This article, "Satralizumab Approved for Treatment of Neuromyelitis Optica Spectrum Disorder," was originally published in NeurologyLive.

The US Food and Drug Administration (FDA) has approved satralizumab for the treatment of adult patients with anti-aquaporin-4 (AQP4-IgG) antibody positive 

neuromyelitis optica spectrum disorder (NMOSD)

The approval, awarded to Genentech, is only the second targeted treatment for this patient population and the first eligible for at-home administration.

Marketed under the name Enspryng, the humanized monoclonal antibody targets and inhibits interleukin-6 receptor activity, which is thought to play a key role in the inflammation observed in 

Novel recycling technology allows for a longer duration of antibody circulation, translating into a subcutaneous dosing regimen of every 4 weeks after an initial loading dose.

The approval pins satralizumab against the only other targeted treatment in this space, Alexion’s eculizumab (Soliris), which was approved with the same indication on June 27, 2019.

“For people with NMOSD, relapses can cause devastating, irreversible and disabling neurological effects,” Jeffrey Bennett, MD, PhD, professor of neurology and ophthalmology at the University of Colorado, and an investigator for the satralizumab pivotal clinical trials, said in a statement. “Having an approved therapy that can be administered subcutaneously in the home and has demonstrated an impact on the frequency of relapses is an important advancement for patients.”

Satralizumab’s approval was based on robust data from the phase 3 SAkuraStar and SAkuraSky clinical trials, which combined included more than 170 patients who were randomly assigned to receive satralizumab 120 mg or placebo.

In SAkuraSky, patients added treatment to baseline immunosuppressive therapy.

All patients received a loading dose of the study drug at baseline, week 2, and week 4, followed by 4-week treatment intervals.

The primary end point in both studies was time to protocol-defined relapse. Notably, both studies included a population of patients who were AQP4-IgG antibody positive and negative to accurately reflect clinical practice.

In SAkuraStar, 30% of patients treated with 

 experienced relapse compared with 50% of those who received placebo (HR 0.45; 95% CI, 0.23–0.89; 

Among those who were AQP4-IgG antibody positive, a 74% reduction in relapse risk was observed.

In the overall satralizumab-treated population, 76.1% and 72.1% were relapse-free at 48 and 96 weeks, respectively, compared with 61.9% and 51.2% with placebo.

Data from the AQP4-IgG seropositive subgroup showed that 82.9% and 76.5% were relapse-free at 48 and 96 weeks compared with 55.4% and 41.1% with placebo, respectively.

In total, 92% (n = 58) of those in the satralizumab group experienced an adverse event compared with 75% (n = 24) of the placebo group. Serious AEs were similar between groups; only 1 event led to study drug discontinuation in the treatment group.

In SAkuraSky, the overall population saw a 62% reduction in the risk of relapse (HR 0.38, 95% CI, 0.16-0.88; 

 =.0184), while the group of AQP4-IgG seropositive patients experienced a 79% reduction in relapse risk (HR 0.21, 95% CI, 0.06-0.75; 

Results showed 88.9% and 77.6% of patients in the total population were relapse-free at 48 and 96 weeks, respectively, compared with 66% and 58.7% of patients in the placebo group.

Among AQP4-IgG seropositive patients, 91.5% treated with satralizumab were relapse-free at 48 and 96 weeks compared with 59.9% and 53.3% of patients in the placebo group.

The most common AEs observed were upper respiratory tract infection, nasopharyngitis, and headache.

Genentech reports that the drug will be available in the US within 2 weeks. It is already approved and available in Japan, Canada, and Switzerland, with applications under review in the European Union and China.

Satralizumab represents only the second targeted treatment for NMOSD and the first cleared for at-home administration.

FDA Approves New Neuromyelitis Optica Spectrum Disorder Treatment

Alicia Bigica

I spoke to a patient, a 63-year-old woman who immigrated to the United States from Central America in 1978, about her experience living with liver disease. She is now an 

 NAFLD patient advocate who was diagnosed with autoimmune hepatitis and NAFLD in 2005. After experiencing the devastation of her diagnosis, she has managed to learn to live with the disease and wants to help others achieve better quality of life.

