Infection Control Today® Editorial Staff

We can say that we didn’t see it coming, but we can’t say that we weren’t warned. Healthcare experts for decades have been telling us that it’s a question of when, not if, we’ll be hit with a worldwide pandemic. And though coronavirus disease 2019 (COVID-19) technically—as the name suggests—reared its spiky head in 2019, most of us didn’t know about it until 2020. Those who did know about it, could only guess what havoc SARS-CoV-2 would cause. As the timeline below of articles that appeared in 

 in 2020 makes clear, even the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) were caught somewhat off-guard.

Here’s where things stand as of yesterday, December 22. There were about 195,000 new cases of COVID-19 reported in the United States, making the 7-day average about 215,000, according to 

. Meanwhile, 3401 people died from the disease. That’s the second-highest number of deaths from the novel coronavirus in a single day.

, 117,777 people were hospitalized for COVID-19. Again, another record; the most hospitalizations for one day since the pandemic began. In addition, 22,213 Americans were in intensive care units and 7830 were on ventilators, according to the COVID Tracking Project.

More grim records will almost certainly be broken, according to President-elect Joe Biden. “Our darkest days in the battle against COVID are 

And yet, though tough months lie ahead for infection preventionists and other healthcare professionals, hope remains that at some point in 2021 things will begin to settle down. 

 have been rolled into the battle, and the healthcare system in general has a better grasp of just what we’re dealing with and how to treat it. Many healthcare experts 

 that infection rates, hospitalizations, and deaths will recede into a past that we’ll be all too happy to be done with. It might take until the end of the year, but it will happen.

In the end, it comes down to a simple formula: We win, COVID-19 loses.

CDC Officially Confirms First Case in the US

The patient had apparently researched the virus online, and upon developing symptoms reached out to his healthcare provider on January 19. The novel coronavirus was confirmed on January 20 using samples shipped overnight. Public health officials from Washington indicated that the patient was hospitalized out of precaution but in overall good condition.

WHO Says the Mysterious Coronavirus That Emerged in China Isn’t a Global Health Threat—Yet

But it may soon become one, warned Tedros Adhanom Ghebreyesus, PhD, director-general of the World Health Organization. The decision was made based on the fact that public health efforts are being implemented to try to contain the disease and a low number of case counts overall.

First Human-to-Human Coronavirus Transmission in US Confirmed

It occurred in the spouse of a Chicago woman who caught the virus when traveling to Wuhan. “In most patients, symptoms are milder, but approximately 1 in 5 individuals have experienced severe illness including severe pneumonia and respiratory failure.”

Infection Preventionists Are Critical Responders to Wuhan Coronavirus Outbreak

Responding to infectious disease outbreaks is not a novel part of infection prevention and control (IPC) work. In fact, many infection preventionists (IPs) are epidemiologists, trained in outbreak response. While IPs normally deal with outbreaks of drug-resistant organisms or norovirus, often emerging and novel infectious diseases occur that challenge our day-to-day activities.

FDA Fast-Tracks Distribution of Test That Can Quickly Diagnose Coronavirus

 rolls the CDC’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel into the battle against the coronavirus. The test had previously only been allowed to be used in CDC labs. It provides presumptive detection of 2019-nCoV (also known as the Wuhan coronavirus) from respiratory secretions, such as nasal or oral swabs

CDC Seeks to Test Some with Flu-Like Symptoms for COVID-19

Health officials say that this is a particularly bad year for an extended influenza season since flu symptoms and some of the symptoms of the novel coronavirus, COVID-19, are the same (fever, cough, shortness of breath).

CDC Wants Schools, Businesses, Citizens to Prepare for Possible US Coronavirus Onslaught

The US Centers for Disease Control and Prevention (CDC) has a more pessimistic view of just how disruptive the novel coronavirus COVID-19 can be than the World Health Organization (WHO). Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, 

 yesterday that she expects the virus will soon begin to spread at the community level in the United States.

PPE Shortages Hamper COVID-19 Containment, Endanger Healthcare Workers

There’s a dwindling supply of personal protective equipment 

 available for infection preventionists and other healthcare workers that hampers their ability to contain COVID-19, warns Tedros Adhanom Ghebreyesus, PhD, the director-general of the World Health Organization (WHO).

Hospitals Slammed for Not Doing Enough to Protect Nurses from COVID-19

National Nurses United wants hospitals to establish protocols in which nurses are immediately notified when a patient who might have COVID-19 is admitted.

