Coronavirus Breaking News

The coronavirus disease COVID-19 is currently reaching pandemic levels in various countries.

Jul 27, 2022 • 1:46 pm CDT
from Pixabay

Florida-based Veru Inc. today announced that the European Medicines Agency's (EMA) Emergency Task Force (ETF) had informed the Company that it has initiated the review of sabizabulin for the treatment of hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS).

Sabizabulin is an oral, novel microtubule disruptor with dual antiviral and anti-inflammatory activity in preclinical models.

On July 27, 2022, the Company stated, "The review will look at all available data, including data from a study involving hospitalized patients with moderate-to-severe COVID-19 who are at high risk of ARDS and death.

"The results of this phase 3 study would indicate that sabizabulin treatment reduces the number of deaths in these patients compared with placebo."

The NEJM published this study on July 6, 2022: Oral Sabizabulin for High-Risk, Hospitalized Adults with Covid-19: Interim Analysis.

Sabizabulin treatment resulted in a 24.9% absolute reduction in deaths compared with placebo in hospitalized patients with moderate to severe Covid-19 at high risk for ARDS and death, with a lower incidence of adverse and serious adverse events compared with placebo. 

Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru, commented in a press release, "This new emergency regulatory pathway may allow the availability of sabizabulin to EU member states before sabizabulin is approved by EMA."

"Separately, we were also informed yesterday that the sabizabulin product is eligible for submission (Article 18) of an application for a centralized marketing authorization."

"COVID-19 infections are sharply rising in Europe. Unfortunately, the death rate in hospitalized patients with moderate to severe COVID-19 at risk for ARDS remains unacceptably high with the current standard of c"re," added Dr. Stein"r.

"By reducing deaths in hospitalized COVID-19 patients, sabizabulin has great potential to play a critical role in the battle against COVID-19 in the"EU."

Additional COVID-19 treatment news is posted at

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Jul 21, 2022 • 7:49 am CDT
by Bruno

A new Correspondence published in peer-review The New England Journal of Medicine examined the neutralizing ability of U.S. FDA-approved monoclonal antibodies, individually and in combination, against recent SARS-CoV-2 Omicron variants.

As of July 20, 2022, this data indicates that bebtelovimab is effective against BA.2.12.1, BA.4, and BA.5.

However, in clinical use, these variants may be less susceptible to combination therapy with casirivimab and imdevimab and with Evusheld (tixagevimab and cilgavimab).

In addition, sotrovimab may not provide effective treatment against BA.2.12.1, BA.4, or BA.5.

'Our findings show that the selection of monoclonal antibodies to treat patients infected with omicron variants should be carefully considered.'

'The main limitation of our study is the lack of clinical data on the efficacy of these monoclonal antibodies (mAbs),' concluded these researchers.

Non-industry grants supported this research, and the research team did not disclose conflicts of interest.

On July 1, 2022, the FDA stated, 'Nonclinical data and pharmacokinetic modeling suggest that activity against the currently circulating SARS-CoV-2 variants and subvariants may be retained for six months at drug concentrations achieved following an Evusheld dose of 300 mg of tixagevimab and 300 mg cilgavimab.'

Since September 24, 2021, the U.S. government has distributed about 5.9 million mAbs.

 Anti-SARS-CoV-2 monoclonal antibody breaking news is posted at

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Jul 21, 2022 • 7:15 am CDT
from Pixabay

A recent analysis of reports from more than 35,000 women offers a comprehensive assessment of menstrual changes experienced by pre- and post-menopausal females in the first two weeks after receiving the COVID-19 vaccine.

Published in the journal Science Advances on July 15, 2022, the study found that 42% of women with regular menstrual cycles bled more heavily than usual, while 44% reported no change after vaccination.

Among respondents, 66% of post-menopausal women reported breakthrough bleeding.

These researchers found that increased/breakthrough bleeding was significantly associated with age, systemic vaccine side effects (fever and/or fatigue), history of pregnancy or birth, and ethnicity.

Generally, changes to menstrual bleeding are not uncommon or dangerous, yet attention to these experiences is necessary to build trust in medicine, stated these researchers.

“Menstruating and formerly menstruating women began sharing that they experienced unexpected bleeding after being administered a COVID-19 vaccine in early 2021,” wrote the scientists who led the study.

Because vaccine trials typically do not ask about menstrual cycles or bleeding, this side effect was largely ignored or dismissed.