Our patient had been diagnosed with autoimmune hepatitis for several years and doing well. She developed pain in her upper right abdomen and saw three specialists. They assumed she was an alcoholic even though she told them she didn’t drink. She talked to her primary care physician who sent her to a liver specialist. 

The doctor spent 90 minutes talking to her and, based on blood work every three months and ultrasounds every six months, determined that her autoimmune hepatitis medication- prednisone, was causing fatty liver. It took three liver biopsies to confirm the diagnosis of NAFLD on top of autoimmune hepatitis.

Helpful Tips About Healthy Diet and Finding Support

This woman has made huge changes to her lifestyle. Sheexercises regularly, meditates, drinks plenty of water and has changedher eating habits by following a healthy diet and avoiding sugary drinks, such as soda and concentrated juice drinks. She prepares her own food and only takes medicine prescribed by a physician, who do so with caution because she has been at the last stage of liver cirrhosis for the last three years.

Though difficult, she has learned to avoid greasy foods found in fast food restaurants, eats abundant greens, incorporates fruit into her breakfast and vegetables for lunch. She’s learned to prepare food in different ways by sautéing, baking or grilling her food using olive oil. She does not fry her food, which she may have done previously. She avoids additives and salt, relying instead on herbs and spices.

Before trying new foods, she and her caregivers research its possible impact on the liver. When she buys groceries, she avoids red meat, high fructose corn syrup and anything with more than five ingredients. She also practices portion control and learned that the palm of your hand is the amount of meat you should eat, which for her is mostly fish, chicken and occasionally lobster.

She advises people tofollow their doctors’ orders and, once diagnosed, find a support group to learn and share information with others living with the same disease. People can find information online from organizations, such as the 

, and Facebook groups, such as Living with Cirrhosis, Living with Fatty Liver/NASH.

She is a true reflection of what it is to live with chronic liver diseases and how changing in your lifestyle can improve liver health and overall health.

This article is the final installment of four articles exploring the epidemic of liver disease called nonalcoholic fatty liver disease and its more severe form, nonalcoholic steatohepatitis.

The Multiple, Complex Challenges of Living with and Managing Liver Disease

Amreen Dinani, MD

Healthcare is in a state of flux. As extraordinary measures are taken to stem the spread of the coronavirus, regular medical care—from routine checkups and screenings to in-office treatments and procedures—has been subject to significant disruptions and challenges. Social distancing requirements of the 

 pandemic have created new limitations on in-person physician visits. 

Office closures and safety concerns have resulted in the delay or cancelation of medical appointments for some patients. Compounding matters is the dynamic and uncertain nature of the pandemic. The issues that patients and physicians are confronting today have evolved since the COVID-19 shutdowns began in March—and further change is undoubtedly on the horizon.

 patients and their eye care professionals, the pandemic has led to an array of stressors, given the progressive but indolent nature of a disease that can lead to blindness and requires close ongoing monitoring and treatment. The current health environment is particularly worrisome for elderly patients because they are most at risk for vision loss from glaucoma and are also among the highest risk groups for COVID-19 mortality.

To better understand the concerns and experiences of glaucoma patients during the pandemic, the Glaucoma Research Foundation (GRF) commissioned an online survey in May 2020. The aim was to gain valuable, real-time patient input that can help eye care professionals better address patients’ emotional needs as they adapt to the new, and continually changing, care requirements of COVID-19. 

The GRF survey, which was supported by Aerie Pharmaceuticals, assessed patients’ confidence in their disease management during the pandemic; specific disease management concerns; patients’ experience with telemedicine; and patients’ comfort in returning to eye professionals’ offices. The survey drew a national response, with 1051 adult glaucoma patients from 49 states participating in the questionnaire.

The survey findings bring to light several key considerations for ophthalmology practices evolving glaucoma care in the COVID-19 environment.

Notably, the survey found that more than half of respondents (53%) had to delay and/or cancel an eye care appointment during the first months of the pandemic. These disruptions seem to have significantly impacted patients’ confidence in their disease management, with approximately one-third (36%) of glaucoma patients surveyed saying they were not confident that their disease was well-managed. Those who had the lowest confidence levels in their glaucoma management were 30% more likely to have had an eye care appointment delayed or canceled.

