Coronavirus Breaking News

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

Apr 25, 2023 • 10:27 am CDT

COVID-19 Vaccine Immune Imprinting Confirmed

by Markus Winkler

Dr. Katelyn Jetelina, MPH Ph.D., a well-known epidemiologist and data scientist, today announced, "We know imprinting is a thing with COVID-19. And, we should expect imprinting."

"The biggest influence of imprinting occurs after the first exposure to the virus through vaccine or infection. We still don't have good evidence that imprinting harms protection, though."

"We simply don't know the risks of stimulating the immune system with six shots in 2 years, too."

"There are always unknown risks, albeit small," wrote Dr. Jetelina on April 25. 2023.

Dr. Jetelina explained in April 2022 original antigenic sin (OAS) is a particular type of immune imprinting. In OAS, prior memory can interfere with and prevent people from generating antibodies against new variants. However, how this occurs is not well understood.

But we know that OAS occurs with other viruses, like the flu.

For example, the first flu infection you get as a child has been shown to impact how you react to flu variants later in life.

These comments follow the World Health Organization's recent announcement that in vitro evidence shows that immune imprinting occurs with repeated exposure to the same antigen from COVID-19 vaccines.

Original antigenic sin is an attribute of immune memory that leads to greater induction of antibodies specific to the first-encountered variant of an immunogen compared with subsequent variants.

The impact of innate and adaptive immunities related to COVID-19 vaccination's original antigenic sin continues to be explored in various studies in April 2023.

Note: Dr. Jetelina publishes "Your Local Epidemiologist." She works at a nonpartisan health policy think tank and is a senior scientific consultant to several organizations, including the U.S. CDC.

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Don Ward Hackett

Apr 27, 2023 • 2:15 pm CDT

COVID-19 Cases Continue Decreasing in Most Countries

WHO COVID-19 map April 26, 2023

The World Health Organization (WHO) today published Edition #140 of its Weekly epidemiological update on the COVID-19 pandemic.

As of April 27, 2023, the WHO confirmed nearly 2.8 million new COVID-19 cases, and over 16,000 related fatalities were reported in the last 28 days.

This data indicates a decrease of 23% and 36%, respectively, compared to the previous period.

Contrary to the overall trend, increases in reported cases and deaths continued to be registered in the South-East Asia and Eastern Mediterranean regions and several individual countries elsewhere.

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Don Ward Hackett

Apr 27, 2023 • 10:44 am CDT

COVID-19 Antiviral Sales Decrease 88%

Merck press release April 27, 2023

Merck today announced financial results for the first quarter of 2023. In addition, Merck stated it realized lower sales of the oral COVID-19 antiviral Lagevrio™ (Molnupiravir), which decreased 88% to $392 million.

This decrease was primarily attributable to sales in the U.S. and U.K. markets in the first quarter of 2022 that did not recur in the first quarter of 2023.

LAGEVRIO's decline was also attributable to lower sales in Japan and Australia.

LAGEVRIO is approved or authorized for use in more than 25 countries. It helps reduce how sick people become when diagnosed with COVID‑19.

Additional COVID-19 antiviral news is posted at Coronavirus Today.

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Don Ward Hackett

Apr 25, 2023 • 2:21 pm CDT

Lagevrio Reduces Severe COVID-19 Risk

by Max from P.

The BMJ today published a study based on U.S. VA data that concluded among people at high risk of progression to severe COVID-19-19, molnupiravir (Lagevrio™) use within five days of SARS-CoV-2 virus infection may be a viable approach to reduce the risk of post-acute sequelae of SARS-CoV-2 (PASC).

Led by VA Saint Louis Health Care System researchers, this study found molnupiravir was also associated with reduced risk of PASC in people who had not received a covid-19 vaccine, had received one or two vaccine doses, and had received a booster dose, and in people with primary SARS-CoV-2 infection and reinfection.

The researchers wrote they don't know whether this study's findings would apply to people without risk factors for severe COVID-19.

As of April 25, 2023, Lagevrio is approved or authorized for use in more than 25 countries, including the United States.

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Don Ward Hackett

Apr 25, 2023 • 11:21 am CDT

U.S. FDA Cleared COVID-19 Monoclonal Antibody Candidate's Application

from Pixabay

Invivyd, Inc. today announced that the U.S. Food and Drug Administration (FDA) had cleared its Investigational New Drug (IND) application for VYD222, a monoclonal antibody (mAb) candidate.

