A new research letter published yesterday in JAMA Network Open shows no new safety concerns or reactogenicity signals among babies and toddlers who received their first COVID-19 vaccines by the age of 2.

The research comes from 5,644 US children who received at least 1 dose of mRNA COVID-19 vaccine between the ages of 6 and 24 months. All of the children had mothers who received a COVID-19 vaccination 30 days before their last menstrual period or during pregnancy.

The mean age at first dose was 12.4 months. Twenty percent of the children included in the study received their COVID vaccine with at least one other vaccine administered at the same time. 

Postvaccination reactions were reported for 46.7% of children, with 21.1% and 38.8% experiencing local and systemic reactions, respectively, the authors said. Only 18 children in the study, 0.3%, experienced reactions described by participants as severe.

Fussiness most common reaction 

The most common reactions were fussiness (30%), local reaction (21.1%), and fever (13.8%). Six participants reported a seizure or febrile seizure after receiving COVID-19 vaccination. No deaths were reported.

Reactions were more common after the first dose of COVID vaccine than the second. 

This difference may reflect maternal vaccination; the first COVID-19 vaccination in our cohort may be some children’s second immunological encounter with a COVID-19 vaccine.

"This difference may reflect maternal vaccination; the first COVID-19 vaccination in our cohort may be some children’s second immunological encounter with a COVID-19 vaccine," the authors said. "These findings add evidence indicating that mild or moderate local and systemic reactions may be experienced, but severe reactions and serious adverse events are rare."

The US Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR) yesterday announced two new investments worth more than $44 million to bolster the supply chain for essential medicines.

In a statement, ASPR said it will supply $32.4 million to Manus Bio, based in Waltham, Massachusetts, to expand its facilities to produce key starting materials for essential medicines. The company has a process for synthesizing chemicals into bioalternatives, including terpenoids, polyketides, phenylpropanoids, and flavonoids.

The new funding also provides $12 million to Antheia, a pharmaceutical ingredient maker in Menlo Park, California. ASPR said the company will focus on key starting materials and active pharmaceutical ingredients used to make essential medicines.

Dawn O'Connell, JD, Assistant Secretary for Preparedness and Response, said the investments help secure an important component of the US supply chain. "To make sure the medicines Americans need during national emergencies are available, we must continue our work to bring pharmaceutical manufacturing back to U.S. shores."

The Texas Department of State Health Services (TDSHS) yesterday announced the state's first locally acquired dengue case of the year, which involves a resident of Cameron County on the southern tip of the state on the border with Mexico.

Officials said that, amid a global surge in dengue activity, 106 travel-related cases, 1 of them fatal, have been reported among Texas residents. The state's imported cases are the most since 2002.

Since 2013, the state has recorded 665 dengue cases, including 40 reported locally from Cameron, Hidalgo, Starr, Val Verde, Webb, and Willacy counties. The TDSHS said mosquitoes remain active in much of Texas into November and December. It urged healthcare providers to consider and test for dengue in people who have symptoms of the virus, and it urged residents to take steps to avoid mosquito bites, such as wearing long sleeves and pants, applying insect repellent, and removing standing water.

Florida and California have also confirmed local dengue cases this year. Florida has reported 66 cases in 10 counties this year, most of them in Miami-Dade County. California has reported 15 cases in Los Angeles, San Diego, and San Bernardino counties. 

Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Clinton Health Access Initiative (CHAI) announced today that they are teaming up to explore interventions to slow the spread of gonorrhea in low- and middle-income countries (LMIC).

The 2-year partnership between CARB-X and CHAI will evaluate the clinical need and address market barriers for diagnostic, therapeutic, and preventive interventions for gonorrhea, which is the second most prevalent sexually transmitted infection in the world. An estimated 82 million gonorrhea infections are reported annually, with the highest prevalence in Africa. 

Focus on antibiotic-resistant gonorrhea

The work will focus on antibiotic-resistant gonorrhea, which has become increasingly common in LMICs. Neisseria gonorrhoeae (the bacterium that causes gonorrhea) has become resistant to every antibiotic that's been used for treatment, and currently has one remaining effective treatment option (ceftriaxone). Untreated gonorrhea can result in a host of serious side effects, including pelvic inflammatory disease and infertility.

The effort will start with a clinical needs assessment in eight LMICs. Using surveys and focused interviews, CARB-X and CHAI hope to develop a better understanding of which solutions should be prioritized, how market barriers might limit implementation of those solutions, and how access can be expanded.