This feedback highlights the central role of communication in enhancing glaucoma care and the importance of nurturing the physician-patient relationship during the pandemic. With physician offices open again, personal and direct doctor-patient communication is paramount to helping patients understand their unique level of risk and rebuild confidence in their disease management. 

Without scaring patients, it’s important that they understand the consequences of delaying an office visit and the real risk it may have for further, even permanent, vision loss.

At my practice in San Francisco, we went through every patient record that had an appointment during the early phase of the pandemic and conducted a risk assessment. We then communicated with each patient to make them aware of their particular situation and the risk of not coming in to be evaluated when our office reopened.

The first step was to speak with our staff about our responsibility to be safe, not just in the office, but also outside of work, with specifics about how to minimize risk. I sought their input and we developed together an action plan with new office protocols.

We also invested in an expansion of our office team. With this increased staff, we are able to directly answer more patient calls and engage in longer, in-depth conversations. In addition, we have placed a greeter at our main entrance who screens patients, which includes basic health questions, a temperature check, and a check for an appropriate mask. 

After completing these safety protocols, the greeter asks patients to use hand sanitizer prior to entering the clinic. These new measures have played a valuable role in boosting our patients’ confidence in their disease management during the pandemic.

The “COVID-19 Office” and Telemedicine

The survey also reveals that glaucoma patients place high value on being able to see their physician in person. Six in 10 (63%) respondents said they are comfortable returning to their eye doctors’ offices as long as social distancing measures, such as face masks and less crowded waiting rooms, are implemented. This preference for in-person physician visits, coupled with technology challenges, make patients largely uninterested in telemedicine. A vast majority (87%) of glaucoma patients surveyed said they would rather wait six weeks for an in-person office visit than have a telemedicine visit in two weeks.

While telemedicine has been a valuable tool in other medical specialties during the pandemic, it has significant limitations for standard diagnostic procedures in glaucoma care. Since intraocular pressure (IOP) checks, visual field evaluation, and other tests cannot be easily conducted virtually, practitioners may lose considerable clinical information by trying to manage glaucoma via telemedicine.

During these unprecedented times, the safety and well-being of patients is the principal concern of all eye care professionals. It is also important to consider the needs of your staff as well. At my center, we have modified several standard procedures that not only have enhanced patient safety during COVID-19 but have also made us operate more efficiently and safely as an eye care practice. 

I have found that when members of my office team feel safe at work, their calmness and confidence extend to the patient-provider relationship, helping patients feel more comfortable about the visit. By fostering a caring and professional approach to glaucoma care in the midst of uncertainty, we can all navigate the COVID-19 pandemic while continuing to protect the vision of our patients.

Andrew Iwach, MD, is Executive Director of the Glaucoma Center of San Francisco, Associate Clinical Professor of Ophthalmology at the University of California, San Francisco, and a faculty instructor at the California Pacific Medical Center Department of Ophthalmology. 

The article reflects the views of the author, not necessarily those of the publication.

A new survey assessed patients’ confidence in their disease management during the pandemic, specific disease management concerns, and experiences with telemedicine.

Managing Glaucoma During COVID-19: Patients Point the Way to Improved Care

Andrew Iwach, MD

An original version of this article was published in Practical Cardiology.

I received my COVID-19 vaccination today.

It was a well-organized process. I received emails, registered, and booked a date and time. The check-in and screening were smooth, and after a brief wait, I was up. I am part of the first phase of vaccinations, and so not many anecdotal reports to go on—some with sore shoulders; one colleague with a 24-hour febrile reaction.

My injection did not hurt at all. No noticeable reaction in the days following. And just like that, it finally feels like there is a light at the end of the tunnel that is the COVID-19 pandemic. It feels like a lifetime ago that news of a novel virus was beginning to spread around the world.

In our era of news as entertainment, at first it seemed to be overblown and overstated. Then Italy became bad. Then New York City reported cases. Then New York became bad. I have family members who live in Queens, and almost all of them contracted it, although luckily had mild enough cases to not need hospital care. But the daily reports were harrowing, and for the rest of us it was clearly just a matter of time.