Invivyd is developing VYD222 to prevent COVID-19 in vulnerable populations, such as immunocompromised people.

"We are pleased that the FDA has cleared our IND for VYD222, and we are excited by the progress we've made in our ongoing Phase 1 VYD222 clinical trial," commented Dave Hering, CEO of Invivyd, in a press release on April 25, 2023.

"We have completed dosing of the first cohort and have moved to the second dosing cohort, with initial readouts from the Phase 1 clinical trial on track for the second quarter."

"The swift progress of our Phase 1 VYD222 clinical trial and the FDA's recent clearance of the VYD222 IND are important steps in our plan to rapidly advance a stream of mAb candidates designed to keep pace with SARS-CoV-2 viral evolution."

The ongoing Phase 1 trial is a randomized, blinded, placebo-controlled, dose-ranging trial that will evaluate the safety, pharmacokinetics, tolerability, and serum virus-neutralizing activity of VYD222 in healthy adult volunteers.

As of April 25, 2023, the FDA has discontinued authorizing mAbs to prevent COVID-19 in the U.S. However, mAbs are available in Europe and other countries.

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Karen McClorey Hackett

Apr 25, 2023 • 10:51 am CDT

Investigational COVID-19 Oral Antiviral Granted Fast Track Status

from Pixabay

Atea Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration granted Fast Track designation to bemnifosbuvir for treating COVID-19.

Bemnifosbuvir (AT-527) is an oral, direct-acting antiviral drug candidate, a nucleotide polymerase inhibitor that targets the SARS-CoV-2 RNA polymerase, a highly conserved gene that is unlikely to change as the coronavirus mutates and variants continue to emerge.

Recent in vitro data confirmed that bemnifosbuvir is active with similar efficacy against all variants of concern and variants of interest that have been tested, including Omicron subvariants BA.4 and BA.5.

Bemnifosbuvir is being evaluated in the global Phase 3 SUNRISE-3 registrational trial for the treatment of COVID-19 in outpatients at high risk for disease progression regardless of vaccination status.

This evaluation includes patients over the age of 80, patients 65 years or older with at least one major risk factor, and anyone over the age of 18 who is immunocompromised.

Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals, commented in a press release on April 25, 2023, "Due to the limitations of current antiviral treatments, including drug-drug interactions and potential risks for genotoxicity and reproductive toxicity, as well as the ability of the virus to evade vaccines and monoclonal antibodies, new treatment options are urgently needed."

CoronavirusToday publishes COVID-19 antiviral and antibody therapy news.

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Don Ward Hackett

Apr 20, 2023 • 3:36 pm CDT

Later COVID-19 Waves Saw a Decrease in Severe Outcomes

WHO Public Health Canada April 2023

The peer-review JAMA Network Open published today results from a study that found more Canadians were hospitalized during later COVID-19 waves compared to the initial year of the pandemic.

However, the health outcomes were less severe in these hospitalized people.

In a cohort study of 55,714 adult and pediatric patients hospitalized with laboratory-confirmed COVID-19 in 155 acute care hospitals in Canada, surveillance data show that during waves 5 and 6 of the COVID-19 pandemic, hospitals experienced a surge in patients hospitalized with COVID-19, an increase in nosocomial transmission of COVID-19, and a decrease in severe outcomes.

These data suggest the importance of COVID-19 vaccination in reducing the burden on the Canadian healthcare system and severe outcomes associated with COVID-19, wrote these researchers.

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Don Ward Hackett

Apr 20, 2023 • 2:55 pm CDT

41 Million At-Home SARS-CoV-2 Virus Tests Completed

U.S. CDC MMWR April 21, 2023

The U.S. CDC Morbidity and Mortality Weekly Report (MMWR) today announced that during January 2022, the COVIDTests.gov program became available to all U.S. households, which could order free-to-the-user at-home test kits from the federal government.

In a probability sample of U.S. households, both awareness of the COVIDTests.gov program and use of kits were high, with more than 41 million households estimated to have used kits during January–May 2022.

This MMWR concluded the long-term availability of government-supplied test kits appears to have significantly improved access to SARS-CoV-2 virus testing for racial and ethnic minorities, underscoring a critically important element of the U.S. national COVID-19 response.

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Don Ward Hackett

Apr 20, 2023 • 6:09 am CDT

COVID-19 Cases Resurge in India

BBC News April 2023

As the COVID-19 caseload recently accelerated in India, the global community is debating the cause of this upsurge.

