5 ways healthcare providers can prep supply chains for COVID-19 vaccines

Health systems will be tasked with doling out millions of doses of COVID-19 vaccines when an antidote is ready.

While providers are well-versed in distributing annual flu vaccines, a COVID-19 vaccine will likely be more nuanced, supply chain experts said. Here are five things providers can do to prepare their supply chains as drug manufacturers test different iterations of potential vaccines.

1. Ready administrative/IT infrastructure for tracking two doses per patient

Several potential vaccines, like ones developed by Moderna and Pfizer, require two doses to be most effective, which could present logistical hurdles, said Michael Hogue, president of the American Pharmacists Association and dean and professor at the Loma Linda University School of Pharmacy.

Unlike the flu vaccine that only requires one dose for immunization, providers will have stock more, maintain inventory for a longer period of time, create a system to track who got doses when and align suppliers to ensure continuity, he said.

“You have to have a process to ensure the same person can get the same vaccine. I’m not sure how many health systems have this on their radar screen,” Hogue said.

Providers should coordinate data analysis and tracking efforts with their pharmacy departments as well as the state-based immunization information systems, he said.

2. Secure multiple suppliers for ancillary products

Glass vials, syringes, rubber stoppers and saline are common bottlenecks in the healthcare supply chain. While vaccine manufacturers, in coordination with the federal government, typically supply all the necessary materials for immunization, adding some redundancy wouldn’t hurt, experts said.

Coordinating supplies with manufacturers now could stem potential shortages, said Clint Hermes, counsel at Bass, Berry & Sims, noting that a Merck official recently said that glass vials are one of the biggest hurdles to having a COVID-19 vaccine ready for distribution.

“All vaccines use certain things in common, that’s why vials and rubber stoppers are real problems,” Hermes said.

3. Outfit outpatient facilities with proper storage and supply chain infrastructure

Vaccines typically aren’t administered at hospitals. They are often funneled through doctors’ offices, pharmacies and other outpatient facilities.

Those facilities will have to have the proper freezers, adequate storage space, tracking system to coordinate multiple doses per patient as well as the requisite staff training, among other logistical issues, Hogue said.

“Outpatient clinics are really the ones who have to deal with this,” said Hogue, adding that it isn’t in their typical purview.

Ultra-low temperature freezers, which may be required depending on the vaccine, can store frozen liquids at around -70 degrees Celsius for up to six months, Pfizer said at last month’s Advisory Committee on Immunization Practices meeting.

After thawing, ultra-low temperature vaccines can be stored in 2 to 8 degrees Celsius refrigerators for up to 24 hours.

Insulated packaging can keep ultra-low temperature vaccines viable for up to 10 days if they are stored at 15 to 25 degrees Celsius without opening, Pfizer noted. When opened, the container should be replenished with dry ice within 24 hours.

But cold-chain requirements tend to loosen up after the initial clinical trials, some experts said.

4. Prepare for above-average flu season

Hospitals should plan to increase their supply of the flu vaccine for potential case spikes, Hogue said, noting that Australia’s flu season started off higher than average but tapered off.

Some of the most populous parts of the world will be tapping flu vaccine supplies at the same time, which makes preparation even more critical, he said.

“We don’t have enough data on if patients can be co-infected with both COVID and the flu at the same time, but it is certainly a possibility,” Hogue said. “We need to protect patients from the flu so we could remove any potential complications involving COVID.”

5. Ready internal/external messaging strategy

First responders and frontline healthcare employees, among other essential workers, will likely have priority access to a vaccine when it is available. Providers should be developing criteria to evaluate the vaccine and figure out their data-driven message to employees as well as the general public, experts said.

“I would very much be talking with my leadership team about how we are going to address staff concerns about safety, particularly if the FDA issues an (emergency use authorization) this fall,” Hermes said.

5 ways providers can prep supply chains for COVID-19 vaccines

Study finds modest drop in illegal medicines’ prevalence

A review of studies looking at the prevalence of substandard and falsified (SF) medicines around the world has found a small drop between 2013 and 2018.

Getting a reliable estimate of the prevalence of the quality of medicines is known to be a challenge, however, and the authors of the review in the British Medical Journal Global Health propose a unified method to improve accuracy in the coming years.