Infection Preventionists Might Perform COVID-19 Risk Assessments on Healthcare Workers

Connie Steed, MSN, RN, CIC, FAPIC, the president of the Association for Professionals in Infection Control and Epidemiology (APIC) told 

 that the IPs would be functioning under the 

 for Risk Assessment and Public Health Management of Healthcare Personnel (HCP) with Potential Exposure in a Healthcare Setting to Patients with Coronavirus Disease (COVID-19). The guidance was modified on March 7 by the US Centers for Disease Control and Prevention (CDC) as part of its response to COVID-19.

Asymptomatic Carriers of COVID-19 Make It Tough to Target

SARS-CoV-2 stays active in or on aerosols for up to 3 hours, copper for up to 4 hours, cardboard for up to 24 hours, and plastic and stainless steel for up to 2 to 3 days.

One of the barriers that has been addressed in recent years was just how providers are to be paid for using telemedicine.

7 Things Infection Preventionists Need to Know When Dealing with COVID-19

We asked Linda Spaulding, RN, CIC, BC, CHEC, CHOP, to list what infection preventionists need to know to get through this suddenly thrusted upon us Era of COVID-19.

Expect Huge Surge in Demand for Personal Protective Equipment in COVID-19 Hotspots

More data to underscore a problem that infection preventionists and other healthcare workers battling the new coronavirus know too well: quickly depleting stores of personal protective equipment (PPE).

Resources Infection Preventionists Need to Battle COVID-19

In efforts to prepare your healthcare facilities for potential COVID-19 patients, it often feels like there is an onslaught of information. Below are resources which, as an infection preventionist, I found helpful in establishing plans, training methods, and more.

Quantity Not the Only Concern About N95 Masks; Quality Also Matters

Most of the news about N95 respirators deals with quantity: There’s a shortage, and too many healthcare workers enter the battle against COVID-19 unarmed. That shortage still exists but, thanks to recent rulings by the US Food and Drug Administration (FDA) that approves decontamination processes for the masks, quantity will hopefully become less of a pressing problem as the battle against COVID-19 moves forward and the curve flattens.

Even COVID-19 Might Not Be Enough to Improve Infection Control’s Standing

Michael L. Millenson: “As we emerge from the COVID-19 crisis, it’s very important for infection control professionals to think, ‘How do we take this crisis and use it as a lever to cause the change that we care about so much?’”

Insight into Community Transmission of COVID-19 (Note: Hospitals Are Communities)

Look to our own practices in hospitals. Are meetings occurring with lots of people for a prolonged period of time without PPE? Breakroom clusters of staff to eat? Exposure is not limited to the patient-caregiver interaction.

Lisa Brosseau, ScD: “What we’re seeing is a lot of magical thinking. A lot of wishful thinking. Cloth masks are wishful thinking.”

Major Federal Project Pushes Development of COVID-19 Vaccine

“Operation Warp Speed,” a federal project that some are likening to the Manhattan Project that developed the atomic bombs that ended World War II, seeks to develop and disburse 100 million doses of a COVID-19 vaccine to the public by the end of the year.

COVID-19 Highlights Crucial Role of Infection Preventionists

Mary Jean Ricci, MSN, RN-BC: “Now we’re looking at [infection prevention] from a global perspective. Every patient needs to be educated because this is a novel virus and it is unknown.”

Keeping the Supply Chain Intact in the Age of COVID-19

For those working in healthcare, the relationship with the supply chain department was an increasingly important one. Between daily mask utilization and supply reporting to scrambling to find more supplies, those working in healthcare supply chains were working exceedingly hard to keep our heads above water.

Q&A: Everybody’s Looking to Infection Preventionists for Answers These Days

Brooke Decker, MD: “Keep in mind that right now you’re generating those stories that you’re going to be telling junior colleagues for decades to come.”

Q&A: COVID-19 Will Affect How Environmental Service Teams Operate

Charles Gerba, PhD: Environmental services plays a crucial-and often unsung-role in infection prevention. “Unfortunately, we don’t honor people enough for things they prevented or that never happened.”

CDC Recommends Resumption of Non-COVID Related Elective Surgeries

While starting to perform elective surgeries, hospitals should also keep an eye on COVID-19 in their communities and have the resources available to respond to a surge in COVID patients without having to resort to a crisis standard of care.