I work in a private cardiology practice in Connecticut, and cover our admitting hospital for a week at a time. Suddenly nothing seemed clear, or safe. In our office, we had a series of hastily assembled partner meetings, and then again with our staff, planning our defense. There was suddenly a hunt for PPE, and screening protocols, and quick adoption of a telehealth platform; but still mostly uncertainty.

Our local hospital numbers spiked, and all of the complications we had read about were now in our hands. Hypoxia, and thrombosis, and widespread inflammation, and rapid decompensation. Colleagues started getting infected. Some died.

I was now coming home directly into our garage, stripping off, putting all my non-clothing items into a UV sterilizing oven, and then showering, before greeting my family. Schools closed. Roads were quiet. Even grocery shopping felt hazardous. We never closed our office, but our volume dipped significantly, and now every in-person visit and hospitalization for a cardiac issue came with an additional gamble of infection.

I am fortunate to live in an area where most were taking the pandemic, and it’s restrictions, seriously. Without overwhelming our healthcare facilities, numbers came down, and we all carried on. We are now in the midst of another surge, due to multiple shortcomings - leadership, planning, insight, trust, resolve. It feels different in our office and in the hospital though.

We know more, and there is at least a degree of predictability and familiarity now. Our office volume is busier than ever, as most patients realize we are in this predicament for the long haul. And now there is a vaccine.

In a frustrating time of science and expertise denial, scientists and experts have accomplished a massive flex, and we have a way out. History now awaits our decision on whether to accept this or not. For how little I have been able to help those with COVID-19 up to this point, my biggest contribution as a healthcare worker is to take the vaccination without hesitation. And, by example, lead others to do the same.

A lipidologist from Connecticut describes his experience during the COVID-19 pandemic and explains why he sees getting the vaccine as his "biggest contribution" to healthcare during the pandemic.

Brett Nowlan, MD: My Year Working During a Pandemic

Brett Nowlan, MD

We have heard the statistics many times. There are more than 7000 

 and for more than 90%, there are no treatments available. Our organization supports a community affected by one of the 90%—Niemann-Pick Disease including ASMD and NPC, both rare genetic, progressive, and often-fatal lysosomal storage disorders.

There are fewer than 2000 known cases worldwide, many affecting children. Symptoms include cognitive impairment, clumsiness and difficulty walking, enlarged spleen and liver, difficulty swallowing and eating, fatigue, increased fracture risk, and early satiety. There are currently no approved treatment options in the US.

The great news for the Niemann-Pick community is that promising treatments are in the later stages of clinical development with the potential for regulatory approval in the coming year. Achieving this milestone would be a significant victory for patients and their families who face significant challenges living with Niemann-Pick. But this potential good news also highlights an important consideration in planning for the introduction of new treatments for patients who are in desperate need. How do you prepare patients and families to transition from an era of no hope to one where treatment is available?

Much of our work at the National Niemann-Pick Disease Foundation (NNPDF) in recent years has focused on meeting this challenge head on and our approach in many ways serves as a template that other rare disease communities might consider.

From our earliest days, NNPDF has provided support services to patients living with Nieman-Pick Disease and their families. These efforts have focused on building broader awareness of the disease and helping to identify and expand the services and resources that families need.

We have also taken steps to keep families updated about the range of clinical research programs that have been initiated in recent years to try to develop new treatments. Our recent annual conference included a full schedule of presentations and updates on these clinical research programs, and we had more participants in our virtual meeting this year than ever before.

As we continue our focus on disease awareness and patient support, we have also in recent years had to expand our efforts to include both information and education to prepare the Niemann-Pick community to transition to an era when treatment might be available. In addition to helping families learn about and understand the process for developing and approving drugs in the US, we are also now providing resources to help them better understand and manage issues related to their healthcare coverage, reimbursement, patient access and industry-sponsored financial assistance programs.

We are helping them understand that there will be indications and eligibility criteria for different treatments and that NNPDF is working to ensure that access to treatment through healthcare coverage is available to as many patients as possible. We are also developing new resources that outline the important questions and topics that patients and families should discuss with their medical provider to empower them to take a more active role in often complex treatment decisions.

While availability of treatment is good news, many of the issues associated with patient access can cause stress and confusion. An important goal in developing programs related to the introduction of an approved treatment is to help reduce anxiety and outline a clear path forward in accessing care. For many rare disease communities, another daunting but welcome challenge for many families may be the need to reconsider many longstanding plans for the future once approved treatment is available.

