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Aug 6, 2023 • 2:44 pm CDT

Swine Flu Cases Confirmed in Michigan

from Pixabay

Every year, rare human infections with zoonotic influenza viruses usually spread in birds and pigs. The U.S. Centers for Disease Control and Prevention (CDC) recently reported the first two human infections with swine flu viruses in 2023.

These infections were caused by two different types of flu viruses that generally spread among pigs, and they occurred in two people who attended various agricultural fairs in Michigan and had exposure to pigs.

These influenza A(H1N2)v virus infections were thoroughly investigated to ensure that such viruses are not spreading in people and to limit further exposure of people to infected animals if infected animals are identified.

As of August 4, 2023, the CDC recommends people take precautions to prevent the spread of swine influenza viruses to people and has guidance for people exhibiting pigs at fairs, people attending fairs, and fair organizers.

Since 2005, over 500 swine influenza infections have been identified in the U.S.

Unlike, avian influenza (Bird Flu), which has recently spread among birds, mammals, and humans, there are no approved swine flu vaccines.

Furthermore, the CDC says the annual 'flu shot' does not prevent swine influenza infections in people.

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Don Hackett

Aug 5, 2023 • 4:46 pm CDT

Airport Screening Keeps Lines Moving

U.S. TSA August 2023

The U.S. Transportation Security Administration (TSA) recently reported the number of air travelers passing through airport security has returned to pre-pandemic levels in July and early August 2023.

About 2.4 million people are being screened by TSA security each day.

And according to new data from the TSA, screening can be measured in minutes if you are a TSA PreCheck® member.

During July 2023, about 89% of air passengers waited less than 5 minutes to be processed by TSA PreCheck.

TSA PreCheck is a Trusted Traveler Program offering expedited security screening services at 200 airports in the U.S. To learn more about TSA PreCheck, visit the TSA PreCheck page or the TSA PreCheck® FAQ webpage.

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Don Hackett

Aug 5, 2023 • 2:50 pm CDT

Before Departing Abroad, Check Your Flu Shot Options

from Pixabay

Each summer, influenza viruses are detected in both the northern and southern hemispheres. What happens in one hemisphere does not necessarily predict what will happen in the other because influenza viruses evolve and impact populations differently.

While the exact timing and duration of any flu season varies by country, the World Health Organization (WHO) recently reported most detections in late July 2023 are moderate.

The WHO recently published Influenza Update N° 450, indicating some countries in the southern hemisphere reported changes in influenza detections in recent weeks, while others seemed to have already peaked.

And Australia's Department of Health and Aged Care published report No. 8, which stated insufficient information to assess the 2023 influenza season's potential severity comprehensively.

The WHO and the U.S. CDC suggest international travelers speak with a healthcare provider about flu shot options before visiting countries reporting influenza outbreaks in August 2023.

As of August 5, 2023, most health clinics and community pharmacies in the U.S. offer various flu shots targeting 2023-2024 influenza viruses.

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Karen McClorey Hackett

Aug 5, 2023 • 7:07 am CDT

Polio Outbreak Continues in the Democratic Republic of the Congo

U.S. CDC polio outbreak map July 28, 2023

The Global Polio Eradication Initiative (GPEI) reported this week the Democratic Republic of the Congo (DRC) recently confirmed ten new cases of circulating vaccine-derived poliovirus type 1 (cVDPV1).

As of August 2, 2023, there are now 46 cases reported so far this year. There were 146 cases in 2022.

Additionally, the DRC reported four new cases involving circulating vaccine-derived poliovirus type 2 (cVDPV2).

There are now 61 cases so far this year and 367 cases reported in 2022.

In response to this polio outbreak, the U.S. CDC included the DRC in its Level 2 - Practice Enhanced Precautions, Global Polio Travel Health Notice.

The CDC said on July 28, 2023, adults who previously completed the full, routine polio vaccine series may receive a single, lifetime booster dose of an IPV polio vaccine before traveling to any of these 30 destinations.