The review of 33 studies finds that the prevalence of SF medicines remained high, with one in four (25 per cent) drugs falling into this category in 2018, down from 28.5 per cent five years ago. That said, variability between the studies in sample size, design and other variables make drawing any conclusion from that figure problematic.

“Is it appropriate to combine individual medicine quality studies, to generate a global SF medicine prevalence?,” asks co-author Dr Bernard Naughton Oxford University, adding: “We understand why this is done, but we discuss some limitations to this approach.”

A key limitation of current medicine sampling studies is that while their methodological quality is improving, according to a scoring system known as the Medicine Quality Assessment Reporting Guidelines checklist (MEDQUARG), they still sometimes do not take into account or record individual study context.

They propose using a standardised methodology to allow reviewers to compare studies like with like, based on recording the specific context from which the samples have been collected.

“In order to provide more accurate prevalence data to support more detailed policy decisions we propose recording the context of the study environment using the adapted version of the Johns et al framework described in our article,” Naughton told SecuringIndustry.com.

Doing so would allow researchers to combine prevalence data from similar contexts, and that in turn could help with making “more detailed policy decisions and SF medicine prevalence prediction based on contextual changes.”

“COVID-19 is an example – we should recognise moving forward that a global pandemic context can cause an increase in SF medicines, as described in a recent Lancet Global Health publication,” he added.

The Lancet paper – published in June – says that the COVID-19 pandemic “threatens a global surge in [SF] medical products, not just for those directly related to COVID-19.”

It goes on: “Many products essential for COVID-19 treatment and prevention are at risk, including face masks, hand sanitiser, and diagnostic tests, and false claims have been made for prevention and treatment.”

https://www.securingindustry.com/pharmaceuticals/study-finds-modest-drop-in-illegal-medicines-prevalence/s40/a12238/#.X1XEr25FzIV

Colleges using COVID dorms, quarantines to keep virus at bay

With the coronavirus spreading through colleges at alarming rates, universities are scrambling to find quarantine locations in dormitory buildings and off-campus properties to isolate the thousands of students who have caught COVID-19 or been exposed to it.

Sacred Heart University has converted a 34-room guest house at the former Connecticut headquarters of General Electric to quarantine students. The University of South Carolina ran out of space at a dormitory for quarantined students and began sending them to rooms it rented in hotel-like quarters at a training center for prosecutors. The Air Force Academy sent 400 cadets to hotels to free up space on its Colorado base for quarantines.

The actions again demonstrate how the virus has uprooted traditional campus life amid a pandemic that has killed nearly 200,000 people in the U.S. and proven to be especially problematic for universities since the start of the school year. Many colleges quickly scrapped in-person learning in favor of online after cases began to spike, bars have been shut down in college towns, and students, fraternities and sororities have been repeatedly disciplined for parties and large gatherings.

Health officials such as White House coronavirus task force member Dr. Deborah Birx have been urging colleges to keep students on campus to avoid them infecting members of their family and community.

A bicyclist rides past a sign showing restricted zones around the Stanford University campus in Stanford, Calif., Wednesday, Sept. 2, 2020. With the coronavirus spreading through colleges at alarming rates, universities are scrambling to find quarantine locations in dormitory buildings and off-campus properties to isolate the thousands of students who have caught COVID-19 or been exposed to it. (AP Photo/Jeff Chiu)

At Sacred Heart, which acquired the 66-acre GE campus in 2016, the guest house that once provided rooms for visiting corporate executives will be used for the rest of the year to isolate any of its 3,000 students who test positive for COVID-19 and are unable to return home, said Gary MacNamara, the school’s director of public safety.

Rooms are stocked with snacks and equipped with TVs and work stations for remote learning. Heath officials will do periodic check-ups, security is stationed outside and card swipes keep track of who enters or leaves.

“With all the stress and fear a student may have if in isolation we believe we need to make it as comfortable as possible,” MacNamara said. “This guest house helps us accomplish that.”

But not every situation is as comfortable.

Ryan Bologna has been locked in his dorm room at the University of Connecticut since 12 cases were found in his building last week. He’s allowed to go to a dining hall next door, but has had no other contact with the outside world.

