Vaccine News

As the respiratory syncytial virus (RSV) activity ramps up for the 2024-2025 season, more children will have access to an innovative therapy this year.

Sanofi U.S. announced today that it is shipping BEYFORTUS™ 50mg and 100mg injection doses to private healthcare providers in the United States.

BEYFORTUS (Nirsevimab-alip) is the first and only long-acting monoclonal antibody approved for the prevention of RSV lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

BEYFORTUS is not an RSV vaccine but offers passive immunization.

Bridgewater, N.J.-based Sanofi stated it anticipates having enough supply so that every eligible baby born outside of the season will have access to immunization at a regular checkup, and those born during the season will have access at birth.

Thomas Grenier, Head of Vaccines, North America, Sanofi, commented in a press release on September 16, 2024, "We're proud to offer BEYFORTUS doses to help protect every eligible baby in the U.S. this RSV season."

"This upcoming season, we look forward to BEYFORTUS offering its demonstrated real-world protection to as many infants as possible."

Sanofi also took additional measures to ensure greater readiness for this season by launching the BEYFORTUS Reservation Program, which provides critical insight into private healthcare provider demand and allows for prioritized fulfillment of requests placed through the program.

Furthermore, the Centers for Disease Control and Prevention's Vaccines for Children program will help ensure that the majority of doses are available before RSV season.

As of May 2024, about 41% of women with young infants reported that their child had received BEYFORTUS.

This announcement is essential as RSV is a highly contagious virus that can lead to serious respiratory illness in infants. Two out of three infants are infected with RSV during their first year of life, and almost all children are infected by their second birthday. 

As the global measles outbreak continues in 2024, a 32nd U.S. state confirmed its initial case.

The Tennessee Department of Health (TDH) recently confirmed that a Tennessee resident who recently traveled internationally is recovering from a measles infection.

As of September 14, 2024, TDH has not identified additional measles cases in Tennessee. The last year in which TDH reported positive measles cases in Tennessee was 2019.

On September 5, 2024, the U.S. CDC reported 251 measles cases in 31 jurisdictions this year. So far this year, Chicago (61), Minneapolis (49), and Portland (31) have reported an unusual number of cases.

The measles virus can spread through the air when an infected person speaks, coughs, or sneezes. It can live for up to two hours in the air or on a surface. 

Symptoms include fever, headache, and general unwellness, followed by fever, rash, cough, red eyes, or congestion, says the TDH.

To notify international travelers of the measles outbreaks, the CDC reissued a Level Travel Health Advisory in August 2024, identifying 56 countries reporting measles cases to alert international travelers of the ongoing health risk.

The CDC recommends that international travelers speak with a healthcare provider at least one month before traveling abroad about measles vaccination options. 

About two years ago, the World Health Organization (WHO) published a report highlighting the first-ever list of fungal priority pathogens, which included 19 fungi representing the greatest threat to public health.

Since then, the WHO has not recommended a fungal vaccine but continues to encourage the development of innovative therapies.

To address this unmet need, F2G Ltd announced a $100 million financing round that will enable the company to complete late-stage development, seek regulatory approval, and prepare for commercialization in the U.S. of olorofim, a novel oral antifungal therapy to treat invasive aspergillosis (IA) and other invasive fungal infections.

It is anticipated that this treatment will be used to treat patients with a serious invasive, rare fungal disease for which existing treatments are inappropriate or no longer effective.

Olorofim is the first orotomide antifungal, an entirely novel class of antifungal agents. It is the only antifungal medication awarded a Breakthrough Therapy Designation for multiple indications by the U.S. Food and Drug Administration.

Olorofim has a novel mechanism of action, different from that of existing classes of antifungals. It exerts fungicidal activity by inhibiting the pyrimidine synthesis pathway.

Henry Skinner, Ph.D., Chief Executive Officer of AMR Action Fund, commented in a press release on September 12, 2024, “Fungal infections are a growing threat to patients worldwide and have a disproportionate impact on vulnerable populations, yet there has been a paucity of innovation in the field of antifungals."

"For decades, clinicians have relied on a handful of antifungal classes, with few mechanisms of action and significant limitations due to spectrum of activity, drug toxicities, or drug-drug interactions. These therapies are increasingly failing in patients."

The U.S. NIH says some fungal infections are more common in people with weakened immune systems or hospitalized individuals, while others can infect anyone, including otherwise healthy people.

As of 2023, fungal vaccine candidates were segmented into broad categories based upon their composition, ranging from multiple to single antigens: whole organism vaccines (live-attenuated or killed fungal cells), crude extracts (fractions derived from cells and medium of fungal cultures), purified subunit vaccines (proteins, peptides), and nucleic acids (RNA and DNA) encoding the antigen(s) of interest.

No fungal vaccine has been approved as of 2024.

