Kevin Kunzmann

This article was originally published in ContagionLive.

The US Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC) have recommended a pause of the Janssen Pharmaceuticals 

 at federal sites during investigation of 6 US cases of rare blood clot disorders linked to the vaccine.

The federal agencies will announce the decision for an immediate pause of the one-shot adenovirus Ad26.COV2.S while advising states distributing the product consider doing the same, as 6 women aged 18-48 years old reported cerebral venous thrombosis, an extremely rare disorder associated with blood clotting, 6-16 days following their vaccination.

As of Tuesday morning, 1 woman afflicted with the condition has died, and a second woman in Nebraska is hospitalized and in critical condition.

FDA and CDC investigators intend to collaborate on assessment of possible links between the Janssen vaccine and cerebral venous thrombosis, in order to discern whether the company’s Emergency Use Authorization (EUA) should continue as-is or become limited.

The FDA reiterated the importance of an indefinite pause during this investigation in a statement shared on Twitter Tuesday morning.

"This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot," 

The CDC’s Advisory Committee on Immunization Practices (ACIP) will hold an emergency meeting on the matter this Wednesday, according to 

Per the CDC, more than 6 million people in the US have received Janssen’s vaccine thus far, and another 9 million doses have been shipped to different states.

Comparatively, Pfizer-BioNTech and Moderna have delivered 23 million-plus doses weekly of their two-dose mRNA vaccines to the US, comprising a significant majority of the US’ vaccine distribution. No significant safety concerns have emerged from either product.

Just last month, the Biden administration announced 

the acquisition of another 100 million doses of Ad26.COV2.S from Janssen

, to be delivered in the latter half of 2021.

 in manufacturing at its Baltimore plant due to the inadvertent mixing of vaccine ingredients. The error resulted in the loss of up to 15 million doses.

Articles

FDA, CDC recommended halting use of the one-shot vaccine at all federal sites. 

FDA, CDC Call for Janssen COVID-19 Vaccine Pause Following 6 Cerebral Venous Thrombosis Cases

A new analysis of a model of the US population showed medicated-assisted treatment of 

 in combination with overdose education and distribution of naloxone was linked to cost-saving reductions in morbidity and mortality due to OUD.

The findings, from a team of Stanford University and Veterans Affairs investigators, suggest a combination of therapy and education access could provide up to 16.9% reduction in deaths and up to $105,000 in lifetime clinical care costs saved.

The research is particularly pressing into the second year of the COVID-19 pandemic, a time which the same investigators predict susceptibility to OUD is likely peaking.

 regarding the findings, study author Douglas K. Owens, MS, MD, of Stanford Health Policy at the Centers for Health Policy and Primary Care and Outcomes Research, discussed the continually proven benefit of OUD agents including buprenorphine, methadone, naltrexone, and psychotherapy—treatments which need to become more available.

“We know many people aren’t being treated with these very good therapies, and that’s a major issue,” Owens said. “Our work and many others’ suggest that the access to opioid use treatment should be expanded.”

Owens also discussed the means of improving access and education relative to more robust screening—a necessary effort following addiction-driving burdens of the pandemic.

“One of the things we need to do is identify people who have OUD and other substance use disorders,” he said. “That’s not always easy, but it’s important work we do a physicians.”

Cost-effectiveness of Treatments for Opioid Use Disorder,

Videos

New data show reduced risk of mortality, and clinical savings upward of $100,000, are linked to sometimes inaccessible substance use disorder therapies.

The Cost Benefit of Treating Addiction

Amid the systemic rush to assure patient care would not be compromised by the COVID-19 pandemic last year, US healthcare may have discovered some measures of telemedicine that are more efficient, and even more beneficial, that previous in-person strategies.

One field that found successes in virtual care was 

 near the end of 2020 showed teledermatology was significantly more cost-effective than conventional care, and discussions with private practice leaders suggested there were particular streamlines to virtual screening and treatment for the field.

So what will a post-pandemic dermatology practice look like?

, Melissa Stenstrom, MD, assistant clinical professor at the University of Illinois College of Medicine Rockford, discussed her colleague’s experiences in telemedicine monitoring and care, and how her team dictates in-person versus virtual visits.

“There have been occasions where I’ll do a telemedicine visit, and then ask them to come in to the office so I can see a lesion more clearly,” she said. “It definitely has been helpful in some cases: pre-cancerous lesions, actinic keratoses, treating those with field therapy has been something we’ve done a lot through teledermatology.”

Stenstrom also discussed the benefit of virtual care for monitoring chronic skin conditions including acne, atopic dermatitis, and psoriasis—instances where treatment plan and disease state have been well-established previously with the patient.

“We’ve had the discussion in the office, and now they’re just on cruise control,” Stenstrom said. “For those patients, just checking in every 6-12 months has been a perfect addition to our practice, and probably one of the good things that has come out of the last year.”

The pandemic forced practices to consider more virtual screening and care. A dermatologist shares perspective on what's been working as telemedicine practice.

Teledermatology: What Happens After COVID-19?

The US Food and Drug Administration (FDA) approved alirocumab (Praluent) for the treatment of 

homozygous familial hypercholesterolemia (HoFH)

The indication, granted to Regeneron Pharmaceuticals, provides patients with the rare, genetic condition a PCSK9 inhibitor therapy associated with significant decreases in cardiovascular risk-building low-density lipoprotein cholesterol (LDL-C).

Alirocumab is a PCSK9 inhibitor therapy shown to help eradicate LDL-C from treated patients’ bloodstreams and enable fat and cholesterol to be better broken down. Praluent was approved by the FDA as a bi-weekly injection.

The agent was originally approved for the reduction of heart, stroke, and unstable angina risks—or 

major adverse cardiovascular events (MACE)

—in adults with cardiovascular disease in 2015. Since then, it was additionally indicated for the lone or add-on treatment for primary hyperlipidemia.

The homozygous form of hypercholesterolemia is characterized by a pair of genetic mutations which alter the body’s ability to clear cholesterol. Its primary effect is extremely high counts of LDL-C, ranging from 500-1000 mg/dL per patient—a four-fold increase in normal levels.

HoFH is associated with premature cardiovascular disease and MACE risk in adolescent and young adult patients. Death by the age of 30 years is a significant risk among under-treated patients.

Currently, 1 in 250,000 individuals is estimated to have HoFH.

Alirocumab’s approval for HoFH was based on findings from a 12-week, double-blind, randomized trial comparing 45 patients receiving 150 mg therapy every 2 weeks, and 24 patients receiving placebo.

All trial participants were taking additional LDL-C-lowering therapies during the trial.

Investigators sough a primary outcome of percent change in LDL-C from baseline to week 12. At trial’s end, patients treated with alirocumab reported a mean 27% decrease in LDL-C, while patients on placebo reported a mean 9% reduction.

Commonly reported adverse events with alirocumab included nasopharyngitis, injection site reactions, and influenza.

The PCSK9 inhibitor was linked to 27% mean reduction in LDL-C over 12 weeks.