In many cases, an approved treatment will mean major changes in how patients think about their own health, plan for their care, and engage with their medical teams. Treatment may present new challenges that require careful planning and monitoring. Patients and caregivers might need to reassess plans related to education, careers, job training, and living independently. Once again, our goal must be to provide the insights and support services that can help reduce any challenges associated with making important life decisions at every stage.

The final focus in supporting patients is often related to helping them manage expectations. In many cases, treatments for rare diseases will have some limitations in areas including efficacy, safety and cost. Advocacy leaders can play a role in helping their communities work with their healthcare teams to assess, understand, and address all the factors related to treatment so that patients and caregivers can make informed decisions.

In some cases, patients and caregivers may need very targeted services to support their psychological and emotional health. Peer-to-peer connections can be especially effective in helping patients handle the emotional impact of the transition to treatment.

Of course, none of these challenges should dampen the new hope that a first approved treatment can bring to a rare disease community. A first treatment is both a milestone and a sign that research is advancing and could lead to more personalized treatment options or combination therapies in the years ahead.

By recognizing the needs of patients and families whenever a new treatment becomes available, advocacy organizations can continue to lead in bringing them the targeted information and support they need to access care and thrive. The key is recognizing that an approved treatment and a new standard of care is not the end of the road in patient advocacy. It is a new direction and the beginning of a new era of hope that requires careful planning, new resources and very customized support.

Joslyn Crowe, MSW, MA, is executive director of the National Niemann-Pick Disease Foundation, Inc., a non-profit, unbiased patient advocacy and family support organization dedicated to supporting and empowering patients and families affected by Niemann-Pick disease, through education, collaboration and research.

The views expressed in this piece are those of the author, not necessarily those of the publication.

Healthcare experts and clinicians interested in contributing to HCPLive may contact the editorial staff 

Getting a Treatment Is Not the End of the Road in Rare Diseases

Joslyn Crowe

The health risks associated with tobacco smoking are well known among consumers and healthcare professionals. Despite this knowledge, the success rate for 

 is low, in part because pharmacotherapy and counseling are under-utilized.

Data show that although 68% of smokers want to quit, only 6.8% utilize behavioral counseling, 29.0% utilize pharmacotherapy such as nicotine replacement therapy and/or non-nicotine prescription smoking cessation therapy (varenicline and bupropion SR), and only 4.7% used both.

One of the factors that might play a key role in this underutilization of proven cessation resources is the barrier to accessing a medical professional who can prescribe smoking cessation medications at the time when a patient decides to quit.

This barrier can be manifested in several ways including long waits for appointment times, distance needed to travel to access a provider, and limited availability of physician appointments outside of typical working hours. Additionally, many primary care physicians report insufficient time within the context of routine office appointments as a key barrier in being able to effectively address tobacco use with their patients.

To bridge this gap in care, in 2017 the US Centers for Medicare & Medicaid Services issued an informational bulletin encouraging states to “facilitate easier access to medically necessary and time-sensitive drugs for Medicaid beneficiaries,” including smoking cessation medications.

More than 90% of Americans live within five miles of a community retail pharmacy,

 and most are open evenings and weekends. Importantly, the ability to walk into a pharmacy without an appointment allows tobacco users to initiate action the moment they feel the desire to quit, a moment that might pass if they must wait for an appointment with a physician.

Currently, a dozen states in the US have statutes or legislation permitting pharmacists to prescribe some or all FDA-approved pharmacotherapy for tobacco cessation.

 These include New Mexico, where pharmacists have had prescriptive authority for this category of medications since 2004, Arizona, Arkansas, California, Colorado, Idaho, Indiana, Iowa, Maine, Missouri, Oregon, and West Virginia. Most of these states have minimum tobacco cessation education requirements for pharmacists who wish to prescribe, and the cessation protocols require (a) patient screening, (b) specific intervention components, and (c) documentation requirements, which collectively help to promote positive outcomes and enhance patient safety. It is notable that no negative reports related to pharmacist-prescribed cessation therapy have occurred in New Mexico across 15 years of protocol existence.

