Federal health officials and their state and local health partners are investigating reports of harmful reactions in women who received counterfeit or mishandled botulinum toxin (Botox) injections, with 19 injuries reported in nine states, the US Centers for Disease Control and Prevention (CDC) announced yesterday.

The reactions occurred following Botox injections from unlicensed and untrained people in non-healthcare settings, including homes and spas. The patients are from Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington.

Botox contains minute amounts of botulinum toxin, which comes from the bacterium Clostridium botulinum. The toxin, which in larger amounts can cause muscle paralysis, in very small amounts is used to smooth wrinkles and treat certain muscle conditions.

Examples of the patients' reactions include vision problems, drooping eyelids, difficulty swallowing, difficulty breathing, and general weakness. Nine were hospitalized, and four were treated with botulinum antitoxin owing to concerns that botulinum could spread beyond the injection site. Five people were tested for botulism, and all were negative.

All patients were women ages 25 to 59, and all but one received the injections for cosmetic purposes.

FDA says no link to approved products

Some women received counterfeit or unverified products, and investigators are still working to determine the sources. In a separate statement, the Food and Drug Administration (FDA) said it is working with AbbVie, the Botox manufacturer, to identify, investigate, and remove suspected counterfeit products. It added that there is no sign that the events were related to AbbVie's FDA-approved products.

The CDC urged people considering Botox injections to ensure that providers are licensed and trained and to ask if the product is approved by the FDA and obtained from a reliable source. "If in doubt, don’t get the injection," the agency added.

Animal health officials in Canada have reported more highly pathogenic H5N5 avian flu detections in wild birds and mammals, according to recent notifications from the World Organization for Animal Health (WOAH).

In May 2023, the country reported the Eurasian H5N5 subtype in racoons found dead on Prince Edward Island, which followed sporadic detections of H5N5 in Canadian wild birds. At the time, WOAH warned of unprecedented genetic variability in avian flu subtypes in wild birds and poultry across the world, creating epidemiologic challenges.

The new detections in mammals also involved raccoons, which were found in February and March on Prince Edward Island and in Nova Scotia. The virus belongs to the same 2.3.4.4b clade as the H5N1 virus currently circulating in several world regions.

Canada also reported more H5N5 detections in wild birds, which involved crows found on Prince Edward Island in early January. 

British drugmaker GSK announced today that the US Food and Drug Administration (FDA) has accepted an application for review of the company's 5-in-1 meningococcal vaccine.

GSK's MenABCWY vaccine candidate will target the five groups of Neisseria meningitidis bacteria (meningococcal serogroups A, B, C, W, and Y) that cause most cases of invasive meningococcal disease (IMD) globally. It combines the antigenic components of GSK's well-established meningococcal vaccines, Bexsero and Menveo.

Simplified immunization

The company says combining the protection offered by these vaccines into a single vaccine will reduce the number of injections, simplify immunization, and help increase series completion. Just under 12% of US adolescents have had the required two doses of Bexsero, which provides protection against meningococcal group B, the most common group of IMD-causing bacteria in US adolescents and young adults. Menveo prevents IMD caused by meningococcal groups A, C, Y, and W-135.

Among those who contract IMD, one in six will die and one in five may suffer long-term consequences such as brain damage. Teens and young adults are among those at greatest risk of contracting it.

The Biologics License Application was submitted based on evidence from a multinational phase 3 randomized, controlled trial that involved 3,650 participants ages 10 to 25. MenABCWY met all primary end points in the trial, showing immunologic non-inferiority to one dose of Menveo and non-inferior immune responses against 110 diverse MenB invasive strains compared with two doses of Bexsero.

GSK says the FDA will make a decision on whether to approve the vaccine in February 2025.