KEVIN KAVANAGH, MD, is the founder of the patient advocacy group Health Watch USAsm and a frequent contributor to 

 Israel announced today that it will begin offering booster shots to its older citizens. Israel is the first country in the world to make this move, offering the COVID-19 booster shot to people aged over 60 to stop the spread of the Delta variant in that country. Those in that age group will be offered a third shot of the Pfizer/Biontech COVID-19 vaccine starting on Sunday. As reported today in 

’s sister publication, a “confluence of three factors—Pfizer’s earnings, a new dominant variant, and a decreasing immunity against COVID-19—are all coming together to incentivize the pharmaceutical company to make the case for a booster shot.” Apparently, Israel didn’t need much convincing. Vaccine efficacy in prevention of infection drops from 75% for those recently vaccinated to 16% for those who received their second dosage in January. The vaccine is still very efficacious for the prevention of hospitalizations and severe COVID-19. Below is a slide from the Ministry of Health of Israel. It should be noted that a similar decrease in efficacy is seen in those less than 60 years of age and even in those with asymptomatic and mild infections can still develop long COVID.

Israelis over 60 who received their second vaccine dose at least 5 months ago will be offered the booster shot. Israeli Prime Minister Naftali Bennett said “gives your body very strong protection. Get the booster shot; take care of yourselves and those near you,” the Israeli newspaper Haaretz 

Bennet said that “reality proves the vaccines are safe, Reality also proves the vaccines protects from severe morbidity and death. And like the flu vaccine that needs to be renewed from time to time, it is the same in this case.”

Haaretz: “'There’s competition between the vaccines and the pandemic,' the prime minister said, arguing that having more vaccinated people would let Israel remain open and avoid the need to impose further restrictions.President Isaac Herzog will get his booster shot on Friday morning, two days before it is available to the general public.”

 reports that the Delta variant was recently reported to be 83% of cases in the US, and has spread quickly over just a couple of months. 

 Editor-in-Chief Jason Gallagher PharmD pointed out in a recent tweet that “ending 5/22 Alpha 69.1%, Delta 3.1% Ending 7/17 Alpha 8.3%, Delta 83.2% That's <2 mos. The fitness of Delta is incredible.”

Recent data about just how immune the vaccines can make someone and for how long has caused concern among some Israeli health officials. In a report in the 

, the findings showed reduced efficacy in the Pfizer vaccine.

“The findings, which are preliminary and based on a small sample, suggest that after two shots the vaccine was 39% effective at reducing the risk of infection and 40% effective at reducing the risk of symptomatic disease during a period when the Delta variant dominated cases in Israel, according to the country’s Health Ministry,” the 

 reported. “The vaccine was 91% effective at preventing severe illness in the same period between June 20 and July 17, the ministry said.”

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 The Ministry of Health of Israel has released data which indicates there is significant concern regarding the Pfizer and BioNTech vaccines in the prevention of COVID-19 

. Overall, they found that after 2 doses of the vaccine the effectiveness in the prevention of infection with the Delta variant was 39% and the prevention of 

. The good news is that hospitalizations and severe COVID-19 were reduced 88% and 91%, respectively. Thus, we all need to become vaccinated.

A relatively small study recently published in the 

 confirmed our fears that long COVID-19 can occur in patients with vaccine 

. The study reported 39 health care workers with SARS-CoV-2 breakthrough infections. Eighty-five percent of the infections were from the alpha (UK) variant. Nineteen percent had persistent symptoms at 6 weeks or longer. These symptoms included: “….a prolonged loss of smell, persistent cough, fatigue, weakness, dyspnea, or myalgia.”

Thus, combining these two reports, there is a strong argument for obtaining a vaccine booster, especially in those who are at high risk. Prevention of hospitalizations and death is of paramount importance, but so is the prevention of long COVID.

Further looking at the Israeli data reviews there appears to be a waning of effectiveness against the Delta variant over time. In the diagram below (with the dumbbell data distribution), as the data regarding the administration of the second dosage progresses from January to May (vertical axis) the Delta breakthrough infections (right side of graph) lessens. However, the main observation is that once immunity takes hold, the infections by the alpha variant (in May—middle graph) almost disappeared. But in late June and July, the Delta variant emerged and markedly decreased the vaccine’s ability to prevent breakthrough infections.

Surprisingly, as indicated by anecdotal reports, the young are not spared. The data indicates there are more breakthroughs in those who are below the age of 60 than above.

mRNA vaccines are excellent vaccines, but they were made using the wild-type virus (or the original virus). Their effectiveness with the Delta variant appears to be waning. And with even more problematic variants in the wings, such as the kappa (Delta plus) and lambda variants, this is not good news.

If one remembers, the initial goal for vaccine approval by the U.S. Food and Drug Administration was a 50% efficacy in the prevention of symptoms. We may currently be close to missing this objective.

The Israeli data appear to be in marked contrast to that from England, which was recently reported by Bernal, et al. They concluded that the Pfizer and BioNTech vaccine was 88% effective in the prevention of symptomatic disease from the 

. Thus, the Israeli data and this analysis needs to be confirmed. A good first step would be for the Centers for Disease Control and Prevention to release its data on reinfections so all can evaluate it.

If the data from Israel holds up, then all those vaccinated need to wear high quality medical grade masks and even the vaccinated can spread the virus, preventing the achievement of herd immunity. Even more important is to slow down the spread of this virus which will also slow down its mutations. The following should be considered:

Everyone (regardless of vaccination status) needs to wear an N-95 mask in public settings, and we need to avoid indoor public spaces, especially if there is poor ventilation.

