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Saturday, September 5, 2020

Many hospital workers infected with coronavirus don’t show symptoms

A new study of 13 U.S. medical centers finds that 6% of staff tested positive for prior infection with the new coronavirus, with almost half (44%) having no idea they’d ever contracted SARS-CoV-2.

In the study, blood antibody testing of more than 3,200 doctors, nurses and other hospital staff was conducted between early April and mid-June. About 1 in 16 of the tests came up positive, researchers found, and 29% of those positive results arose in people who said they’d had no symptoms suggestive of COVID-19.

Infection rates among staff also varied widely between hospitals, ranging from just 0.8% at one center to more than 31% at another. According to the study author, that likely reflects the level of coronavirus circulating in the city each hospital served.

One thing was clear, however: Use of masks, gowns, gloves and other protective gear by staff kept infection rates down. And when hospitals faced shortages of personal protective equipment (PPE), COVID-19 infections rose.

“A higher percentage of participants who reported a PPE shortage had detectable SARS-CoV-2 antibodies [9%] than did those who did not report a PPE shortage [6%],” reported researchers led by Dr. Wesley Self of Vanderbilt University Medical Center in Nashville, Tenn. About 12% of the workers interviewed in the study said they’d already encountered some form of PPE shortage at their medical center.

One emergency physician working on the frontlines of the pandemic agreed that prevention is key.

“Having an adequate supply of PPE is vital in order to mitigate the increased risk that all health care workers face on the frontlines,” explained Dr. Robert Glatter, who practices at Lenox Hill Hospital in New York City.

“This represents one of the major ongoing challenges that has confronted hospitals and medical centers as the pandemic continues,” he said.

Frequent testing of frontline health care workers is also crucial to curbing outbreaks early on because “a high proportion of personnel with antibodies did not suspect that they had been previously infected,” Self’s group said.

“What’s important is that health care workers don’t become a reservoir for asymptomatic spread of infection within the hospital setting or in the community,” Glatter said. “As a result, we must invest in frequent testing of such vital workers.”

The new study was published Aug. 31 in Morbidity and Mortality Weekly Report, a journal of the U.S. Centers for Disease Control and Prevention.

https://medicalxpress.com/news/2020-09-hospital-workers-infected-coronavirus-dont.html

Trial to test nasal irrigations as COVID-19 treatment

Researchers from Vanderbilt University Medical Center (VUMC) are conducting a clinical trial to determine whether nasal saline irrigations can reduce viral shedding and symptoms in patients with COVID-19.

Prior studies have shown that using simple, over-the-counter nasal saline irrigations can decrease viral shedding in upper respiratory infections—including other coronaviruses—helping patients feel better, resolving symptoms in less time and potentially reducing transmissibility of the virus.

“Much of the focus early in the fight against this virus centered around hand hygiene, but as an otolaryngologist, I found that hardly anyone talked about nasal hygiene. Several studies have identified the nasal cavity and nasopharynx as the primary sites of viral entry, replication and expulsion, which made me think: Why don’t we wash our nose like we wash our hands?” said Kyle Kimura, MD, fourth-year resident in the Department of Otolaryngology-Head and Neck Surgery and principal investigator for the study.

“The principle behind good hand hygiene is that rinsing with soap and water can remove viral particles before they can infect yourself or spread to others. I wanted to see if we could apply the same concept in the nose with nasal irrigations to potentially wash away the virus before it can really take hold.”

While many medications and treatments have been proposed for COVID-19, there has not yet been a study targeting intervention within the nasal cavity, which is often where a patient first comes into contact with the virus, where the viral load is highest, and where the virus is most likely to exit the body when a person coughs, sneezes or breathes.

“There are other trials that are ongoing and that have been completed for COVID-19 treatments, but most of them are for pharmaceuticals, and in many cases, they’re very expensive. This is something that’s considered affordable, is available without a prescription, is easy to do and has few side effects,” said Justin Turner, MD, Ph.D., associate professor of Otolaryngology-Head and Neck Surgery at VUMC and the study’s director.

“If it has some significant effect on symptoms or disease resolution, or if it has the potential to reduce transmissibility of the virus, then it’s something that would be easy to incorporate into the population at large.”

The trial is already close to meeting its enrollment goal of more than 100 participants with COVID-19.

Participants are randomized into three groups: a control group that receives no intervention, a group that receives nasal saline irrigations twice per day, and a group that receives nasal saline irrigations plus half a teaspoon of baby shampoo (which acts as a surfactant, potentially helping to kill the virus) twice per day.

Participants are followed for 14-21 days and self-swab their nose every few days so the researchers can examine their viral load. They also keep a daily symptom diary noting their temperature and symptom severity.