“We focused our analysis on those who regularly menstruate and those who do not currently menstruate but have in the past,” commented Kathryn Clancy, a professor of anthropology at the University of Illinois Urbana-Champaign, in a related press release.

“The latter group included post-menopausal individuals and those on hormonal therapies that suppress menstruation, for whom bleeding is especially surprising.”

Because the study relied on self-reported experiences logged more than 14 days after vaccination, it cannot establish causality or be seen as predictive of people in the general population.

But it can point to potential associations between a person’s reproductive history, hormonal status, demographics, and changes in menstruation following COVID-19 vaccination.

For example, the analysis revealed that respondents who had experienced a pregnancy were most likely to report heavier bleeding after vaccination, with a slight increase among those who had not given birth.

Most non-menstruating premenopausal respondents on hormonal treatment experienced breakthrough bleeding after receiving the vaccine.

More than 70% of respondents using long-acting reversible contraception and 38.5% of those undergoing gender-affirming hormone treatments reported this side effect.

“Unexpected breakthrough bleeding is one of the early signs of some cancers in post-menopausal people and in those who use gender-affirming hormones, so experiencing it can make people worry and require expensive and invasive cancer-screening procedures,” said Katharine Lee, an anthropology professor at Tulane University.

“Menstruation is a normal process that responds to all kinds of immune and energetic stressors. People notice changes to their bleeding patterns, yet we don’t tend to talk about it publicly.”

The Beckman Institute, the CSBS, and the Interdisciplinary Health Sciences Institute at Illinois supported this research, as did the National Institutes of Health, the Foundation for Barnes-Jewish Hospital, and the Siteman Cancer Center in St. Louis, MO.

Note: This study and press release were manually curated for mobile readers.

Jul 20, 2022 • 12:32 pm CDT
Image by Tumisu

France-based Valneva SE today announces that the European Commission (EC) has approved an amendment to the Advance Purchase Agreement (APA) for its inactivated whole-virus COVID-19 vaccine, VLA2001.

Under this amendment, the Member States' purchases will consist of 1.25 million doses of VLA2001 in 2022, with the option to purchase an equivalent quantity for delivery in late 2022.

The first vaccine doses are expected to be delivered to participating EU Member States (Germany, Austria, Denmark, Finland, and Bulgaria) in the coming weeks.

Thomas Lingelbach, CEO of Valneva, commented in a press release issued on July 20, 2022, "We welcome the fact that the EC has decided not to terminate the APA, although we feel the order volume does not reflect the interest we see from European citizens."

"Despite this, we have decided to enter into this amendment to make our vaccine available to the Europeans who have been waiting for it."

"While the pandemic had been declining, the latest COVID-19 wave in Europe underlines the need for alternative vaccines."

About "15% of European adults are not yet vaccinated, and we continue to receive messages from Europeans who are awaiting a more traditional vaccine technology."

"Recent market studies conducted in several EU member states suggest that making our inactivated vaccine available in Europe could increase vaccine uptake and have a meaningful impact on public health."

VLA2001 is the only whole virus, inactivated, adjuvanted COVID-19 vaccine, which has received marketing authorization in Europe for primary vaccinations in people from 18 to 50 years of age.

It is produced on Valneva's established Vero-cell platform, leveraging the manufacturing technology for Valneva's licensed Japanese encephalitis vaccine, IXIARO®

The vaccine was also granted conditional marketing authorization in the United Kingdom and emergency use authorization in the United Arab Emirates and the Kingdom of Bahrain.

Note: The company's press release was manually curated for mobile readers.

Jul 6, 2022 • 3:13 pm CDT

 The peer-review journal Brain published the findings of a new study that focused on the underlying mechanisms by which the SARS-CoV-2 virus leads to acute and long-term neurological manifestations.

This National Institutes of Health study announced on July 5, 2022, describes the immune response triggered by COVID-19 infection that damages the brain's blood vessels and may lead to short- and long-term neurological symptoms.

In this brain autopsy study, these researchers characterized the vascular pathology, neuroinflammatory changes, and cellular and humoral immune responses by immunohistochemistry.

All study participants were found to have multifocal vascular damage as determined by leakage of serum proteins into the brain parenchyma.

'Injury to the microvasculature by immune complexes with complement activation is the key central event that results in the breakdown of the blood-brain barrier, microthromboses, perivascular inflammation, and neuronal injury.'

