Coronavirus Breaking News

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

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

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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May 30, 2022 • 7:00 am CDT
by RazorMax

As the COVID-19 pandemic continues into June 2022, a growing population of people has new or recurring symptoms long after the initial infection, wrote the Annals of Internal Medicine.

As of May 27, 2022, many refer to this condition as "long COVID."

However, the U.S. National Institutes of Health's official name for the condition is 'postacute sequelae of SARS-CoV-2' (PASC).

Whatever we call it, the current understanding of this condition's pathophysiology, epidemiology, and the course makes caring for these patients a vexing challenge, stated the Annals.

To provide practical guidance for clinicians based on current knowledge, the Annals of Internal Medicine and the American College of Physicians held their ninth COVID-19 forum on May 24, 2022.

The program began with Dr. H. Clifford Lane summarizing the results of a study he and colleagues recently published in Annals that attempted to characterize the sequelae after recovery from COVID-19 in a cohort of survivors and controls.

The ongoing study documented a high burden of persistent symptoms in persons after COVID-19.

It revealed no specific cause of reported symptoms in most cases and highly variable antibody levels after COVID-19.

'As we await high-quality evidence to guide our clinical decisions, we must acknowledge how many patients are suffering and do our best to help mitigate their symptoms while avoiding harm, summarized this related Annals Editorial.

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May 30, 2022 • 6:18 am CDT
AcadeMab

Taiwan-based AcadeMab Biomedical Inc. recently announced it developed several potent and broad-spectrum COVID-19 therapeutic antibodies for the SARS-CoV-2 virus Omicron and Delta variants.

On May 26, 2022, AcadeMab confirmed its monoclonal antibodies for COVID-19 patients using single B cell technology, showing the best neutralization ability (IC50 = 11.4 and 4.3 ng/ml) in both Omicron variants BA.1 and BA.2 respectively.

"We are excited to announce that our research and development efforts have paid off at a fast pace with our single B cell technology that's shown neutralizing efficacy against the world's most common and deadly Omicron variant," shared Juz-Hsiang Chiu, M.D., AcadeMab CEO, in a press release.

This type of treatment is beneficial to those who have a documented history of severe adverse reactions to existing COVID-19 vaccines or their components and are unable to be vaccinated.

Additional antibody development news is posted at CoronavirusToday.com/Antibody.

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May 26, 2022 • 6:45 am CDT
from Pixabay

A new study published yesterday in the peer-review Nature Medicine journal concluded, "COVID-19 vaccination partially reduces the risk of death and post-acute sequelae."

And, 'The burden of death and disease experienced by people with [breakthrough infection] is not trivial,' wrote these researchers on May 25, 2022.

The post-acute sequelae of severe acute respiratory SARS-CoV-2 infection, also referred to as Long COVID, have been described, but whether breakthrough SARS-CoV-2 infection (BTI) in vaccinated people results in post-acute sequelae was not apparent.

In this study, they used the US Department of Veterans Affairs national healthcare databases to build a cohort of 33,940 individuals with BTI and several controls of people without evidence of SARS-CoV-2 infection, including contemporary (n = 4,983,491), historical (n = 5,785,273) and vaccinated (n = 2,566,369) controls.

At six months after infection, these researchers showed that, beyond the first 30 days of illness, compared to contemporary controls, people with BTI exhibited a higher risk of death (hazard ratio (HR) = 1.75, 95% confidence interval (CI): 1.59, 1.93) and incident post-acute sequelae (HR = 1.50, 95% CI: 1.46, 1.54), including cardiovascular, coagulation and hematologic, gastrointestinal, kidney, mental health, metabolic, musculoskeletal and neurologic disorders.

The results were consistent in comparisons versus the historical and vaccinated controls.

Compared to people with SARS-CoV-2 infection who were not previously vaccinated (n = 113,474), people with BTI exhibited lower risks of death (HR = 0.66, 95% CI: 0.58, 0.74) and incident post-acute sequelae (HR = 0.85, 95% CI: 0.82, 0.89).

