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With the winter months ahead, most hikers are not focused on catching Lyme disease. However, once the snow melts, millions of people will once again not have access to a vaccine.
There are currently no approved human vaccines for Lyme disease.
To address this significant health risk, Pfizer Inc. and Valneva SE today announced that they have completed recruitment for the Phase 3 clinical trial Vaccine Against Lyme for Outdoor Recreationists (VALOR) for Lyme disease vaccine candidate VLA15.
The VALOR trial, initiated in August 2022, has enrolled 9,437 participants five years of age and older at sites where Lyme disease is highly endemic across the U.S., Europe, and Canada.
As part of the primary vaccination series, participants receive three doses of VLA15 or a saline placebo (1:1 ratio) within the first year and one booster dose approximately one year after completion of the primary immunization.
The trial builds on previous positive Phase 1 and 2 trial results and includes adult and pediatric participants to confirm the efficacy, safety, lot consistency, and immunogenicity of VLA15.
"Lyme disease is the most prevalent vector-borne infectious disease in the United States and Europe, can sometimes even lead to long-lasting consequences," said Annaliesa Anderson, Ph.D., Senior Vice President and Head Vaccine Research and Development, Pfizer, in a press release on December 4, 2023.
"If approved, a vaccine could prevent the disease and ease the burden of acute, severe, and sometimes persistent consequences in adults and children."
"We look forward to progressing the trial with the goal of submitting a Biologics License Application to the U.S. Food and Drug Administration and Marketing Authorization Application to the European Medicines Agency in 2026, subject to positive data."
VLA15 is an alum-adjuvanted formulation administered intramuscularly and has demonstrated a strong immune response and a satisfactory safety profile in pre-clinical and clinical trials.
This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease.
OspA is a surface protein the bacteria expresses when present in a tick. Blocking OspA inhibits the bacterium's ability to leave the tick and infect humans.
The vaccine candidate covers the six most common OspA serotypes expressed by the Borrelia burgdorferi sensu lato species prevalent in North America and Europe.
Valneva SE today announced positive antibody persistence data twenty-four months after vaccination with a single dose of its chikungunya vaccine IXCHIQ®.
As reported on December 4, 2023, 97% of the 316 healthy adults still enrolled in a phase 3 study retained neutralizing antibody titers above the seroresponse threshold.
The persistence of antibodies in older adults aged 65 and above was as robust as in younger adults and even slightly higher in terms of geometric mean titers and seroconversion rates.
This outcome underscores the vaccine's potential to offer strong and lasting protection against chikungunya across different age groups.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, said, "We are very pleased about these twenty-four-month data, which confirm IXCHIQ®'s ability to induce a robust, long-lasting antibody response in both younger and older adults with a single vaccination."
"Being the world's first approved vaccine against chikungunya, each positive outcome further strengthens the defense against this significant and expanding public health threat."
These results from VLA1553-303 follow the completion of the pivotal Phase 3 study published in the Lancet in which a seroresponse rate of 96% six months after a single vaccination1 was reported.
Valneva was granted U.S. FDA approval for IXCHIQ in November 2023, and two marketing applications are currently under review by Europe and Canada, with potential approvals in mid-2024.
The U.S. CDC intends to review the use of IXCHIQ in 2024.
The World Health Organization says the chikungunya virus was identified in over 100 countries, and 340 related deaths have been reported in the past year.
As the multi-year Zika vaccine development process continues in late 2023, the mosquito-spreading disease is impacting more people in the Region of the Americas.
As of December 2, 2023, the Pan American Health Organization's data dashboard indicates there have been 31,780 Zika cases across the Americas, with the highest proportion of Zika cases reported in Brazil, Bolivia, Belize, Columbia, Paraguay, and Venezuela.
Brazil has reported the most Zika cases in 2023, with over 30,000 confirmed cases, primarily in high precipitation areas and low sewage network coverage.
Previous studies conducted in the states of Rio de Janeiro and São Paulo also indicated that temperature influenced the distribution patterns of Zika virus carrying Ae. aegypti and Ae. albopictus mosquitoes, consequently affecting the incidence of diseases they transmit.
While there have not been any Zika cases confirmed in the continental United States in 2023, two frequently visited destinations have reported locally acquired cases.
In the U.S. territory of Puerto Rico, week #44 shows 43 probable Zika cases as of 2023 and 20 cases during 2022.
And in Central America, Costa Rica's Ministry of Health recently confirmed there have been 27 Zika cases confirmed this year. In 2022, there were 45 Zika cases reported in Costa Rica.
According to the U.S. Centers for Disease Control and Prevention, about 25% of infected people may develop Zika symptoms, and the illness is usually mild, lasting between two and seven days,
However, Congenital Zika-associated syndrome is seen in infants born to mothers with a history of gestational Zika fever. These children may also develop microcephaly.
As of December 2023, various Zika vaccine candidates are conducting clinical trials without any indication of pending U.S. FDA approval. These trials include DNA, modified vaccinia Ankara vector platform, and purified inactivated virus vaccine technologies.
