Vaccine News

In the northeastern section of the United States, concerns about the impact of Eastern equine encephalitis (EEE) and West Nile virus (WNV) have continued into September 2024.

The Massachusetts Department of Public Health (DPH) announced on September 5, 2024, one additional human case of EEE and one additional human case of WNV in Massachusetts this year.

The total number of EEE cases in Massachusetts this year is three, with seven WNV cases.

WNV risk levels in the following communities are being raised to high: Stoneham and Wakefield in Middlesex County.

Throughout the U.S., 38 states have reported WNV cases in 2024.

The last outbreak of EEE occurred in 2019-2020 and resulted in 17 human cases and seven deaths. In 2023, there were six human cases of WNV.

As of September, EEE risk levels have been raised to high in Acton, Ayer, Boxborough, Carlisle, Littleton in Middlesex County, and Harvard in Worcester County. The following communities are being raised to moderate: Bedford, Billerica, Chelmsford, Concord, Framingham, Groton, Lincoln, Shirley, Stow, Tyngsborough, Wayland, and Westford in Middlesex County; and Berlin, Bolton, Clinton, and Lancaster in Worcester County.

Public Health Commissioner Robbie Goldstein, MD, PhD., commented in a press release, “It is essential that residents continue to use mosquito repellent with an EPA-registered active ingredient every time they are outdoors. We also strongly recommend that residents and towns in high-risk areas for EEE reschedule their evening outdoor events to avoid peak mosquito biting hours.”

EEE and WNV are transmitted to humans through the bite of an infected mosquito.

“Mosquito behavior starts to change in September,” said State Epidemiologist Dr. Catherine Brown. “They will be less active during cooler temperatures. However, during warmer weather, such as being forecast for the end of next week, mosquitoes will be out and looking for their next meal.”

To the north of Massachusetts, the New Hampshire Department of Health and Human Services reported on September 4, 2024, that ten mosquito batches tested positive for EEE this year, with one fatal human case.

The last reported human cases of EEE in New Hampshire were in 2014 when three cases were identified. Two of those patients died.

As of September 6, 2024, no vaccines are available for people to protect themselves against EEE or WNV.

During the global dengue virus outbreak in 2024, Puerto Rico was the most impacted area in the United States. The U.S. CDC says that Dengue is endemic in Puerto Rico, cases are increasing, and it issued a Dengue travel advisory earlier in 2024.

As of week #32 in August 2024, Puerto Rico reported 2,704 dengue cases, with San Juan reporting over 950 cases.

The local health department's report for August 2024 indicates that 1,234 dengue-related hospitalizations and two dengue-related deaths occurred this year.

Last year, 1,242 dengue cases were reported in Puerto Rico. 

Since 2019, the U.S. Food and Drug Administration (FDA) has approved the Dengvaxia vaccine for certain people with laboratory evidence of a previous dengue infection and living in areas where Dengue is endemic, such as Puerto Rico.

However, in late August 2024, Puerto Rico's Health Department issued a Notice of Discontinuation regarding access to Dengvaxia.

This announcement indicates that millions of visitors to Puerto Rico in 2024 will be unable to access a Dengue-preventive vaccine.

The FDA may approve various dengue vaccines in the coming months and once again become available throughout the U.S.

Additionally, diseases such as Chikungunya have been transmitted to people by the Aedes aeqypti mosquito.

The good news is that Valneva SE's IXCHIQ® single-dose chikungunya vaccine is available in the U.S. at travel clinics and pharmacies. 

The World Health Organization (WHO) announced today it considers the current global risk from cholera as very high since cholera cases increased by 13% and deaths (~4,000) by 71% last year compared to 2022.

Across all continents as of mid-August 2024, 342,800 cholera cases and 2,400 related deaths have already been reported to WHO.

Unfortunately, as of September 4, 2024, there is insufficient oral cholera vaccine (OCV) supply to meet the global demand.

Since October 2022, the International Coordinating Group, which manages emergency vaccine supplies, has suspended the standard two-dose vaccination regimen in cholera outbreak response campaigns, adopting a single-dose approach instead to reach and protect more people given limited supplies.

Despite the low stockpile of OCV, a record 35 million doses were shipped last year, with the one-dose strategy in effect.

The WHO has prequalified Dukoral®, Shanchol™, Euvichol®, and the Euvichol-S OCVs to address the supply shortfall.

In the United States, OCVs are available at travel clinics and pharmacies.

