Vaccine News

The U.S. Centers for Disease Control and Prevention (CDC) confirmed last month that respiratory syncytial virus (RSV) is the most common cause of hospitalization among U.S. infants.

Since last year, when Beyfortus™ became the first U.S. FDA-approved single-dose, extended half-life monoclonal antibody (mAb) offering passive immunization to prevent lower respiratory tract infections caused by RSV, numerous researchers have focused on determining its real-world effectiveness.

The CDC has clarified that mAbs are not vaccines but offer disease protection.

According to a study's results published by The Lance in October 2024 (Volume 8, Issue 10p721-729), Beyfortus's estimated effectiveness against RSV-associated hospitalizations for bronchiolitis was 73% (61–84), corresponding to one hospitalization averted for every 39 (26–54) doses administered.

And in sensitivity analyses, nirsevimab remained effective against RSV-associated hospitalizations for bronchiolitis after emergency department attendance.

As of October 4, 2024, there is ample supply of Beyforus in the U.S., well ahead of the 2024-2025 RSV season's peak, expected in December or January.

The World Health Organization (WHO) reported today that West Nile Virus (WNV) had been detected in a child from Bagatelle, a parish in St. Thomas, located in Barbados, an island country in the Caribbean Sea.

On October 3, 2024, the WHO's Disease Outbreak News stated that this was the first human case of WNV detected in Barbados, which has a population of about 280,000.

Additionally, thousands of people visit Barbados yearly as it is a favorite vaccination destination and cruise ship port.

Additionally, no infections have been previously documented in birds or horses in Barbados, making this case both unusual and unexpected, wrote the WHO. Although no cases of WNV have been documented in birds or horses in the country, the virus may be circulating in these populations undetected. 

However, the WNV has previously spread throughout the Caribbean, likely via infected migratory birds.

The WHO's risk of international dissemination of WNV from Barbados is low, as the virus is primarily transmitted through mosquito bites, with birds as the natural hosts.

Based on available information on this event, WHO does not recommend any restrictions on travel and/or trade for Barbados and will continue to evaluate the epidemiological situation in Barbados. 

In the United States, 46 states have reported over 1,400 WNV cases in 2024.

From a prevention perspective, no approved West Nile virus vaccines are available for people in 2024.

The Republic of Rwanda Ministry of Health posted on X that the death toll from the recent Marburg virus disease (MVD) outbreak has reached eleven out of 36 confirmed cases. 

As of October 2, 2024, about 26 additional people are in isolation from this rare viral hemorrhagic fever in Kigali, the capital city of Rwanda, which has a population exceeding 1.7 million.

As of September 30, 2024, the World Helath Organization (WHO) assessed the risk of this MVD outbreak as very high at the national level, high at the regional level, and low at the global level.

The WHO says the source of this MVD outbreak, geographical extent, likely onset date, and additional epidemiological information on cases are still pending further investigation. Rwanda declared its initial MVD outbreak on September 27, 2024.

According to the AP, Rwandan Health Minister Sabin Nsanzimana said that vaccine clinical trials would start “within days” but failed to clarify which type of vaccine will be used.

As of October 3, 2024, various Marburg vaccine candidates are conducting studies. For example:

Public Health Vaccines, LLC launched its Phase 1 clinical trial in March 2024, evaluating its single-dose vaccine candidate, PHV01 (rVSV∆G-MARV-GP [Angola]).

On April 15, 2024, the U.S. FDA granted orphan drug designation to the active ingredient in MarVax™, the subunit protein vaccine of recombinantly expressed MARV glycoprotein, for "the prevention and post-exposure prophylaxis against MARV infection.

The U.S. CDC's recent travel advisory remains in effect, which states If you travel to the Republic of Rwanda, you should:

Avoid contact with sick people with fever, muscle pain, and rash symptoms.

Avoid contact with blood and other body fluids.

Avoid visiting healthcare facilities in the outbreak area for nonurgent medical care or for non-medical reasons.

PDS Biotechnology Corporation today announced updated data from the Phase 2 clinical trial evaluating Versamune® HPV (PDS0101) with chemoradiation to treat locally advanced cervical cancer were presented at the American Society for Radiation Oncology Annual Meeting 2024.

The company stated 100% 36-month overall survival (OS) and progression-free survival (PFS) rates in patients fully treated with Versamune® HPV combined with chemoradiation (N=8), and 88% (15/17) of patients had a complete metabolic response.

“We are pleased that data from the Phase 2 IMMUNOCERV trial demonstrate compelling clinical activity and a promising safety profile,” said Frank Bedu-Addo, Ph.D., President and Chief Executive Officer of PDS Biotech, in a press release on October 2, 2024.

