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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.

Vaccine Treats:

Respiratory Syncytial Virus (RSV)

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by Gerd Altmann

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

London

Vaccine:

AREXVY RSVPreF3 OA Vaccine

Chikungunya Outbreaks Accelerate and Turn Fatal

PAHO issued Epidemiological Alert Chikungunya in the Americas

March 9, 2023

Fact checked by Robert Carlson, MD

Epstein-Barr Virus Vaccine 2023

Epstein-Barr virus Vaccine June 2023

Epstein-Barr virus (EBV), also known as human herpesvirus 4, is a member of the herpes virus family, says the U.S. Centers for Disease Control and Prevention. Most people get infected with EBV at some point in their lives. However, as of April 21, 2023, the are no approved Epstein-Barr virus vaccines, says National Institutes of Health (NIH). “A vaccine that could prevent or reduce the severity of infection with the Epstein-Barr virus could reduce the incidence of infectious mononucleosis and might also reduce the incidence of EBV-associated malignancies and autoimmune diseases,” commented Anthony S. Fauci, M.D., on May 6, 2022.

Epstein-Barr virus Vaccine Candidates

The National Institute of Allergy and Infectious Diseases (NIAID) launched an early-stage clinical trial on May 6, 2022, evaluating an investigational preventative gp350-Ferritin nanoparticle vaccine for EBV. The Phase 1 clinical study is conducted at the NIH Clinical Center in Maryland. Last Update Posted on November 17, 2022.

MDX-2201 leverages ModeX’s innovative biologics platform to target multiple EBV proteins. OPKO Health, Inc. entered into an exclusive worldwide license and collaboration agreement with Merck to develop MDX-2201.

A panel of investigational monoclonal antibodies (mAbs) targeting different sites of the EBV blocked infection when tested in human cells in a laboratory setting. Moreover, one of the experimental mAbs ( EBV gH/gL 769B10) provided nearly complete protection against EBV infection and lymphoma when tested in mice. The study results were published in the journal Immunity on October 27, 2022. Our findings provide structural and antigenic knowledge of the viral fusion machinery, yield a potential therapeutic antibody to prevent EBV disease, and emphasize gH/gL as a target for herpesvirus vaccines and therapeutics, wrote these researchers.

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Reviewer:

Robert Carlson, MD

Last Reviewed:

Friday, June 2, 2023 - 11:25

Description:

Epstein-Barr virus lacks a preventive vaccine in June 2023.

Condition:

Epstein Barr Virus

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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.

Vaccine Treats:

Polio

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U.S. CDC polio detections March 2023

Live Blog Update Author:

Don Hackett

Location Tags:

Atlanta

Vaccine:

nOPV2 Polio Vaccine

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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.

Vaccine Treats:

Hepatitis B

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U.S. CDC March 10, 2023

Live Blog Update Author:

Don Hackett

Location Tags:

Atlanta

Vaccine:

Hepatitis Vaccines 2023

Norovirus Upsets Spring Break for Cruisers

HIL-214 virus like particle-based bivalent vaccine candidate is conducting research

March 9, 2023

Fact checked by Robert Carlson, MD

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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.

Vaccine Treats:

Influenza

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WHO March 6, 2023

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Geneva

Vaccine:

Flumist Quadrivalent Influenza Vaccine

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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.

Vaccine Treats:

Marburg Virus

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ECDC Marburg cases March 2023

Live Blog Update Author:

Don Hackett

Location Tags:

Geneva

Vaccine:

cAD3-Marburg Vaccine

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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.

Vaccine Treats:

Epstein Barr Virus

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