We need to upgrade workplaces and schools with proper ventilation and air sanitization.

, all workplaces should test employees (regardless of vaccination status) at least weekly; and in schools testing of all (regardless of vaccination status) staff and children at least twice weekly. Pool testing can be implemented to conserve resources and staff.

With previous variants, outdoors was much safer because of rapid dissipation of viral aerosols. However, infection with the Delta Variant produces up to 1000 times the number of virons as the Wild-Type of virus increasing the risks of aerosolization, and within six feet spread by large droplets can still occur.

Every county and region in the United States needs to enact and follow the same strategies. We are too mobile of a society and every county and region will have pockets of under vaccinated individuals which gather together.

Finally, we need to allow our pharmaceutical vaccine development and production to catch up with the virus. And above all we all need to get vaccinated, some of us with a booster, to avoid hospitalization and death from COVID-19, and at the same time to wear a mask and follow public health strategies to avoid long COVID.

Articles

Israeli announced today that it will begin offering a booster shot to its older citizens to try to stop the spread of the Delta variant. It is the first country in the world to make this move.

Israel to Offer COVID-19 Booster Shots to Older Citizens

Frank Diamond has been with Infection Control Today since November 2019. He has more than 30 years of experience working for magazines, newspapers, and television news. 

As President Biden weighs the pros and cons of 

 that federal employees must get the COVID-19 vaccine, one federal agency decided to not wait for a presidential directive. The Department of Veterans Affairs is telling its health care professionals that they must be vaccinated within the next two months.

 Monday that “we’re mandating vaccines for Title 38 employees because it’s the best way to keep Veterans safe, especially as the Delta variant spreads across the country. Whenever a Veteran or VA employee sets foot in a VA facility, they deserve to know that we have done everything in our power to protect them from COVID-19. With this mandate, we can once again make—and keep—that fundamental promise.”

Title 38 refers to doctors, nurses, and other health care providers who interact with patients. The VA’s move comes in the same week when the Centers for Disease Control and Prevention (CDC) revised 

, saying that fully vaccinated individuals should begin wearing masks again when indoors in public settings in parts of the US with substantial to high transmission. CDC Director Rochelle Walensky, MD, in a 

 yesterday also cited the Delta variant, which is fueling a new wave of infection in some parts of the country, as the reason for revising guidelines. According to the CDC, about 50% of the US population is fully vaccinated, which is nowhere near the 70% to 80% that health care experts say would lead to herd immunity.

“I have seen new scientific data from recent outbreak investigations showing that the Delta variant behaves uniquely differently from past strains of the virus that cause COVID-19,” Walensky said at the press conference. “Information on the Delta variant from several states and other countries indicate that in rare occasions, some vaccinated people infected with the Delta variant after vaccination may be contagious and spread the virus to others. This new science is worrisome and unfortunately warrants an update to our recommendations.”

 that “this virus is about one or two iterations away from completely avoiding the vaccine.

About the VA’s mandate, Kavanagh says that “it is becoming increasingly apparent to even the most conservative policymakers that we are in this pandemic for the long term. One of our most pressing needs is for a nationally integrated and coordinated public health care system. I believe this would fit well into the Department of Veterans Affairs fourth mission which is to respond and aid the United States in health emergencies. The VA has both the infrastructure and knowledge to implement this strategy.”

 that the US could see about 200,000 new cases of COVID-19 in the next month or so, a number that was last seen in the COVID surge in January. Frieden added that the country will not see the “horrific death tolls” of those earlier surges thanks to the vaccines, but avoidable deaths will occur.

Leana Wen, MD, an emergency room physician and a visiting professor of health policy and management at George Washington University, 

 that “the vaccinated are currently paying a price for the unvaccinated. 

 is surging again, with spillover to the vaccinated. Masks are coming back, because the honor system isn’t working.”

At yesterday’s press conference, Walensky said that in areas of high COVID-19 transmission, the fully vaccinated should “wear masks in public indoor settings to help prevent the spread of the Delta variant and protect others. This includes schools. CDC recommends that everyone in K-12 schools wear a mask indoors, including teachers, staff, students, and visitors, regardless of vaccination status.”

The press release the VA issued Monday states that 4 VA health professionals have died in recent weeks, all of them unvaccinated and “at least three of those employees died because of the increasingly prevalent Delta variant. There has also been an outbreak among unvaccinated employees and trainees at a VA Law Enforcement Training Center, the third such outbreak during the pandemic.”

’s website examined the problem of compassion fatigue among health care professionals as they have to care for patients who refuse to get the COVID-19 vaccine.

 reached out to was Robbie Hilliard, MSN, RN, CIC, the infection control coordinator for Carl Vinson VAMC in Dublin, Georgia. (Hilliard recently wrote an 

 about how VA nurses tackle infections.)

Hilliard said that there’s a danger that compassion fatigue could set in when it comes to treating unvaccinated COVID-19 patients, but tries not to simply dismiss the concerns of the unvaccinated.

“As a nurse, I am vaccinated for COVID-19, but I still have co-workers who are not, which just emphasizes the importance of understanding and accepting people’s personal choices,” Hilliard told 

. “Most of these providers are very educated individuals, who are compassionate, but continue to feel that not enough research on side effects, etc., was done for a vaccine released on an emergency basis.”

