FDA to review 5-in-1 meningococcal vaccine candidate

News brief

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.

Feds probe injuries from counterfeit Botox injections

News brief

Lisa Schnirring

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.

counterfeit Botox — Counterfeit Botox photo courtesy of FDA

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.

Canada reports more H5N5 avian flu virus detections in mammals, wild birds

News brief

Lisa Schnirring

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.

Study shows increase in serious alcohol-related complications early in pandemic

News brief

Stephanie Soucheray, MA

A new study in JAMA Health Forum shows increases in serious alcohol-related complications in 4 of 18 COVID-19 pandemic months studied (through September 2021), and suggests that women aged 40 to 64 years experienced increases of 33.3% to 56.0% in serious alcohol complication episodes in 10 of the 18 months.

The study is based on US national insurance claims data from March 2017 to September 2021, with researchers comparing prepandemic rates of serious alcohol-related problems to rates seen during pandemic months. A secondary outcome was the subset of episodes of alcohol-related liver disease (ALD).

Overall, in 4 of the 18 pandemic months beginning in March 2020, rates of serious alcohol-related issues were statistically higher than expected, the authors said, by 0.4 to 0.8 episodes per 100,000 people.

Middle-aged women most affected

Of the serious complications, 54% to 66% were ALD-related, 29% to 39% were alcohol withdrawal or alcohol-related mood disorders, 3% to 5% were alcohol-related cardiomyopathy, and 1% to 3% were alcohol-related gastritis with bleeding.

Middle-aged women experienced statistically significant increases in 10 of the 18 pandemic months (range of absolute and relative increases: 1.3 to 2.1 episodes per 100, 000 women; 33.3% to 56.0% increase), mostly of ALD complications.

The COVID-19 pandemic was associated with increased alcohol consumption, particularly among women, likely due to social isolation and stress.

"The COVID-19 pandemic was associated with increased alcohol consumption, particularly among women, likely due to social isolation and stress, " the authors write. "These findings imply a need for increased attention to alcohol use disorder (AUD) risk factors, alcohol use patterns, alcohol-related health effects, and related interventions, especially among women aged 40 to 64 years. "