Aside from collecting data on the effectiveness of the nasal treatments, the researchers are examining participants’ nasal swabs as part of a separate study funded by the National Institutes of Health (NIH) to learn more about disease progression, the impact of co-infections and the association between nasal viral load and the severity of symptoms.

The researchers will also examine changes the virus causes to the nasal microbiome, when the virus clears and who is more likely to transmit the virus to others by following participants’ household contacts to see if they also develop the disease.

“This study epitomizes personalized health—the backbone of Vanderbilt’s philosophy of patient care. Indeed, the personalized health can be expanded to population health—with an effective, safe and inexpensive option—we hope, depending on the test results,” said Roland Eavey, MD, Guy M. Maness Professor and chair of Otolaryngology and director of the Vanderbilt Bill Wilkerson Center.

https://medicalxpress.com/news/2020-09-trial-nasal-irrigations-covid-treatment.html

FBI Raids Pa. Nursing Home That Saw Huge 447 COVID-19 Infections

A nursing home which has seen at least 73 residents die of COVID-19 and more than 400 residents and staff infected has been raided by the FBI late this week after being flagged for rampant health violations, including administering experimental doses of hydroxychloroquine to about half its 435 residents in an attempt to stave off the outbreak, despite not having state health authorities or families’ approval to do so.

Brighton Rehabilitation and Wellness Center, located northeast of Pittsburgh, drove headlines last spring into the summer for seeing the single biggest coronavirus outbreak numbers of any facility in the state. 

Over three weeks ago Pennsylvania Attorney General Josh Shapiro launched a criminal investigation related to unsafe “conditions and practices” of the nursing home, namely according to a prior statement, that it failed to meet a “high threshold of certain circumstances when the caretaker of a person fails to properly provide for their health, safety and welfare.”

In other press statements “neglect” of patients has been central to the allegations, including abandoning patients for long periods of time, without access to clean clothes, or simple needs like tissues and enough water to drink. 

According to police records, local law enforcement had at some point stopped responding to calls to the facility, given the danger to police of potentially catching the virus.

Investigators from the Pennsylvania Attorney’s general office assisted in Thursday’s FBI raid, including at another nearby hard hit care center, the Mt. Lebanon Rehabilitation and Wellness Center outside Pittsburgh.

Essentially all of Brighton’s elder residents caught the disease as well as many staff over a few month period, totaling a whopping 447 residents and staff testing positive, according to Pennsylvania Department of Health data. One staff member had died as well in addition to the 73 deceased residents.

In April NBC News wrote that the entirety of the residents and staff were “presumed infected”:

The Pennsylvania nursing home where all 750 residents and staffers may be infected with the coronavirus was hit last year with a “below average grade” by state inspectors who warned that lax sanitary conditions could lead to the “spread of infection and diseases,” Medicare records revealed.

Even months prior to the coronavirus pandemic, health authorities were investigating the facility over widespread reports that patients were living in filth and being mistreated:

The report [from Sept. 2019] “identified repeated deficiencies related to proper infection control procedures not maintained during dressage change, improper storage of soiled linens and failure to provide appropriate facilities for hand washing which created the potential for cross contamination and the potential spread of infections and diseases.”

The facility in reaction to the investigation appeared to point the finger at the failed response of state and federal health officials, however, stating: “We will leave the readers to determine why some politicians seek ‘investigations’ into people and facilities instead of looking at governmental response to better their directives.”

https://www.zerohedge.com/medical/fbi-raids-pennsylvania-nursing-home-which-saw-whopping-447-residents-staff-get-covid-19

Roche, Blueprint lung cancer drug wins FDA approval

Roche Holding AG on Friday said a therapy it co-developed with Cambridge-based Blueprint Medicines Corp was approved by the U.S. health regulator for the treatment of patients with a type of non-small cell lung cancer (NSCLC).

The drug, Gavreto, is an oral therapy which selectively targets so-called RET-altered cancers that have mutations that drive tumor growth, which are detected by a test approved by the U.S. Food and Drug Administration.

Swiss drugmaker Roche in July struck a pact worth up to $1.7 billion with Blueprint Medicines, for rights to Gavreto, which also awaits FDA approval for treating advanced RET mutant and RET fusion-positive thyroid cancers.

The drug will be jointly marketed in the United States and will be available within a week, Blueprint said.

