox 5 Atlanta reported this week that mosquitos positive for West Nile Virus were found in DeKalb County.  Because the symptoms are similar to COVID-19, which is still running rampant throughout the country, health experts warn to not overlook West Nile when diagnosing.

“Mosquitoes do not carry COVID, but because the symptoms are so similar you’ll need to talk with your doctor to see about getting a COVID test,” Juanette Willis, with the DeKalb County Board of Health, told FOX 5.

BLOOD TEST IDENTIFIES WHICH CORONAVIRUS PATIENTS MAY BE HELPED OR HARMED BY STEROID TREATMENT

Dr. Paul Auwaerter, clinical director of the division of infectious diseases at Johns Hopkins Hospital, told Yahoo Life regarding West Nile infections, “About 20 percent might develop a flu-like illness [also known as West Nile fever] that is probably indistinguishable from COVID-19. “ The professor of medicine at John Hopkins University School of Medicine also told the media outlet: “They can have headache, fever, muscle aches, gastrointestinal symptoms [vomiting and diarrhea], and swollen lymph glands.”

Auwaerter said in the article with the diseases sharing similar characteristics, “People are just assuming they have COVID-19,” rather than a mosquito bearing disease.  “Statistically, it’s probably true that it’s COVID in these cases,” the article cited Auwaerter, “But it’s not always the case.”

Health officials at Cleveland clinic, according to the media outlet, stated a skin rash on the trunk and chest, can occur with the West Nile virus while it is not as typical with COVID-19 patients who, if they do present with a rash, typically report it on their toes.

Both diseases can have detrimental effects on a person’s health and can affect the nervous system, according to the CDC, which also states on its website that nearly “1 in every 150 people who are infected with West Nile disease can develop a severe illness affecting the central nervous system” such as encephalitis (brain inflammation) or meningitis (inflammation of the brain and spinal cord). Doctors told Fox News, in some cases of West Nile infections, patients can show symptoms including high fever, stiff neck, severe headache, and can even become confused, weak and experience possible seizures.

DOGS ABLE TO SNIFF CORONAVIRUS IN HUMAN SALIVA, GERMAN STUDY FINDS

The novel coronavirus can also show neurological effects. Some cases reported peripheral neuropathy in the legs and complaints of “brain fog,” some physicians explained to Fox News. COVID-19 can also affect the trigeminal and olfactory nerves which affect the sense of smell. which is not typical with the West Nile infection. Besides those symptoms, neurologists told Fox News that coronavirus can present with headache, difficulty focusing, blood clotting, weakness and some studies are linking it with the neurological condition Guillain-barre.

One main difference, according to health experts, is that the coronavirus is a contagious respiratory disease where West Nile is not. The West Nile illness is contracted typically by a mosquito bite, while novel coronavirus is currently believed to spread through sneezing, coughing or touching, according to the CDC. To differentiate clinically between the two illnesses, a physician can perform a nasal swab test to detect novel coronavirus while a blood test can determine if a person has been infected with the West Nile virus infection.

Texas hospital CEO: COVID inpatient count ‘misinterpreted,’ level of alarm ‘unwarranted’

By Daniel Payne June 25th 2020

Health officials in Texas are logging every single COVID-19-positive hospital patient in the state as a COVID-19 hospitalization, even if the patients themselves are admitted seeking treatment for something other than the coronavirus. 

That policy may be serving to artificially inflate what ostensibly seems like a significant COVID-19 surge in the state. Texas has lately been the focal point of national anxiety over concerns that a “second wave” of the coronavirus has begun there after the state began reopening nearly two months ago. 

COVID-19 hospitalizations there have been on a steady upward track for about the last two weeks, per the state’s coronavirus dashboard, which on Thursday recorded about 4,400 coronavirus hospitalizations in the state. But at least part of that trend may be due to liberal coding policies by state officials. 

Lindsey Rosales, a spokeswoman for the Texas Department of State Health Services, confirmed to Just the News this week that the state is categorizing every inpatient in the state with a positive COVID-19 test as a COVID-19 hospitalization. 

“The number of hospitalized patients includes patients with a lab-confirmed case of COVID-19 even if the person is admitted to the hospital for a different reason,” Rosales said. 

Asked if inpatients in the state are tested for COVID-19 whenever they arrive for treatment, Rosales said, “Hospitals set their own protocols for determining when and if to test patients for COVID-19.”

She said the state does not keep track of the patients hospitalized with the coronavirus versus those hospitalized specifically because of it. 

Texas Health Resources, one of the state’s largest hospital systems, says on its website that its “patients [are] tested before most procedures.” Elective surgeries and other medical procedures in Texas have gone up in recent weeks as the state has gradually re-opened following its lockdown. 

Amid worry, major hospital leaders stress calm

Queries to multiple Texas hospital officials this week went unanswered. But leaders of several major hospitals in Houston this week urged the public to remain calm, suggesting that the extent of the outbreak has been overstated. 

At a virtual press conference on Thursday, the chief executives of Houston Methodist, Memorial Hermann Health System, St. Luke’s Health, and Texas Children’s hospitals stated that their hospitals are well-prepared to handle an even greater increase in patients than that which has emerged over the past few weeks. 

The number of hospitalizations are “being misinterpreted,” said Houston Methodist CEO Marc Boom, “and, quite frankly, we’re concerned that there is a level of alarm in the community that is unwarranted right now.”

“We do have the capacity to care for many more patients, and have lots of fluidity and ability to manage,” Boom said.

