Vaccine News

As the three-day Advisory Committee on Immunization Practices (ACIP) meeting ended today, the morning session focused on Respiratory syncytial virus (RSV), the leading cause of hospitalization among U.S. infants.

Led by Sarah S. Long, MD, the Maternal/Pediatric RSV Work Group presentations included the summary of the effectiveness of Beyfortus™ (nirsevimab) in infants.

Beyfortus is a single-dose, extended half-life monoclonal antibody (mAb) that offers passive immunization to prevent lower respiratory tract infections. It has been approved by the U.S. FDA and other health agencies. 

On June 28, 2024, Amanda Payne, PhD, MPH, stated that Beyfortus was about 80% effective against RSV-associated encounters and hospitalizations among infants in their first RSV season during the 2023-2024 RSV season.

Furthermore, the U.S. CDC's RSVVaxView recently reported that among females with a young infant, over 43% reported that their infant received Beyfortus. 

The ACIP group, which comprises vaccine experts, loudly expressed its enthusiasm for the effectiveness and uptake of this first-year mAb therapy.

The group's primary concern was product availability for the 2024-2025 RSV season.

While Beyfortus was available in the U.S. for the 2023-2024 RSV season, demand quickly outstripped supply.

Beyfortus's producers, Sanofi and AstraZeneca, confirmed on May 2, 2024, that the expansion of the manufacturing network is progressing. In late 2024, the companies could have more than tripled their manufacturing capacity and increased mAb supply.

Of note, should Beyfortus production fall behind demand during the next RSV season, the U.S. FDA has approved a vaccine that pregnant women can receive, which enables antibodies to be passed to the unborn child.

With a third respiratory syncytial virus (RSV) vaccine approved by the U.S. FDA, many people ask which one offers the best protection from disease. With the 2024-2025 RSV season fast approaching, the U.S. CDC's recent vaccine meeting helped answer questions.

Moderna's presentation on June 26, 2024, to the CDC’s Advisory Committee on Immunization Practices, led by Rituparna Das, MD, PhD, disclosed that mRESVIA® (mRNA-1345) showed about 81% efficacy after 3.7 months, but around 50% (37.5%, 60.7%) efficacy in preventing illness after 18 months.

Additionally, Moderna stated that the RSV vaccine is generally well tolerated in over 19,700 adults over 60 years old vaccinated with a 50g licensed dose and that there are no safety concerns.

mRESVIA is an RSV vaccine containing an mRNA sequence encoding a stabilized prefusion F glycoprotein. It uses the same lipid nanoparticles as Moderna's other approved vaccine.

As of May 2024, an estimated 24.4% (95% Confidence Interval: 23.7%-25.2%) of adults 60 years and older reported receiving an RSV vaccine during the last RSV season.

GSK plc today announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted in favour of recommending the routine use of Respiratory Syncytial Virus (RSV) vaccines in all adults aged 75 and above.

The ACIP also recommended RSV immunization for adults aged 60-74 who are at increased risk for severe RSV disease.

These recommendations replace the previous recommendation for shared clinical decision-making in these age groups and have the potential to positively impact access to RSV immunization, particularly for the estimated 23 million U.S. adults aged 75 and older.

In May 2023, the U.S. FDA approved GSK’s AREXVY™ RSV vaccine, which is currently available at clinics and pharmacies before the 2024-2025 RSV season.

The ACIP recommendations will be forwarded to the director of the CDC and the Department of Health and Human Services for review and approval. Once approved, the final recommendations will be published in a future CDC Morbidity and Mortality Weekly Report.

Bavarian Nordic A/S today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of the Company’s vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years and older.

CHIKV VLP is an adjuvanted VLP-based, single-dose vaccine candidate for active immunization to prevent disease caused by CHIKV infection.

The MAA application was granted accelerated assessment by the Committee for Medicinal Products for Human Use in February 2024, supporting the potential approval of the vaccine by the European Commission in the first half of 2025.

In the past 20 years, the chikungunya virus has emerged in several previously non-endemic regions in Asia, Africa, southern Europe, and the Americas, often causing large, unpredictable outbreaks.

The ECDC says Chikungunya is not endemic in mainland Europe, and most cases are travelers infected outside of the mainland European Union/European Economic Area.