Since CARB-X was founded in 2016, diagnostics, vaccines, and therapeutics for antibiotic-resistant gonorrhea have been among its funding priorities. In June, the group announced an award of $1 million to Prompt Diagnostics LLC to develop a rapid, low-cost, portable diagnostic test for drug-resistant gonorrhea.

"We are excited to embark on this initial body of work with CHAI, leveraging their experience in market assessment and thoughtful implementation of interventions for HIV and other STIs in LMICs over the past 20 years," CARB-X Chief of R&D Erin Duffy, PhD, said in a press release. "Our goal is to build off work done by others in this space, such as FIND and the Global Antibiotic Research & Development Partnership (GARDP) and share our learnings broadly so that all entities working toward gonorrhea-focused interventions can provide meaningful solutions where they are needed the most."

A primary care study in France found that more than two thirds of patients with negative chest x-rays were prescribed antibiotics for community-acquired pneumonia (CAP), researchers reported yesterday in the Annals of Family Medicine.

The prospective cross-sectional study, conducted from November 2017 through December 2019, included adults with clinically suspected CAP who had received chest radiography (CR) as part of their evaluation. While French guidelines require a positive CR result for diagnosis of CAP, they don't specify the course of action when a patient with clinically suspected CAP has a negative chest x-ray. The aim of the study was to determine how CR results effect general practitioners' decision to initiate antibiotics for suspected CAP.

"Beyond the presumed necessity of CR and the possibility in daily practice of performing CR without delay, it is important to analyze antibiotic initiation by general practitioners (GPs) for suspected CAP according to CR results," researchers from Universite Paris Cite and Universite Sorbonne Paris Nord wrote.

Negative CR has low impact on antibiotic initiation decision

Of the 259 patients (median age, 58 years) in the study, 144 (55.6%) had a positive CR. Antibiotics were initiated for 142/143 (99.3%) patients with positive CR and 79/115 (68.7%) with negative CR. Patients with positive CR results had higher body temperature, faster heart rate, faster breathing rate, more difficulty breathing, more frequent unilateral chest pain, and longer-lasting symptoms than patients with negative CR results.

The researchers also note that among the CR-negative patients, there wasn't much difference in clinical symptoms between those who received antibiotics and those who didn't.

"The effect of a negative CR on the antibiotic initiation decision appears to be low," the researchers concluded. "This raises questions regarding the role of CR in the management strategy for CAP and justifies clarification of the guidelines as to what should be done in case of clinical suspicion of CAP without radiologic confirmation."

An online survey of physicians in the United States, France, and Germany reveals that they consider pertussis (whooping cough) vaccines less important than those against COVID-19, influenza, and pneumococcal disease, although they recognize that adults with weakened immune systems and chronic respiratory illnesses are at elevated risk.

For the study, published today in BMC Primary Care, a team led by researchers from the University of Pittsburgh and vaccine developer Sanofi surveyed 400 US physicians and 200 each in France and Germany from November 2022 to January 2023. The respondents were listed in an independent database of physicians who indicated an interest in participating in research.

"Pertussis is a highly contagious respiratory tract infection that affects all ages, though it is most severe in young infants," the authors wrote. "Adults, especially those with respiratory conditions or other chronic illnesses can also suffer serious consequences of pertussis."

Attitudes similar pre-, post-pandemic

In total, 65% of respondents indicated that universal vaccination against pertussis is important, a lower percentage than for vaccination against COVID-19 (82%), flu (81%), pneumococcal disease (76%), and tetanus (73%). The results were similar by country and before and after the COVID-19 pandemic.

Physicians recognized the need to immunize vulnerable adults who are at risk of severe pertussis ... but this awareness frequently did not result in vaccination of these priority groups, especially without official recommendations.

Physicians recognized that adults with weakened immune systems, chronic obstructive pulmonary disease (COPD), asthma, and other respiratory diseases were at high risk from pertussis.

Respondents estimated that of the adults for whom they recommend the pertussis vaccine, two-thirds agree to receive it but said a common reason for not following through with vaccination was the perception of low personal risk.

Most surveyed physicians (76%) said that adult pertussis vaccination uptake is suboptimal and agreed on the importance of protecting vulnerable people against pertussis by vaccinating the person (77%) or their close contacts (78%).

"Physicians recognized the need to immunize vulnerable adults who are at risk of severe pertussis, such as those with asthma and/or COPD, but this awareness frequently did not result in vaccination of these priority groups, especially without official recommendations to support such vaccination in these groups," the researchers wrote.