Why the Public Should Wear Masks During the COVID-19 Pandemic

Over 100 prominent healthcare experts have sent a letter to the United States’ governors to recommend that the public wear fabric masks, and combined with other measures, the epidemic’s R0 can be driven below 1, halting the spread of the virus. And over 100 countries now recommend the wearing of cloth masks by the public.

Q&A: Reopening After COVID-19: Proceed With Caution

Kevin Kavangh, MD: “What worries me the most about reopening is that people are going to say, ‘Oh, it’s over with’ and not do any sort of protection, whether it’s social distancing, wearing masks, not gathering in crowds. I really think that people will think, ‘Well, we got this beat.’”

Answering Your Infection Prevention Questions Regarding COVID Reopening

Sharon Ward-Fore: “Rather than reusing gowns, consider bundling patient care activities to conserve gowns. Donning a gown that has already been used can be tricky, and a source of contamination to the user.”

Infection Preventionist Role Will Expand Because of COVID-19

Rebecca Leach, RN, BSN, MPH, CIC: “Infection preventionists had to work very closely with our supply chain and look at all of our options and really keep track of it. I also think working with lab more closely will be important in the future, to understand testing modalities, understanding our abilities to test and interpreting those tests.”

FDA COVID-19 Ruling: Not All N95 Respirators Eligible for Decontamination and Reuse

Decontaminated respirators should only be resorted to when unused devices are not available, but that happened a lot in the last few months.

COVID-19 Forced Hospitals to Build Negative Pressure Rooms Fast

A portable anteroom can be used as an extra layer of protection between the isolation space and the rest of the hospital. A positively pressured anteroom, for instance, lets staff don PPE in a protected environment.

Infection Preventionists, Environmental Services Need to Work More Closely Together

Sharon Ward-Fore, MS, MT(ASCP), CIC: “It is a collaboration, and I think the most successful environmental services department has an infection preventionist who really enjoys working with EVS.”

New Method Needed to Determine Infection Preventionist Staffing Levels

The common method used to determine IP staffing-using a ratio of IPs to the number of beds or the number of patients-might not be the best way of determining just how many IPs an institution needs.

Infection Preventionists Prepare to Ride the Second Wave of COVID

Those of us in healthcare and infection prevention must focus on sustainable efforts to combat COVID-19. How do we maintain readiness and response without burnout? There’s no solid answer to this, but a big piece really goes into the establishment of plans and education.

Q&A: States Need to Mandate That Infection Preventionists be Certified

Ann Marie Pettis, RN, BSN, CIC, FAPIC, president-elect of the Association for Professionals in Infection Control and Epidemiology (APIC): “If indeed flu comes at the same time a second wave of COVID comes, that’s going to be difficult—unbelievably difficult because the symptoms obviously are somewhat similar. We’ll be trying to rule both of those things out. It will create more of a risk for a surge, and it will put more taxing on our PPE supplies.”

Just-in-Time Fit Testing Allows for Rapid Response During Pandemics Like COVID-19

Just-in-time (JIT) fit testing allows a healthcare organization to offer evaluation, training, and fitting of healthcare professionals during rapid intervals, as needed, based on specific patient care assignments.

COVID-19 Reveals Fatal Infection Prevention Flaws at Long-Term Care Facilities

Many healthcare facilities, not only LTCFs, have turned to online training for staff and then designate the employee as competent to do their job. Online training does not prove competency; it provides training.

Telehealth in the Time of COVID-19: A 20-Year Overnight Success

The Infectious Diseases Society of America updated its position statement to educate its membership on the use of telemedicine and telehealth technologies to provide “evidence-based, cost-effective, subspecialty care.”

Environmental Services During COVID-19: No Longer ‘Unsung’ Heroes

The swiftness and severity of the COVID-19 spread meant some hospitals were scrambling to adjust. Environmental services often led the way.

To enact social change such as better hand hygiene, only about 25% of a group needs to adopt the change and move the rest of the group forward.

National Reporting System for All Dangerous Pathogens Needed

After decades of reluctance to implement a national reporting system, when COVID-19 came along we witnessed almost overnight the formulation of case definitions and comprehensive national reporting from all healthcare facilities.

How to Build Cost-Effective Infection Prevention Programs at Long-Term Care Facilities

Infection control at LTCFs needs to be a balanced approach that addresses the risk of infection, and not just the treatment of infection. Money is saved when this approach is used.

