Vaccine News

CSL and Arcturus Therapeutics today announced the results of a follow-up analysis of a Phase 3 study evaluating a booster dose of ARCT-154, the world's first approved self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine, compared to a conventional mRNA COVID-19 vaccine.

The new analysis at six months post-vaccination shows that ARCT-154 induces a longer immune response than Comirnaty® for both the original Wuhan strain and Omicron BA.4/5 variant and an advantage in antibody persistence.

ARCT-154 was administered at one-sixth the dose of Comirnaty® (5 μg vs 30 μg, respectively).

"These results further support sa-mRNA's differentiating attribute to provide prolonged protection against COVID-19 at lower doses," said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL, in a press release on February 5, 2024.

"Protecting the global public from viral respiratory diseases remains a top priority for us, and we look forward to continuing to collect and share data at the twelve-month post-booster mark."

Unlike standard mRNA vaccines, these companies commented that self-amplifying mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response.

The Central American country of Costa Rica has been battling an outbreak of dengue fever, both classic and hemorrhagic, for the past few years. This mosquito-transmitted virus continues to impact Costa Rica residents and visitors in 2024.

On February 2, 2024, the Costa Rica Health Ministry reported that 1,076 dengue cases led by Central Norte have been confirmed this year.

Throughout 2023, there were about 24,914 dengue cases reported, a significant increase from the 7,485 patients in 2022.

Costa Rica is not alone in the Region of the Americas with the acceleration of dengue cases.

The Pan American Health Organization (PAHO) recently issued various dengue Risk Assessments that said dengue is endemic in most countries of South America, Central America, and the Caribbean. In 2023, the Americas experienced a 57% increase in dengue cases compared to 2022.

As of December 2023, the PAHO issued a Situation Report that assessed the risk of dengue outbreaks in the Americas as high at the regional level due to the widespread distribution of the Aedes spp. Mosquitoes.

In the U.S., the Centers for Disease Control and Prevention (CDC) has issued Travel Health Notices regarding dengue outbreaks in the Americas. The CDC reported on January 3, 2024, that there were 2,343 dengue cases reported by 52 U.S. jurisdictions during 2023.

The CDC says dengue is endemic in the U.S. territories of Puerto Rico, American Samoa, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of Marshall Islands, and the Republic of Palau.

Dengue is a vaccine-preventable disease, with two vaccines currently in use in the Americas and several dengue vaccine candidates in development in 2024.

According to new data posted by the National Center for Health Statistics (NCHS) Mortality Surveillance, 0.9% of all deaths in the U.S. that occurred during the week ending January 27, 2024 (Week 4), were due to influenza. 

On February 2, 2024, the U.S. CDC stated this percentage decreased by ≥ 0.1 compared to Week 3.

During week 1, with about 100% of the data tabulated, there were 703 influenza-related deaths reported by the NCHS.

From October 2, 2022, to September 9, 2023, 9,697 (4%) deaths were listed as influenza.

Additionally, the CDC reported eight influenza-associated pediatric deaths during the 2023-2024 season, which were reported to the CDC during Week 4. A total of 65 influenza-associated pediatric deaths have occurred this flu season and have been reported by the CDC.

Last flu season, there were 178 influenza-associated pediatric fatalities. The mean age at death was about seven years, and 83% of these children were not fully vaccinated.

The CDC continues to recommend annual flu shots (egg, cell, or nasal-based) for most people and booster vaccinations for some people after conferring with a healthcare provider.

Malaria continues to be the most significant cause of death in young African children, with over 600,000 deaths globally each year. A recently approved malaria vaccine has been proven safe and effective to reduce this global health risk.

The Lancet today published peer-reviewed results from a Phase 3 efficacy clinical trial of the R21/Matrix-M™ malaria vaccine. 

The publication reported on February 1, 2024, the following findings:

• Efficacy of 75% when administered before the high transmission season: In areas with highly seasonal malaria transmission (where malaria transmission is primarily limited to 4 or 5 months per year), the R21/Matrix-M vaccine was shown to reduce symptomatic cases of malaria by 75% during the 12 months following a 3-dose series.
• Efficacy of 68% when administered in an age-based schedule in regions where malaria is present perennially during the 12 months following the first three doses.
• Significantly increased immune responses to the R21/Matrix-M vaccine and slightly higher vaccine efficacy were observed in 5-17-month-olds supporting planned vaccine deployment initially from 5 months of age in young African children.
• The most common adverse events with the vaccine were fever (47%) and injection site pain (19%).

