Vaccine News

A new framework was recently released by the World Health Organization (WHO) that will guide health authorities, communities, and other stakeholders in preventing and controlling mpox outbreaks, eliminating human-to-human transmission of the disease, and reducing spillover of the virus from animals to humans.

Mpox is a viral illness caused by the monkeypox virus (MPXV).

There are two different clades of the MPXV: clade I and clade II. Clade I outbreaks are deadlier than clade II outbreaks. 

In the United States, clade II cases were reported to have a fatality rate of .002%.

A significant outbreak of the clade I virus in the Democratic Republic of the Congo (DRC) continues today, where cases have been detected for decades. Since the beginning of 2024, over 6,500 cases and 345 deaths have been reported in the DRC.

This data reflects a fatality rate of .05%.

As of May 26, 2024, most U.S. mpox cases continue to be in people who are not vaccinated or have only received one dose of the JYNNEOS® (MVA-BN®, IMVAMUNE®) vaccine. The U.S. CDC recommends that persons at risk for mpox exposure complete the 2-dose  vaccination.

In the U.S., the JYNNEOS vaccine is offered at clinics and pharmacies in select cities.

The U.S. Centers for Disease Control and Prevention (CDC) recently reported that three additional measles cases were confirmed in 2024.

As of May 23, 2024, the CDC confirmed a total of 142 measles cases were reported by 21 jurisdictions: Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York City, New York State, Ohio, Pennsylvania, Vermont, Virginia, Washington, West Virginia, and Wisconsin.

Recently, the city of Philadelphia reported another measles case after managing an outbreak earlier in 2024.

About 44% of these cases are in unvaccinated children under five years of age, with 63% hospitalized.

Ten measles outbreaks (3+) were reported in 2024, compared to four outbreaks in 2023.

Globally, about 50 countries have reported measles outbreaks in the past year.

The CDC says it is uncommon for someone fully vaccinated to develop measles. In 2024, the number of breakthrough infections (approximately 5%) was consistent with previous years' reports.

Two doses of MMR vaccine are 97% effective at preventing measles, and one dose is 93% effective. Measles vaccines are available at most clinics and pharmacies in the U.S.

The Inflation Reduction Act (IRA) eliminated cost sharing for vaccines covered by Part D beginning in January 2023 to improve the affordability of vaccines for Medicare beneficiaries.

To help determine if the impact matches the IRA's intent, a team led by Dima Qato—Hygeia Centennial Chair and Associate Professor at the USC Mann School of Pharmacy and Pharmaceutical Sciences—evaluated the policy removing patient out-of-pocket costs for the uptake of shingles vaccinations, the most commonly administered vaccine covered by Part D.

A Research Letter published by the JAMA Network evaluated the association of this zero cost-sharing policy on the use of shingles vaccinations, which account for more than 90% of Part D vaccinations.

Following the implementation of the new policy, total Part D shingles vaccinations dispensed increased by 46%.

Between January 2022 and December 2023, 16.3 million shingles vaccines (8.3 million to individuals with Part D and 8 million to those with commercial insurance) were dispensed at retail pharmacies.

These researchers wrote, 'The implementation of the IRA policy eliminating out-of-pocket costs for Part D–covered vaccinations was associated with substantial increases in shingles vaccinations dispensed to Part D enrollees compared with commercially insured individuals at retail pharmacies.'

"Policy matters," said Qato in a press release on May 23, 2024, who also directs the Mann School's Program on Medicines and Public Health and is a senior fellow at the USC Schaeffer Center for Health Policy & Economics. "And when these policies eliminate the costs, they remove barriers in accessing essential medications and preventive services, including vaccinations."

Recently, a long-term study revealed that the leading shingles vaccine delivers extensive value.

In April 2024, GSK plc announced that data from a long-term follow-up phase III trial showed that the Shingrix® vaccine, also known as Recombinant Zoster Vaccine, remained effective against shingles for more than a decade in adults over 50.

As of May 24, 2024, the Shingrix vaccine is available at most pharmacies in the U.S.

According to the U.S. CDC's Tick Bite Data Tracker dashboard, emergency room visits for tick bites have accelerated.

As of mid-May 2024, most tick disease cases in the U.S. have been concentrated in the Northeast, followed by the Midwest.

The CDC estimates that approximately 476,000 people are diagnosed and treated for Lyme disease yearly.

While Lyme disease received the most media attention, common Tickborne diseases in the United States include Babesiosis, Ehrlichiosis, and Rocky Mountain Spotted Fever.

While the Lyme disease vaccine candidate (VLA15) continues conducting late-stage research, it previously received the U.S. Food and Drug Administration Fast Track designation. The vaccine manufacturers have indicated updated study results in 2025.

