- The Centers for Disease Control and Prevention (CDC) today announced the release of 77,000 more doses of Beyfortus (nirsevimab-alip), a new long-acting monoclonal antibody injection to protect newborns against respiratory syncytial virus (RSV). In an e-mail press release, the CDC said the doses will be released immediately to doctors and hospitals through the Vaccines for Children program and private channels. The group said it and the Food and Drug Administration (FDA) will continue to stay in close contact with manufacturers to ensure that there is enough of the drug to meet demand through the end of the year and into early 2024. Officials also said they have stepped up talks with medical groups to encourage greater use of the maternal RSV vaccine, another new tool for reducing the RSV threat to babies. The drug's codeveloper, Sanofi, said in October that it had an aggressive supply plan but didn't accurately estimate the high demand for the product.
- Iowa has reported highly pathogenic avian influenza at a layer farm that has more than 1 million birds, part of ongoing activity that has ramped up since early October, leading to losses at commercial farms in several states, as well as in backyard flocks. Iowa's layer farm is in Taylor County, according to the latest notifications from the US Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS). The state also reported an event at a commercial farm in Kossuth County, as well as detections in backyard birds in two other counties. Elsewhere, Minnesota, Missouri, North Dakota, and South Dakota reported the virus at more commercial turkey farms. Other states also reported more detections in backyard flocks, including Montana, Oregon, and Texas.
- In an amendment to a spending bill for the Department of Health and Human Services (HHS), a Republican-led proposal to ban funding for gain-of-function research passed on a November 14 voice vote, Science reported yesterday. The House has not voted on the entire spending bill, and the amendment faces an uncertain future in the Senate, which hasn't yet voted on an HHS spending bill. The amendment broadens a ban passed last year barring such work in China and other adversary countries. It also seeks to eliminate funding reviews, imposing a funding ban on all research involving potential pandemic pathogens. The scientific community has raised concerns that the ban would prevent work on a large portion of infectious disease countermeasures such as development of new flu vaccines.
Quick takes: More Beyfortus doses for RSV, avian flu on Iowa farm, gain-of-function in hot seat
WHO and CDC warn of rising measles cases, deaths
In a joint report today, the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) said amid ongoing declines in measles vaccination, cases in 2022 rose by 18%, and deaths were up 43% globally compared to 2021.
The groups detailed their findings in Morbidity and Mortality Weekly Report. Last year, 37 countries reported large or disruptive outbreaks, up from 22 in 2021. The African region was hit hardest, with 28 outbreaks, followed by the Eastern Mediterranean (6), South East Asia (2), and European regions (1).
The researchers also saw coverage gaps of the vaccine, which is given as a two-dose series. Though global vaccine coverage was up modestly between 2021 and 2022, 33 million kids missed a measles vaccine dose, including 22 million who didn't get their first dose and 11 million who never received their second shot. Global coverage rates are still below the 95% two-dose goal needed to protect communities from outbreaks.
Measles deaths were highest in low-income countries, where coverage rates were lower, with no sign of recovery after the pandemic. Of 22 million who missed their second measles vaccine dose last year, more than half were from just 10 countries: Angola, Brazil, the Democratic Republic of the Congo, Ethiopia, India, Indonesia, Madagascar, Nigeria, Pakistan, and the Philippines.
In a CDC press release, Kate O'Brien, MD, the WHO's director for immunization, vaccines, and biologicals, said the report's findings are an alarm bell for action. "Measles is called the inequity virus for good reason. It is the disease that will find and attack those who aren’t protected," she said.
In a statement, Gavi, the Vaccine Alliance, said the findings reiterate the ongoing need to speed and support recovery following the pandemic. Aurelia Nguyen, Gavi's chief program officer, said filling coverage gaps was a challenge even before the pandemic. "And with cases, outbreaks and preventable deaths rising so sharply due to increased immunity gaps related to the pandemic, it shows how even more important it is that our Alliance provides an unprecedented level of support to countries in 2024," she said.
FDA clears first at-home collection test for chlamydia, gonorrhea
The Food and Drug Administration (FDA) yesterday authorized the first at-home sample-collection test for chlamydia and gonorrhea, the two most common bacterial sexually transmitted infections (STIs). The group notes that levels of both infections are increasing, with an estimated 1.6 million chlamydia cases reported each year, along with more than 700,000 gonorrhea cases.
