Kevin Kunzmann

FDA approved this intravenous tocilizumab (Actemra) for hospitalized adults with COVID-19.

The highly transmissible and dominant Omicron variant of COVID-19 places added pressure on infection preventionists and other clinicians to determine just what they’re dealing with.

In the space of 2 days, the FDA approved at-home oral treatments for patients with mild-to-moderate COVID-19, drug that were months in development. Today, it was Merck and Ridgeback Biotherapeutics’ turn.

Moderna’s phase 2/3 pediatric trial showed a lesser dose of the company’s 2-dose COVID-19 vaccine mRNA-1273 is associated with a significant neutralizing antibody response in children aged 6 to <12 years old.

Investigators concluded that their data demonstrate the “high and stable effectiveness” of the single-dose COVID-19 vaccine across both high-risk patient subpopulations, as well as residents in areas more adversely affected by the delta variant.

Health care experts hope that the move will induce the vaccine hesitant—in the public, and among health care professionals—to get inoculated in the hope that that will stem the rising tide of the delta variant.

The findings provide support for 2-dose vaccine uptake in the wake of surging cases driven by the highly transmissible delta variant.

A multiplex PCR assay may be capable of simultaneously detecting and differentiating influenza viruses, respiratory syncytial virus (RSV), and SARS-CoV-2.

Though children and adolescents are generally subjected to milder forms of COVID-19 compared to adults, the EUA expansion marks a new threshold for immunization rate opportunity and likelihood of pandemic mitigation.

The CDC and FDA are expected to announce an immediate pause for administering the one-shot adenovirus Ad26.COV2.S while advising states distributing the product to consider doing the same.

The study states that it is “extremely unlikely” the pandemic virus occurred through a laboratory leak in Wuhan, China.

The CDC guidance states that persons past 2 weeks of their final COVID-19 vaccine dose face little risk from unmasked, non-distancing indoor visiting of unvaccinated, low-risk members from a single household.

Janssen Ad26.COV2.S is an intramuscular injection vaccine consisting of a replication-incompetent recombinant adenovirus type 26 (Ad26) vector which expresses the SARS-CoV-2 spike (S) protein.

Angela Rasmussen, PhD: “Even if you are in the first group to get the vaccine, even if the vaccine becomes available widely beyond the first groups that are going to get it, we still need to be wearing masks, social distancing, thinking about ventilation, and avoiding large gatherings for some time to come.”

The FDA’s Related Biologic Products Advisory Committee meeting on Thursday will be the US’ first public forum on phase 3 data for a COVID-19 vaccine, a possible prelude to approval.

Efficacy against severe COVID-19 is 100%—based on the benchmark of 30 total severe cases, all in the placebo group. Consistent efficacy was seen across patient age, race and ethnicity groups, as well as gender demographics.

The submission comes in the days following announcement from Pfizer and partnering company BioNTech that their phase 3 trial assessing the two-dose mRNA vaccine achieved all its primary efficacy endpoints.

Data show none of the treated volunteers to develop COVID-19 experienced a severe form of the disease, versus 11 given placebo.

The company is still awaiting its threshold for total COVID-19 infections in its 44,000-patient assessment. Nonetheless, they believe they have made history.

Investigators in Hong Kong report they have observed a reinfection of SARS-CoV-2 in a 33-year-old man nearly 5 months after his first positive test.

The webinar ran well over the hour it had been scheduled for and drew at least 2500 viewers who watched it on average for 71 minutes. And there were 422 questions from the audience afterward.

The trial, in which 1077 healthy adults in the UK are being assessing for the vaccine comprised of the ChAdOx1 virus for the prevention of SARS-CoV-2, shows enough promise for further assessment.

New findings show the vaccine candidate mRNA-1273, encoded with a stabilized prefusion SARS-CoV-2 spike protein, induced anti-SARS-CoV-2 immune responses in all of the trial’s participants, without any trial-limiting safety concerns identified.

The US Food and Drug Administration (FDA) has issued an emergency use authorization of the antiviral drug remdesivir for the treatment of patients with coronavirus 2019 (COVID-19).