In the U.S., IPV vaccinations are offered by travel pharmacies.

In the U.S., poliovirus is often detected in wastewater surveillance systems.

Separately, the GPEI published the 6th Transition Independent Monitoring Board report in July 2023, which evaluates the progress and challenges of transferring the responsibility of polio immunization and response efforts to national governments.

The report includes a series of recommendations to strengthen the process at the global, regional, and country levels.

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Don Hackett

Aug 4, 2023 • 4:33 pm CDT

25th Country Confirms Cholera Outbreak in 2023

WHO cholera outbreak country map August 2023

The World Health Organization's (WHO) latest multi-country cholera outbreak situation (#5) says that Based on the large number of outbreaks and their geographic expansion, WHO continues to assess the risk at the global level as very high.

As of August 4, 2023, twenty-five countries have reported cholera outbreaks since the beginning of 2023.

India became the 25th country on May 15, 2023.

The WHO African Region remains the most affected region, with 14 countries reporting cholera cases this year.

In the Region of the Americas, Haiti reported 54.826 cholera cases last year.

The overall capacity to respond to multiple and simultaneous outbreaks continues to be strained due to the global lack of resources, including shortages of the Oral Cholera Vaccine (OCV).

Since the start of 2023 and as of July 24, 2023, a total of 49.9 million OCV doses have been requested, of which 19.3 million (39%) have been approved for 11 countries. The available (not yet allocated) global OCV stockpile was 2.7 million doses.

In the current outbreak context, only one-dose courses have been validated and implemented in these reactive campaigns. Doses for preventive campaigns cannot be supplied due to the low global stockpile, says the WHO.

In the U.S., the CDC recommends that adults traveling to areas with active cholera transmission get vaccinated with a newly licensed cholera vaccine, Bavarian Nordic's Vaxchora®.

This OCV is indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in adults.

According to Vaxchora's manufacturers, the vaccine has limited availability in 2023.

Another vaccine. Valneva SE's Dukoral® is administered with a buffer solution that, for adults, requires 150 ml of clean water. Dukoral can be given to all individuals over the age of 2 years.

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Don Hackett

Aug 4, 2023 • 1:04 pm CDT

166th Influenza-Associated Pediatric Fatalities Reported

from Pixabay

The U.S. Centers for Disease Control and Prevention (CDC) today reported the 166th influenza-associated pediatric death for the 2022-2023 flu season.

As of August 4, 2023, the CDC reported two additional influenza-associated pediatric deaths during week #30. Both deaths were associated with influenza A(H1N1) viruses.

Last flu season, there were only 47 flu-related pediatric deaths confirmed.

The CDC says the current flu shots offer protection against this type of influenza. For most persons, including children, who only one dose of an approved influenza vaccine is needed for the season.

Furthermore, vaccination should ideally be offered during September or October in the U.S.

And flu season in the Southern Hemisphere usually occurs between April and September.

Moreover, vaccination should continue throughout each flu season as long as influenza viruses are circulating.

Recent news indicates there will be plenty of flu shots available this season.

As of early August, about 100 million vaccines have already been distributed for the 2023-2024 flu season. Last season, the CDC reported that about 173.37 million flu shots were distributed in the U.S.

Various flu shots are available at health clinics and community pharmacies in the U.S.

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Karen McClorey Hackett

Aug 4, 2023 • 7:04 am CDT

$18 Million Award to Develop RNA Chikungunya Vaccine

by Emilian Danaila

The Access to Advanced Health Institute (AAHI) today announced that it has received an $18 million award from the National Institutes of Health (NIH) to develop a temperature stable, single-dose, RNA chikungunya vaccine candidate.

The NIH award disclosed on August 3, 2023, supports the development, preclinical testing, and human clinical evaluation of a vaccine that meets an increasingly urgent need for a reliable, abundant supply.