In this Sept. 2, 202, file photo, a woman wears a mask as she walks on campus at San Diego State University in San Diego. San Diego State University on Wednesday halted in-person classes for a month after dozens of students were infected with the coronavirus. (AP Photo/Gregory Bull, File)

Zoom classes and virtual marching band practice and video gaming are not what the communications major had envisioned for the start of his senior year.

“I do have friends I’ve made throughout the years that I can talk to,” he said. “But If I were a freshman, I’d be really struggling right now as far as the social aspect.”

Isolating students seems to be working in states like Connecticut, where the infection rate at UConn on Thursday was 1.34% among residential students tested for the virus.

But the results haven’t been as good elsewhere.

The University of Alabama recently informed students in half of a five-story complex that they had to move to other housing to make room for infected or potentially infected students, because two other quarantine-and-isolation facilities would reach capacity.

So far, more than 1,000 students on the Tuscaloosa campus have tested positive since mid-August. As of Thursday, the system’s online dashboard showed its quarantine housing was 36% full.

In this Aug. 17, 2020, photo provided by University of Connecticut senior Ryan Bologna, he poses for a photo in his dorm room in Storrs, Conn. Bologna is under indefinite quarantine in his dorm room at Garrigus Suites after several students in that dorm tested positive for coronavirus. (Lisa Bologna/Courtesy of Ryan Bologna via AP)

The university banned on-campus events for two weeks and the city of Tuscaloosa ordered bars closed amid concern about virus spread. The football-obsessed school is still planning to allow fans for games—with a ban on tailgating—when the Crimson Tide begin their season this month.

Freshman Zachary Bourg, 18, spent 10 days in a quarantine dorm after testing positive on Aug. 23. He’s now back in his regular room.

“I want to stay here for the fall semester,” he said. “But if cases continue to rise at the rate they are then the likelihood of that occurring is starting to get lower.”

The University of South Carolina has about 35,000 students on its main Columbia campus. More than 1,400 have tested positive for COVID-19 so far, with many more ordered into quarantine after exposure to COVID-positive students.

A woman rolls her belongings into the Ernest F. Hollings National Advocacy Center at the University of South Carolina on Wednesday, Sept. 2, 2020, in Columbia, S.C. The university ran out of space at a dormitory for quarantined students and began sending them to rooms it rented in hotel-like quarters at a training center for prosecutors. (AP Photo/Jeffrey Collins)

They were first housed in a dormitory called Bates West, where some students are allowed to room together. But once that filled the university began sending students to off-campus at a training center for prosecutors.

“We do feel like we can surge additional space, either on campus or nearby, to support the students,” said Larry Thomas, a school spokesman.

Brown University has delayed the start in-person learning until next month at the earliest because of concerns over where to put those who might test positive. Schools such as Georgia College & State University, a 7,000-student school in Milledgeville which has reported more than 600 cases since the beginning of August, are telling students that if they have COVID-19, they should leave campus.

There’s a debate in the health community about whether to send students home or keep them in quarantine.

Dr. Joseph Gerald, associate professor of public health policy and management at the University of Arizona, said the idea of identifying cases, contact tracing and quarantining is the right approach. He said it’s just going to be hard to do in dorms, frat houses or places where students congregate.

“One of the things we’re struggling with here at the University of Arizona is what to do with multi-story buildings, where kids need to get to their rooms, but we have one or two elevators,” he said. “It’s not really possible to make an elevator safe.”

Dr. Peter Hotez, a Baylor College of Medicine infectious disease expert, dean of the National School for Tropical Medicine and co-director Texas Children’s Hospital Center for Vaccine Development said many colleges simply cannot open safely.

“There’s only so much you can do with Plexiglas and social distancing and testing,” he said. “That will help get you about 20% to 30% of the way, the other 70% is whether you have an adequate suppression of transmission. You might get away with it at Bowdoin College … but clearly it’s going to fail at the University of Alabama, the University of Georgia and places like that.”

https://medicalxpress.com/news/2020-09-colleges-covid-dorms-quarantines-virus.html

Moderna Reports 71% Enrollment in Coronavirus Vaccine Trial

Moderna (NASDAQ: MRNA) continues to make progress enrolling patients in the phase 3 clinical trial testing its coronavirus vaccine, mRNA-1273. In its weekly update, the biotech said 21,411 patients were enrolled in the study. With a target of approximately 30,000 participants, the 71% enrollment in the study is up substantially from last week, when the company reported enrollment of 17,458 participants, or 58% of the targeted enrollment.

