Coronavirus Breaking News

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

Mar 11, 2023 • 12:04 pm CST

Severe Mpox Prevented By Vaccination

The Centers for Disease Control and Prevention (CDC) recently released a Morbidity and Mortality Weekly Report (MMWR) titled: Interim Clinical Treatment Considerations for Severe Manifestations of Mpox—United States, February 2023.

Published on March 3, 2023, this MMWR provides updated clinical treatment considerations about using therapeutic countermeasures to treat severe mpox cases.

Until data gaps are filled through randomized controlled studies and other carefully controlled research studies, this MMWR represents the best available information about human mpox treatment.

Previously, the CDC updated the U.S. National Mpox Vaccination Strategy on February 6, 2023.

The CDC continues to recommend people who have been exposed to the Mpox virus and people who may be more likely to contract mpox should be vaccinated.

The JYNNEOS® vaccine is available at certain clinics and pharmacies in the U.S.

Mpox is a disease caused by infection with the Monkeypox virus, an Orthopoxvirus in the same genus as the Variola virus, which causes smallpox.

In 2022, a global outbreak involving mpox clade IIb was detected sourced from the Canary Islands in early May. Since then, 1,201,210 JYNNEOS doses have been administered in the 57 U.S. Jurisdictions reported data.

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Don Hackett

Mar 11, 2023 • 3:51 am CST

New Yorkers Visiting Israel at Risk for Polio

JFK Airport NY March 2023

The New York State Department of Health today announced New Yorkers are planning to travel abroad to Israel and other countries with circulating poliovirus to get fully immunized against polio.

Recently, Israel's Ministry of Health confirmed four children had tested positive for poliovirus in Northern Israel.

Furthermore, Israel has reported widespread detection of poliovirus in wastewater systems.

This latest outbreak follows one that was detected in February 2022 when seven children tested positive for poliovirus in Jerusalem.

With the latest polio case, New York health officials have contacted their Israeli counterparts to ensure a coordinated response.

As of March 10, 2023, enhanced precautions are encouraged when visiting the United Kingdom, Ukraine, Afghanistan, Pakistan, Indonesia, Nigeria, Côte d'Ivoire, several other central African countries, and Israel.

In the U.S., polio vaccines are available at health clinics and community pharmacies.

Additional polio outbreak 2023 news is posted at Vax-Before-Travel.

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Don Hackett

Mar 10, 2023 • 2:57 pm CST

Avoiding Crowds in Amsterdam Advised

Rudy and Peter Skitterians

U.S. Consulate General Amsterdam, Netherlands, announced significant demonstrations are expected to occur on March 11, 2023, and advised visitors to avoid these crowds.

Furthermore, U.S. government personnel in Amsterdam have also been advised to avoid the pending, conflicting demonstrations near The Hague in Zuiderpark and around Koekamp near Central Station, including on the A12.

To help bypass the crowds, the Consulate advises U.S. citizens to enroll in the Smart Traveler Enrollment Program to receive digital security updates related to these events.

Or visit the U.S. Consulate General Amsterdam at Museumplein 19, 1071 DJ Amsterdam.

And to call 1-1-2 for emergency service from Dutch Police, Rescue, and Fire Departments.

Recently the U.S. Department of State reissued its Level 2: Exercise Increased Caution alert on March 9, 2023, highlighting the ongoing civil unrest in The Netherlands.

And from a health perspective, the U.S. CDC suggests various travel vaccines for visiting the Netherlands.

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Don Hackett

Mar 10, 2023 • 3:29 am CST

RSV Vaccine Supply Un-Constrained

by Gerd Altmann

Reuters recently confirmed GSK plc expects to launch its respiratory syncytial virus (RSV) vaccine in the U.S. in 2023 without supply constraints.

"We are ready to launch without capacity or supply constraints... to supply the market (from its plant in Wavre, Belgium) that we see," Phil Dormitzer, Global Head of Vaccines R&D at GSK, commented in an interview on March 8, 2023.

GSK plc previously announced that the U.S. Food and Drug Administration (FDA) vaccine voted that the available data support the safety and effectiveness of GSK's AREXVY™ vaccine candidate for preventing lower respiratory tract disease caused by RSV in adults aged 60 years and older.

