Despite an observed association between initial COVID-19 pandemic social distancing measures and higher rates of neonatal mortality, a new study based on US health statistics shows no such link. The study was published in JAMA Network Open. 

Though initial shutdowns due to the pandemic helped control the spread of the virus, they also resulted in disrupted medical services and limited access to healthcare. 

The study compared neonatal outcomes collected by the National Center for Health Statistics, a population-level US database, from 2016 through 2020 and included 18,011,173 births, of which 2,874,577 were from the pandemic period.

Late preterm births higher during pandemic

"The mortality rates during the pandemic period did not significantly differ from the expected rates," the authors said. 

The mortality rates during the pandemic period did not significantly differ from the expected rates.

The social distancing index (SDI) was not significantly correlated with neonatal mortality in an unadjusted analysis, but it was significantly associated with higher neonatal mortality rates with a 2-month lag period.

"The finding of significant associations between the SDI and higher neonatal and early neonatal mortality with a 2-month lag period, and higher births at 22 to 27 weeks’ and 28 to 32 weeks’ gestational age with a 1-month lag period could possibly be due to disruptions in prenatal care and the resultant pregnancy complications that were more pronounced not immediately but after a lag period," the authors concluded. 

The Administration for Strategic Preparedness and Response (ASPR), part of the US Department of Health and Human Services (HHS), today announced $25 million in funding to Walgreen's through the Biomedical Advanced Research and Development Authority (BARDA) Project NextGen to support a COVID vaccine clinical trial featuring a decentralized approach to diversify the pool of study participants.

In a news release, Dawn O'Connell, JD, assistant secretary for preparedness and response at HHS, said, "Americans are diverse. Clinical trials should be, too. We want to make clinical trials easy to access so that more people who want to participate can do so."

The agreement with Walgreens, the first of its kind, will cover a vaccine correlate of protection study using licensed or authorized COVID vaccines. Correlates of protection are measurable immunity markers that correlate with protection against disease. ASPR said identifying correlates helps scientists assess immunity duration and would play a key role in vaccine development, potentially shaving time and cost off future clinical trials.

Study sites include about 20 Walgreens pharmacies

ASPR said throughout the pandemic, pharmacies and retail clinics were hubs for vaccines, treatments, and testing. It added that conducting clinical trials in decentralized locations closer to where participants live would enable scientists to collect data that reflects real-world use and harder-to-reach populations. 

The clinical trial sites will include about 20 Walgreens pharmacies in urban, suburban, and rural communities.

Project NextGen is a $5 billion program led by BARDA and the National Institute of Allergy and Infectious Diseases that is geared toward streamlining the development of innovative COVID vaccines and treatments. 

Merck today announced promising safety and efficacy results from a phase 2/3 clinical trial of a monoclonal antibody it is developing to protect infants from respiratory syncytial virus (RSV) infection.

If approved by federal regulators, clesrovimab (MK-1654-004) would be the second prophylactic monoclonal antibody injection against RSV for babies. In July 2023, the Food and Drug Administration (FDA) approved the first such RSV preventive for infants, nirsevimab-alip (Beyfortus), which is made by AstraZeneca. Unprecedented demand for Beyfortus last fall and winter led to some supply shortages.

In its announcement, Merck said clesrovimab met its primary safety and efficacy endpoints, including reductions in medically attended lower respiratory infections caused by RSV through day 150. The drug is given as a single fixed-dose injection.

Merck said it would release details about the study at an upcoming scientific meeting and will submit the data to global regulatory authorities.

In the middle of June, Iran's health ministry reported the country's first two locally acquired dengue infections, the World Health Organization (WHO) said yesterday in an outbreak announcement.

The patients with confirmed infections are from Bandar-Lengheh in Homozgan province, located in southern Iran. Neither had a recent travel history, and their illnesses were confirmed at the Pasteur Institute in Bandar Abbas.

As of July 17, Iran's number of locally acquired cases had risen to 12, all from the same city. The WHO said Iran averages about 20 imported dengue cases per year but this year has seen a sharp rise, with 137 reported between May and July.

"The confirmation of local dengue virus transmission in 2024 is therefore an unusual although expected event due to the presence of the vector in the country and movement of people from endemic areas to Iran," the WHO said. 

Dengue vectors in 5 provinces

Mosquito surveillance in Iran suggests two mosquitos that carry the virus, Aedes aegypti and Aedes albopictus, are present in five of Iran's provinces: Sistan and Balouchistan, Hormozgan, Bushehr, Khuzastan, and Gilan. 

Iran's health ministry has stepped up hospital readiness in response to the emerging threat and has identified high-risk provinces for targeted mosquito control activities. The WHO said it is supporting the ministry to enhance surveillance and by distributing medical and rapid diagnostic supplies.

The WHO said the risk to Iran from dengue is high due to the presence of the vector, favorable conditions for mosquitoes, and movements of people from countries where the disease is endemic into Iran.