The week-over-week enrollment growth is especially impressive considering Moderna has said it’s slowed enrollment slightly in order to increase the number of minorities that are enrolled in the study. People of different races can react differently to some drugs and vaccines, so it’s important for the clinical trial to test the vaccine on a diverse population.

Moderna is neck and neck with Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX), which launched their phase 3 clinical trial at a similar time. Pfizer’s most recent update on Monday said the duo had enrolled 20,006, or 66% of their similarly sized clinical trial. On Friday, Pfizer pointed out that 6,000 participants had received a second dose of the vaccine. https://products.gobankingrates.com/r/d9360ea31bf06ea8b9d0ef49288e28fb

While completing enrollment in the clinical trials is essential for determining safety, the pace of enrollment is actually more important for efficacy because the companies can’t start measuring whether the vaccine protects people until the booster shot is given three to four weeks after the initial shot. Participants enrolled early in the study will receive their second dose earlier and can help determine whether the full course of treatment helps prevent COVID-19 compared to two placebo shots.

https://www.msn.com/en-us/money/topstocks/moderna-reports-71-enrollment-in-coronavirus-vaccine-trial/ar-BB18KeXo

Ivermectin Moves Towards Mainstream for Covid-19

Recently, the National Institutes of Health (NIH) got around to formally addressing ivermectin in their COVID-19 Treatment Guidelines. Although their only recommendation is for use in clinical trials, that’s a start. TrialSite has been working tirelessly to chronicle and accumulate data centering on the off-label use, case series, observational and randomized clinical trial information possibly pointing to the future acceptance of this cheap and available drug as but one possible contributing way to help fight COVID-19. TrialSite has reported that in at least three randomized clinical trials (Egypt, Bangladesh, and Iraq), the use of the drug targeting early-stage COVID-19 patients leads to positive results; in addition to several observational and hospital approved case series efforts, TrialSite applauds the nation’s research institution for at least taking the time to acknowledge and review the recent Broward County study led by Dr. Jean Jacques Rajter. The apparent fact that this generic drug, which costs about $7 per pill in the US, may be useful as a treatment to alleviate symptoms of COVID-19 is given traction in the mainstream media in the United States as the Miami Herald recently embraced the topic showcasing the Broward County physician and his ICON study results. They also emphasized several doctors in Florida who are prescribing the drug, including Key West-based Dr. Bruce Boros, who reports that he is using the drug successfully to help COVID-19 patients in South Florida.   

It all Starts in Australia

TrialSite commends the Miami Herald and journalist David Goodhue for making a good faith attempt to introduce this controversial topic to the mainstream in a relatively fair and balanced way. The scientific roots of the interest in ivermectin go back to the spring, during the onset of the pandemic when researchers in Australia were working furiously to explore possible ways to fight off this novel coronavirus. The result of a collaborative study led by Monash Biomedicine Discovery Institute (BDI) with the Peter Doherty Institute of Infection and Immunity (Doherty Institute)—a joint venture of the University of Melbourne and Royal Melbourne Hospital—revealed that ivermectin kills SARS-CoV-2. 

Back in early April, TrialSite first reported on these findings. The response was overwhelming—in aggregate, some of the articles received well over a hundred thousand visits. The Monash-led study revealed that this anti-parasitic drug widely available worldwide could destroy the SARS-CoV-2 virus within 48 hours in a cell culture. The university showed the importance of, and urgency for, clinical research funding to support an effort to find effective dosages that are safe for humans. Ivermectin, FDA approved, is widely used in the tropics today to combat parasite-born disease. The Monash University-led collaborative study was published in Antiviral Research, a peer-reviewed medical journal published by Elsevier. 

Use of Ivermectin Targeting COVID-19 Expands: But Why?