But how effective are pharmacists in helping patients quit? Several studies have shown that tobacco quit rates achieved when pharmacists prescribe cessation medications and provide counseling are similar to rates achieved by other healthcare professionals.

 Importantly, in a study based in New Mexico, more than one third of patients assisted were non‐white, and 53.4% did not have health insurance,4 suggesting that pharmacists are effective in reaching vulnerable and uninsured populations.

Given that only 7.4% of smokers are successful when quitting unassisted,1 pharmacists could play an important role in enhancing quit rates. Pharmacies may also provide more cost-effective access to smoking cessation therapy.

Physician burn-out, which is being at least partially driven by increased workloads, is a serious and growing challenge for the healthcare community.

 Collaboration between physicians and pharmacists with respect to prescribing smoking cessation therapy, could achieve two beneficial goals of reducing demands on physicians’ time while increasing access to therapy that can help those motivated to quit smoking succeed in this difficult endeavor.

Physicians could benefit themselves and their patients by learning about options in their states to collaborate with pharmacists in the area of smoking cessation therapy and sharing appropriate information with patients regarding the role that pharmacists can play in helping them reach their quitting goals.

New digital solutions will also enable patients and providers to find a pharmacist who can prescribe smoking cessation therapy. Work is currently ongoing to launch a website that can help patients find a pharmacy near them that prescribes smoking cessation therapy, similar to the birthcontrolpharmacies.com project that has helped connect women with pharmacists who can prescribe birth control.

Although 2021 has already started, it’s not too late to resolve to quit smoking. Physicians and patients alike should know that, in some states, the local pharmacist can be a valuable and accessible resource for achieving this important but challenging goal.

Physicians in states that don’t yet permit pharmacists to prescribe smoking cessation therapy are encouraged to consider recommending this approach to their state health officials and legislators. Quitting smoking is difficult, and those who seek to do so deserve as much support as the healthcare community and our elected leaders can provide.

Karen Hudmon, DrPH, is a Professor of Pharmacy Practice at Purdue University.

Katy Ellis Hilts, PhD, is a Postdoctoral Fellow at the Indiana University School of Nursing.

Clinicians interested in responding to this piece or submitting to HCPLive can reach the editorial team here.

 Babb S, Malarcher A, Schauer G, Asman K, Jamal A. Quitting smoking among adults - United States, 2000-2015. MMWR Morb Mortal Wkly Rep. 2017;65(52):1457e1464.

 American Lung Association. Indiana’s standing order for tobacco cessation: A case study. Available at: 

https://www.lung.org/getmedia/a673abfe-eb7e-4801-a374-01724df6ca6c/standing-order-indiana-case-study-final.pdf

 National Alliance of State Pharmacy Associations. Pharmacist prescribing: Smoking cessation aids. Available at: 

https://naspa.us/resource/tobacco-cessation/

 Adams AJ and Hudmon KS. Pharmacist prescriptive authority for smoking cessation medications in the United States. J Am Pharm Assoc. 2018;58(3):253-257. doi: 10.1016/j.japh.2017.12.015

 Csikar JI, Douglas GV, Pavitt S, Hulme C. The cost-effectiveness of smoking cessation services provided by general dental practice, general medical practice, pharmacy and NHS Stop Smoking Services in the North of England. Community Dent Oral Epidemiol. 2016;44:119e127

 Scheepers R, Silkens M, van den Berg J, Lombarts K. Associations between job demands, job resources and patient-related burnout among physicians: results from a multicentre observational study. BMJ Open. 2020;10(9):e038466. Published 2020 Sep 24. doi:10.1136/bmjopen-2020-038466

More than two-thirds of smokers want to quit, but lack proper resources. A prescribing professional could help make up that difference.

The Important, Evolving Role of Pharmacists in Helping Patients Quit Smoking

Karen Hudmon, DrPH & Katy Ellis Hilts, PhD

An original version of this article was published by sister publication Contagion.

The US continues to ramp up vaccine administration, with an estimated 12.2 million doses of 

 to its population doled out as of January 18, per estimated counts from the 

US Centers for Disease Control and Prevention (CDC)

 that the supposed federal reserve of COVID-19 vaccines that was intended for an expanded distribution does not exist.

 reported Friday that doses of the vaccines BNT162b2 and mRNA1273 that were declared by Health and Human services Secretary Alex Azar, MD, to be in storage for second-dose administration were actually distributed at the end of December.