"Patients often develop neurological complications with COVID-19, but the underlying pathophysiological process is not well understood," commented Avindra Nath, M.D., clinical director at NINDS and the senior author of the study in an NIH press release.

"We had previously shown blood vessel damage and inflammation in patients' brains at autopsy, but we didn't understand the cause of the damage."

"I think in this paper, we've gained important insight into the cascade of events."

This was accompanied by widespread endothelial cell activation.

Platelet aggregates and microthrombi adhered to the endothelial cells along vascular lumina.

Immune complexes activating the classical complement pathway were found on the endothelial cells and platelets.

Perivascular infiltrates consisted of predominantly macrophages and some CD8+ T cells.

Only rare CD4+ T cells and CD20+ B cells were present.

Astrogliosis was also prominent in the perivascular regions, and microglial nodules were predominant in the hindbrain, which was associated with focal neuronal loss and neuronophagia.

Antibody-mediated cytotoxicity directed against the endothelial cells is the most likely event leading to vascular leakage, platelet aggregation, neuroinflammation, and neuronal injury.

Therapeutic modalities directed against immune complexes should be considered.

The study builds on their previous research, which found evidence of brain damage caused by thinning and leaky blood vessels.

However, they suspected the damage may have been due to the body's natural inflammatory response to the coronavirus.

Importantly, these studies suggest that therapeutic approaches targeted against the development of immune complexes should be considered.

Note: This NIH announcement was manually edited for mobile readership.

Jul 6, 2022 • 2:32 pm CDT

The U.S. Food and Drug Administration (FDA) announced today it revised the oral COVID-19 treatment Paxlovid™ previous authorization to empower state-licensed pharmacists to prescribe the pill to eligible patients, subject to defined limitations.

The FDA authorizes Paxlovid to treat mild-to-moderate COVID-19 in most adults and pediatric patients.

Patrizia Cavazzoni, M.D., director for the FDA's Center for Drug Evaluation and Research, commented in a media statement issued on July 6, 2022, "Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19."

Paxlovid may not be an appropriate therapeutic option based on the current Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.

Patients who have tested positive for COVID-19 and are seeking to determine their eligibility for receiving Paxlovid at locations where prescribing by state-licensed pharmacists is available should bring the following information to ensure that the state-licensed pharmacist has sufficient information to determine their eligibility to receive Paxlovid:

  • Electronic or printed health records less than 12 months old, including the most recent reports of laboratory blood work for the state-licensed pharmacist to review for kidney or liver problems. State-licensed pharmacists could also receive this information through a consult with the patient's health care provider.
  • A list of all medications they are taking, including over-the-counter medicines, so that the state-licensed pharmacist can screen for drugs with potentially serious interactions with Paxlovid.

Under the limitations outlined in the authorization, the state-licensed pharmacist should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs if any of the following apply:

  • Sufficient information is not available to assess renal and hepatic function.
  • Sufficient information is not available to assess for a potential drug interaction.
  • Modification of other medications is needed due to a potential drug interaction.

Since December 2021, the U.S. government has distributed about 3,963,802 Paxlovid treatments in the USA.

Additional COVID-19 treatment news is posted at CoronavirusToday.

Note: The FDA announcement was manually curated for mobile readership.

Jul 6, 2022 • 8:23 am CDT
by Gerd Altmann

Florida-based Veru Inc. announced today positive results from a Phase 3 COVID-19 study evaluating the efficacy and safety of oral sabizabulin, a novel dual antiviral and anti-inflammatory agent, for the treatment of hospitalized moderate-severe COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS) and death, was published in The New England Journal of Medicine (NEJM) Evidence.

The study's Primary Endpoint, published in a NEJM Original Article on July 6, 2022, showed a statistically significant and clinically meaningful 55.2% reduction in deaths compared to placebo in Moderate-Severe Hospitalized COVID-19 Patients.

"Unfortunately, COVID-19 is here to stay with new variants emerging and rising rates of new cases, hospitalizations, and deaths. The current death rate from COVID-19 infection is unacceptable," commented Alan Skolnick, M.D., Principal Investigator with HD Research, who conducted this Phase 3 COVID-19 study at Memorial Hermann Memorial City Medical Center in Houston, TX, co-author of the NEJM Evidence publication.

And the Key Secondary Endpoints showed that Sabizabulin treatment had a significant and clinically meaningful reduction in Days in ICU, Days on Mechanical Ventilation, and Days in the Hospital rations.