The Simple 2 Test, from LetsGetChecked, is available over the counter and is indicated for people ages 18 and older. The only other at-home sample-collection test for an STI is for HIV.
After purchasing the test, the user activates the test online and fills out an evaluation for a health provider to review. The user then collects a vaginal swab or urine sample and sends the sample to a designated lab, which delivers the result online, with follow-up from a health provider if results are positive or inconclusive. According to the company's website, patients order STI tests for the two diseases online for $99. The cost of medication, if needed, is not included in the virtual consultation.
The FDA said both infections are easily treated and that home sample collection can help people get quicker results. Jeff Shuren, MD, JD, who directs the FDA's Center for Devices and Radiological Tests, said in an FDA statement, "This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home."
Nearly half of US veterans had long-COVID symptoms up to 6 months later
Nearly half of 363,000 US veterans who tested positive for COVID-19 still had symptoms up to 6 months later, and the risk factors for this condition were Black race, older age, diabetes, and severe infection, concludes a study published yesterday in the Annals of Epidemiology.
Researchers from Emory University and the Atlanta Veterans Affairs (VA) Medical Center retrospectively determined the rates of and risk factors for long COVID (also called post-acute sequelae of COVID-19 [PASC]) among 363,825 veterans who tested positive for COVID-19 from February 2020 to September 2022. Participants were predominantly White men younger than 65 years living in a city. Of all participants, 31% were unvaccinated, 23% had received two COVID-19 vaccine doses, and 40% had received a booster.
Potential racial disparities
A total of 45% of veterans had long-COVID symptoms 1 to 6 months after infection. Risk factors for long COVID were Black versus White race (adjusted odds ratio [aOR], 1.14), ages 50 to 64 versus 50 or younger (aOR, 1.80), diabetes (aOR, 8.46), and severe infection (aOR, 1.42).
Results demonstrate potential health inequities for vulnerable individuals, as well as increased risk for individuals with pre-existing comorbidities.
"Results demonstrate potential health inequities for vulnerable individuals, as well as increased risk for individuals with pre-existing comorbidities," the study authors wrote. "The prevalence of PASC provides estimates for future health care utilization. The risk factors identified can aid public health interventions to reduce the burden of PASC."
4th COVID vaccine dose tied to reduced infection, poor outcomes in those with rheumatic disease
People with rheumatic disease who received a fourth mRNA COVID-19 vaccine dose had a 41% lower risk of infection and a 65% lower risk of hospitalization or death than those who received only three doses, according to a study published yesterday in The Lancet Rheumatology.
A team led by Mass General Brigham researchers analyzed observational data to determine the risk of COVID-19 infection, hospital admission, and death among 4,305 patients with systemic autoimmune rheumatic disease. The patients were taking disease-modifying antirheumatic drugs (DMARDs) and were eligible for a fourth vaccine dose from January to June 2022, a period of Omicron variant predominance.
The authors noted that patients with rheumatic diseases who take DMARDs have suppressed immune systems.
"In addition to the use of DMARDs, comorbidity burdens, systemic autoimmune rheumatic disease activity, and dysregulated immune responses also contribute to this increased risk," they wrote. "However, many patients with systemic autoimmune rheumatic diseases receiving DMARD therapy also have blunted humoral responses to COVID-19 vaccines."
Importance of COVID boosters
After overlap propensity score weighting, an equal number of patients (2,563) had received and not received a fourth dose. Median follow-up was 135 days among fourth-dose recipients and 65 days among fourth-dose nonrecipients.
These patients should be encouraged to stay up-to-date with COVID-19 mRNA vaccines, including boosters after the primary vaccination series.
COVID-19 infection risk was lower among fourth-dose recipients (hazard ratio [HR], 0.59). The additional dose reduced the risk of hospitalization or death from 3 days before to 14 days after infection (HR, 0.35).
"These patients should be encouraged to stay up-to-date with COVID-19 mRNA vaccines, including boosters after the primary vaccination series," the researchers wrote.
In a related commentary, Jessica Widdifield, PhD, of Sunnybrook Research Institute in Toronto, and colleagues said that waning vaccine effectiveness is concerning. "Unfortunately, there is no perfect evidence base to guide patients and rheumatologists on the timing of fourth and subsequent doses," they wrote, citing a Kaplan-Meier curve showing a spike in risk 60 to 75 days after vaccination but few data thereafter.