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.

The Pan American Health Organization (PAHO) is reporting an uptick in pertussis (whooping cough) cases in several countries.

In an alert published yesterday, PAHO said that the 7,251 pertussis cases reported in the United States through the first half of 2024 marks a 300% increase from the same period in 2023, while cases in Mexico are 242% higher than reported in all of 2023. Brazil and Peru are also seeing increases compared with 2023. PAHO notes that cases have also been rising in Europe.

The increase comes after a decade of progressive annual declines in reported pertussis cases in the Region of the Americas. From 2012 to 2022, reported cases fell from a high of 72,328 to a low of 3,238 during the COVID-19 pandemic. But coverage with the first and third doses of diphtheria, tetanus, and pertussis vaccines (DTP1 and DTP3) also declined during the pandemic, and 2021 was the lowest-coverage year in the region when compared with the previous 20 years.

Countries urged to strengthen surveillance

Pertussis is a highly contagious respiratory infection caused by the bacterium Bordetella pertussis. Easily transmitted from person to person through droplets expelled by sneezing or coughing, it's a major cause of illness in children, who can have coughing fits that last 4 to 8 weeks.

PAHO is encouraging member states to strengthen surveillance activities and maintain constant monitoring of vaccination coverage in children under 1 and 5 years of age.

"In addition, countries are encouraged to strengthen their laboratory diagnostic capabilities, which will improve the reporting and characterization of pertussis outbreaks in the Region," the agency said. "Each pertussis outbreak should be carefully studied to improve understanding of the epidemiology of the disease in the Region of the Americas."