"This landmark study published in The New England Journal of Medicine Evidence shows the high consistency of sabizabulin treatment to significantly reduce deaths across patient subgroups regardless of the standard of care treatment received, baseline WHO scores, age, comorbidities, vaccination status, COVID-19 variant, or geography," said Mitchell Steiner, M.D., Chairman, President, and CEO of Veru and co-author of the NEJM Evidence publication, in a press release.

The Company confirmed it previously submitted a request to the U.S. FDA for authorization on June 7, 2022.

The Company stated it has scaled manufacturing and expects to produce sufficient commercial drug supply to address anticipated drug needs following potential FDA authorization in the U.S. and subsequent authorizations in other countries and regions.

Veru Inc. is a biopharmaceutical company focused on developing novel medicines for COVID-19, viral and ARDS-related diseases, and managing breast and prostate cancers.

Additional COVID-19 antibody and treatment news is posted at CoronavirusToday.

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Jul 5, 2022 • 11:17 am CDT
by Abobo

Maryland-based Novavax, Inc. announced today that the European Commission (E.C.) had approved the expanded conditional marketing authorization (CMA) of the Nuvaxovid™ COVID-19 vaccine in the European Union (E.U.) for adolescents aged 12 through 17.

The E.C. authorization was based on data from the ongoing pediatric expansion of PREVENT-19, a pivotal Phase 3 clinical trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the USA.

In the trial, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% overall clinical efficacy when the Delta variant was the predominant circulating SARS-CoV-2 strain.

The U.S. Food and Drug Administration has not authorized Novavax's vaccine for use in the USA.

Stanley C. Erck, President, and CEO, of Novavax, stated in a press release issued on July 5, 2022, "Our protein-based vaccine was developed using an innovative approach to traditional technology and has demonstrated efficacy and safety in both adolescents and adults."

Preliminary safety data from the clinical study showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number, balanced between vaccine and placebo groups, and not considered related to the vaccine.

And no new safety signal was observed through the placebo-controlled portion of the study.

The E.C. granted authorization for adults in December 2021.

In addition, India recently granted authorization to the 12 through the 17-year-old population.

Note: The company's press release was manually curated for mobile readers.

Jun 29, 2022 • 11:11 am CDT
by Tumisu

Indiana-based Eli Lilly and Company announced today a modified purchase agreement with the U.S. government to supply an additional 150,000 doses of bebtelovimab for approximately $275 million.

The existing U.S. government supply of bebtelovimab monoclonal antibodies (mAbs), including the new purchase, is expected to meet present demand through late August 2022.

Delivery of doses will begin immediately and be complete no later than August 5, 2022.

This additional mAbs purchase is supported in whole or in part with federal funds from the Department of Health and Human Services.

As of June 29, 2022, HHS had distributed about 490,081 Bebtelovimab doses in the USA.

On February 11, 2022, Eli Lilly announced an agreement with the U.S. government to supply up to 600,000 doses of bebtelovimab, with an option of 500,000 additional doses for delivery no later than July 31, 2022. 

To date, over 700,000 patients have been treated with Lilly's mAbs in the U.S., potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths during the worst of the pandemic.

"Lilly and its collaborators have partnered closely with the federal government throughout the pandemic to ensure broad and equitable access to our monoclonal antibodies," said David A. Ricks, Lilly's chair and CEO, in a press release issued on June 29, 2022.

Bebtelovimab is a neutralizing IgG1 mAb directed against the spike protein of SARS-CoV-2.

According to Lilly, Bebtelovimab continues to maintain neutralization activity against the Omicron variants (BA.2.12.1 and BA.4/BA.5) in addition to all known variants of interest and concern.

However, Bebtelovimab has not been approved by the U.S. FDA as of June 29, 2022.

But it has been authorized for emergency use by the FDA under a EUA for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. 

The emergency use of bebtelovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologicals.

Jun 24, 2022 • 12:12 pm CDT

Valneva SE today announced that the European Commission (EC) had granted marketing authorization in Europe for Valneva's inactivated whole-virus COVID-19 vaccine, VLA2001, for use as primary vaccination in people from 18 to 50 years of age.

With this approval, VLA2001 becomes the first COVID-19 vaccine to receive standard marketing authorization for all 28 European Union Member States, Iceland, Liechtenstein, and Norway.