Hilliard added that compassion fatigue comes with a provider’s job “and I am sure, at times, compassion fatigue creeps in with COVID patients, but most of us understand the fear associated with the unknown/new pharmaceutical treatments that have long-term unknown effects.”

In making the announcement, the VA noted that 4 of its employees have died in recent weeks, all of whom were unvaccinated. And 3 died as a direct result of the Delta variant.

VA Mandates That Health Care Providers be Vaccinated

 that in response to the Delta variant that’s causing yet another wave of COVID-19, that the Centers for Disease Control and Prevention (CDC) will have to update the agency’s recommendations regarding masking. The CDC must have been listening. 

CDC Director Rochelle Walensky, MD, today announced that the agency is updating its recommendations, stating that vaccinated individuals should begin wearing masks again when indoors in public settings in parts of the US with substantial to high transmission.

Additionally, the CDC reversed its recommendations on masking in K-12 schools, stating that all teachers, staff, students and visitors should wear a mask indoors regardless of vaccination status.

"In recent days I have seen new scientific data from recent outbreak investigations showing that that Delta variant behaves uniquely differently from past strains of the virus that cause Covid-19," Walensky said. "This new science is worrisome and unfortunately warrants an update to our recommendations."

 are up 65% across the country, nearly 3 times as high as 2 weeks ago. New cases are currently averaging at around 43,700 a day.

The CDC's announcement today may come as a surprise to many. As recently as last week, a spokesperson for the CDC said that the agency had no plans to change its guidance unless there was a significant change in the science.

One of the experts who challenged the CDC’s guidelines is Kevin Kavanagh, MD, a member of the 

’s Editorial Advisory Board who just last week in an 

 implored the agency to take a different approach to COVID-19.

“We need to have a paradigm shift in the way we view this virus, planning and implementing strategies to allow us to live with an endemic pathogen,” Kavanagh wrote. And in a 

’s website this morning with a headline—“Everybody Needs to be Vaccinated and Wear a Mask”—that may prove to be prescient, Kavanagh said that he’s “convinced this virus is about one or two iterations away from completely avoiding the vaccine. And remember, we have the lambda variant and the kappa variant which are sitting out there in the wings, waiting for immunity to drop and possibly cause another wave.”

But, as Kavanagh said, it’s the Delta variant that’s really changed the nature of the battle against COVID-19. The CDC relaxed masking guidelines for the fully vaccinated based on data taken from previous iterations of the coronavirus. Kavanagh said that his biggest concern is that “everybody’s in the mindset that this pandemic is over with. We don’t need to do anything else. And if you’re vaccinated, you have a get-out-of-jail card, and you can go on with your life as if it was normal. And with this Delta variant, nothing could be further from the truth. I feel it is imperative that everyone, even those vaccinated, start wearing masks and start following public health strategies, which were followed over the surge of the winter holidays. I can’t stress that more.”

Celine Gounder, MD, an infectious disease specialist at Bellevue Hospital Center in New York, tells the 

  that “I think that’s great” about the CDC’s expected move.

In May, when the CDC announced that fully vaccinated individuals no longer needed to wear masks, they pointed to 2 studies touting the efficacy of the Pfizer and Moderna COVID-19 mRNA vaccines.

New CDC guidelines say that vaccinated individuals should begin wearing masks again when indoors in public settings in parts of the US with substantial to high transmission.

CDC Tightens Masking Rules for Fully Vaccinated in COVID-19 Hot Spots

Kevin Kavanagh, MD, has been sounding the alarm about the threat COVID-19 poses to society from the very beginning of the pandemic. Kavanagh, a member of 

’s Editorial Advisory Board, is still sounding the alarm, even though, as he puts it, “everybody’s in the mindset that this pandemic is over with.” It’s far from over with, Kavanagh argues. Thanks to the Delta variant, the United States battles a fourth wave of COVID-19, and some states battle a fifth wave. Fifty percent of the U.S. population is fully vaccinated according to 

, and that’s just not enough to get us to herd immunity. Science can stop the COVID-19 variants (at least for now), says Kavanagh. “I’ve been told they can make a new vaccine in three days,” he tells 

®. “And that’s great news, but you can’t make 300 million doses and get them in arms in two days, especially when you have half of the country being anti-vaxxers and not wanting to take the vaccine.” His vision is not a bridge from where we are in this pandemic to a new normal, but rather an overhaul of our infrastructure—including installing better ventilation systems in schools—so that we can coexist with the virus, because it’s not just going to magically disappear, says Kavanagh. “There have been civilizations which have been wiped out due to infectious diseases. Species which have gone extinct. And currently what separates us is our science and our knowledge. We can handle this pandemic. But unless we take advantage of that science and knowledge, we’re no better off than a tadpole.”

What concerns you most about the state of play regarding the COVID-19 pandemic in the United States these days, Doctor Kavanagh?