TrialSite chronicled how the use of ivermectin spread around the world right after the Monash findings, especially in low and middle-income countries (LMICs), but also in the United States and France. From the Andes to India, from the Amazon to Bangladesh, the use of ivermectin spread rapidly. But why? Was it simply based on the early-stage research of Monash, or was there additional evidence? No one knew with any certainty. In a quest to learn more, TrialSite monitored the press, medical reports, national regulatory and research agencies worldwide andconducted a series of interviews. We brought in Carlos Chaccour, one of the world’s top ivermectin specialists, heavily involved with significant research. TrialSite showcased the work Bangladesh Medical College’s Dr. Tarek Alam, who observed considerable success with treating COVID-19 with ivermectin—reporting a 98% success rate in Dhaka. An interview with Dr. Jose Natalio Redondo, president of Dominican Republic’s leading private hospital network, Grupo Rescue, revealed a near 100% success rate; Dr. Redondo declared at the time of the interview that the health system had documented clear success in treating 1,300 early-stage COVID-19 patients with ivermectin. 

TrialSite researchers became more intrigued and tracked and monitored ivermectin research around the world, including the production of an original documentary “How Peru Uses Ivermectin” to help get to the bottom of why the use of this drug was accelerating worldwide. Based on a substantial amount of research, it becomes apparent that at least in many LMICs and even in some cases in the US, the urgency of the pandemic led to a grass roots, physician-driven push to explore the use of the drug targeting COVID-19, at least in the early stages of the disease. Medical professionals needed to act, as patients were dying and with a lack of any established, approved, and effective medication, the Monash study incited a wave of “real world” experimentation during the pandemic. 

All involved physicians, from Peru to Bangladesh to India and Mexico to the US, agree that we need randomized controlled trials. That is the net takeaway from the TrialSite Peru documentary as well.

From LMICs to Key Largo

The only difference between the position of the US FDA and NIH on the one hand, and the community-based physicians around the world on the other, are the practicalities on the ground—in a pandemic situation, there often isn’t the time, the money, or the resources in many parts of the world to conduct research and then clinical practice in a serial fashion (e.g., first lengthy randomized trials and then treatment). Rather many felt compelled based on health urgency to work in parallel. That is, they knew the safety profile of ivermectin and hence prescribed off-label, carefully monitoring, documenting, and continuing assessing results. Thus far, the results have been overwhelmingly positive, but this is not evidence for purposes of a listing under the NIH COVID-19 Treatment Guidelines. Yet Dr. Bruce Boros operates a clinic in Key Largo, Florida, and The Miami Herald reports he has become a proponent for using the drug to treat COVID-19 patients—much like Dr. Rajter to the north in the Fort Lauderdale area. The cardiologist owns and operates Advanced Urgent Care clinics on the island chain. A pragmatic physician and businessman, Boros was an early advocate warning about the danger of COVID-19—he was apparently pro-social distancing and other measures such as stopping tourism early on in the pandemic’s trajectory.

Ivermectin Part of the Broward County Drug Portfolio

The Miami Herald’s Goodhue introduces one Dave Lacknauth, executive director of pharmacy services and system integration at Broward Health, a four-hospital network. Again, it was this health system that approved the use of ivermectin for the Dr. Jean Jacques Rajter/ICON study. The Miami Herald uncovered that the South Florida health system maintains a “portfolio” of drugs used by its doctors to treat patients infected with SARS-CoV-2, the virus behind COVID-19. These include not only ivermectin, but also the controversial drugs hydroxychloroquine and remdesivir. None of these therapies, including those approved for emergency use authorization (e.g., remdesivir or convalescent plasma), are “cures.” As mentioned previously, the Miami Herald story reminds the reader that absolutely no clinical evidence exists for the effective use of the drug. Rather health systems and providers in various parts of the world are doing their part to do their best to save lives with imperfect science.

TrialSite notes that the US currently spends billions of dollars on vaccines and high-priced therapies that are also scientifically unproven. NIH should adapt to include some real-world studies; there are over 30 clinical trials of ivermectin ongoing in multiple countries, including the US. A few of these trials are completed and evidence positive results. And of course, there may be more money to be made in new therapies backed by the massive government and private funds, versus the humble ivermectin. Given the severity of the pandemic worldwide, why wouldn’t governments around the world be more curious about prospective low-cost, economical options to inhibit this insidious pathogen?

Ivermectin Moves Towards Mainstream