John Jacobs, Novavax President and CEO, commented in a press release, "Approximately 1,300 children die from malaria every day, a staggering statistic for a preventable disease."

"The R21/Matrix-M Phase 3 efficacy data published in The Lancet reinforce the potential of R21/Matrix-M vaccine to protect children against this disease."

"We are proud of the role of Novavax's patented saponin-based Matrix-M adjuvant, which has been demonstrated to enhance the immune response, in the outcome of this clinical trial and are eager to see the realized impact of the vaccine when it is rolled out globally." 

The study was conducted across multiple sites in four African countries with 4,800 children aged 5-36 months. Data from this trial served as the basis for the World Health Organization's (WHO) recent prequalification of the R21/Matrix-M vaccine, paving the way for a global rollout expected to commence in mid-2024 by Serum Institute of India.

Ghana, Nigeria, Burkina Faso, and regulators in other countries have licensed the vaccine.

Beginning in February 2024, about 25 million R21/Matrix-M vaccine doses will become available. The availability of the R21/Matrix-M vaccine is expected to help close the gap in the vast demand for malaria vaccine doses to protect children against the disease.

This innovative vaccine contains Novavax Inc.'s saponin-based Matrix-M™ adjuvant.

The Matrix-M adjuvant comes from saponins, naturally occurring compounds in the bark of the Quillaja saponaria (Soapbark) tree. Saponins have a long history of being used for their medicinal properties. The U.S. Food and Drug Administration has approved a vaccine containing another saponin‐based adjuvant.

GlobalData confirmed today that Beyfortus™ (nirsevimab), a long-acting monoclonal antibody (mAb), has been approved in China for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants entering or during their first RSV season.

With the first approved preventive option for RSV, AstraZeneca and Sanofi's Beyfortus will dominate the market in China, says GlobalData, a leading data and analytics company.

GlobalData's RSV Forecast in Asia-Pacific Markets (India, Urban China, Australia, South Korea, and Japan) to 2028 reveals that Urban China will lead the Asia-Pacific market for RSV in 2028, accounting for 34.8% of the overall market size.

Nelluri Geetha, Pharma Analyst at GlobalData, commented in a press release on January 31, 2024, "RSV infection is a leading cause of viral lower respiratory tract infections, with a higher rate seen in children than adults. RSV infection occurs most commonly in children below six months of age in China."

"Beyfortus is the first approved drug for RSV in a broad infant population, which includes healthy term, late preterm, and preterm infants, as well as infants with specific health conditions that make them vulnerable to severe RSV disease."

"Hence, the approval addresses an urgent need for novel prophylactic treatment options for the pediatric population in China."

Geetha concludes: "Beyfortus is the only preventive option for RSV in the infant population, meaning that the drug will continue to dominate the Chinese market shortly."

"However, competition may intensify over the long term as other drugs are in late-stage development for the pediatric population in this market. These include Merck & Co's clesrovimab and Zhuhai Trinomab Biotechnology's TNM-001 in Phase III development."

"These are mAbs in Phase III development for the prevention of RSV among pediatric patients."

As of February 1, 2024, Beyfortus is available in the U.S., U.K., and European markets for the 2024 RSV season. In 2023, Beyfortus sales reached €547 million in 2023.

GSK plc announced that the European Medicines Agency (EMA) has accepted the company's regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) AREXVY™ vaccine to adults aged 50-59 who are at increased risk for RSV disease.

A European regulatory decision is anticipated in the second half of 2024.

If accepted, AREXVY would be the first vaccine available to help protect this population. 

GSK recently estimated that nearly 80 million adults in the U.S. could receive an RSV shot for the first time. 

GSK announced on November 1, 2023, that AREXVY's third-quarter 2023 sales were approximately $850 million. 

As of January 30, 2024, AREXVY is approved in Europe, Japan, the United States, and several other countries for adults aged 60 and over to prevent lower respiratory tract disease caused by RSV.