Medical experts have warned that the new XBB1.16 coronavirus variant can evade people's immune systems, regardless of vaccine or naturally induced immunity.

For example, India's Ministry of Health reported 12,591 new cases and 40 deaths on April 19, 2023.

Dr. Randeep Guleria recently told ANI .... while the country was seeing a fresh surge in Covid-19 infections, the situation isn't one to induce panic.... the majority of the infections are mild.

And the rate of hospitalization hasn't gone up either.

In reaction to this new data, most states in India have reordered COVID-19 vaccines, such as CoviSheld, CorbeVax, and CovoVax™.

As of April 11, 2023, a total of 2,206,624,273 COVID-19 vaccine doses have been administered in India.

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Don Ward Hackett

Apr 19, 2023 • 7:33 am CDT

Long-Acting Antibody Candidate Neutralizes COVID-19 Variants

by Bruno G.

AstraZeneca recently highlighted new data at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), reinforcing its ambition to provide long-lasting immunity for millions globally.

For example, data featuring AZD3152, AstraZeneca’s investigational long-acting COVID-19 antibody, shows the investigational COVID-19 long-acting antibody neutralizes all known variants of concern identified to date.

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, stated in a press release on April 14, 2023, “Our first in vitro data from our next generation long-acting antibody, AZD3152, shows its potential to protect the immunocompromised from all known COVID-19 variants of concern to date.”

Last updated on April 3, 2023, the aim of the phase I/III clinical study is to evaluate the safety and neutralizing activity of AZD3152 compared with AZD7442 for pre-exposure prophylaxis of COVID-19 and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061.

Other COVID-19 antibody news is posted by CoronavirusToday.com.

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Don Ward Hackett

Apr 19, 2023 • 7:22 am CDT

Pharmacies Lead COVID-19 Vaccinations

U.S. HHS Secretary Becerra April 2023

According to the U.S. government, pharmacies are the leading distribution outlet for COVID-19 vaccines. During the 2022-2023 season, available data show that more than two-thirds of adult COVID-19 vaccinations were administered at pharmacies.

Announced on April 18, 2023, the U.S. Department of Health & Human Services (HHS) announced the ‘HHS Bridge Access Program For COVID-19 Vaccines and Treatments Program (“Program”) to maintain broad access to COVID-19 vaccines for millions of uninsured Americans.

The program will create a unique $1.1 billion public-private partnership to help maintain uninsured individuals’ access to COVID-19 care at local pharmacies.

HHS wrote pharmacies had been a critical partner in the Administration’s response to COVID-19 and a vital access point for millions of Americans in receiving convenient and timely COVID-19 vaccines, treatments, and tests.

In the future, HHS aims to ensure that the pharmacy setting remains a place of access for the uninsured.

In building the Program, CDC will establish contracts with pharmacies to enable them to continue offering COVID-19 vaccines and designated treatments with no out-of-pocket costs to uninsured individuals, maintaining this critical access point for this population.

And pharmacies will also be expected to conduct outreach regarding the availability of the COVID-19 vaccine, including through community partnerships focusing on underserved populations.

Together, these efforts will create a unique public-private partnership that will help maintain uninsured individuals’ access to COVID-19 care at their local pharmacies, local health centers, and public health infrastructure.

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Don Ward Hackett

Apr 18, 2023 • 8:17 am CDT

Which State Managed COVID-19 Best

The Lancet state map COVID-19 impact March 2023

The Lancet recently published results from an analysis that assessed COVID-19 pandemic policies and behaviors in the U.S.

These researchers revealed where a person lived indicated COVID-19 risk.

Published on March 23, 2023, this analysis found nearly four-fold differences that existed across states in COVID-19 death rates, even when standardized for factors such as age and comorbidities, suggesting that lower death rates were achievable.

The states with the lowest standardized COVID-19 death rates were Hawaii, New Hampshire, Maine, Vermont, and Maryland, which are not confined to a single geographical region.

And the states and territories with the highest standardized cumulative death rates were Arizona (581 per 100 000 [509–672]), Washington, DC, New Mexico, Mississippi, and Colorado.

In summary, these researchers stated that the policy mandates and protective behaviors adopted during this pandemic effectively reduced SARS-CoV-2 infections.