Unnamed sources informed the publication that the issuance of vaccines will remain flat in the coming week. This comes at a time when the CDC is reporting that just 36% of the 30.6 million vaccine doses have been administered, a much slower rate that initially anticipated.

 that the novel variant of COVID-19, SARS-CoV-2 B.1.1.7, may lead to a large increase in the number of cases, potentially becoming the dominant strain in the US in the coming months. B.1.1.7 has been reported in 76 cases in 10 states, although that number is believed to be much higher. The variant is spreading faster and appears to be more contagious than other COVID-19 strains.


Data TableData per Our World in Data (Jan 18, 2021, 12 AM EST)

New Jersey, the second most densely populated state in the US, has come into the top 10 of vaccines administered since last week after a slow initial rollout.

Data TableData per CDC COVID-19 Tracker (Jan 15, 2021, 9 AM EST)

For more information on COVID-19 vaccination research, distribution, and assessment, check out some of these recent Contagion stories:

J&J COVID-19 Vaccine Shows a 90% Immune Response in Interim Data

CDC Requires All Flyers to US to Test Negative for COVID-19

Trump Administration Recommends Wider Vaccine Eligibility and Vaccinating All Over 65

New Jersey enters the top 10 of total vaccines administered.

US Close to 800,000 Daily COVID-19 Vaccine Doses

Killian Meara

In March 2020, the United States was in the early stages of the coronavirus disease 2019 (COVID-19) pandemic. The entire country was shut down, and the economy grinded to a halt, to slow the spread of the virus. Think back to March. Think back to how much uncertainty we were all living under.

In just nine months, the US Food and Drug Administration (FDA) authorized a pair of COVID-19 vaccines: 

By New Year’s Day, millions of Americans had received the vaccine, including frontline physicians and health care providers and nursing home patients, our most vulnerable citizens.

Nine months. Take a moment to let that sink in.

A narrative crafted around the COVID-19 pandemic has depicted a situation that is completely negative. In the interest of ratings and clicks, mainstream media has described the US response to the pandemic as nothing more than a series of blunders, from one mistake to the next.

There is another way—a more accurate and under-appreciated way—to tell the story of the past nine months. It is a story of heroism, innovation, and precise science, performed under unbelievable pressure.

Let’s not mince words: The US and the world must appreciate the role of the pharmaceutical industry—the investigators, physicians and business leaders—who are rescuing the world from COVID-19. It’s the medical breakthrough of our lifetime.

Instead of dwelling on the reasons why the media are ignoring this historic win, let’s review some facts.

Since the discovery of COVID-19, scientists have identified a novel virus; unlocked and sequenced its genetic code; created new therapies to save lives; and developed multiple safe and effective vaccines using messenger RNA technology, a technology hopefully applicable to future vaccine development. Margaret Liu, MD, a biomedical scientist and member of the MJH Life Sciences™ COVID Coalition, called it a breakthrough for mRNA vaccines. 

In addition to the two groundbreaking vaccines, there are at least 60 more undergoing clinical trial at this moment, including 20 in phase 3 trials. In the US and throughout the world, the pharmaceutical industry has answered the call and invested heavily in this effort.

This was the fastest vaccine development program in history, and it’s not even close. David Pride, MD, PhD, a microbiologist at the University of California, San Diego, estimates that vaccines typically take 10 to 15 years to develop. Until the COVID-19 pandemic, the fastest development timeline was 4 years, for the mumps vaccine.

Many government systems moved quickly to lessen the burden of onerous regulations and provide funding so that vaccines could be developed quickly but with rigorous standards. Perhaps it should be a lesson to all of us that regulation and innovation can be calibrated more effectively during “normal” times as industry races to develop new therapies for other epidemics—cancer, diabetes, heart disease, and more.

The next step of the process—distribution of the vaccine—will be as challenging as the development phase, if not more so. But we are again witnessing the pharmaceutical industry rising to the occasion. Factories worldwide are working overdrive to produce hundreds of millions of vaccine doses.