Well, what’s most concerning is I think everybody’s in the mindset that this pandemic is over with. We don’t need to do anything else. And if you’re vaccinated, you have a get-out-of-jail card, and you can go on with your life as if it was normal. And with this Delta variant, nothing could be further from the truth. I feel it is imperative that everyone, even those vaccinated, start wearing masks and start following public health strategies, which were followed over the surge of the winter holidays. I can’t stress that more. This Delta variant is much more infectious, possibly two times or more infectious than the wild-type virus. There are data which indicate that it’s producing 1000 times more virions, and it is spreading like wildfire. The vaccines 

that we have were made from the original wild-type virus. We are now several iterations of viruses away from that. Data out of Israel indicates that vaccine efficacy for preventing infections is around 60%. Now, the data from the public health agencies in England are much better than that. But from what I’m seeing from reports from around the nation, infections and prevention of infections by this vaccine is mirroring that of Israel. I think those that are vaccinated can still become infected. And if you’re infected, you can spread the virus to others, and the virus can mutate. I think agreement by all is that your chances of being in the hospital are less, and your chances of dying are much less, which is a huge plus, so everyone needs to get vaccinated. But as we talked about last year, even an asymptomatic infection carries risks of both lung damage and also cardiovascular and heart disease such as myocarditis. This is often asymptomatic, and this virus tends to infect everybody a little bit differently. Some people are having GI symptoms, some people are having mainly pulmonary symptoms, and others can have cardiac vascular symptoms. And these type of individuals oftentimes are asymptomatic. We need to take the virus seriously, and even those who are vaccinated need to wear masks. I am convinced this virus is about one or two iterations away from completely avoiding the vaccine. And remember, we have the lambda variant and the kappa variant which are sitting out there in the wings, waiting for immunity to drop and possibly cause another wave. We are going now through our fourth wave. And some of the states are going through their fifth wave. I can’t tell you enough that this is not characteristic of a particular type of a virus. Most viruses don’t do this. They’ll have one or two waves, and then they go away. We’re being hit by wave after wave, many times being caused by different variants. Everybody needs to follow public health advice. This is absolutely crucial.

How concerned are you about the lambda variant? There’s a study out of Chile that it might—might—be able to shrug off the vaccines. But it sounds like the Delta virus is what really has you worried.

Well, the Delta virus is really concerning. The lambda variant may not be as an infectious. And even though the vaccines may not be efficacious, if it’s not as infectious, it still gives our immune system a jump on it. Because remember, 1000 times the soldiers landing on a beachhead can overwhelm your immune system and defenses. And that’s one of the problems we have with the Delta variant. Also in Chile, and in Peru, the major vaccine that they were using was the China vaccine. It was not the mRNA vaccine. I think the data on that, although it is still very concerning, there’s still some hope that we may be able to avoid a major surge such as what we’re seeing now. Now, I should add with this surge, because of the infectivity this virus, I would expect it to rise very quickly, come to a very high peak, and then it may fall off just as quickly. We saw that pattern in India. Unfortunately, many people who are not vaccinated, which is over half of our population—over half is not fully vaccinated—they will be susceptible to this virus. Even if you get the vaccine today, your protection will not kick in until five weeks from now. Everyone needs to follow strict public health advice.

As you know, there’s a lot of misinformation out there. And even last weekend, someone in my family said “Yes, viruses mutate, but they always get weaker whenever they mutate.” I said I’m just a beat reporter, but I’ve read a lot about this, and I don’t think that’s the case. Was I correct on the science of that?

I think you’re correct. This virus, every time it’s mutated it becomes more infectious, and sometimes more lethal. You can look at the D614G variant, which was the first mutation. It was about a third more infections. Then we were hit with the alpha variant, or the UK variant, and that caused the Christmas surge. This was 70% more infectious. And now we’re dealing with the Delta variant which is 70% more infectious than the UK or alpha variant. And it also appears to be more lethal and causing more severe disease and causing disease in children. We’re hearing reports out of [the Oklahoma State Department of Health] and also from the [Mississippi State Department of Health] that this virus is causing severe disease in children. Mississippi reports seven children in the ICU, two on the ventilator. Oklahoma has similar warnings coming out of the university there. The idea that children are protected no longer applies with this variant. And one of the things that concerns me is this. The 

 is extremely deadly, and also spreads like wildfire. Luckily, it was snuffed out with public health strategies. But that virus also attached to the H2 receptor. And that’s what caused this virus to be so lethal. That’s the SARS virus. Well, the viruses are similar. They’re both coronaviruses. This virus that we’re currently dealing with has a lot of room to continue to mutate, and to become more infectious and more lethal. And it may do so up until it becomes similar to SARS and [the 

]. We may get hit with wave after wave. The good news is we have the science to stop this. But we cannot manufacture vaccines fast enough. I’ve been told they can make a new vaccine in three days. And that’s great news, but you can’t make 300 million doses and get them in arms in two days, especially when you have half of the country being anti-vaxxers and not wanting to take the vaccine. It is extremely frustrating. And as I said in my 

, there have been civilizations which have been wiped out due to infectious diseases. Species which have gone extinct. And currently what separates us is our science and our knowledge. We can handle this pandemic. But unless we take advantage of that science and knowledge, we’re no better off than a tadpole. You can try to wish away this virus, that it will miraculously disappear, as was stated last year. Well, that’s not going to work this year either. We need to change our behavior. And we need to prepare for the next wave because it will come. We will get another wave after this one. We need to get vaccinated. We need to slow down the viral spread. Our knowledge in our manufacturing of vaccines can keep pace with the mutations.

You have some things to say to the vaccinated as well, right?

