Moderna today reported positive interim results from a phase 1/2 trial of its mRNA combination vaccine against COVID and flu and said it would advance the vaccine, called mRNA 1083, to a phase 3 trial.

In a statement, the company said researchers evaluated the vaccine's safety and immunogenicity compared to a standard dose of Fluarix flu vaccine in adults ages 50 to 64 and to a the high-dose Fluzone vaccine in adults ages 65 to 79. For both age-groups, they compared mRNA 1083 to its Spikevax COVID booster.

Antibody titer levels for mRNA 1083 were similar to or greater than both of the flu vaccines. Also, neutralizing antibody titers were similar to the bivalent Spikevax booster. Local and systemic effects for mRNA 1083 were similar to Moderna's standalone COVID booster. No new safety concerns were noted compared to the COVID vaccine.

Moderna said it plans to start the phase 3 trial in 2023, with a goal of submitting the vaccine for regulatory approval in 2025.

Stephane Bancel, Moderna's chief executive officer, said combination vaccines offer an opportunity to streamline the experience for consumers and health providers and increase compliance with public health recommendations. "We are excited to move combination respiratory vaccines into Phase 3 development and look forward to partnering with public health officials to address the significant seasonal threat posed to people by these viruses," he said.

The European Centre for Disease Prevention and Control (ECDC) and the Public Health Agency of Sweden today released a 36-page after-action report on how decisions were made whether to keep schools open during the earlier pandemic months. According to an ECDC press release, the reviewers looked at how the policies were made, gauged their impact, and assembled detailed lessons on good practices and areas for improvement in future health emergencies.

The report focuses on the period of November 2020 to January 2021, a time when Sweden experienced a second wave that was much larger than its first. Sweden's policy was distance learning for secondary-school students and keeping in-person learning in place—alongside infection control measures for younger students, except when local outbreaks occurred.

Multiple stakeholders working with the national education agency and regional health officers collaborated on the advice for schools. Decisions were influenced by health outcomes and the broader impact on the public, the well-being of students, families, and school staff, and socioeconomic inequalities. The advice changed as new evidence emerged.

The review also identified data missing during guidance development, including data on children's perspectives and aggregated data on student absenteeism. It also identified guiding principles, including a focus on what was best for children, that adults are responsible for cutting the burden of disease spread, equal access for all students, and a priority to keep schools open.

Andrea Ammon, MD, MPH, ECDC's director, said the after-action report shows the complexity of decision-making around public health measures such as school closures that were designed to cut SARS-CoV-2 transmission but affected children, especially those from vulnerable groups.

"Pandemic preparedness plans everywhere should be updated to account for such complexities, through activities such as enhancing cross-sectoral coordination, developing strategies for communicating the rationale behind recommended measures and establishing approaches for listening to the affected stakeholders," she said.

A new study presented at the American College of Cardiology (ACC) Quality Summit 2023 this week shows door-to-balloon (D2B) procedure time during acute heart attacks has suffered since the COVID-19 pandemic began in 2020, partly because of the need for COVID-19 screening, associated isolation procedures, and terminal cleaning in the cardiac catheterization lab.

The study is based on heart attack patients seen at Ocean University Medical Center in New Jersey from 2018 through 2022.

"Some of the new national standards created in response to the COVID-19 pandemic created obstacles to heart attack care by adding minutes to D2B time," said study author Sara Belajonas, MSN, MBA, APN-C, at Ocean University Medical Center, in a press release.

D2B refers to the time from entrance in the emergency department to the cath lab for insertion of a catheter balloon to reopen a blockage in the heart and restore blood flow. Previous research has shown a D2B time of under 90 minutes, with a goal of 60 minutes, is the best way to save a patient’s life during an ST elevation myocardial infarction (STEMI), the most severe type of heart attack.

Staff shortages contribute to delays

For the 2 years prior to the COVID-19 pandemic, Ocean University Medical Center’s D2B time was hovering around 60 minutes, but study data show it climbed to 73 minutes by April 2022.

Many of these shortages unfortunately started during the COVID pandemic and have been linked to burnout.

In addition to patient testing for COVID, the wait for results, and enhanced cleaning procedures, the authors of the study said healthcare and emergency worker shortages also contribute to longer D2B times.

"Many of these shortages unfortunately started during the COVID pandemic and have been linked to burnout. Simply, the demand for nurses and EMS [emergency medical services] workers outweighs what is available," Belajonas said.

Globally, studies have shown heart attack hospitalizations decreased by 28% during the COVID-19 pandemic because patients did not seek medical treatment.