Less than a month after the Pfizer vaccine was approved, more than 15.4 million doses of vaccine have been distributed throughout the country, and more than 4.6 million individuals have received their first dose, according to CDC data. Many patients are already receiving their second dose.

Although 15.4 million doses are impressive, some expected 20 million doses. But that is moving the goal line, as many observers didn’t think a vaccine would be available until 2021 as recently as 6 months ago.

Members of our COVID Coalition told us that the holidays slowed the rollout considerably. Nancy Messonnier, MD, a physician with the National Center for Immunization and Respiratory Diseases at the CDC, expects a rapid increase in administered vaccines during the first few days of 2021.

Every day, more people will be vaccinated. After health care workers and our most vulnerable citizens, other frontline workers will be next. Teachers will be vaccinated so our children can return to school. And soon, all Americans will be able to receive the vaccine at their doctor’s office or a pharmacy.

With the help, dedication, and expertise of pharmaceutical industry heroes, the unprecedented was accomplished in nine months. Next time you turn on the TV and see negativity, turn it off and imagine instead where we will be in nine months.

- Mike Hennessy Sr., Founder and Chairman, MJH Life Sciences

A narrative has depicted a pandemic situation that is completely negative.  There is another way to tell the story of the past nine months.

How Pharmaceutical Innovation Is Saving the World

Mike Hennessy Sr, Founder and Chairman, MJH Life Sciences

Takeda Pharmaceuticals

This article was originally published on 

 were more likely to experience the neurological complications, including bleeding in the brain and stroke, that come with the virus.

Based on CT and MRI images, investigators from the Perelman School of Medicine at the University of Pennsylvania determined that these chronic conditions could play a role in which patients are impacted by more than just the hallmark lung inflammation that comes with viral infection.

“COVID-19’s effects extend far beyond the chest,” said lead study author Colbey W. Freeman, M.D., chief resident in the Penn Medicine radiology department. “While complications in the brain are rare, they are an increasingly reported and potentially devastating consequence of COVID-19 infection.”

Freeman’s team will present their findings during this year’s Radiological Society of North America (RSNA) annual meeting. 

In an effort to better understand how COVID-19 impacts the body, they examined head CT and/or MRI images for patients positive for the virus who presented to the University of Pennsylvania health system from January 2020-April 2020.

A total of 81 of the 1,357 COVID-19-positive patients who were admitted underwent a brain scan prompted by either altered mental state or focal neurological deficits, including speech and vision problems.

Based on the team’s analysis, 18 patients – slightly over 20% – had findings that were considered critical, such as strokes, brain bleeds, or blocked blood vessels. And, of that group, at least half also had a pre-existing history of high blood pressure or type 2 diabetes.

“COVID-19 is associated with neurological manifestations, and hypertension and type 2 diabetes mellitus are common in individuals who develop these manifestations,” Freeman said. “These populations may be at higher risk for neurologic complications and should be monitored closely.”

The team also found that two-thirds of the patients who had critical findings were African American, indicating COVID-19 positive patients in that minority group should be monitored more closely. And, among the entire group of 18 with emergent findings, three died while in the hospital, the team said.

Although this study revealed a role for high blood pressure and type 2 diabetes in the neurological impact of the virus, investigators still do not know exactly what causes those complications.

The mechanisms could be multi-factorial, and the generally accepted belief is that infection-associated inflammation is responsible, they said. In this study, in particular, they reported blood markers for inflammation were high in patients who had critical results.

“When your body is in an inflammatory state, it produces all these molecules called cytokines to help recruit the immune system to perform its function,” Freeman said. “Unfortunately, if cytokines are over-produced, the immune response actually starts doing damage.”

Using data from this study, the team is also looking at the how frequently COVID-19-positive patients on extracorporeal membrane oxygenation (ECMO) – a pump system that circulates and replenishes oxygen in the blood – experience neurological complications. Many patients included in this study required ECMO during hospitalization.

Future plans include a larger prospective study to investigate delayed, long-term, and chronic neurologic manifestations that have not currently been identified, but that might manifest later.

Diabetes, Hypertension May Increase Risk of COVID-19 Brain Complications

About 20% of 81 positive patients experienced critical neurological complications; further, half had a pre-existing history of high blood pressure or type 2 diabetes.

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