The New England Journal of Medicine recently published results from late-stage clinical trials that concluded among persons with early Alzheimer's disease (AD), the use of Gantenerumab led to a lower amyloid plaque burden than placebo at 116 weeks.
However, Gantenerumab, a monoclonal antibody (mAb), was not associated with slower clinical decline as of November 16, 2023.
According to these researchers, mAb target amyloid-beta (Aβ) has the potential to slow cognitive and functional decline in persons with early Alzheimer's disease.
Gantenerumab is a subcutaneously administered, fully human, anti-Aβ IgG1 mAb with the highest affinity for aggregated Aβ that has been tested for treating AD.
In 2021, Gantenerumab was granted the U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation in AD.
Genentech, F. Hoffmann–La Roche, produces Gantenerumab and continues exploring multiple approaches and molecules that may address key pathways of AD.
AD is a progressive, fatal disease of the brain characterized by a decline in memory, language, and other thinking skills, as well as changes in mood and behavior.
Biological changes in the brain are believed to start decades before clinical symptoms of AD become evident.
Alzheimer's is the most common form of dementia. Given the medical and societal complexities of AD, several tools and treatment options will likely be required to meet the multiple and diverse needs of people living with the disease, says Genentech.
Recently, LEQEMBI®, a humanized immunoglobulin gamma 1 mAb directed against aggregated soluble and insoluble forms of Aβ, was approved in Japan.
LEQEMBI reduces the rate of disease progression and slows cognitive and functional decline by selectively binding to and eliminating the most toxic Aβ aggregates that contribute to neurotoxicity in AD.
Japan is the second country to approve LEQEMBI, following the FDA approval in July 2023.
As of December 2, 2023, the FDA has not approved an Alzheimer's preventive vaccine candidate.
According to the U.S. Centers for Disease Control and Prevention, influenza-related deaths increased during week #47.
As of December 1, 2023, the CDC's Weekly U.S. Influenza Surveillance Report confirmed five additional influenza-associated pediatric deaths occurring during the 2023-2024 flu season were reported to CDC last week.
The CDC's FluView has now reported a total of 8 influenza-associated pediatric deaths.
These new deaths occurred between October 28 and November 25, 2023.
Two pediatric deaths were associated with influenza A(H1N1) viruses, and three were associated with influenza B viruses with no lineage determined.
The vaccination status of these children was not disclosed.
Overall, the weekly flu-related deaths that occurred during weeks #45 (52), #46 (38), and #47 (21) were updated.
Of the deaths reported by the National Center for Health Statistics from October 2022 to September 9, 2023, 9,697 (4%) were listed as influenza.
As we enter the month of December, the CDC recommends that everyone six months and older get an annual flu vaccine, as there are still vaccines available at clinics and pharmacies.
As of November 18, 2023, about 151 million flu shots had been distributed in the U.S.
People can choose from up to nine different influenza vaccines (nasal, egg, cell-based) for the 2023-2024 flu season.
South Africa's latest Public Health Bulletin shows that influenza activity peaked during epidemiological week #22 (June 4, 2023) and had an overall detection rate of 12% (942) for the 2023 season.
The mean onset of the influenza season in South Africa from 2005-2019 was week #17 (3rd week of April).
As of December 1, 2023, Influenza infections this year were dominated by A(H3N2) (98%), with most influenza infections causing mild illness.
For the current flu season, vaccine effectiveness for any influenza in individuals of all ages was 81% [95% confidence interval (CI) 29%-95%)], and for A(H3N2) was 76% [95% CI 10%-94%].
The World Health Organization (WHO) recently announced its recommendations for the composition of the 2024 Southern Hemisphere influenza vaccines, including a change to the A(H3N2) vaccine component.
In addition, the WHO confirmed that including a B/Yamagata lineage antigen in quadrivalent influenza vaccines is no longer warranted for the next flu season.
Since the discovery of the Ebola virus disease (EVD) in 1976, more than 30 outbreaks have been reported in Africa. While Ebola vaccines have been approved for adults, infants have not been protected from the EVD.
Published by The Lancet Global Health in November 2023, this analysis concluded an Ebola vaccine combination was well tolerated and induced strong humoral responses in infants younger than one year.
Furthermore, this phase 2 study concluded there were no safety concerns related to Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo) vaccination.
And the reactogenicity profile comprised mild-to-moderate adverse events (grade 1 or 2). Within seven days of administration of either dose, there were no grade 3 solicited adverse events in the Ebola vaccine group.
The two-dose Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen induced robust antibody responses in 100% of infants 21 days after receiving dose two.
The serum antibody levels declined over the follow-up period, but 93% of the younger and 100% of the older infants were still considered responders 12 months post-dose 1.
In addition to its EMA-approved use in individuals aged one year or older, the results of the current Vaccines & Prevention B.V.-funded study could support the use of Ad26.ZEBOV and MVA-BN-Filo in infants aged 4–11 months, as recommended for off-label use in 2021.
As of November 30, 2023, access to Ebola vaccinations in the U.S. is limited. The U.S. CDC updated its Ebola Overbreak History on August 30, 2023.