He pointed out that his hospital one year ago was at 95% ICU capacity, similar to the numbers the hospital is seeing today. “It is completely normal for us to have ICU capacities that run in the 80s and 90s,” he said. “That’s how all hospitals operate.” 

He noted that around 25% of ICU patients are COVID-19-positive. But the hospital “[has] many levers in our ability to adjust our ICU,” he said, claiming that the hospital capacity regularly reported by the media is “base” capacity rather than surge capacity. 

Texas Children’s Hospital CEO Mark Wallace added that his facility has “a lot of capacity.”

“We have the ability to take care of all of the Houstonians that need a critical care environment, that need to be operated on, or acute care,” Wallace said.

“There is not a scenario, in my opinion, where the demand for our beds … would eclipse our capability,” he continued. “I cannot imagine that. I just cannot.”

As of Thursday afternoon, Texas had around 13,000 open hospital beds statewide. 

https://justthenews.com/politics-policy/coronavirus/texas-government-counting-every-covid-positive-hospital-case

Texas Governor Hits ‘Pause’ On Further Reopening Amid COVID-19 Surge

June 25, 2020 by Laurel Wamsley

Updated at 12:45 p.m. ET

Texas Gov. Greg Abbott has announced the state will “pause” any further reopening of its economy for now, a day after he said that Texas is facing a “massive outbreak” of the coronavirus.

“As we experience an increase in both positive COVID-19 cases and hospitalizations, we are focused on strategies that slow the spread of this virus while also allowing Texans to continue earning a paycheck to support their families,” Abbott said in a statement Thursday morning. “The last thing we want to do as a state is go backwards and close down businesses. This temporary pause will help our state corral the spread until we can safely enter the next phase of opening our state for business.”

Texas was among the first states to begin the process of reopening, and many businesses are in operation once again. Those businesses that are already permitted to be open may continue to operate under the existing health protocols and capacity restrictions. Bars and restaurants have already opened for indoor seating, and gymsmalls and movie theaters have been allowed to open, too.

Nearly 90,000 Texans filed for unemployment last week, NPR member station KUT reported — about 5,480 ​fewer new claims than the previous week.

Abbott also halted elective surgeries in four of the state’s largest counties. That move is aimed at expanding hospital capacity as the spike in hospitalizations threatens to overwhelm intensive care units and outstrip available ventilators.

His order suspends elective surgeries at hospitals in Bexar, Dallas, Harris and Travis counties — home to the respective cities of San Antonio, Dallas, Houston and Austin. It directs hospitals in those counties to “postpone all surgeries and procedures that are not immediately, medically necessary to correct a serious medical condition or to preserve the life of a patient who without immediate performance of the surgery or procedure would be at risk for serious adverse medical consequences or death, as determined by the patient’s physician.”

Abbott said he may add or subtract counties from the list as needs arise.

In San Antonio, ventilator availability dipped below 70% for the first time on Wednesday, Texas Public Radio reported. In Houston, one hospital’s ICU reportedly was at 120% capacity, while another one’s was at 88%.

Texas Medical Center in Houston said Tuesday that 97% of its ICU beds were occupied and that 27% of those patients were people who had tested positive for the coronavirus. It said its normal ICU occupancy is 70% to 80%. On Thursday, the Houston Chronicle reported that the medical center has reached 100% of its ICU capacity.

On Wednesday the state reported 5,551 new coronavirus cases, its highest daily figure yet. Twenty-nine new COVID-19 deaths were reported, with cumulative fatalities in the state now numbering 2,249.

Just nine days ago, Abbott touted the state’s “abundant” hospital capacity as the numbers of cases in the state were rising quickly. According to state data, as of Wednesday, the Dallas area had 1,130 people hospitalized with COVID-19, Houston had 1,342, San Antonio had 549, and Austin had 274.

“These four counties [Bexar, Dallas, Harris and Travis] have experienced significant increases in people being hospitalized due to COVID-19 and today’s action is a precautionary step to help ensure that the hospitals in these counties continue to have ample supply of available beds to treat COVID-19 patients,” Abbott said in Thursday’s statement.

“As we work to contain this virus, I urge all Texans to do their part to help contain the spread by washing their hands regularly, wearing a mask, and practicing social distancing.”

https://www.npr.org/sections/coronavirus-live-updates/2020/06/25/883311877/texas-governor-hits-pause-on-further-reopening-amid-covid-19-surge

Texas stops reopening amid surge in COVID-19

Texas Governor Greg Abbott announced that reopening will be paused as the state is seeing a major surge in COVID-19 cases.

The state reported 5,500 cases in a single day this week. Over 125,000 cases of COVID-19 have been reported in the state since the outbreak began.

Texas is one of many states seeing a massive uptick in COVID-19 cases. Arizona and Florida are also seeing major rises with each state seeing record numbers of cases this week.

California is also seeing a surge in cases with over 5,000 daily cases reported this week.

In all, 26 states are seeing some increase in COVID-19 cases.

While Abbott announced a pause in reopenings due to the disease, he said that he will not reimplement shutdowns.

“The last thing we want to do as a state is go backwards and close down businesses,” Governor Abbott said in a statement. “This temporary pause will help our state corral the spread until we can safely enter the next phase of opening our state for business. I ask all Texans to do their part to slow the spread of COVID-19 by wearing a mask, washing their hands regularly, and socially distancing from others.”

https://www.healthline.com/health-news/coronavirus-live-updates