Professional development educators and infection control specialists need to design educational programs that create a lasting behavior change when it comes to hand hygiene.

Navigating the New Normal in Infection Prevention

It will also be necessary to again train other professionals the way IPs have historically trained them about infection prevention, because a lot of the old rules had to be set aside when COVID-19 surged.

IPs Must Ensure the Supply of PPE for COVID-19’s Second Wave

Supply chain issues are a larger, more systemic aspect of healthcare and national preparedness. Although IPs may not be able to fix them individually, there are ways we can ensure the safety of our hospitals.

Q&A: COVID Presents Unique Challenges to NICUs

Jenny Hayes, MSN, RN, CIC: “Asking the patient to wear a mask, which is something that we do in our facility, can be challenging at that point, especially as labor progresses, and you’re to the point of pushing. That right there offers a set of unique challenges for both the patient and the staff in the room.”

HAIs Didn’t Go Away When COVID-19 Came Along

As the pandemic seems not to abate, patients will start to present to the hospital after delaying crucial primary and preventive care visits, meaning sicker non–COVID-19 infected patients, with the potential for increased CLABSI and CAUTI rates.

Articles

Though tough months lie ahead for infection preventionists and other healthcare professionals, hope remains that at some point in 2021 things will begin to settle down. In the end, it comes down to a simple formula: We win, COVID-19 loses.

Year Zero: How COVID-19 Changed Everything 

A special advisory panel of experts to the US Food and Drug Administration (FDA) voted yesterday that the agency should grant emergency use authorization (EUA) to Moderna’s coronavirus disease 2019 (COVID-19) vaccine. In light of the speedy approval that the FDA granted to Pfizer/BioNTech’s COVID-19 vaccine last week—coming the day after the Vaccines and Related Biologic Products Advisory Committee (VRBPAC) urged an EUA for that product—the approval for Moderna’s product could very well come today. Millions of doses of the Pfizer/BioNTech vaccine were 

 to hundreds of distribution sites around the country this week.

, followed the deliberations by VRBPAC throughout the day yesterday right up until the time when the panel announced that it approved the EUA in a 20-0 vote, with one abstention.

 reports “the 1 abstention stated that he was uncomfortable with the wording of the voting question. He expressed his concern that in the midst of a pandemic, a blanket statement like ‘18 years or older’ is too broad, and that it could be interpreted as full approval in the minds of the general public. He said that he wasn’t sure if the benefits of the vaccine do in fact outweigh the risks.”

The messenger RNA (mRNA) vaccine was created in collaboration between Moderna and investigators from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID). The phase 3 trial data was evaluated in the full-day meeting.

The ongoing randomized, stratified, observer-blind, placebo-controlled study has included 30,351 participants who were randomized 1:1 to receive intramuscular injections of either 100 μg of mRNA-1273 or a placebo. The vaccine was administered in 2 doses given 28 days apart in adults who were 18 years of age or older.

The participants were stratified by age and health risk into 3 groups:

18 to <65 years of age and not at risk for progression to severe COVID-19

18 to <65 years of age and at risk for progression to severe COVID-19

The latter 2 groups constituted 41.4% of the study population. The risk for progression to severe was based on underlying comorbidities, including diabetes, chronic lung disease, severe obesity, significant cardiovascular disease, liver disease, or infection with HIV.

Included in the study were 24,907 (82.1%) participants who were considered to be at occupational risk for acquiring the SARS-CoV-2 infection, of whom 7613 (25.1%) were healthcare workers.

A panel of experts advising the FDA voted 20-1 (with 1 abstention) to tell the FDA that it should grant an emergency use authorization to Moderna's COVID-19 vaccine.

OK for Moderna’s COVID Vaccine Could Come Today

Patients at high risk—older people and people with comorbidities—for coronavirus disease 2019 (COVID-19) can now turn to a treatment given emergency use authorization (EUA) by the US Food and Drug Administration yesterday.

, Eli Lilly said that bamlanivimab, a monoclonal antibody, can be used for anyone 65 or older. Those with comorbidities who are 12 and older who have an underlying health condition can also use the product if they have been diagnosed with mild-to-moderate COVID-19. However, the EUA doesn’t approve the use of bamlanivimab for hospitalized patients nor for those who require oxygen because of COVID-19. In those cases, bamlanivimab could worsen clinical outcomes.