Only about 1-2% of patients with NSCLC have RET fusions, according to Roche.

https://www.reuters.com/article/us-roche-hldg-fda-blueprint/roche-blueprint-lung-cancer-drug-wins-fda-approval-idUSKBN25W00D

China’s CNBG, Sinovac find more countries to test coronavirus vaccines

China National Biotec Group (CNBG) and Sinovac Biotech Ltd said on Saturday four more countries have agreed to run late-stage clinical tests of their coronavirus vaccine candidates, as China steps up its efforts in the global race.

Serbia and Pakistan are among the new countries agreeing to Phase 3 trials, as the two companies seek more data overseas amid dwindling new cases in China.

Serbia will test two vaccines developed by CNBG’s Wuhan and Beijing units, and Pakistan will test the Beijing unit’s candidate, the company told Reuters.

CNBG’s Phase 3 trials are expected to involve 50,000 people in about 10 countries, said CNBG vice president Zhang Yuntao. Trials have already begun in United Arab Emirates, Bahrain, Peru, Morocco, Argentina and Jordan.

Zhang said foreign countries have expressed interest in ordering a combined 500 million doses of its vaccines.

CNBG is expected to be able to produce 300 million doses of vaccine a year once it upgrades manufacturing techniques, and is working on a plan to raise its annual capacity to 1 billion doses, Zhang said.

Sinovac’s vaccine candidate CoronaVac, being tested in Brazil and Indonesia, also obtained approvals from two other countries for Phase 3 trials, said Helen Yang, senior director of global strategy and business development at Sinovac.

While the final stage of trials are still underway to prove the vaccines are safe and effective, China has already authorized the vaccine candidates from Sinovac and CNBG for emergency use for those in high-risk groups such as medical workers.

Several tens of thousand people have already taken CoronaVac through the emergency programme, Sinovac’s Yang said.

CNBG will soon begin providing its vaccines to Chinese staffers working in overseas embassies and consulates, Zhang said.

https://www.reuters.com/article/us-health-coronavirus-vaccine-china/chinas-cnbg-sinovac-find-more-countries-to-test-coronavirus-vaccines-idUSKBN25W0BA

Sanofi France chief: future COVID-19 vaccine seen below 10 euros

Sanofi’s SAY.PA chief in France, Olivier Bogillot, said on Saturday that its future COVID-19 vaccine was likely to be priced below 10 euros per shot.

“The price is not totally set … We are assessing production costs for the coming months … We will be below 10 euros,” Bogillot told France Inter radio.

Drugmakers and government agencies worldwide are racing to combat the pandemic and develop vaccines and treatments for COVID-19.

Asked about rival AstraZeneca (AZN.L), which is expected to price its shot at about 2.50 euros in Europe, Bogillot said:

“The price gap for us can be that we use all our internal resources, our own researchers, our own research centres. AstraZeneca outsources part of its production,”

Earlier this week Sanofi and Britain’s GlaxoSmithKline (GSK.L) said they had started a clinical trial of their protein-based COVID-19 vaccine candidate, and aimed to reach the final testing stage by December.

If the results are conclusive, Sanofi and GSK hope to get the vaccine approved in the first half of next year.

https://www.reuters.com/article/us-health-coronavirus-sanofi/sanofi-france-chief-future-covid-19-vaccine-seen-below-10-euros-idUSKBN25W0EU

Operation Warp Speed head: ‘Would immediately resign if there is undue interference’

Moncef Slaoui, PhD, the head of Operation Warp Speed, the White House’s task force to develop a COVID-19 vaccine, voiced his opposition to political interference in the vaccine approval process during a Sept. 3 interview with ScienceInsider.

Operation Warp Speed has been faced with criticism from the medical community and the public in recent weeks, as many Americans worry political motivations may be hindering the effort. A recent survey conducted by STAT and the Harris Poll reveals that 78 percent of Americans feel worried the COVID-19 vaccine approval process is more influenced by politics than science.

Here are four key quotes Dr. Slaoui provided during his interview with ScienceInsider

  • “The science is what is going to guide us. And the science is what our team is focused on and will be judged by. And at the end of the day, the facts and the data will be made available to everyone who wants to look at them and will be transparent.”
  • “[An emergency use authorization] needs to be absolutely shielded from the politics. I cannot control what people say. The president says things, other people will say things. Trust me, there will be no [emergency use authorization] filed if it’s not right.”
  • “I would immediately resign if there is undue interference in this process.”
  • “I would, I would,” Dr. Slaoui said when asked if he would have joined Covax, an international effort intended to expedite COVID-19 vaccine development and ensure equitable distribution, if the decision were up to him. The Trump administration said the U.S. will not join the effort just days prior to Dr. Slaoui’s interview with ScienceInsider.

https://www.beckershospitalreview.com/pharmacy/operation-warp-speed-head-i-would-immediately-resign-if-there-is-undue-interference.html