Well, that’s correct. Because you’re seeing breakthrough infections—and even mild infections can be problematic—the vaccinated individuals need to also follow public health advice. They do not want to be spreading this virus to those who are immunocompromised, which is about 1 out of every 37 individuals in our society. Those are people who have, for example, an inflammatory disorder, rheumatoid arthritis, lupus, or have had a transplant or are on chemotherapy. There are a lot of citizens for whom the vaccine won’t work. And of course, our children are not fully vaccinated. Only half of those older than 12 years of age have taken advantage of the vaccines, and below 12 years, they’re not approved yet or even authorized for use. So yes, you need to continue to wear a mask both to protect others and to protect yourself. I think this is crucial. And in my mind, when I do the math, if you’re 30 points less protected in a virus that’s more than two times as infectious—in other words, you’re going to come across it two times more frequently—that doesn’t put you in a much better situation … maybe a little bit better, than what you were last year. And, also, decreasing viral load is absolutely critical. And this includes viral exposure. So that if you’re vaccinated, and you don’t have a mask on and you get exposed to the virus, you’ll be exposed to more virions, and you may develop a more severe infection. If you have a mask on the infection will probably be less. And what I worry about is that we’re using data from countries where people are vaccinated plus wearing masks and saying, “Well, you know, they do really well.” But if you don’t wear a mask, you go into a crowded indoor setting where there’s poor ventilation, a lot of viral particles, you may well develop a significant infection. So yes, I think these advisements need to go out for everybody. We need to wear a mask. We need to also get vaccinated. Both interventions are layers of armor. They reduce your viral exposure. And because of that, we need to do both of them. And if we don’t, as a society, we’re not going to do well through this wave or the next which will be coming. I think without a doubt, if you’re going through four or five waves of this virion with changing variants, to think that you’re not going to have another one is really magical thinking.

 website in which you argue that the Centers for Disease Control and Prevention is not getting the right message out to the right people at the right time. Do you think that the CDC will be changing its method of operation soon?

Well, I hope that they do. I hope today, they’ll come out with an advisement that states that masks need to be worn by everyone. But you know, by this time you already have the 

, multiple municipalities also doing the same thing of advising people to wear masks regardless of vaccination status. Now, a lot of people will say, “Well, it depends upon viral spread in the communities.” But one of the things you need to realize is that many countries have a zero tolerance for this virus. In Israel, in Jerusalem, I was reading news reports, where when the positivity rate got above 1%, they were considering enacting new and more stringent strategies such as passports. In our country, if it’s not above 5%, we don’t worry about it much. That is completely unacceptable with this type of a virus. We need to really start taking it seriously. And we need to start thinking about changing our infrastructure. One of the big items which is coming up for debate [concerns schools] for the fall. Right now, I consider ourselves in worse shape than what we were last year. Very few children vaccinated. A virus which can cause breakthrough infections and spread. A virus which is now targeting more of the younger population. And this is problematic. We need to change our infrastructure for schools with ventilation systems, increasing complete air exchanges. We need to test everyone vaccinated or not vaccinated twice a week. We need to reduce class size, to do podding. It means having hybrid options. And if someone wants to learn from home and do tele-schooling, this needs to be available. And these need to be permanent because we’re going to have another wave after this. We need to change the way that we live. We’ve been talking about this for months. I think last year we were giving these advisements. And we need to start taking them seriously. And start investing in—not a bridge to when the pandemic goes—but an infrastructure to safely live with this virus so we can get back to a more normal way of life.

You’re fully vaccinated. So, when you leave your house, do you often wear a mask?

I wear a mask when I leave the house, I avoid indoor settings. Now, if I’m outside, when nobody’s around, I’ll be carrying a mask, not necessarily having a mask on. Certainly, when you exercise, you can’t wear a mask. But on the other hand, when you’re exercising, you’re spreading a lot of large droplet particles which won’t dissipate in the air, and you’re projecting them further. So, if you’re exercising, don’t run by someone on the sidewalk. You should be staying at least 30 feet away from people. And if you can’t do that, then don’t exercise outdoors. Get yourself a stationary bike and exercise indoors. This Delta variant, again, is much more infectious—1000 times more viral particles. We need to respect it. And we need to respect others. And that’s the key. Our society needs to start respecting others. And that means not just worrying about your rights but worrying about the safety of other people.

We’ve been flying at 30,000 feet here. As you know, 

 goes out to infection preventionists, sterile processors, vascular access nurses, environmental services crews, and other professional groups. How do you translate your advisements to the people right there on the frontlines in hospitals?

Well, first of all, they all need to get vaccinated. Too many health care workers are not vaccinated. There’s a lot about burnout on health care workers and frustration of people who aren’t getting vaccines. But you need to realize that one of the biggest arguments that I hear from people is, “Well, I know a health care worker who’s afraid to get the vaccine, so I am, too.” So before you expect other people to follow your advice, you need to be taking it yourself. There is no reason with these vaccines—their safety profile and the length of time that safety data has now been gathered, which is much greater than six months—that everyone in the health care setting is not vaccinated. And as we said back in April in a story [in 

—vaccinations of health care workers need to be mandatory. So that’s the first thing infection preventionists should be doing. The second is to recognize that this virus is highly infectious. Everybody needs to wear a mask. Visitation to hospitals at this point needs to be curtailed. And above all, we need to be wearing respirators or N95s. Cloth masks, surgical masks with holes on the sides—those will not work. And there should also be strong consideration of wearing goggles because that will also decrease your viral exposure. Remember, this is a numbers game. We want to decrease the number of viruses everyone is exposed to.

This interview has been edited for clarity and length.

Videos

Kevin Kavanagh, MD: “I am convinced this virus is about one or two iterations away from completely avoiding the vaccine. And remember, we have the lambda variant and the kappa variant which are sitting out there in the wings, waiting for immunity to drop and possibly cause another wave.”