Thomas Lingelbach, CEO of Valneva, commented in a media statement issued on June 24, 2022, "We are extremely pleased that the EC granted full marketing authorization for VLA2001, the only inactivated whole-virus COVID-19 vaccine available in Europe."

"Since we began working on VLA2001, we have continued to receive messages from Europeans who are waiting for a more traditional vaccine technology."

"Now that we have received this full marketing authorization, we hope that the EC and its member states will place orders that reflect this demand.... as we believe that making our inactivated vaccine available could increase vaccination coverage and have a meaningful impact on public health."

This new marketing authorization in Europe follows conditional marketing authorization in the U.K., granted in April 2022, and emergency use authorization in the United Arab Emirates and Bahrain in May 2022 and March 2022, respectively.

VLA2001 is produced on Valneva's established Vero-cell platform, leveraging the manufacturing technology for Valneva's licensed Japanese encephalitis vaccine, IXIARO®.

VLA2001 consists of inactivated whole virus particles of the SARS-CoV-2 coronavirus with high S-protein density, combined with two adjuvants, alum and CpG 1018.

This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1.

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Jun 18, 2022 • 3:17 pm CDT
by Gerd Altmann

The Gamaleya National Research Center of Epidemiology and Microbiology recently announced that Vaccines, the leading peer-reviewed medical journal, had published the results of a joint study showing the two-dose Sputnik V vaccine is 97% effective against hospitalization caused by the Omicron variant of coronavirus (B.1.1.529) among those vaccinated with 3 or 4 components (re-vaccination with Sputnik Light or Sputnik V after Sputnik V).

The study was conducted from January 11 to February 21, 2022, involving over 1,000 patients in Moscow. 

The article was published on June 13, 2022.

As the study authors noted, '... vaccination with Sputnik V and Sputnik Light has high effectiveness for protection against hospitalization.'

'The reduction in the severity of COVID-19 regarding the Omicron variant was also observed.'

To date, Sputnik V has been authorized in 71 countries with a total population of over 4 billion people, and Sputnik Light has been approved in more than 30 countries.

Sputnik Light is a universal booster to other COVID-19 vaccines optimally configured on the adenoviral platform.

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Jun 15, 2022 • 8:09 am CDT
by Markus Winkler

New York-based Pfizer Inc. recently shared data from the Phase 2/3 EPIC-SR study evaluating the use of PAXLOVID™ in patients at standard risk for developing severe COVID-19.

In an updated analysis through December 2021, Paxlovid showed a non-significant 51% relative risk reduction (treatment arm: 5/576; placebo: 10/569).

And a subgroup analysis of 721 vaccinated adults with at least one risk factor for progression to severe COVID-19 showed a non-significant 57% relative risk reduction in hospitalization or death (treatment arm: 3/361; placebo: 7/360).

Additional secondary endpoint data analyses showed that treatment with PAXLOVID resulted in a nominally significant 62% decrease in COVID-19-related medical visits per day across all patients relative to placebo (p=0.0228).

An additional pre-specified descriptive analysis showed a 72% reduction in the average number of days in hospital among PAXLOVID-treated patients versus placebo in EPIC-SR.

Other not statistically significant findings included no PAXLOVID-treated patients admitted to the intensive care unit, compared to three in the placebo group, and no deaths in patients who received PAXLOVID with one death in the placebo group.

The rates of serious adverse events (1.4% vs. 1.9%) and discontinuation of the study drug due to adverse events (1.7% vs. 1%) were also comparable between PAXLOVID and placebo.

“Results from our Phase 2/3 EPIC-HR and EPIC-SR studies, as well as post-authorization experience, support the efficacy and safety profile for PAXLOVID in the treatment of mild-to-moderate COVID-19 patients with at least one risk factor for progressing to severe COVID-19, regardless of vaccination status,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer, in a press release issued on June 14, 2022.

Due to a very low rate of hospitalization or death observed in the standard-risk patient population, Pfizer has decided to cease enrollment into EPIC-SR and include available data in this month’s planned New Drug Application submission to the U.S. FDA to support the use of PAXLOVID in appropriate individuals at high risk of progression to severe illness.

The company will focus on generating further data on PAXLOVID in vulnerable populations, including longer treatment durations in immunocompromised individuals.

Analyses of the data are ongoing, and final results will be made available via publication or presentation.

