Travel Vaccine Breaking News

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.

Pfizer Inc. recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for its 20-valent pneumococcal conjugate vaccine candidate (20vPnC, PREVNAR 20®, APEXXNAR®) for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age.

The CHMP’s positive opinion will now be reviewed by the European Commission (EC) to decide whether to approve the vaccine.

This EC decision is expected in the coming weeks and will apply to all 27 EU member states plus Iceland, Liechtenstein, and Norway.

“Pfizer has a longstanding history of developing groundbreaking pneumococcal conjugate vaccines to help protect infants and their families from life-threatening infections,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer, in a press release on January 26, 2024.

“Today’s CHMP positive opinion represents a significant step forward in our continued efforts and, if approved, 20vPnC has the potential to cover more disease burden than any other available pediatric pneumococcal conjugate vaccine in the EU.”

In April 2023, the U.S. Food and Drug Administration approved PREVNAR 20® for most infants and children.

In February 2022, the EC Decision was adopted for APEXXNAR® (20vPnC) to prevent invasive disease and pneumonia caused by the 20 S. pneumoniae serotypes in the vaccine in adults.

The unedited Pfizer press release is available at this link.

The journal Clinical Microbiology and Infection published the results from a post-hoc analysis regarding the relative effectiveness of high-dose quadrivalent influenza vaccine (QIV-HD) vs. standard-dose quadrivalent influenza vaccine (QIV-SD) against recurrent hospitalizations for seniors.

Published on January 27, 2024, this analysis found that among 12,477 randomly assigned participants, receiving QIV-HD was associated with lower incidence rates of hospitalisations for pneumonia or influenza (10 vs. 33 events, IRR 0.30 [95% CI 0.14-0.64], p=0.002).

And all-cause hospitalisations (647 vs. 742 events, IRR 0.87 [95% CI 0.76-0.99], p=0.032) compared with QIV-SD.

These researchers wrote, 'Our exploratory results correspond to a number needed to treat 65 (95% CI 35-840) persons vaccinated with QIV-HD compared with QIV-SD to prevent one additional all-cause hospitalization per season.'

'Further research is needed to confirm these hypothesis-generating findings.'

As of January 29, 2024, over 156 million cell, egg, and nasal-based influenza vaccines were distributed in the U.S. during the 2023-2024 flu season.

In September 2023, the Taiwan Centers for Disease Control (Taiwan CDC) announced that mRNA vaccines would continue to be available in response to the continued spread of COVID-19.

However, according to Novavax Inc.'s announcement on January 23, 2024, the updated protein-based non-mRNA COVID-19 vaccine (Nuvaxovid™XBB.1.5 dispersion for injection) is now available for use in Taiwan for the prevention of COVID-19 in individuals aged 12 and older.

Doses have been distributed by Taiwan CDC to local vaccination clinics across the country.

The Taiwan CDC stated that adding a protein-based vaccine will diversify the country's vaccine portfolio and provide a non-mRNA option to help protect against COVID-19.

"We are working closely with Taiwan's authorities to ensure doses of our updated protein-based non-mRNA COVID-19 vaccine are made available at vaccination centers across Taiwan as soon as possible," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release posted on December 18, 2023.

Throughout the multi-year pandemic, about 90% of Taiwan's population contracted COVID-19, and 19,005 people died.

Taiwan's authorization was based on non-clinical data showing that Novavax's updated COVID-19 vaccine induced functional immune responses for XBB.1.5, XBB.1.16, and XBB.2.3 variants.

Additional non-clinical data demonstrated that Novavax's NVX-CoV2601 vaccine-induced neutralizing antibody responses to subvariants BA.2.86, EG.5.1, FL.1.5.1, and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6.

These data indicate Novavax's vaccine can stimulate both arms of the immune system and induce a broad response against circulating variants, says Novavax.