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Pfizer and Valneva plan to seek regulatory approval for their new Lyme disease vaccine, which reduced the number of tick-borne infections by over 70% in clinical trials, in today's bite-sized hospital and health industry news from Indiana, Maryland, and New York.
- Indiana: Eli Lilly recently issued a warning about compounded versions of its GLP-1 drug tirzepatide combined with vitamin B12. Based on testing of compounded tirzepatide and B12, there were significant levels of an impurity caused by a chemical reaction between the two ingredients. According to Lilly, the effects of the impurity are unknown, but it could lead to potential toxicity, immune reactions, and interactions with GLP-1 and GIP receptors. So far, Eli Lilly has notified FDA of the findings and encouraged patients who are taking compounded tirzepatide-B12 treatments to talk to their physicians about treatment options. In response to Lilly's claims, Scott Brunner, CEO of the Alliance for Pharmacy Compounding (APC), said the drugmaker has not provided enough information about the source or the handling of the sample products or the nature and levels of the reported impurity so that outside experts can evaluate the findings. APC would take any verified safety risks around compounded drugs seriously, Brunner said, but he urged Lilly to share more data with regulators and the public since its announcement "raises more questions than it answers." (Jeffries, Becker's Hospital Review, 3/12)
- Maryland: FDA has cleared a respiratory syncytial virus (RSV) vaccine from GSK for use in adults ages 18 to 49 who are at an increased risk of severe disease from the virus. The vaccine, which is called Arexvy, was first approved in 2023 for use in adults ages 60 and older. In 2024, FDA expanded its approval to include adults ages 50 to 59 who have a health condition that increases their risk of severe RSV complications. According to GSK, around 21 million U.S. adults under the age of 50 have at least one risk factor for severe RSV. RSV also leads to an estimated 2 million outpatient visits, 277,000 ED visits, and 17,000 hospitalizations from U.S. adults ages 18 to 49 every year. "This age expansion can help address a significant medical need for adults in the United States at higher risk of severe RSV disease due to certain underlying conditions, and help ease pressure on the healthcare system," said Sanjay Gurunathan, head of vaccines and infectious diseases research and development at GSK. (Cerutti, Becker's Hospital Review, 3/16)
- New York: Pfizer and Valneva are planning to submit their experimental Lyme disease vaccine for regulatory approval after clinical trials showed that four doses were able to reduce cases of Lyme disease by over 70%. However, even with relatively high efficacy, the vaccine did not meet a key statistical requirement that it be at least 20% effective even in the worst-case scenario. In a statement, Pfizer said that the companies are "confident in the vaccine's potential" and would submit it for regulatory approval. If approved, it would become the only vaccine for Lyme disease available to people. Previously, another Lyme disease vaccine from GSK called LYMErix was pulled from the market in 2002 amid reports of adverse events following the vaccine and poor sales. It's not clear how Pfizer and Valneva's new vaccine will fare with regulators. (Johnson, Washington Post, 3/23; Reuters/NBC News, 3/23)
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