Vaxcyte, Inc. today announced that it has commenced an underwritten public offering of $1.0 billion of its common stock and pre-funded warrants.

As of August 3, 2024, Vaxcyte intends to grant the funding underwriters a 30-day option to purchase up to an additional $150 million of shares of its common stock offered in the public offering (including shares underlying the pre-funded warrants).

Vaxcyrte confirmed this offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases.

VAX-31 is a Phase 3-ready 31-valent, carrier-sparing pneumococcal conjugate vaccine (PCV) candidate being developed for the prevention of invasive pneumococcal disease (IPD) in adults and infants and is the broadest-spectrum PCV candidate in the clinic today.

VAX-24, the Company’s 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market and is currently being evaluated in a Phase 2 infant study.

Both VAX-31 and VAX-24 are designed to improve upon the standard-of-care PCVs by covering the serotypes in circulation that are responsible for a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance, and meningitis while maintaining coverage of previously circulating strains that are currently contained through continued vaccination practice.

Valneva SE and Pfizer Inc. today announced positive immunogenicity and safety data from their VLA15-221 Phase 2 study following a second booster vaccination of their Lyme disease vaccine candidate, VLA15, given one year after receiving the first booster dose.

VLA15 is an investigational multivalent protein subunit vaccine that uses an established mechanism of action for a Lyme disease vaccine. It targets the outer surface protein A of Borrelia burgdorferi, the bacteria that causes Lyme disease.

There are currently no approved human vaccines for Lyme disease, and VLA15 is the candidate that has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a September 3, 2024, press release, "We are encouraged by these data, which support the potential benefit of booster doses across all examined age groups."

"As Lyme disease continues to spread, it represents a significant unmet medical need, affecting numerous individuals throughout the Northern Hemisphere."

"Each new set of positive data brings us one step closer to potentially bringing this vaccine to adults and children living in areas where Lyme disease is endemic."

Subject to positive Phase 3 data, Pfizer aims to submit a Biologics License Application to the U.S. FDA and a Marketing Authorization Application to the European Medicines Agency in 2026.

The Centers for Disease Control and Prevention (CDC) estimated that approximately 476,000 people in the U.S. are diagnosed and treated for Lyme disease yearly. This disease was first identified in Lyme, Connecticut.

On August 14, 2024, the CDC reported (Volume 30, Number 9—September 2024) that the overall incidence of Lyme disease was about seven times higher than that reported through public health surveillance.

Unfortunately, the northeastern United States is the leading area for Lyme disease-carrying ticks.

For example, the Pennslyvania Department of Health Tickborne Disease Dashboard shows that while cases of Lyme disease peak in June through August, the threat exists year-round, primarily in the northwestern section of the state.

The European CDC Communicable Disease Threats Report, published on August 30, 2024, disclosed that France had reported three autochthonous (locally-acquired) chikungunya virus disease cases in the Department of La Réunion from the same neighborhood.

The last major chikungunya outbreak in La Réunion was from 2005 to 2006.

The ECDC says the risk of chikungunya infection for residents and travelers to La Réunion is currently low. This mosquito-transmitted disease activity has been reduced as it's winter in La Réunion.

However, further cases cannot be excluded, says the ECDC.

La Réunion is an island in the Indian Ocean east of Madagascar and Africa that welcomes over 350,000 visitors annually.

As of September 2, 2024, the U.S. CDC had not issued a Travel Healht Advisory regarding La Réunion's chikungunya outbreak.

From a disease prevention option, Valneva SE's IXCHIQ® single-dose, live-attenuated chikungunya vaccine has been approved by the U.S. FDA and throughout Europe. Travel vaccination services are offered throughout the United States at certain pharmacies and Passport Health USA.

The U.S. Centers for Disease Control and Prevention (CDC) recently updated its annual vaccination recommendations for the 2024-25 flu season, noting two fundamental changes.

On August 29, 2024, the CDC stated (73(5);1–25) the primary updates include the following two topics: the composition of 2024–25 seasonal influenza vaccines with the return to trivalent vaccines and updated recommendations for vaccination of adult solid organ transplant recipients.

The CDC recommends that everyone six months and older, with rare exceptions, receive an annual flu shot beginning in the Fall of 2024—decisions about timing need to consider the unpredictability of the flu season.

As of September 2, 2024, various flu shots are available at most pharmacies in the United States. Last flu season, over 157 million influenza vaccines were distributed in the U.S.