Trends

Moderna agrees to supply deal with EU for coronavirus vaccine

Moderna and the EU formally agreed in November 2020 to supply 160 million doses of Moderna's mRNA-based COVID-19 vaccine, bringing the bloc's overall supply to more than 2 billion doses. Because Moderna's vaccine must be administered in a two-dose regimen, this order could inoculate 80 million patients. This supply deal occurred almost a week after the EU accepted Moderna's vaccine, mRNA-1273, for rolling review based on phase 3 study results showing 95% efficacy.

Vaccine pricing for mRNA-1273 has not yet been announced. According to Reuters, the EU is hoping to pay $25 per vaccine dose, meanwhile Moderna CEO Stéphane Bancel is seeking a rate between $27 and $35 per dose.

Moderna has contracted with Sweden's Recipharm to handle fill-finish duties for mRNA-1273 at its manufacturing plant in Monts, France. Recipharm has, in turn, made investments in increased staff to grow its manufacturing capabilities.

Source:asamonitor.pub/33ffwzG

Five states participate in HHS pilot program with ‘NBA Bubble’ rapid COVID-19 test

The U.S. Department of Health and Human Services (HHS) will ship Cue Health's rapid, point-of-care coronavirus test used on players in the “NBA Bubble” this year to five states as part of a government pilot program. Alaska, Florida, Louisiana, New Jersey, and Texas will participate in the program.

State governors and health department officials will collaborate with HHS to distribute tests to facilities whose health care workers will also receive onboarding and training support from Cue. The test is slated for use confirming COVID-19 cases in health care facilities with large high-risk patient populations, such as long-term-care facilities. The U.S. Department of Defense (DOD) will also provide the test to veterans.

Cue's founder and CEO, Ayub Khattak, says the molecular test can provide real-time results in approximately 20 minutes. The hand-held test, which was authorized by the FDA in June 2020, uses nasal swabs and a cartridge-based reader to display results on a connected smartphone.

The DOD has contracted Cue to supply at least 6 million tests to the federal government in 2021, including 30,000 readers by March.

Source:asamonitor.pub/3fM0mXn

Technology

Could melatonin be used as a COVID-19 treatment?

Researchers at Cleveland Clinic used an artificial intelligence tool to analyze data from 26,779 patients in the group's COVID-19 registry – 8,274 of whom tested positive for SARS-CoV-2 – in search of existing products that could potentially be used to treat COVID-19. The researchers found that after adjusting for factors such as age, sex, and underlying diseases, patients who were taking melatonin were 28% less likely to test positive for SARS-CoV-2.

The effects of the popular over-the-counter sleep aid were stronger in African Americans, who experienced a 52% reduction in the likelihood of testing positive for SARS-CoV-2. The reduced likelihood of a positive test in White patients was 23%.

Cleveland Clinic researchers also found that the beta-blocker carvedilol was associated with a 26% reduction in a patient's chance of testing positive.

The applications of melatonin could potentially go even further in COVID-19 treatment. Scientists at Columbia University have linked the sleep aid with an increased chance of clinical improvement in critically ill COVID-19 patients on intubation or mechanical ventilation.

Further testing, including larger, randomized control trials must be completed before melatonin could be officially adopted as a COVID-19 treatment.

Iowa State University and Zeteo Biomedical partner on nasal spray COVID-19 vaccine

Iowa State University's Nanovaccine Institute and drug delivery specialist Zeteo Biomedical have partnered to develop a next-generation nanovaccine against SARS-CoV-2 formulated as a single-dose nasal spray. Nanovaccines pack viral proteins into nanoparticles – about 300 billionths of a meter across – made from biodegradable polymers.

The nasal spray alternative to traditional glass vials and syringes could both persuade needle-adverse patients to receive the vaccine as well as save on highly sought-after supplies needed for traditional vaccine delivery. Nasal spray delivery could also provide the potential for patient self-administration of the vaccine at home, minimizing the burden of vaccine administration for health care workers, as well as reducing the risk of viral spread created by patient visits to a health care facility for vaccination.

The Iowa State University vaccine is also intended to be room-temperature stable thanks to Zeteo Biomedical technology. If accomplished, this design element would eliminate the need for vaccine refrigeration, greatly easing storage requirements.

Vaccine development is funded by a $2 million award from the federal Coronavirus Aid, Relief and Economic Security (CARES) Act, delivered through the state of Iowa to the University. The project is still in the early stages but has been fast-tracked for expected completion by the end of 2020.

GE Healthcare's new chest X-ray tool checks ventilator tube placement

GE Healthcare has launched a new product to help clinicians overwhelmed with increasing numbers of COVID-19 cases treat patients with better accuracy; the company's new algorithm can read X-rays to help assess for correct ventilator tube placement. The new artificial intelligence program is housed on the mobile X-ray scanner and works by automatically detecting the tube in chest X-ray images, providing measurements of the tube's position within the windpipe, and alerts clinician to potentially dangerous cases.

According to GE Healthcare estimates, misplaced endotracheal tubes may occur in about one-in-four patients who are intubated outside of an ER. The company has designed its new X-ray artificial intelligence to help solve this problem, which, when unaddressed, can lead to life-threatening complications such as over-inflating or collapsing a lung, or cardiac arrest.

In-home peritoneal dialysis system cleared by the FDA

The FDA has cleared Baxter's Homechoice Claria system for use in adults and children. The automated peritoneal dialysis system is designed for home use with the aid of a digital platform meant to help patients with kidney disease manage their care remotely. The system is available in 38 languages and guides patients through their therapy with an app featuring step-by-step, voice-activated instructions.

Over 6 million home dialysis treatments in the U.S. and over 20 million peritoneal treatments globally already use Baxter's two-way Sharesource platform to provide patient data and notifications to clinicians if complications arise during treatment, such as a patient's nonadherence to their therapy schedule.

Baxter aims to make Homechoice Claria system available this winter.

New Central Line Podcast

Dr. Steven L. Shafer, Professor of Anesthesiology, Perioperative and Pain Medicine at the Stanford University Medical Center and Editor-in-Chief of the ASA Monitor, returns to the show to discuss “The 2020 Pandemic” and preview upcoming issue topics. Head online to listen to Episode 30.

https://www.asahq.org/podcasts/central-line/episode-thirty