Altogether, these findings suggest that vaccination before infection confers only partial protection in the post-acute phase of the disease.

Hence, reliance on it as a sole mitigation strategy may not optimally reduce the long-term health consequences of SARS-CoV-2 infection stated these researchers.

This analysis suggests that this risk reduction (of post-acute sequelae) was most pronounced in recipients of BNT162b2 and mRNA-1273 vaccines compared to Ad26.COV2.S. 

'Although the absolute rates are smaller than those with SARS-CoV-2 infection without prior vaccination, given the scale of the pandemic and the potential for breakthrough cases to continue to accumulate, the overall burden of death and disease after BTI will likely be substantial.'

Note(s): This research was funded by the US Department of Veterans Affairs and two American Society of Nephrology and KidneyCure fellowship awards. No industry conflicts were disclosed. The funders had no role in the study design, data collection, analysis, publication decision, or manuscript preparation. The contents do not represent the views of the US Department of Veterans Affairs or the US government.

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May 25, 2022 • 2:56 pm CDT
from Pixabay

Based on a new preclinical pseudovirus study, AstraZeneca announced today that the monoclonal antibody combination Evusheld retains neutralization activity against the emerging Omicron BA.4 and BA.5 (BA.4/5) variants assay data from the University of Oxford, located in England.

AstraZeneca's press release issued on May 25, 2022, 'these results are consistent with previous data from multiple studies showing that Evusheld retains potent neutralizing activity against Omicron BA.2, the current dominant circulating variant, and neutralizes all variants tested to date.'

John L. Perez, MD, MBA, MA, SVP, Head of Late Development, Vaccines & Immune Therapies, AstraZeneca, stated, "By combining two antibodies with different and complementary activities against SARS-CoV-2, Evusheld was engineered from the start to outsmart the COVID-19 virus and to remain potent in the face of this virus' ability to mutate rapidly."

"These findings further support Evusheld as an important option to help protect vulnerable populations such as the immunocompromised who are unable to respond adequately to COVID-19 vaccination and are at high risk for severe disease."

Approximately 2% of the global population is at increased risk of an inadequate response to COVID-19 vaccination and may benefit from pre-exposure prophylaxis (prevention) with Evusheld.

This population includes immunocompromised people, such as cancer patients, transplant patients, and anyone taking immunosuppressive medicines. 

People at increased risk of exposure to the SARS-CoV-2 coronavirus could also benefit from protection with Evusheld. 

Emerging evidence indicates that protecting vulnerable populations from getting COVID-19 could help prevent viral evolution, an essential factor in the emergence of variants.

Evusheld, formerly known as AZD7442, is a combination of two long-acting antibodies - tixagevimab (AZD8895) and cilgavimab (AZD1061) - derived from B-cells donated by individuals previously infected with the SARS-CoV-2 virus.

Evusheld has marketing authorization in the EU and was granted conditional marketing authorization in Great Britain for pre-exposure prophylaxis of COVID-19. 

And, Evusheld is authorized for emergency use for pre-exposure prophylaxis of COVID-19 by the U.S. FDA.

Note: This announcement was manually edited and curated for mobile readers.

May 24, 2022 • 6:14 pm CDT
CDC

The U.S. CDC published an Early Release Morbidity and Mortality Weekly Report focused on an expanding number of persons previously infected with SARS-CoV-2, the virus that causes COVID-19, who have reported persistent symptoms, or the onset of long-term symptoms, ≥4 weeks after acute COVID-19.

The occurrence of 26 clinical conditions previously attributed to post-COVID illness was assessed by reviewing the scientific literature.

These symptoms are commonly referred to as post-COVID conditions or long COVID.

Issued on May 24, 2022, this study found COVID-19 survivors have twice the risk of developing pulmonary embolism or respiratory conditions.