Until a preventive Lyme disease vaccine becomes available, the CDC recommends protecting yourself from ticks by applying DEET or picaridin, treating clothing with products containing 0.5% permethrin, and conducting thorough tick checks after outdoor activities.

Assembly Biosciences, Inc. today announced that the company will present data from its herpes simplex virus (HSV) program at the International Herpesvirus Workshop in Portland, Ore., July 13-17, 2024.

At the Workshop, Assembly Bio will present data describing the preclinical profile of ABI-5366, a long-acting helicase-primase inhibitor candidate in development for treating recurrent genital herpes.

Additionally, the company will present data highlighting the preclinical characterization of ABI-1179, a structurally distinct long-acting helicase-primase inhibitor candidate.

William Delaney, PhD, chief scientific officer of Assembly Bio, commented in a press release on May 22, 2024, "Improved therapeutic options are urgently needed for people living with recurrent genital herpes, as the current standard of care is only partially effective in controlling recurrences."

"Our HSV program employs a highly innovative approach, with candidates designed from the start for long-acting administration and targeting the viral helicase-primase complex, a different viral target than the standard of care."

"We look forward to an important year for the program, as we remain on track to begin dosing in a Phase 1a/1b study for ABI-5366 by mid-year (2024) and anticipate bringing ABI-1179 into the clinic by the end of the year."

Details of the presentations are as follows:

Poster Presentation: The Helicase-Primase Inhibitor ABI-5366 is a Novel, Potent, Long-Acting Inhibitor for the Treatment of Recurrent Genital Herpes
Presenter: Ran Yan, PhD, Assembly Bio
Poster Session Date and Time: Not Yet Available

As of May 23, 2024, there are no U.S. FDA-approved herpes vaccines available.

Following the initial shortage of the newly approved long-acting, monoclonal antibody Beyfortus™ (nirsevimab) for preventing infant respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI), a new digital app may help identify newborns at the highest risk for developing serious RSV LRTI, according to research published at the ATS 2024 International Conference.

 These researchers wrote, 'To predict whether these infants developed severe RSV LRTI requiring ICU admission during the first year of life, we developed a multivariable logistic regression model. The model includes demographic and clinical variables collected at or shortly after birth–19 variables, such as prenatal smoking, delivery method, maternal age, and assisted breathing (ventilation) during birth hospitalization.'

"Timely identification of infants at highest risk of RSV-related morbidity is key to prevention," said lead author Brittney M. Snyder, PhD, assistant professor, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, in a press release on May 21, 2024.

"Our personalized risk prediction tool may have applications in allocating expensive and/or limited immunoprophylaxis (immunization with nirsevimab or palivizumab) to achieve the greatest benefit and promote RSV prevention among families with high-risk infants."

During the 2023-2024 RSV peak season in the U.S., Beyfortus reduced RSV hospitalizations by about 82% in infants compared to infants who received no passive immunization against RSV.

As of March 2024, among females with an infant <8 months, 41.3% reported that their infant received Beyfortus.

As of May 2024, access to Beyfortus is not constrained in the U.S.

Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) today announced it would award $3.96 million to the Center for Vaccine Development and Global Health (CVD) at the University of Maryland School of Medicine to develop a maternal vaccine that prevents sepsis caused by Klebsiella pneumoniae in newborns and infants.

The CVD vaccine candidate, which targets the surface sugars of K. pneumoniae, is expected to be given to pregnant women, thereby protecting their babies from this deadly infection.

If successful, researchers expect the vaccine will prevent 80-90% of K. pneumoniae neonatal sepsis infections.

“With this award, the CVD team has even greater potential to bring a maternal vaccine for neonatal sepsis to market and save the lives of millions of infants worldwide, especially in low-and-middle income countries through its global partnership with Auro Vaccines of India,” said Erin Duffy, PhD, R&D Chief of CARB-X, in a press release on May 21, 2024.

“By vaccinating expectant mothers, the risk of neonatal sepsis might be reduced substantially as babies who are too young to be vaccinated would receive antibodies from their mothers in utero as well as through breastfeeding after birth.”

The CARB-X award supports examining the feasibility of this project to maximize its potential impact on the vulnerable patient population.

The CVD team aims to develop and evaluate their vaccine further in partnership with Auro Vaccines Private Limited, a step-down subsidiary of Aurobindo Pharma Limited, India.

Neonatal sepsis is a life-threatening response to bloodstream infections that occur in newborns fewer than 28 days old. Due to their immature immune systems, newborns are particularly susceptible to infections.

The BARNARDS study estimated that 2.5 million neonates or infants in the first month of life die annually of sepsis, with the most significant burden in low- and middle-income countries.

Since neonatal sepsis progresses rapidly, it requires immediate treatment with IV fluids and antibiotics. The risk of death from neonatal sepsis increases by 7.6% every hour a treatment is delayed.

Federal funds from the U.S. Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and others support CARB-X funding for this research.