Everybody Needs to be Vaccinated and Wear a Mask

Adults aged 18 years and older with increased risk of immunodeficiency or immunosuppression have been given another means to fight the disease thanks to the approval by the US Food and Drug Administration (FDA) of the non-live, recombinant sub-unit adjuvanted vaccine Shingrix for the prevention of 

The GlaxoSmithKline (GSK) vaccine, which is given intramuscularly to patients through 2 doses, was originally 

 for the prevention of shingles in adults 50 years or older. The newest indication by the FDA is set to expand upon the number of patients who can be protected against shingles.

“We’re proud to offer Shingrix in the US for the prevention of shingles in those who are immunocompromised, with FDA granting a broad indication for use in adults at increased risk of this disease,” said Thomas Breuer, chief medical officer at GSK Vaccines, in a recent statement by the company.

Breuer mentioned that in addition to old age, being immunocompromised is among the most common of risk factors for shingles, and that GSK is committed to aiding this vulnerable group with the Shingrix vaccine.

According to a report by Avalere Health, more than 17 million doses of recommended vaccines were missed by adults during the ongoing COVID-19 pandemic. However, more than 100 million adults 50 years and older received Shingrix prior to COVID-19.

Breuer hopes that individuals who missed their Shingrix vaccine due to the pandemic will catch up on their immunizations soon.

An estimated 1 million cases of shingles are recorded each year in the US, and 1 in 3 Americans will develop shingles in their lifetime.

However, with the 2 recent FDA approvals, and marketing authorization for Shingrix being granted in Europe in August 25, 2020, GlaxoSmithKline remains optimistic that their vaccine can continue to help an ever-growing number immunocompromised patients in the prevention of shingles.

Shingrix was originally approved by the FDA in 2017 for the prevention of shingles in adults 50 years and older. Now, it’s approved for those 18 years and older who are immunocompromised.

FDA Approval Helps Immunocompromised Shingles Sufferers

Comes a point in a health care provider’s work life when she or he might be tempted to throw up their hands. It can happen when they’re dealing with the person with diabetes who won’t stay away from sweets, or the person with a substance abuse problem who refuses to seek counseling, or the person with heart problems who won’t take their medications. Compassion fatigue has been around a long time and providers should always be on guard against it says the 

Centers for Disease Control and Prevention

 (CDC). Perhaps especially these days when it comes to infection preventionists and other health care professionals who have to treat people who refuse to get vaccinated for COVID-19. The CDC says that as of yesterday, only 49.1% of Americans have been vaccinated, nowhere near the number needed to fend off variants such as the rapidly spreading 

. The ability of variants to circulate among the unvaccinated increases the possibility that COVID-19 might mutate into a strain that can neutralize the vaccines, a possibility some experts have detected in the 

Heather Saunders, MPH, RN, CIC, the director of infection control at the Johns Hopkins Office of Population Health, and a member of 

’s Editorial Advisory Board (EAB), says that it’s impossible to generalize about compassion fatigue though “I do think that for some individuals, providing care to unvaccinated patients could trigger compassion fatigue. Health care workers are experiencing various degrees of psychological trauma, including [post-traumatic stress disorder], as a result of their experiences during the pandemic. This trauma could lead some individuals to feel a sort of indifference or irritability toward unvaccinated individuals who they believe are perpetuating the pandemic.”

EAB member Linda Spaulding, RN, BC, CIC, says that while she hasn’t seen compassion fatigue affect patient care “it is depressing staff because we know the patients could avoid getting COVID and decided not to get the vaccine. Patients ask for it [pre-admission] but that’s too late and they can’t get vaccinated while sick with COVID. It’s just very sad.”

EAB member Kevin Kavanagh, MD, has written extensively for 

. Kavanagh points out that compassion fatigue can always pounce because poor decisions made by patients necessitates much of health care treatment.

“Vaccination rates are not only low with the public but also with health care workers,” Kavanagh points out. “All need to realize that the public looks up to health care workers for guidance and many have cited the example of unvaccinated workers as influencing their decision.”

Kavanagh also points out that many health care workers suffer from PTSD, as 

“Ideally, counseling and time off of work is desperately needed,” says Kavanagh. “Unfortunately, this is not possible and we will be soon facing a health care worker shortage. The solution is for everyone who can, to become vaccinated and we all need to adopt strict public health strategies. And for all to support, however possible, our frontline workers.”

Robbie Hilliard, MSN, RN, CIC, the infection control coordinator for Carl Vinson VAMC in Dublin, Georgia, recently wrote an 

 about how Veterans Affairs nurses tackle infections. Hilliard says that there’s a danger that compassion fatigue could set in when it comes to treating unvaccinated COVID-19 patients, but tries not to simply dismiss the concerns of the unvaccinated.

“As a nurse, I am vaccinated for COVID-19, but I still have co-workers who are not, which just emphasizes the importance of understanding and accepting people’s personal choices,” Hilliard tells 

Hilliard agrees that compassion fatigue comes with a provider’s job “and I am sure, at times, compassion fatigue creeps in with COVID patients, but most of us understand the fear associated with the unknown/new pharmaceutical treatments that have long-term unknown effects.”

The attitude that both Kavanagh and Hilliard encourage—patience in the face of vaccine hesitancy—might be easier said than done. For instance, CNN 

 a nurse identified as “Sunny,” who works in Western Arkansas. Sunny says that it’s difficult to watch people die and then “so many people on Facebook or in a Walmart tell you you’re a liar…. Nurses have really been the symbol of the pandemic and all of the hate has been centralized around us…. We heard it more than once that we were killing people on purpose to make it look like it [the COVID-19 pandemic] was worse than it was.”

 states that the tools used before COVID-19 to alleviate compassion fatigue among physicians might not suffice now. “The pandemic has only increased the need for physicians to receive social/emotional support from their institution and to feel their workplace contributions are valued,” the study states. “Successful pre-pandemic workplace interventions may not adequately support physicians during the pandemic.”

