Moderna Tees Up for Approval; Boosters Now at 6 Months? Infusion Pump Recall

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Moderna said it completed the application for full FDA approval of its COVID vaccine, which is marketed as Spikevax abroad.

Not to be outdone, Pfizer and BioNTech said they would submit the remaining data for approval of their COVID booster shots by week’s end.

Speaking of boosters, third doses of the mRNA COVID-19 vaccines may start at 6 months from the last dose, rather than the previously announced 8 months. (Wall Street Journal)

Newly minted New York Gov. Kathy Hochul (D) said the state will officially publicize close to 12,000 COVID deaths that went uncounted by her predecessor — the numbers were already included in CDC’s tally, however, and trackers like the one below. (AP)

As of Thursday at 8 a.m. EDT, the unofficial COVID-19 toll in the U.S. reached 38,225,849 cases and 632,283 deaths, increases of 148,326 and 1,445, respectively, from this time yesterday.

The toll includes a 32-year-old unvaccinated pregnant nurse in Alabama who died after being hospitalized for COVID-19 earlier this month; her unborn child died as well. (NBC News)

As cases surge across Texas, the National Rifle Association canceled its early September annual meeting in Houston. (NBC News)

Updated NIH guidelines for severe COVID-19 now say intravenous sarilumab (Kevzara) and tofacitinib (Xeljanz) can be used in combination with dexamethasone as alternatives to tocilizumab (Actemra) and baricitinib (Olumiant), respectively, if either of those are unavailable.

Is CDC missing crucial data as it decides how to respond to breakthrough cases? (Politico)

Meanwhile, the agency had a ribbon-cutting ceremony for its new southeast Asia office stationed in Vietnam.

In a flurry of FDA news, a long-acting prodrug of somatropin — lonapegsomatropin (Skytrofa) — was approved as the first once-weekly therapy for growth hormone deficiency in kids 1 year and up, Ascendis Pharma announced.

And Servier Pharmaceuticals said ivosidenib (Tibsovo) was okayed as a second-line treatment for adults with advanced cholangiocarcinomas that harbor IDH1 mutations.

FDA gave a class I designation to the recall on certain repaired BD Alaris infusion pumps, as cracked or separated bezel posts in the units could result in an interruption, under-delivery, or over-delivery of fluids to patients.

And they said to check your N95s to make sure they’re not made by Shanghai Dasheng, as the company’s masks are no longer authorized for use due to lax quality control.

Thinking about the milk crate challenge to impress your followers on social media? Don’t do it, says an Atlanta-based orthopedic surgeon, who warns on the potential for lifelong debilitating injuries. (NBC News)

In mental health news, President Biden signed a bill into law that allows military veterans with post-traumatic stress disorder to train and adopt service dogs. (Stars and Stripes)

With the latest CDC data showing that over 60% of the eligible U.S. population has been fully vaccinated against COVID, here’s a look at how one health system tracked down individuals who slipped through the cracks of the vaccination drive. (STAT)

Pennsylvania-based Geisinger Health System said it will require all of its workers to be vaccinated against COVID-19 by mid-October as a condition of employment.

Meanwhile, Delta Air Lines will charge its unvaccinated workers a $200 monthly penalty in an attempt to boost vaccinations. (Bloomberg Law)

Online ads targeting conservatives tout that COVID vaccines are “trusted by the U.S. military” and a “shot to restore our freedoms.” (Houston Chronicle)

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    Ian Ingram is Managing Editor at MedPage Today and helps cover oncology for the site.

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