The FDA Committee voted unanimously 12-0 on effectiveness and 10-2 on safety.

As of March 10, 2023, the FDA has yet to authorize AREXVY for use in the U.S.

Phil Dormitzer commented in a press release on March 1, 2023, "Today's vote brings us an important step closer to delivering one of the world's first vaccines for RSV, a respiratory virus that causes potentially debilitating disease and imposes a major burden on healthcare systems."

AREXVY is also under regulatory review by the European Medicines Agency, Japan's Ministry of Health, Labour and Welfare, and several other regulators, with initial decisions expected later in 2023.

RSV is one of the major remaining infectious diseases for which no vaccine or specific treatment is available for adults. Older adults are at high risk for severe disease due in part to age-related decline in immunity,

Additionally, RSV is a very serious disease in young children.

Unlike seniors, children already have FDA-approved RSV protection from a monoclonal antibody (Synagis®), with another version under final review.

The European Medicines Agency recommended marketing authorization for Beyfortus® (nirsevimab) in 2022 to prevent RSV lower respiratory tract disease in infants during their first RSV season when there is a risk of RSV infection in the local community.

Additional RSV vaccine candidates and antibody therapy news are posted at PrecisionVaccinations.com/RSV.

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Karen McClorey Hackett

Mar 9, 2023 • 3:05 pm CST

Polio Remains a Global Health Risk

U.S. CDC polio detections March 2023

The U.S. Centers for Disease Control and Prevention (CDC) recently published an update to its Alert - Level 2, Practice Enhanced Precautions global polio travel notice.

The CDC says some international destinations, such as Israel, have circulating poliovirus.

As of March 7, 2023, there have been reports of four polio cases in children during 2023. And about 150,000 children in Israel remain unvaccinated against poliovirus.

Before traveling to any listed destination, the CDC recommends that adults who previously completed the full, routine polio vaccine series receive a single, lifetime booster dose of a polio vaccine.

Furthermore, children should be current on their routine polio vaccines before traveling abroad.

The CDC says most people with polio do not feel sick.

Some people have only minor symptoms, such as fever, tiredness, nausea, headache, nasal congestion, sore throat, cough, neck and back stiffness, and arm and leg pain. In rare cases, polio infection causes permanent loss of muscle function.

Polio can be fatal if the muscles used for breathing are paralyzed or if there is an infection of the brain.

In 2022, the virus that causes polio was detected in the wastewater of cities such as New York, London, and Montreal.

In the U.S., polio vaccines are offered at most health clinics and community pharmacies.

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Don Hackett

Mar 9, 2023 • 2:39 pm CST

New Recommendations Help Identify Hepatitis B

U.S. CDC March 10, 2023

The U.S. Centers for Disease Control and Prevention (CDC) today published enhanced recommendations for the screening and testing for Hepatitis B Virus (HBV) infection.

As of March 10, 2023, the CDC confirms universal screening of adults for HBV infection is cost-effective compared with risk-based screening and averts liver disease, cirrhosis, and death.

Furthermore, chronic HBV infection is detectable using reliable and inexpensive screening tests.

In addition, although not quantifiable, management of chronic infection through prevention efforts can prevent further transmission to others.

These recommendations consider a more straightforward and less stigmatizing implementation strategy than previous risk-based HBV screening recommendations, says the CDC's Morbidity and Mortality Weekly Report.

The CDC's new recommendations also provide guidance complementary to the 2022 recommendations to vaccinate all adults aged 19–59 years against HBV infection by providing a means to establish immunity, any history of infection, or the need for vaccination to protect from future infection.

Previously, on February 23, 2022, the CDC's Hepatitis Vaccines Work Group presented an HVB vaccine update.

The CDC says effective vaccines to prevent hepatitis B are available in the U.S.

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Don Hackett

Mar 9, 2023 • 12:14 pm CST

Global Influenza Surveillance Subsides

WHO March 6, 2023

The World Health Organization (WHO) recently published Influenza Update N° 440, influenza activity continued to decrease following a peak in late 2022.

As of March 6, 2023, influenza A viruses predominated, and the proportion of influenza B virus detections increased during the current reporting period.

In the countries of North America, most indicators of influenza activity decreased to levels similar to or below levels typically observed towards the end of the season.