The study, by investigators with the Icahn School of Medicine at Mount Sinai, states that “the personal and professional aftershocks of the current SARS-CoV-2 pandemic for physicians will likely persist well into the foreseeable future. Our results suggest that institutions may be able to mitigate these effects using targeted interventions aimed at conveying to physicians that they are valued.”

Not nearly enough Americans are vaccinated to prevent COVID-19 from doing further damage. For some providers, dealing with patients who refuse to do what’s best for them can trigger compassion fatigue.

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A patient returns to your hospital after a vaginal ultrasound procedure with an infection. A look-back of this potential health care-associated infection (HAI) includes a review of the vaginal ultrasound probe that was used to perform this patient’s procedure. Can the probe be traced to the patient? Was the probe high-level disinfected based on intended use?

To answer these questions, a health care facility must have standard policies and procedures (P&Ps) in place, procedures that outline the approach to the high-level disinfection process and traceability of a vaginal ultrasound probe (or a surface probe based on intended use). Additionally, knowledge of the 3 definitions outlined in Table 1 should be understood to navigate our scenario. Staff should be trained and retrained to ensure consistent implementation of P&Ps to help ensure patient and staff safety.

An understanding of law and regulation (i.e., the Food and Drug Administration (FDA), the ultrasound probe manufacturer’s instructions for use, and nationally recognized evidence-based guidelines for high-level disinfection. Guidelines from, for example, the Centers for Disease Control and Prevention (CDC), the Association for the Advancement of Medical Instrumentation (AAMI), and the Association of periOperative Registered Nurses (AORN) should be consulted when developing and implementing P&Ps.

The FDA regulates the labeling of medical devices such as ultrasound probes and liquid chemical sterilants/high-level disinfectants. The FDA uses the Spaulding Classification System, and here are some examples.

Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. Guidance for Industry and Food and Drug Administration Staff

Cleaning, Disinfection, and Sterilization that

 “the probe used in a semi-critical application should be cleaned and undergo sterilization or at least receive high level disinfection after use even if a sheath was used. Sheaths can fail during use, and the level of resulting contamination may not be easily visible.” 

In the Code of Federal Regulations, Title 21, 

a liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semi-critical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semi-critical devices make contact during use with mucous membranes or nonintact skin.”

Having a complete organization-wide inventory and location of all ultrasound probes and their respective ultrasound units is an advised initial approach. This should then be followed by a comprehensive review of all ultrasound probe instructions for use (IFUs). When IFUs are not clear, or information is missing, contacting the manufacturer is recommended. It is important to consult IFUs for compatible disinfection products and other information. For example, one manufacturer IFU states: “

When choosing a disinfectant, determine the required level of disinfection based on device classification. If the possibility of cross-contamination or exposure to unhealthy or non-intact skin exists, then high-level disinfection should 

.” It is important to review the IFUs in their entirety for complete instruction.

Examples of recommended evidence-based guidelines on high-level disinfection and traceability include those from AAMI and AORN. These documents detail the importance of traceability and information that should be collected and linked to the 

. They recognize that maintaining high-level disinfection records helps ensure that parameters for correct high-level disinfection have been met, helping manage recalls in potential outbreak situations, and establishing traceability and accountability. For each high-level disinfection cycle, one of the elements that should be recorded and maintained, in addition to the high-level disinfection parameters and unique device, includes the patient’s name and medical record number, if available.

The documentation log displayed in Figure 1 is an example log for an automated high-level disinfection (HLD) process. This method incorporates sticking the printed label generated from the automated HLD process in the documentation log-book next to the patient label or sticker. The label generated from the automated HLD process can also include the serial number of the HLD automated unit, the date and time, the HLD cartridge lot number, and expiration date, along with the chemical indicator lot number and expiration date, the operators, and probe. Where this is not available, space in the log can be made available to record this information, as shown in Figure 1. Incorporating the use of automatically generated labels can help save time and reduce the risk of error from manually recording and checking information.

When an ultrasound probe is not compatible with an automated process, as determined by the manufacturer, a manual HLD process may be the recommended method by the manufacturer. To complete documentation, the following needs to be recorded by staff: the HLD product, date processed, lot number, expiration date, temperature, immersion time (time-in and time-out), operator initials, and minimal effective concentration of the test strip used to check the HLD. The test strip used corresponds to the HLD product. The quality monitoring of the test strip, lot number, and expiration date are recorded in the documentation log. Documentation logs for a manual process may be found from the manufacturer of the HLD product for consideration. These key elements are essential to documenting the HLD process of the ultrasound probe, in addition to providing the patient label or sticker to the uniquely identified ultrasound probe to link the probe to the patient. All HLD product and test strip instructions for use should be consulted and followed.

Having one standardized method to complete traceability that links the ultrasound probe that has been high-level disinfected to the patient is best practice in a department and across a facility. A routine review or audit of the documentation components to identify any gaps or omissions is essential to supporting a highly reliable HLD process.

Traceability in ultrasound probe infection prevention enables facilities to demonstrate at any time that they have met their standard of quality and safe care for their patients. Traceability demonstrates that the facility and its staff are following law and regulation, manufacturer IFUs, and nationally recognized evidence-based guidelines across any department utilizing ultrasound probes that require high-level disinfection based on the intended use.