And 20% of COVID-19 survivors aged 18–64 years and 25% of survivors aged ≥65 years experienced at least one incident condition that might be attributable to the previous COVID-19.

The most common incident conditions in both age groups were respiratory symptoms and musculoskeletal pain.

'As the cumulative number of persons infected with SARS-CoV-2 increases, the number of survivors suffering post-COVID conditions is also likely to increase,' stated these researchers.

Therefore, implementation of COVID-19 prevention strategies, as well as routine assessment for post-COVID conditions among persons who survive COVID-19, is critical to reducing the incidence and impact of post-COVID diseases.'

'These findings can increase awareness for post-COVID conditions and improve post-acute care and management of patients after an illness.'

Note: This CDC report was edited for mobile readership.

May 12, 2022 • 4:48 pm CDT
John9527 from Pixabay

In a Lancet news release issued yesterday, two years after infection with COVID-19, about half of the patients admitted to the hospital still have at least one symptom, according to the most comprehensive follow-up study published in The Lancet Respiratory Medicine. 

In general, patients who recovered from COVID-19 tend to be in poorer health two years after the initial infection compared to the general population, indicating some patients need more time to recover fully.

Regardless of initial disease severity, COVID-19 survivors had longitudinal physical and mental health improvements. Most returned to their original work within two years.

However, the burden of symptomatic sequelae remained relatively high. 

Senior author Bin Cao, M.D., of the National Clinical Research Center for Respiratory Diseases, stated in a press release issued on May 11, 2022, that the results show that some COVID-19 survivors may still need medical attention two years or more after infection.

"There is a clear need to provide continued support to a significant proportion of people who've had COVID-19 and understand how vaccines, emerging treatments, and variants affect long-term health outcomes," he said.

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May 12, 2022 • 1:31 pm CDT
CDC

The U.S. CDC's Advisory Committee on Immunization Practices (ACIP) website announced the committee would conduct a digital meeting on May 19, 2022, from 11:00 am to 4:00 pm ET.

While the ACIP website disclosed this meeting is open to the public and published the link to attend, it has yet to publish the agenda for this out-of-normal-schedule meeting.

Previous ACIP meeting agendas and presentations are posted.

Note: This is a developing story, and updates will be posted asap.

 

 

Apr 28, 2022 • 5:40 am CDT
by Oleg Ilyushin

The Danish Health Authority recently announced it is suspending its COVID-19 vaccination efforts, given the high vaccine uptake and the diminishing epidemic.

However, they added that the vaccine program would 'resume in Fall 2022 when SARS-CoV-2 virus infections could increase.'

Since December 2020, over 4.8 million citizens have accepted the COVID-19 vaccination, and over 3.6 million have received 3rd dose.

Thus, Denmark's population has a high level of vaccine-induced immunity.

"Spring has arrived, and we have good control of the epidemic, which seems to be subsiding. Admission rates are stable, and we also expect them to fall soon. Therefore, we round up the mass vaccination program against covid-19," said Bolette Søborg, unit manager at the National Board of Health, in a press statement issued on April 26, 2022.

"This means, among other things, that from May 15, 2022, we will no longer send out invitations for COVID-19 vaccination."

Meanwhile, Danish experts will thoroughly assess vaccine program policies, with a release of the 2022-2023 plan expected before the summer holidays.

The National Board of Health recommends that people receive their entire vaccine course. 

And the fourth dose is recommended for those with very weakened immune systems.

'If you have an individual need for vaccination that is not due to a health professional recommendation, you also can be vaccinated. However, in that case, it is a prerequisite that the vaccination takes place within the National Board of Health guidelines.'

Furthermore, there has been an increase in adherence to more childhood vaccinations.

'We have a child vaccination program in Denmark that we can be proud of.'

'It is gratifying that parents have backed the program despite the covid-19 epidemic.'

Note: These Danish press statements were edited for clarity and manually curated for mobile readers.