In Europe, overall influenza detections remained stable, and influenza positivity from sentinel sites increased in the most recent week, remaining above the epidemic threshold at the regional level.

Out of 39 countries, 18 reported high or moderate intensity, and over half continued to report widespread influenza case activity.

Other indicators of influenza activity remained stable or decreased in most countries, while a few countries reported increases.

Various types of flu shots remain available in the U.S. and Europe as of March 9, 2022.

As of February 25, 2023, the Centers for Disease Control and Prevention confirmed about 173.26 million flu shots had been distributed in the U.S. during this season.

Additional 2022-2023 flu season news is posted at PrecisionVaccinations.com/Flu.

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Karen McClorey Hackett

Mar 9, 2023 • 11:51 am CST

Are We Prepared for Marburg Virus's Next Outbreak?

ECDC Marburg cases March 2023

The World Health Organization (WHO) today announced it would conduct a digital webinar tomorrow discussing Marburg virus vaccine and therapeutic candidates and how research can be integrated during future outbreaks.

The recent emergence of the Marburg virus (MARV) in Equatorial Guinea (Feb. 2023) and Ghana triggered the assembly of the "MARVAC" consortium in 2022 to facilitate a rapid response to this infectious disease threat.

As of March 9, 2023, several MARV vaccine candidates are conducting early-stage clinical studies.

On March 10, 2023, at 14:00 CET, from this Zoom link, the WHO R&D Blueprint is organizing a consultation with the MARVAC partners and focal points from at-risk countries to discuss this preliminary agenda:

Outbreak sit rep, including diagnostics and epidemiology,
Review of core trial protocols for vaccines and therapeutics,
Panel discussion from at-risk country focal points

Since 1967, Angola, DR Congo, Equatorial Guinea, Cameroon, Germany, Ghana, Guinea, Kenya, Serbia, South Africa, and Uganda have confirmed Marburg cases.

The U.S. Centers for Disease Control and Prevention published the History of Marburg outbreaks.

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Don Hackett

Mar 9, 2023 • 8:06 am CST

Another Epstein-Barr virus Vaccine Candidate Announced

by Luis Oliveira

ModeX Therapeutics, Inc. recently announced it entered into an exclusive worldwide license and collaboration agreement with Merck to develop MDX-2201, a preclinical nanoparticle vaccine candidate targeting Epstein-Barr virus (EBV).

Under the terms of the agreement, ModeX and Merck will jointly advance MDX-2201 to a U.S. FDA Investigational New Drug application filing, after which Merck will be responsible for clinical and regulatory activities and product commercialization.

MDX-2201 is based on ModeX’s ferritin nanoparticle vaccine platform, which can express as many as 24 copies of a recombinant antigen on its surface to enhance the presentation of key virus components and stimulate durable protective immunity.

MDX-2201 presents antigens from four viral proteins involved in viral entry into host cells.

These include a recombinant antigen designed from the proteins gH, gL, and gp42 and an antigen derived from gp350.

By using ModeX’s multi-targeted approach, this combination inhibits infection in two cell types, B cells and epithelial cells, contrasting with efforts previously focused on gp350 alone.

“At Merck, we have a proud legacy of developing vaccines, including several that have the potential to help protect against certain types of cancer,” said Tarit Mukhopadhyay, Ph.D., Vice President, Infectious Diseases and Vaccine Discovery, Merck Research Laboratories, in a press release on March 8, 2023.

EBV is a member of the herpes virus family and is one of the most common human viruses.

EBV can cause infectious mononucleosis and is associated with other illnesses, including specific types of cancer and multiple sclerosis. Unfortunately, there are currently no FDA-approved vaccines or treatments for EBV infection.

However, Moderna Inc. has been conducting a phase 1 clinical study for its mRNA-1189 vaccine candidate.

The viral proteins in mRNA-1189 are expressed in their native membrane-bound form for recognition by the immune system.

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Don Hackett

Mar 7, 2023 • 1:49 pm CST

Spain's Balearic Island Reconfirms Dengue Risk

by Lutz Hirschmann

Charlotte Elton with EuroNews today reported Ibiza health officials are urging tourists to be on alert for symptoms of a Dengue infection.

The scenic Balearic Island, located off Spain's east coast, has recently experienced several dengue outbreaks.

For example, a message from Germany in 2023 alerted Spain to six cases of native dengue reported between May and November last year.