Speed is an important factor when administering bamlanivimab, the company says. The therapy should be administered via a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

The company’s chairman and CEO, David A. Ricks, said in the press release that “this emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients—adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic. The rapid development and availability of bamlanivimab could not have been achieved without the relentless work of our Lilly team, collaboration across the industry and the urgent work being done by the government to ensure appropriate allocation to patients who need it the most.”

What sealed the EUA was data demonstrating that a one-time infusion of bamlanivimab reduced the need for hospitalization and visits to the emergency room for patients at high-risk for COVID-19.

“The EUA is based on data from BLAZE-1, a randomized, double-blind, placebo-controlled Phase 2 study in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting,” the press release states. “Patients treated with bamlanivimab showed reduced viral load and rates of symptoms and hospitalization. In BLAZE-1, frequency and types of adverse events were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity. Infusion reactions and other allergic hypersensitivity events have been reported. The EUA includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions.”

Eli Lilly plans to begin shipping bamlanivimab via the distributor AmerisourceBergen. However, regional allocations will be determined by the federal government, which has purchased 300,000 doses of the treatment. And, as mandated by the government, Americans will not have to pay for the medicine, although hospitals and other healthcare facilities may charge for providing bamlanivimab.

Daniel Skovronsky, MD, PhD, Lilly’s chief scientific officer and president of Lilly Research Laboratories, said in the press release that “the BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus. We’re proud of the speed with which we have been able to bring patients this therapy specifically designed to treat COVID-19. We thank those who have contributed to this medical advancement, particularly the clinical trial investigators and participants around the country.”

The company plans to produce one million doses of the monoclonal antibody by the end of this year. Those doses will be available globally. The company expects that the supply will increase dramatically next year. An independent third party will review records and other data about bamlanivimab.

Another potential future product is composed of LY-CoV555 and LY-CoV016 antibodies. Both products in previous reports had 

. The combination product, having two different antibodies, would be expected to be less susceptible to the development of resistance. So far, Eli Lilli has not observed the development of resistant variants using the combination product.

Eli Lilly stated the combination product had no drug related serious adverse events. The LY-CoV555 monoclonal antibody was “well tolerated” without the observation of any drug-related serious events. But it did have “isolated drug-related infusion reactions or hypersensitivity,” two of which were reported as “serious reactions” with all patients recovering. Both products had adverse events were similar to placebo.

Eli Lilly has also observed that most hospitalizations occurred in patients who had an increased age or BMI. Underscoring the importance of the co-morbidities of age and obesity in COVID-19 disease.

A related product, convalescent serum, was found to have clinical efficacy when it was given within three days of diagnosis and in high concentration. And although given an FDA emergency authorization, its overall benefit has since been panned in the news media.

One may ask, why are the Eli Lilly results different from the positive but somewhat disappointing results of convalescent serum? The short answer is, they are not. Both monoclonal antibodies target the same clinical sweet spot where convalescent serum was found to be most effective.

Bamlanivimab, a monoclonal antibody, can be used for anyone 65 or older. It can also be used for patients 12 and over who have an underlying health condition and have been diagnosed with mild-to-moderate COVID-19.

Update: Eli Lilly’s Anti-COVID Product Approved by FDA

The experts on the MJH Life Sciences COVID-19 Coalition are sharing their insights on the state of the pandemic and why the U.S. has been unable to contain it. MJH Life Sciences is the parent company of 

The top reasons given by the coalition members were widespread misinformation and lack of a comprehensive national strategy, both with 33.3 percent. Other reasons included lack of public health leadership, 22.2 percent, and other, with 11.1 percent.

 is a partnership with 10 nationally recognized experts in infectious disease, public health, epidemiology, and virology, who work to generate the most accurate, up-to-the-minute information on the pandemic's ever-evolving impact on health care professionals and the patients they treat through live, biweekly webinar events, white papers, and surveys.

The next COVID-19 Coalition event, “Thinking Long-Term: COVID-19’s Clinical Consequences and Mental Health Effects,” will be held November 12, 2020, at 7:30PM ET. Register 

The MJH Life Sciences COVID-19 Coalition experts share their insights on the state of the pandemic.

Infection Control Today® Editorial Staff

Articles

Year Zero: How COVID-19 Changed Everything

OK for Moderna’s COVID Vaccine Could Come Today

Update: Eli Lilly’s Anti-COVID Product Approved by FDA

Reasons Given for Why the US Unable to Contain COVID-19