“Based on our continued research in various HPV-positive cancers, Versamune® HPV appears to work in combination with a variety of therapeutic agents to generate clinical responses and promote improved survival in patients with minimal toxicity. We look forward to the next steps in the development of Versamune® HPV for locally advanced cervical cancer.”

PDS Biotech’s oncology pipeline leverages the Versamune® platform and Versamune® plus PDS01ADC in combination with proprietary tumor-specific proteins or peptides (antigens) in developing targeted cancer immunotherapies.

As the new flu season arrives in the United States, data has reaffirmed the benefits of getting an annual flu shot this year.

CSL Seqirus today announced data from a range of real-world evidence (RWE) studies, highlighting the important role influenza vaccination plays in protecting public health.

RWE complements randomized controlled trial research, assessing influenza vaccine effectiveness continuously and providing an ever-growing data set on health outcomes. 

"CSL Seqirus remains committed to evaluating vaccine effectiveness through the rigorous generation of real-world evidence," said Gregg Sylvester, Chief Health Officer of CSL Seqirus, in a press release on October 1, 2024.

Among others, RWE studies being presented by CSL Seqirus at OPTIONS XII include:

Results of a study of the 2022/23 influenza season in the U.S. showed that cell-based quadrivalent (QIVc) vaccines prevented more outpatient test-confirmed influenza for those aged six months to 64 years compared with the egg-based quadrivalent (QIVe) vaccines.

Results from a study of the 2023/24 influenza season in the U.S. showed that cell culture-based inactivated influenza vaccine (ccIIV4) generated real-world effectiveness against medically attended, laboratory-confirmed influenza, compared with unvaccinated participants. Vaccine effectiveness was highest in children six months to three years of age at 88%.

Results from a review of the 2017 to 2020 influenza seasons revealed a higher relative effectiveness of QIVc over QIVe/egg-based trivalent (TIVe) vaccines across the three influenza seasons for test-confirmed and clinically diagnosed influenza.

Results from a study of the 2022/23 influenza season in the U.S. showed comparability between MF59® adjuvanted quadrivalent inactivated influenza vaccine (aQIV) and high-dose quadrivalent inactivated influenza vaccine (HD-QIV) in preventing test-confirmed influenza-related emergency department visits and/or inpatient admissions settings among adults aged 65 and over.

Various influenza vaccines for the 2024-2025 flu season are available at clinics and pharmacies in the U.S.

The Chikungunya Virus outbreak in the Region of the Americas has now exceeded 393,000 cases in 2024 and may soon surpass last year's record of 411,548.

Throughout 2024, the Pan American Health Organization has reported 170 Chikungunya-related fatalities in the Americas.

Before 2006, Chikungunya, a mosquito-transmitted virus, was rarely identified in U.S. travelers. However, that trend has changed,

The Centers for Disease Control and Prevention (CDC) data dashboard reported 113 chikungunya cases in 2024, an increase of 34 patients since September 2024. Over 20 states have reported Chikungunya cases this year, led by Massachusetts, New Hampshire, California, Colorado, Illinois, and New York.

The CDC did confirm some good news today; these confirmed cases are travel-related. 

Locally acquired Chikungunya cases have not been reported from U.S. states or territories since 2019.

Furthermore, the CDC says all travelers to countries with a risk of Chikungunya should avoid mosquito bites and discuss the need for vaccination with their healthcare provider.

As of October 2024, the Valneva SE's IXCHIQ® single-dose Chikungunya vaccine is readily available at travel clinics and pharmacies in the U.S.

For the first time in the United States, 55.8% of infants were protected by two approved immunization methods last year against respiratory syncytial virus (RSV) infections.

According to survey results published in a Morbidity and Mortality Weekly Report (73(38);837–843) on September 26, 2024, 33% of eligible pregnant women reported receiving an RSV vaccination. Most vaccinated women (54.1%) reported receiving the vaccine at an obstetrician or gynecologist's office.

Among women with an infant, 45% reported that their infant received the passive immunization Beyfortus™ (nirsevimab). However, the availability of Beyfortus was limited during the 2023–24 RSV season, creating access challenges and clinical confusion.

Overall, 14.2% of infants were protected by both products.

Furthermore, about 50% of pregnant women did not report receiving a provider recommendation for maternal RSV vaccination or nirsevimab, indicating missed opportunities to protect infants from RSV disease.

These researchers wrote this survey's findings 'underscore the importance of a strong provider recommendation for immunization during the 2024-2025 RSV season.'

As of September 27, 2024, the U.S. CDC's latest RSV data indicates the current RSV season has started slowly but is anticipated to peak in December/January 2025.

The CDC encourages at-risk groups to protect themselves against RSV this winter.