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Don Ward Hackett

Apr 18, 2023 • 7:07 am CDT

Universal Masking... A Strategy Whose Time Has Come and Gone, For Now

Annals of Internal Medicines April 2023

The Annals of Internal Medicine today published an opinion article that confirmed during the COVID-19 pandemic, the expanded use of facemasks as part of “universal masking” for healthcare personnel (HCP), patients, and visitors in healthcare settings was implemented to reduce the risk for morbidity and mortality associated with the spread of a novel virulent pathogen.

However, the context and conditions of the pandemic have changed dramatically, and evidence-based public health policy should also adapt in response.

The time has come to manage SARS-CoV-2 as we generally manage other endemic respiratory viruses in healthcare settings through correct and consistent application of Standard Precautions and Transmission-Based Precautions.

Moving away from universal masking policies should be accompanied by reconsidering other pandemic-era strategies, such as asymptomatic testing and resource-intensive contact tracing.

In conclusion, this article published on April 18, 2023, stated .... Interactions between humans and pathogens are inherently dynamic.

Therefore, they are constantly evolving, and we have achieved significant advancements in preventing and managing SARS-CoV-2 since the pathogen was initially identified in 2019.

In recognition of these achievements, the time has come to deimplement policies inappropriate for an endemic pathogen when the expected benefits of such policies are low.

Universal masking in health care is a policy whose time has come and gone ... for now.

Face mask research is posted by Coronavirus Today.

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Don Ward Hackett

Apr 12, 2023 • 4:04 pm CDT

National COVID-19 Preparedness Plan Announced in the U.S.

U.S. National COVID-⁠19 Preparedness Plan April 12, 2023

The U.S. government today announced it is releasing the National COVID-19 Preparedness Plan. This plan lays out the roadmap to help fight COVID-19 in the future.

'We look to a future when Americans no longer fear lockdowns, shutdowns, and our kids not going to school,' wrote the U.S. government on April 12, 2023.

'It's a future when the country relies on the powerful layers of protection we have built."

"And invests in the next generation of tools to stay ahead of this coronavirus."

The President's National COVID-19 Preparedness Plan focuses on four key goals, which are linked here.

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Karen McClorey Hackett

Apr 12, 2023 • 3:50 pm CDT

COVID-19 Vaccination Can Clear this Coronavirus

by Mauricio Keller Keller

CanSinoBio Biologics Inc. recently announced an article titled "Successful clearance of persistent SARS-CoV-2 asymptomatic infection following a single dose of Ad5-nCoV (Convidecia™) vaccine," published in the medical journal Signal Transduction and Targeted Therapy, revealed for the first time the role of vaccination in clearing the coronavirus infections.

The prevalence of asymptomatic COVID-19 infection accounts for 40%-45% of cases.

On April 7, 2023, CanSinoBio reported in a media release in cases of long-term asymptomatic infection, Ad5-nCoV vaccination can generate a rapid and robust antibody response and coordinate B-cell and cTfh cell immune responses to facilitate subsequent virus clearance.

In addition, vaccination-induced antibodies exhibited broad-spectrum neutralizing activity and immune-persisting activity against various virus strains.

This study's highlights include, but are not limited to, the following:

After Ad5-nCoV vaccination, humoral immune responses were effectively enhanced, while antigen-specific CD4 and CD8 T cell responses were modestly improved, suggesting that enhanced humoral responses after primmunizationnation play a role in clearing viral RNA and treating persistent SARS-significant significant role in infection,
And an essential role of B cells and cTfh cells in antibody production, both nAb and RBD-specific IgG titers were positively correlated with RBD B cells, ASC and cTfh,
Following vaccination, the frequencies of SARS-CoV-2 RBD B cells and ASCs increase rapidly, peaking at 2–6 weeks post-vaccination, respectively,
Furthermore, cTfh cells exhibit similar kinetics to ASC,
In contrast to strongly enhanced antibody responses, SARS-CoV-2-specific CD4+ and CD8+ T cells did not increase significantly after vaccination.

Taken together, this study reveals that prolonged asymptomatic infection with SARS-CoV-2 may be attributed to impaired immune activation, manifested by low levels of initial inflammation, interferon, and weak antibody responses, markedly reduced cTfh, and specific CD4+ and CD8+ T cell responses were insufficient, wrote the company.

CanSinoBio's Convidecia™ is a novel recombinant viral vector vaccine for COVID-19, and the inhaled version, Convidecia Air™, was approved as a booster dose on September 4, 2022.

These COVID-19 vaccines are available in about ten countries as of April 12, 2023.

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Don Ward Hackett