Chikungunya is a viral disease transmitted to humans through the bites of mosquitoes infected with the chikungunya virus (CHIKV), says the U.S. CDC.

Chikungunya outbreaks are significant causes of morbidity and mortality in Asia, Africa, and Latin America, for which no vaccine is currently approved.

From 2006–2021, 4,590 chikungunya cases in travelers were reported in the U.S.

Several vaccine candidates are conducting late-stage clinical trials, such as Valneva SE's VLA1553, a monovalent, single-dose, live-attenuated vaccine candidate.

AAHI's approach to an RNA vaccine against chikungunya differs from the RNA vaccines the U.S. FDA currently approves to prevent other diseases.

“This project will demonstrate the use of RNA vaccine technology to avoid some of the classic manufacturing challenges in the large-scale manufacture of live-attenuated vaccines,” said Emily Voigt, Ph.D., Principal Scientist, AAHI RNA Platform Lead, and Co-Principal Investigator for the award, in a press release.

Unlike other RNA vaccines, this candidate will generate a live "attenuated" virus that could induce strong and long-lasting immune protection against this mosquito-borne disease.

The new 5-year project builds upon work supported by the NIH (R43AI127053) for AAHI's proof-of-concept ground-laying work, which demonstrated that a liquid presentation of this live-attenuated chikungunya RNA vaccine candidate elicited strong immune responses in animals after a single dose, protecting them from mortality and joint swelling after being challenged with the virus (Voigt et al. 2021).

AAHI is a nonprofit biotech research institute located in Seattle, Washington, that combines the high-quality science of an academic research organization with the product development capabilities of a biotech company to help combat some of the world's deadliest diseases, including infectious diseases

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Don Hackett

Aug 3, 2023 • 4:28 pm CDT

540 Dengue Cases Reported by the U.S. CDC

U.S. CDC Dengue case map August 2, 2023

The U.S. Centers for Disease Control and Prevention (CDC) today reported the global dengue outbreak is impacting the United States.

On August 2, 2023, the CDC provisionally confirmed the U.S. States reported 225 dengue cases, and Territories reported 315.

For all of 2022, the CDC reported, the CDC reported 2,016 dengue cases.

From a state perspective, the Florida Health Department reported as of week #30 in 2023, there had been 147 travel-associated dengue cases. The majority (98) of travel cases were related to Cuba.

Florida has also reported six locally acquired dengue cases in 2023.

To alert travelers to their dengue health risk, the CDC recently issued Travel Health Notices for the Americas (2023), Africa/Middle East (July 21, 2023), Costa Rica, and Asia/Pacific Islands (July 25, 2023).

The CDC says dengue is a vaccine-preventable disease. As of August 3, 2023, two dengue vaccines are in use worldwide.

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Don Hackett

Aug 3, 2023 • 2:29 pm CDT

COVID-19 Cases Continue Declining

WHO COVID-19 response timeline August 3, 2023

The World Health Organization (WHO) today reported (Edition 154) that during this recent 28-day period, 46% (107 of 234) of countries and territories reported at least one COVID-19 case, a proportion that has been declining since mid-2022.

While five WHO regions have reported decreases in both cases and deaths, the Western Pacific Region has reported an increase in patients and a decline in fatalities.

Globally, over 3,100 COVID-19-related deaths were reported between July 3 and 30, 2023.

Click on these action circles to learn more about the COVID-19 pandemic.

As of August 3, 2023, the WHO has LIsted 12 COVID-19 vaccines that are available in certain countries.

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Don Hackett

Aug 3, 2023 • 12:13 pm CDT

U.S. CDC Debates RSV Protection for Infants

by Cheryl Holt

The U.S. CDC's Advisory Committee on Immunization Practices (ACIP) is meeting today to review Respiratory Syncytial Virus (RSV) Maternal/Pediatric vaccine and a long-acting monoclonal antibody.

