All articles tagged with #valneva
Pfizer and Valneva's Lyme disease vaccine posted 73.2% efficacy starting 28 days after the fourth dose in a late-stage trial, but the study missed its primary endpoint under the worst-case scenario (15.8% efficacy in the initial analysis); a second analysis showed 74.8% efficacy, leading to plans for regulatory submissions, with no Lyme vaccine currently approved.
Pfizer intends to seek FDA approval for its Lyme disease vaccine candidate even after a late-stage trial failed to meet statistical goals due to too few Lyme cases; the company says efficacy exceeded 70% in vaccine recipients versus placebo, which they consider strong enough to move forward. Partner Valneva projects up to $1 billion in peak annual sales. The Phase 3 study started with about 18,000 participants but was reduced to roughly 9,400 due to site-quality issues, and Pfizer reports no safety concerns; the vaccine requires three initial doses followed by a booster and targets the outer surface protein A of the bacteria.
The FDA has suspended the biologics license for Ixchiq, a live-attenuated chikungunya vaccine by Valneva, due to serious safety concerns including reports of chikungunya-like illness in some recipients, following its accelerated approval less than two years ago.
The FDA has approved Ixchiq, the world's first licensed vaccine for the mosquito-borne chikungunya virus. Developed by Valneva, the single-dose vaccine aims to prevent the potentially debilitating disease that causes fever and severe joint pain. Chikungunya is considered an emerging global health threat, with millions of cases reported since 2008. The approval of Ixchiq provides a significant advancement in preventing the disease, especially for travelers to endemic regions. Valneva plans to commercialize the vaccine in the U.S. early next year.
The U.S. Food and Drug Administration (FDA) has granted approval to Valneva SE for IXCHIQ®, the world's first chikungunya vaccine. The single-dose, live-attenuated vaccine is indicated for individuals aged 18 and older who are at increased risk of exposure to the chikungunya virus. The approval is based on accelerated approval, contingent upon verification of clinical benefit in confirmatory studies. Valneva plans to monetize the Priority Review Voucher received from the FDA to support its research and development programs.
Two Lyme disease vaccines are currently in development, one by Valneva and Pfizer using a traditional protein-based approach, and another by the University of Pennsylvania using mRNA technology. The vaccines aim to prevent the spread of Lyme disease, which has become increasingly widespread in the eastern United States. The previous Lyme vaccine was discontinued due to concerns about adverse effects, but infectious-disease specialists are optimistic that public acceptance will be stronger this time. Early results from the vaccine trials are promising, with strong immune responses observed in participants. However, it remains to be seen whether there will be sufficient public demand for the vaccines.
Pfizer expects to enroll fewer participants than originally estimated for the Phase III trial of Valneva's Lyme disease vaccine candidate, known as the VALOR study. The trial will now enroll approximately 9,000 people aged five or older, instead of the initial estimate of 18,000 participants.
A vaccine for chikungunya, a mosquito-borne infection, has shown promising results in a late-stage trial, according to a study published in the Lancet. The vaccine, made by Valneva, was safe, well-tolerated, and provoked an immune response that indicates protection against the disease. Common side effects included headaches, fatigue, muscle and joint pain, and pain at the injection site. The trial enrolled 4,115 healthy adults across the U.S., and researchers measured the immune system's response to test whether the vaccine protects against disease caused by infection with the virus.
Moderna, Pfizer, and Valneva are developing vaccines against Lyme disease, which has nearly doubled in cases since 1991, particularly due to climate change. Pfizer and Valneva's vaccine candidate is already in late-stage clinical trials, but they can still apply for FDA approval as early as 2025. The most efficient way to protect against Lyme disease is by using insect repellent and wearing clothes that cover your skin in areas with high tick populations, as well as checking yourself for ticks.