Vaccine News

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.

With more than 150 countries and territories reporting rabies cases, accessing one of the four authorized vaccines is essential to reducing this viral disease, says the World Health Organization. 

Bavarian Nordic recently announced it is in agreement with the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) regarding reports of rubber particles after reconstitution of the Rabipur rabies vaccine.

Bavarian Nordic has recently received an unexpected number of product quality complaints about visual particles in the vaccine solution.

Recommendations, issued on August 14, 2024, have been provided to minimize health risks. The analysis revealed that these particles consisted of rubber transferred from the rubber stopper of the vaccine vials during (coring) reconstitution.

The MHRA's letter to healthcare providers recommends that the reconstituted Rabipur vaccine be carefully inspected visually and not administered if visible particles are present. Suspected adverse drug reactions can be reported to the MHRA through the Yellow Card scheme. 

While most of the world traces rabies infections in people to bites from an infected dog, in the United States, rabid bats are the leading source of infection.

UNICEF today announced that it had issued an emergency tender for the procurement of mpox vaccines. The emergency tender is designed to secure immediate access to available mpox vaccines and expand production.

Depending on demand, manufacturers' production capacity, and funding, agreements for up to 12 million doses through 2025 can be made.

Based on recent announcements, there are four mpox vaccines available in 2024.

“Addressing the current mpox vaccine shortage and delivering vaccines to communities who need them now is of paramount importance. There is also a pressing need for a universal and transparent allocation mechanism to ensure equitable access to mpox vaccines,” said Director of UNICEF Supply Division Leila Pakkala in a press release on August 31, 2024.

UNICEF is the world’s largest single vaccine buyer, procuring more than 2 billion doses of vaccines annually for routine child immunization and outbreak response on behalf of nearly 100 countries.

Emergent BioSolutions Inc. today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application for the expansion of the indication for the single-dose ACAM2000® Smallpox vaccine to include the prevention of mpox disease in individuals determined to be at high risk for mpox infection.

ACAM2000® is administered percutaneously via a bifurcated needle dipped into the vaccine solution. The skin is pricked several times in the upper arm with a droplet of the vaccine.

ACAM2000 was first approved by the FDA in 2007.

Dr. Amesh A. Adalja, FIDSA FACP FACEP & health security and emerging infectious diseases expert, Johns Hopkins Center for Health Security, commented in a press release on August 29, 2024, “ACAM2000®, a direct descendant of the Jenner vaccine (humanity’s first) which was used to eradicate smallpox, and now with the broadened indication, will be an invaluable tool in this endeavor.”

The FDA's labeling for ACAM2000® contains a contraindication for individuals with severe immunodeficiency. Severe localized or systemic infection with vaccinia (progressive vaccinia) may occur in persons with weakened immune systems. Individuals with severe immunodeficiency who are not expected to benefit from the vaccine should not receive ACAM2000®.

The risk of experiencing severe vaccination complications must be weighed against the risk of experiencing a potentially severe or fatal smallpox or mpox infection.

Additionally, there are warnings and precautions for myocarditis, pericarditis, encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson Syndrome), eczema vaccinatum resulting in permanent sequelae or death, accidental eye infection (ocular vaccinia), which can cause ocular complications that may lead to blindness, and fetal death.

These side effects may occur following primary or revaccination with live vaccinia virus vaccines, including ACAM2000®. These risks are increased in certain individuals and may result in severe disability, permanent neurological sequelae, and/or death.

As of late August 2024, four mpox vaccines are in use globally.

ARS Pharmaceuticals, Inc. recently announced today that the European Commission (EC) has approved EURneffy® (adrenaline nasal spray) for the emergency treatment of allergic reactions for adults and children (≥30 kg) with severe allergies.

ARS Pharma anticipates that EURneffy will be made available in certain European Union Member States in Q4 2024. It is the first novel adrenaline delivery method approved in over three decades.

The pharmacodynamics and pharmacokinetics of 2 mg EURneffy were evaluated across a range of dosing conditions, including single and repeat dosing, self-administration by patients, dosing in pediatrics, and during multiple nasal conditions that can cause congestion and rhinorrhea such as nasal allergen challenge or infectious rhinitis caused by a cold/flu.

“Adrenaline is the only first-line treatment (not a preventive vaccine) for allergic reactions including anaphylaxis, yet there is significant underutilization of adrenaline due to the limitations of currently available therapy,” said Antonella Muraro, MD PhD, Professor of Food Allergy at the University of Padua, and lead author of the European Academy of Allergology and Clinical Immunology treatment guidelines for anaphylaxis, in a press release on August 26, 2024.

Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only approved medication for these reactions in the European Union.

While adrenaline autoinjectors have been shown to be highly effective, well-published limitations result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency, says the company.