On August 3, 2023, Dr. Grace Lee is leading the ACIP meeting agenda, which includes, but is not limited to, the following presentations:

Introduction - Dr. S Long
EtR summary for nirsevimab - Dr. J Jones
Nirsevimab implementation considerations - Dr. G Peacock
Clinical considerations for nirsevimab & Workgroup considerations / proposed recommendations - Dr. J Jones

At around 2 pm ET today, the ACIP is scheduled to vote on two recommendations.

Previously, the U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

In the U.S., the RSV season generally starts in Florida in the fall. As of August 3, 2023, there have not been any RSV outbreaks reported this year.

UPDATED at 2:55 CT

The ACIP unanimously recommends routine use of Beyfortus™ to protect all infants below 8 months of age. The committee also voted unanimously to include Beyfortus in the Vaccines for Children program, supporting equitable access for all eligible infants.

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Karen McClorey Hackett

Aug 3, 2023 • 11:08 am CDT

England's Mpox Outbreak Continues in 2023

UKHSA mpox cases August 3, 2023

The UK Health Security Agency (UKHSA) today published Research and Analysis, Mpox outbreak: epidemiological overview, as of August 3, 2023.

Up to December 31, 2022, there were 3,732 confirmed and highly probable mpox cases reported in the UK. Of these, 3,553 were in England, 34 were in Northern Ireland, 97 were in Scotland, and 48 were in Wales.

In 2023 (up to July 31, 2023), a further 39 cases of mpox were reported in the UK.

Of these, 38 were in England. The most recent mpox cases, seen from April 2023 onwards, have been focused in London.

In reaction, mpox vaccinations have been extended in London because of a spike in infections, says the UKHSA.

The leading mpox vaccine is Bavarian Nordic's JYNNEOS® (MVA-BN) vaccine, which is based on a live, attenuated vaccinia virus.

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Karen McClorey Hackett

Aug 3, 2023 • 8:22 am CDT

$120 Million Mpox Vaccine Order Placed

by Gerd Altmann

Bavarian Nordic A/S today announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) placed a new order valued at USD 120 million, primarily covering the manufacturing of new bulk product for the Company's JYNNEOS® smallpox/mpox vaccine.

The bulk product, representing USD 96 million of the contract value, will be manufactured and invoiced in 2023 and will only partly restore the inventory used to manufacture vaccines in response to the global mpox outbreak that began in May 2022.

Nearly 5.5 million JYNNEOS doses have been manufactured for the U.S. government throughout 2022 and 2023, and replenishment of the bulk inventory is necessary to fulfill the Company's long-term commitment to deliver a freeze-dried version of the vaccine for U.S. smallpox preparedness.

In addition, Bavarian Nordic will manufacture and supply additional liquid-frozen vaccine doses in 2023, valued at USD 3 million.

The agreement includes additional services totaling USD 21 million, of which the majority will be received in 2024 and 2025.

Paul Chaplin, President & CEO of Bavarian Nordic, said in a press release on August 3, 2023, "The U.S. government's foresight enabled us last year to rapidly respond to the global mpox outbreak by converting the readily available bulk product into final vaccine dose."

"Together with our U.S. manufacturing partner, we have completed manufacturing all doses ordered by the U.S. government during the mpox outbreak."

"However, maintaining the readiness to respond to future health crises is essential, and this new contract will enable us to deliver on the contract for a freeze-dried version of the vaccine, awarded to us by the U.S. government back in 2017, which aims to strengthen the nation's preparedness against smallpox."

Since 2003, Bavarian Nordic has worked with the U.S. government on the development, manufacturing, and supply of a non-replicating smallpox vaccine. The JYNNEOS (MVA-BN, IMVANEX®) vaccine has been deployed globally since 2022.