The Centre for Coordination of Health Alerts and Emergencies (CCAES) recently confirmed one of the potential carriers of dengue is the Aedes albopictus or tiger mosquito.

These mosquitoes are found throughout the Spanish Mediterranean, northern Spain, including France.

From May to December 9, 2022, 272 imported cases of dengue fever were identified in metropolitan France, most from implantation by Aedes albopictus.

In addition to Europe's dengue outbreaks, several countries have reported dengue cases in 2023, including south Florida in the U.S.

Dengue can take up to two weeks to develop, with the illness generally lasting less than a week, says the U.S. CDC.

Health effects from dengue include fever, headache, nausea, vomiting, rash, muscle and joint pain, and minor bleeding. And dengue can become severe within a few hours.

Severe dengue is a medical emergency, usually requiring hospitalization.

Dengue is a vaccine-preventable disease. And there are two dengue vaccines available in specific countries.

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Don Hackett

Mar 7, 2023 • 12:12 pm CST

Uber'ing to Cancun Beaches Contested by Cabs

by Michelle Raponi

When Uber Inc. reintroduced its ride-sharing service in Cancun, Mexico, in 2023, most international travelers were excited to use a known transportation service.

Uber customers have digital access to the same features while traveling at home, including safety features such as 24/7 support, GPS tracking, and emergency assistance.

And after a long day at the beach, Uber delivers Cancun cuisine with just a few taps.

However, according to USA Today reporting on March 6, 2023, local cab services contest Uber's availability.

Earlier this year, the U.S. Department of State issued a security notice regarding incidents involving Uber drivers in Quintana Roo and Cancun.

However, official complaints against Uber drivers do occur, and past disputes between these services and local taxi unions have occasionally turned violent, resulting in injuries to U.S. citizens in some instances, says the State Department.

U.S. citizens are reminded of guidance provided on Travel.State.gov, specifically about using application-based transportation services in Mexico.

From a health perspective, the U.S. CDC recommends several vaccinations before visiting Mexico.

And the dengue virus transmission has been documented in Yucatan, Mexico, since 1979. Dengue is reported in 28 of 32 states in Mexico.

And dengue is an ongoing risk when enjoying Cancun's beaches!

Visitors to areas of risk should protect themselves from dengue infection by preventing mosquito bites.

There are two authorized dengue vaccines, but access requires testing.

Note: This news article is not paid content.

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Don Hackett

Mar 7, 2023 • 7:16 am CST

Personalized Cancer mRNA Vaccine Seeks Acceleration

by Peter W.

Moderna Inc. president Stephen Hoge commented at a conference on healthcare on March 6, 2023, indicating it would accelerate the approval pathway for its personalized cancer vaccine candidate mRNA-4157/V940.

"At some point, this randomized 150-person Phase IIb study that we ran might — might — be able to become the basis of accelerated approval," Hoge said, according to EndPoint News.

"It's too early to say, but we are hopeful that the data will mature that way."

On December 13, 2022, mRNA-4157/V940, combined with KEYTRUDA, demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death compared to KEYTRUDA monotherapy in stage III/IV melanoma patients with a high risk of recurrence following complete resection.

An advantage of Moderna's mRNA platform is that it allows for investigational medicines that combine several different approaches to activate the immune system to attack cancer in a single mRNA therapy.

The U.S. Food and Drug Administration has already issued breakthrough therapy designation for mRNA-4157/V940 ahead of a potential Phase 3 study for the treatment expected in 2023 for adjuvant melanoma, a type of skin cancer.

In 2019, the latest year for which incidence data are available, 88,059 new cases of melanoma of the skin were reported, and 8,092 people died of this cancer in the U.S. Cancer is the second leading cause of death in the U.S., exceeded only by heart disease, says the U.S. CDC.

The CDC's real-time cancer dashboard is available at this link.

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Don Hackett

Mar 7, 2023 • 12:52 am CST

Vitamin D Found Effective Against Adult Prediabetes

from Pixabay

The Annals of Internal Medicine today published a systematic review and meta-analysis of three randomized clinical trials in adults with prediabetes.

The U.S. Centers for Disease Control and Prevention (CDC) says prediabetes is a serious health condition where blood sugar levels are higher than normal but not high enough to be diagnosed as type 2 diabetes (T2D).