PAXLOVID is currently approved or authorized for conditional or emergency use in more than 65 countries across the globe to treat high-risk COVID-19 patients.

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Jun 6, 2022 • 4:28 pm CDT
from Pixabay

Increasing evidence suggests SARS-CoV-2 coronavirus antibody levels are correlated to immune protection, which is useful when choosing vaccine types and monitoring its decay over time.

But its quantitation relies on intensive laboratory techniques.

On May 3, 2022, Science Advances published a report on a decentralized, instrument-free microfluidic device that directly visualizes SARS-CoV-2 antibody levels.

Magnetic microparticles (MMPs) and polystyrene microparticles (PMPs) can bind to SARS-CoV-2 antibodies simultaneously.

In a microfluidic chip, this binding reduces the incidence of free PMPs escaping from magnetic separation and shortens PMP accumulation length at a particle dam.

This visual, quantitative result enables use in either sensitive mode [limit of detection (LOD): 13.3 ng/ml; sample-to-answer time: 70 min] or rapid mode (LOD: 57.8 ng/ml; sample-to-answer time: 20 min) and closely agrees with the gold standard enzyme-linked immunosorbent assay.

Trials on 91 vaccinees revealed higher antibody levels in mRNA vaccinees than inactivated vaccinees and their decay in 45 days, demonstrating the need for point-of-care devices to monitor immune protection.

'Similar to an ordinary mercury thermometer, the result is readable and unambiguous.'

'Thus, our device is particularly suitable for the general public to routinely check immune protection at local clinics.'

Furthermore, these researchers from the University of Hong Kong suggested that antibody-based 'immunity passports 'instead of vaccination records might offer enhanced evaluations before flight travel.

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Jun 3, 2022 • 1:15 pm CDT
by David Mark

Throughout the COVID-19 pandemic, testing individuals for a SARS-CoV-2 virus infection remains a crucial action. An innovative approach to rapid testing is to consider the olfactory capacities of trained detection dogs.

According to a peer-reviewed study in PLOS One on June 1, 2022, compared with reverse-transcription polymerase chain reaction (RT-PCR) testing, dogs can detect coronavirus infections via scent with high sensitivity (97%).

The study authors concluded, "Our results show the excellent sensitivity of SARS-CoV-2 detection by dogs using nasopharyngeal RT-PCR as the reference for comparison."

"These results are consistent with previous results in proof of concepts studies using sweat in hospitalized patients."

"Non-invasive detection of SARS-CoV-2 infection by canine olfaction could be an alternative to NPS RT-PCR when it is necessary to obtain a result quickly."

The trial was supported by a grant from the French Ministry of Health, Region Ile de France, and Assistance Publique-Hôpitaux de Paris Foundation. 

A similar study published in May 2022 by BMJ Global Health demonstrated how trained dogs could detect coronaviruses in airline travelers.

Note: This study's results were manually curated for mobile readers.

Jun 2, 2022 • 3:47 pm CDT
by Niek Verlaan

New Jersey-based Bristol Myers Squibb today announced topline results from the Phase 3 Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-1) Immune Modulators clinical trial, sponsored by the National Institutes of Health (NIH).

The study evaluated the safety and efficacy of a single dose of immune modulators, including the U.S. FDA-approved Orencia (abatacept) IV (10 mg/kg) versus placebo when given with standard of care.

Treatment with Orencia versus placebo displayed a strong but not statistically significant improvement in the primary endpoint of time to recovery as measured by the day of hospital discharge.

However, analyses of the secondary endpoints, which included mortality and clinical status, demonstrated Orencia reduced participants’ risk of death and improved their clinical status at 28 days after entering the study when compared with placebo.

The risk of death was lower for participants who received Orencia at 11%, versus 15% for those who received placebo, and the odds of dying were 37.4% lower.

People in the Orencia group had 34.2% better odds of clinical improvement than those in the placebo group.

Samit Hirawat, MD, chief medical officer, Bristol Myers Squibb, commented in a press release issued on June 2, 2022, “We are pleased with the data demonstrating the risk of death was lower for participants who received Orencia and look forward to continued collaboration with the NIH to assess the data and potentially bring this treatment option to those in need.”

Given the positive findings from the topline data, Bristol Myers Squibb plans to discuss these data and potential next steps with the U.S. FDA, stated the company.

These highlights do not include all the information needed to use ORENCIA safely and effectively. See full prescribing information for ORENCIA.

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