In 2023, mpox outbreaks have been reported Africa, the Americas, Chicago, China, Denver, France, Japan, London, New York, Portugal, South Korea, and Spain. Furthermore, mpox breakthrough cases in vaccinated people have been confirmed in 2023.

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Don Hackett

Aug 3, 2023 • 7:23 am CDT

Ebola Zaire Vaccine Approved for Young Children

by Peter Roe

Merck today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for the ERVEBO® vaccine, which is now indicated for preventing disease caused by Zaire ebolavirus in individuals 12 months of age and older.

ERVEBO was previously approved for use in individuals 18 and older.

This Ebolavirus vaccine does not protect against other species of Ebolavirus (Sudan) or Marburgvirus.

As of March 2023, over 500,000 doses of ERVEBO had been delivered to a stockpile administered by the International Coordinating Group on Vaccine Provision.

"Ebola virus disease is contagious and potentially deadly in children and adults. We're proud of the approval of ERVEBO for the prevention of disease caused by Zaire ebolavirus in children as young as 12 months old, which is another milestone in our continued commitment to help address the global health threat caused by Zaire ebolavirus," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, in a press release on August 3, 2023.

The vaccine's effectiveness when administered concurrently with antiviral medication, immune globulin, and/or blood or plasma transfusions is unknown, and the duration of protection conferred by ERVEBO is unknown.

ERVEBO includes a contraindication for individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including rice protein.

The initial Ebola virus disease case first appeared in 1976 in Africa. Since then, numerous outbreaks of Zaire and Sudan have been confirmed.

As of August 3, 2023, the FDA and European Medicines Agency have approved other ebola prevention and treatment products.

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Don Hackett

Aug 2, 2023 • 4:02 pm CDT

Drug Applications Filed Seeking Expanded Pediatric Indication for HIV-1 Therapy

by Patou Ricard

The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of EDURANT® to include the treatment of human immunodeficiency virus type 1 (HIV-1) infection in children weighing 10 kg or more.

As of July 28, 2023, a parallel Marketing Authorization application was submitted to the European Medicines Agency to support a type II variation and line extension for expanded pediatric use in Europe.

If the new applications are approved, EDURANT could be administered to younger pediatric patients via standard 25 mg tablets or new 2.5 mg tablets for oral dispersion that were developed to aid administration and weight-adjusted dosing for children.

“We’ve been working to fight HIV for decades and are proud to have helped bring forward nine medicines for people living with HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen Research & Development, LLC, in a related press release.

“These filings are the latest example of our longstanding work to make different treatment options available to meet the diverse needs of people living with HIV.”

EDURANT is not a preventive vaccine but is an HIV-1 specific, nonnucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL.

As of August 2, 2023, the FDA has not approved an HIV vaccine.

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Karen McClorey Hackett

Aug 2, 2023 • 2:09 pm CDT

RSV Vaccine Patent Litigation Filed

by Anna Varsányi

GlaxoSmithKline Plc filed a lawsuit alleging Pfizer Inc.'s respiratory syncytial virus (RSV) vaccine infringes on four patents for AREXVY™ RSV OA, a single dose, monovalent RSV vaccine.

AREXVY was the first RSV vaccine approved by the U.S. Food and Drug Administration.

Pfizer's RSV vaccine was the second one approved.

Bloomberg Law reported on August 2, 2023, the GlaxoSmithKline Biologicals SA et al v. Pfizer Inc. complaint was filed in the U.S., District of Delaware.

"Upon information and belief, Pfizer knowingly uses GSK's claimed inventions in ABRYSVO™, a bivalent prefusion F subunit vaccine, without permission," wrote GSK.

GSK is seeking a jury trial, monetary damages, and is asking a judge to prevent Pfizer from selling Abrysvo to adults 60 and older in the U.S.

The U.S. Centers for Disease Control and Prevention announced on June 29, 2023, and July 21, 2023, the use of RSV vaccines for people ages 60 years and older, requires shared clinical decision-making.

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Don Hackett