“Our CHIKV VLP vaccine is designed for ease of use in individuals 12 years of age and older at risk of chikungunya virus and represents an important contribution to the development of preventative solutions against this debilitating disease,” said Paul Chaplin, President and CEO of Bavarian Nordic, in a press release on June 26, 2024.

The MAA submission includes results from two phase 3 clinical trials in more than 3,600 healthy individuals 12 years and older. The results showed that the CHIKV VLP vaccine was highly immunogenic, as demonstrated by the strong induction of Chikungunya neutralizing antibodies 21 days after vaccination, with antibody titers equal to or above the threshold agreed with authorities as a marker of seroprotection in the majority of individuals. The CHIKV VLP vaccine was well-tolerated across both studies, and vaccine-related adverse events were mainly mild or moderate in nature.

Osivax today announced that it had completed enrollment in its Phase 1 clinical trial with OVX033, the company’s broad-spectrum vaccine candidate against sarbecoviruses.

OVX033 is a first-in-class coronavirus vaccine candidate that targets the nucleocapsid (N), a highly conserved internal antigen. Osivax is creating a revolutionary universal sarbecovirus vaccine that will uniquely empower both the B-cell immune response and the T-cell immune response. 

Unlike surface antigens such as Spike (S), N is much less likely to mutate, providing a broader and more universal immune response to induce broad-spectrum protection against all current and future variants of the SARS-CoV-2 coronavirus and against future pandemic coronavirus strains.

“Sarbecoviruses remain a threat as evidenced by the (recent) pandemic, which continues to have long-term consequences for global health. By completing enrollment for our Phase 1 trial with OVX033, we are taking a significant step forward in addressing the need for a broad-spectrum vaccine to protect against these rapidly mutating viruses,” said Dr. Nicola Groth, CMO of Osivax, in a press release.

Osivax’s oligoDOMTM technology enables the design and production of a recombinant version of the nucleocapsid, which self-assembles into a nanoparticle and thus triggers powerful T- and B-cell immune responses.

The study is designed to evaluate the safety and immunogenicity of OVX033 at three dose levels. To date, no safety concerns or signals have been observed at any dose level, justifying a dose escalation up to the maximum dose level of 500µg.

The single-center, randomized, double-blind, placebo-controlled Phase 1 clinical study is being conducted at the Clinical Investigation Center in Vaccinology Cochin Pasteur in Cochin Hospital in Paris.

The French government supports this project through France 2030.

According to a recent study published by the journal Nature, coronaviruses (CoVs) are a group of enveloped viruses belonging to the Coronaviridae and currently contain four known genera: Alpha, Beta, Gamma, and Delta-CoVs. Sarbecovirus, a subgenus within Beta-CoV, has resulted in the emergence of the highly pathogenic human viruses SARS-CoV and SARS-CoV-2.

Novavax, Inc. today announced that it has filed for a type II variation of existing Marketing Authorization with the European Medicines Agency (EMA) for its JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older.

The submission follows guidance from EMA and the World Health Organization to target the JN.1 lineage for the Fall 2024 season. 

Novavax's non-mRNA JN.1 COVID-19 vaccine targets the "parent strain" of KP.2 and KP.3.2 

NVX-CoV2705 is an updated version of Novavax's authorized COVID-19 vaccine (NVX-CoV2373).

"Novavax is working closely with European markets seeking to offer a protein-based alternative to mRNA this fall for COVID-19 vaccination," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on June 24, 2024.

"Our updated COVID-19 vaccine is active against current circulating (SARS-CoV-2) strains, including KP.2 and KP.3."

Nonclinical data have demonstrated that Novavax's JN.1 COVID-19 vaccine induces broad neutralization responses to JN.1 lineage viruses, including those containing the F456L and R346T mutations, and to "FLiRT" and "FLuQE" variants.

Novavax's vaccine also produces conserved polyfunctional, Th1-biased CD4+ T cell responses to a range of JN.1 lineage variants.

Novavax confirmed it intends to have its JN.1 COVID-19 vaccine in unit-dose vials available for immediate release in the European Union after approval.

Novavax has also filed with the U.S. FDA and is working with other regulatory authorities globally to authorize or approve its JN.1 COVID-19 vaccine.