Bavarian Nordic A/S today provided an update on its supply and manufacturing activities supporting the ongoing mpox outbreak. The Company produces MVA-BN® (JYNNEOS®, IMVAMUNE®, and IMVANEX®), a leading smallpox and mpox vaccine.

Since the recent declaration of a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO), Bavarian Nordic has intensified the collaboration with global stakeholders to support efforts to combat the mpox outbreak.

Thanks to donations from the European Commission, the U.S. government and Bavarian Nordic, the first doses of MVA-BN arrived last week in the Democratic Republic of Congo, the epicenter of the mpox clade 1b outbreak. More than 250,000 doses have already been shipped, and other countries have pledged further donations of more than 500,000 doses of MVA-BN.

Bavarian Nordic stated that by focusing the full capacity to address the current public health emergency, the Company could supply up to 13 million MVA-BN doses by the end of 2025, including 2 million in 2024.

Paul Chaplin, President & CEO of Bavarian Nordic, said in a press release on September 12, 2024, “As the supplier of the only non-replicating mpox vaccine that has shown to be highly effective during a mpox outbreak, we have been working closely with all governments and organizations to support the international efforts to combat the latest public health emergency."

"Just as during the clade two mpox outbreak in 2022/23, we will support all requests for vaccine and have already secured agreements and submitted responses to the UNICEF tender that will hopefully secure more access to MVA-BN globally."

The JYNNEOS vaccine is commercially available in the United States at select travel clinics and pharmacies. 

The U.S. government recommends two JYNNEOS doses to provide robust protection against disease. However, routine immunization against mpox is not recommended for the general public, and a booster dose (3rd) is not endorsed.

Moderna, Inc., today announced program and financial updates at its annual R&D Day event, demonstrating progress and strategic prioritization of its mRNA pipeline.

Stéphane Bancel, CEO of Moderna, commented in a press release, "The size of our late-stage pipeline combined with the challenge of launching products means we must now focus on delivering these ten products to patients, slow down the pace of new R&D investment, and build our commercial business."

Moderna's updates on September 12, 2024, include but are not limited to, several seasonal influenza vaccine candidates in clinical development.

The Company's investigational seasonal flu vaccine, mRNA-1010, has demonstrated consistently acceptable safety and tolerability across three Phase 3 trials.

In the most recent Phase 3 trial (P303), which was designed to test the immunogenicity and safety of an optimized vaccine composition, mRNA-1010 met all immunogenicity primary endpoints, demonstrating higher antibody titers compared to a licensed standard-dose flu vaccine (Fluarix®).

In an older adult extension study of P303, mRNA-1010 met all primary immunogenicity, including superiority for all compared to a licensed enhanced flu vaccine (Fluzone HD®), and showed an acceptable reactogenicity profile.

The Company plans to start a confirmatory vaccine efficacy study for mRNA-1010 in 2024, funded by previously announced project financing through Blackstone Life Sciences.

Moderna also confirmed it is no longer pursuing an accelerated approval pathway for the regulatory submission of its standalone flu vaccine, mRNA-1010, to focus its resources on submitting a potentially more impactful flu/COVID combination vaccine, mRNA-1083, in 2024.

With the 2024-2025 flu season beginning in the United States, most health clinics and pharmacies offer flu shot vaccination services.

About 158 million flu vaccines had been distributed during the 2023-2024 season. 

According to an American Academy of Pediatrics study, the effectiveness of a single dose of the rotavirus vaccine against emergency department visits or hospitalizations for inflammation of the gastrointestinal tract was 78% in children younger than five years and 53% in older children.

On September 10, 2024, these researchers wrote rotavirus vaccines remain highly effective in preventing disease in children.

The U.S. Centers for Disease Control and Prevention says two types of rotavirus vaccine are available for infants, and both are safe and effective. Two or more doses of the rotavirus vaccine are recommended as the best way to protect against it.

The Vaccines for Children (VFC) Program allows children to access no-cost vaccines such as rotavirus. The VFC program helps families of eligible children who may not be able to afford or have access to vaccines.

Merck today announced positive top-line results from its pivotal Phase 3 clinical trial evaluating the company’s 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL ® 9 vaccine, in Japanese males ages 16 to 26.

This trial (V503-064) met its primary and secondary endpoints demonstrating that administration of a 3-dose regimen of GARDASIL 9 reduced the combined incidence of anogenital persistent infection caused by nine types of HPV compared with a placebo.

“A decade after the first approval of GARDASIL 9, Merck continues to evaluate this important vaccine in additional patient populations and remains committed to helping prevent certain HPV-related cancers through broad and equitable access globally,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, in a press release on September 11, 2024.

“These data build on the clinical efficacy of GARDASIL 9 for the prevention of persistent infection in males and can potentially make a significant impact in addressing the global burden of certain HPV-related cancers and diseases.”

This HPV vaccine is generally available at clinics and pharmacies in the U.S. However, Merck says the GARDASIL 9 vaccination may not protect all vaccine recipients.