Traceability information and documentation logs are essential tools for infection preventionists (IPs), department heads, and risk and quality management. From a legal, risk management standpoint, having records that demonstrate P&Ps are being followed by staff helps minimize the risk of an adverse patient safety event, and can help identify potential areas that require staff retraining or improvement. As HLD processes are heavily scrutinized during accreditation or regulatory surveys and remain a top non-compliant scored standard, attention to these elements is advised.

Standardizing ultrasound infection prevention and traceability in a facility helps ensure the safety of patients and fellow staff. It is important to develop and maintain an ultrasound probe inventory with clear identifiers for each device in use. A standard approach should be used to select evidence-based guidelines for P&Ps, and when implementing P&Ps, standardizing high-level disinfection processes across the organization to include documentation is advised.Consider incorporating digitization of documentation into the workflow, if and where available, to minimize manual record-keeping and any associated risk of error. Be knowledgeable and perform oversight, audits, and validation on a routine basis.

The IP reviewed the documentation log for traceability of the patient in the above scenario. The department that had performed the vaginal ultrasound procedure had complete traceability documentation based on following the guidance above. They were able to demonstrate the probe had undergone HLD successfully before it was used in the vaginal exam on the patient.

Lisa Waldowski, DNP, RN, CIC, is an expert in the field of infection prevention and control with over 30 years of experience in the health care industry. An expert in accreditation and regulatory standards, Waldowski knows how to develop and implement comprehensive infection prevention and control programs. 

She currently works as a Regional Director in Infection Prevention and Control at Kaiser Permanente. The views expressed in this article are Lisa Waldowski’s, and not Kaiser Permanente’s.

The high-level disinfection process of an ultrasound probe, when indicated, includes documentation that demonstrates high-level disinfection was performed, and patient identifiers were documented to link the ultrasound probe to the patient. This is often referred to as traceability.

How to Document the High-Level Disinfection Patient Connection

strikes again, but this time the deadly Superbug’s super toxic powers seem to have been enhanced. The Centers for Disease Control and Prevention (CDC) reports that 

uris outbreaks have occurred in two hospitals in the Dallas-area, and a nursing home in Washington, D.C. What makes this a particularly troublesome development is that the Superbugs appear to be pan-resistant—that is resistant to all antibiotics available—and that includes echinocandins, a class of anti-fungal drugs that have proven to be the most effective against 

“These two simultaneous, independent clusters of pan- or echinocandin-resistant 

 cases in patients with overlapping inpatient health care exposures and without previous echinocandin use provide the first evidence suggesting that pan- or echinocandin-resistant 

 strains might have been transmitted in U.S. health care settings,” CDC researchers 

). “Surveillance, public health reporting, and infection control measures are critical to containing further spread. Clinicians should consider early antifungal susceptibility testing in patients with 

 infection, especially in those with treatment failure.”

Also worrying, the clusters in the 3 health care facilities seem to have been created as a result of 

Meghan Lyman, MD, medical officer in the CDC’s Mycotic Diseases Branch

“Among 22 clinical and screening cases of 

 in Texas during the same period, two were pan-resistant and five were resistant to both echinocandins and fluconazole,” the 

 report states. “These seven cases were identified in patients who were cared for at two facilities that share patients in the same city; two patients were at a long-term acute care hospital, three at a short-term acute care hospital, and two at both facilities.”

Meghan Lyman, MD, a medical officer in the CDC’s Mycotic Diseases Branch and the report’s corresponding author, said that “this is really the first time we’ve started seeing clustering of resistance” in which patients seemed to be getting the infections from each other.

 report states that “data are lacking about the most appropriate therapy for pan-resistant infections. Combination and investigational antifungal treatments can be considered, but evidence in clinical settings is limited. More information is needed to evaluate patient outcomes and identify proper treatment for 

 cases with pan-resistance or echinocandin resistance.”

 has been diagnosed in 40 countries since the first report about it in 2009, when clinicians found a single isolate from the discharge of the external ear canal of a 70-year-old inpatient at Tokyo Metropolitan Geriatric Hospital. By 2016, 13 cases had been identified in the United States, leading the CDC to issue interim recommendations, as well as a clinical alert, requesting laboratories to report cases and send samples to state and local health departments and the CDC.

 is difficult to identify with standard laboratory methods. It can be misidentified in labs without specific technology, which can lead to mismanagement.

Elizabeth Jefferson, PhD, CIC, an infection preventionist in the infection prevention and clinical epidemiology department at Scripps Memorial Hospital La Jolla, explained at the annual conference of the Association for Professionals in Infection Control and Epidemiology in June how quick action at her facility stopped 

 that “it’s really important to know that it just takes like one single case. You have to really pay attention and make sure that it stays contained so that you don’t have an outbreak. It just takes one case.”

 of pathogenic threats. The other list categories are “serious” and “watch.” The CDC also encourages quick action when faced with 

 on antibiotic resistant threats, the agency cites a case of a patient in a long-term care facility who tested positive for the disease. “An extensive, aggressive containment response followed that involved screening hundreds of patients. When a new patient was identified as carrying or infected with 

they were immediately put under special precautions to prevent spread. This vigilant action by public health officials and health care facilities helped control the spread of 

in Orange County, protecting hundreds of vulnerable patients.”

 report states: “Approximately 85% of 

For the first time, according to the CDC, health care institutions in the United States have to grapple with a form of C. auris that’s resistant to all antibiotic and antifungal treatments.

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