Published on March 7, 2023, this analysis concluded vitamin D usage effectively decreased the risk of developing TD2.

This data found vitamin D use reduced the risk for diabetes by 15% (hazard ratio, 0.85 [95% CI, 0.75 to 0.96]) in adjusted analyses, with a 3-year absolute risk reduction of 3.3% (CI, 0.6% to 6.0%).

Among participants assigned to the vitamin D group who maintained an intratrial mean serum 25-hydroxyvitamin D level of at least 125 nmol/L (≥50 ng/mL) compared with 50 to 74 nmol/L (20 to 29 ng/mL) during follow-up, cholecalciferol reduced risk for diabetes by 76% (hazard ratio, 0.24 [CI, 0.16 to 0.36]), with a 3-year absolute risk reduction of 18.1% (CI, 11.7% to 24.6%).

And Vitamin D increased the likelihood of regression to normal glucose regulation by 30% (rate ratio, 1.30 [CI, 1.16 to 1.46]).

Furthermore, there was no evidence of a difference in the rate ratios for adverse events (kidney stones: 1.17 [CI, 0.69 to 1.99]; hypercalcemia: 2.34 [CI, 0.83 to 6.66]; hypercalciuria: 1.65 [CI, 0.83 to 3.28]; death: 0.85 [CI, 0.31 to 2.36]).

This study's limitations included 'people with prediabetes do not apply to the general population.'

The CDC says approximately 96 million American adults have prediabetes. However, more than 80% of those with prediabetes don't know they have it.

This study had no external funding, and the researchers did not disclose any industry conflicts of interest.

In May 2022, the U.S. Food and Drug Administration approved Eli Lilly's Mounjaro injection to improve blood sugar control in adults with type 2 diabetes as an addition to diet and exercise. Mounjaro is not indicated for use in patients with type 1 diabetes.

As of March 7, 2023, no FDA-approved vaccine prevents diabetes.

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Don Hackett

Mar 6, 2023 • 4:37 pm CST

Americans Kidnapped in Northern Mexico

U.S. Dept of State Mexico March 2023

Oliver Rich, Special Agent in Charge of the San Antonio Division of the Federal Bureau of Investigation (FBI), announced today that the FBI is seeking the public’s assistance in identifying the person(s) responsible for the assault and kidnapping of four U.S. Citizens, in Matamoros, Tamaulipas, Mexico.

On March 3, 2023, four Americans crossed into Matamoros, Tamaulipas, Mexico. Shortly thereafter, unidentified gunmen fired upon the passengers in the vehicle.

All four Americans were placed in a vehicle and taken from the scene by armed men.

The US ambassador to Mexico, Ken Salzar, said in a statement that “US law enforcement officials from numerous agencies are working with Mexican authorities at all levels of government to secure the safe return of our compatriots."

The FBI, federal partners, and Mexican law enforcement agencies are investigating, and the FBI announced a reward of $50,000 for the return of the victims and the arrest of those involved.

Previously, the U.S. Department of State has issued its highest level travel advisory for most of Mexico, warning Americans 'do not go.'

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Don Hackett

Mar 6, 2023 • 12:51 pm CST

Alzheimer’s Disease Antibody Treatment Awaits Final Approval

by Nancy Jane P.

Eisai Co., Ltd. and Biogen Inc. today announced that the U.S. Food and Drug Administration (FDA) had accepted Eisai’s supplemental Biologics License Application (sBLA) for LEQEMBI™, supporting the conversion of the accelerated approval of LEQEMBI to an FDA traditional approval.

The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act action date of July 6, 2023.

As of March 6, 2023, the FDA plans to hold an Advisory Committee meeting to discuss this humanized immunoglobulin gamma 1 monoclonal antibody application but has not publicly announced the meeting date.

LEQEMBI was approved under accelerated approval in the U.S. and was on January 18, 2023.

This indication is approved under accelerated approval based on a reduction in amyloid beta plaques observed in patients treated with LEQEMBI.

The accelerated approval was based on data demonstrating that LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining AD feature.

Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

Continued approval for this indication may be contingent upon verification of clinical benefit.

The FDA has not approved any AD vaccine candidates as of March 6, 2023.

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Don Hackett