A year ago, we were just starting to feel the weight coronavirus disease 2019 (COVID-19). The seriousness of a novel respiratory pathogen, the worry that we weren’t ready, and then the reality that this was getting worse, and it wasn’t going away anytime soon. March in particular was a grueling month and one that frankly seemed to be that moment where we all took pause.

 against rising cases and overwhelmed hospitals, still sits with us and bears a continued reminder of the early signs that COVID-19 was going to be devastating. It was March 2020 that New York City initiated a full lockdown and for many of us, served as a warning of things to come. The stressed hospitals, extremely ill patients, and challenges of responding to a novel disease, were all something we were witnessing before us and in many ways, felt helpless to stop. I remember at this time thinking that what was happening in New York City was the warning we needed to listen to and one that told us to prepare for not only the hurdles ahead, but the longevity of a pandemic.

It seems like March is a month for reflection. While many thought a year out we would be done dealing with COVID-19, I think so many of us working in infection prevention and public health knew that it would take longer. I wonder, though, what has changed and will this be a different March or are we set to relive the same issues like a COVID-19 version of 

Now, it seems as if we have a more clear-cut goal and less of a divisive approach to pandemic response for the United States as a whole. Two (almost 3!) effective vaccines are being distributed across the US and we’re working to address vaccine hesitancy and equity. While there have been some discussions around a potential plateau of cases in an otherwise downward trend, it’s likely too early to tell. Moreover, there’s increasing 

 from a Centers for Disease Control and Prevention (CDC) that is now much more communicative and involved in response.

When we look at where we’ve come in the past year, it seems as if we’re settled in response—we know the drill. From personal protective equipment (PPE) to patient management and isolation precautions, the infection prevention piece to COVID-19 is pretty settled. Now is about sustainability, reducing health care-associated infections in those critically ill COVID-19 patients, and operational nuances to updated guidance, such as quarantine for those vaccinated or double-masking. More transmissible variants are a newer concept as well, testing our ability to stay vigilant in both health care and the community, but also reinforcing that continued efforts like genomic surveillance are necessary to stay limber in a pandemic.

One thing though, as we look to the past year and our efforts in infection prevention, is that it becomes apparent that we will likely be dealing with COVID-19 for longer than hoped. Moreover, as we have addressed many of the challenges in health care, our IPC efforts also must turn to the community level. The nuances of how to function in this partially vaccinated world, in the face of variants and questions about sterilizing immunity, are often confusing. Infection prevention isn’t unique to health care, but rather representative of a bigger role within the community – it’s where health care and public health meet. In the past year we’ve seen how critical infection prevention is and how these skills and pragmatic educational efforts are so vital to address transmission. I’m hopeful that our work in harm reduction, risk education, and infection prevention across multiple venues mean that this March is one focused on vaccine distribution and continued downward trends instead of racing to catch up.

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Infection prevention isn’t unique to health care, but rather representative of a bigger role within the community – it’s where health care and public health meet.

Avoid March Madness—Keep COVID Contained

Bug of the Month helps educate readers about existing and emerging pathogens of clinical importance in healthcare facilities today. Each column explores the Bug of the Month's etiology, the infections it can cause, the modes of transmission, and ways to fight its spread. The pathogen profiles will span bacterial, viral, fungal and parasitic species. We encourage you to use Bug of the Month as a teaching tool to help educate healthcare personnel and start a dialogue about microbiology-related imperatives.

Bug of the Month helps educate readers about existing and emerging pathogens of clinical importance in healthcare facilities today.

Bug of the Month: If a Flea I Infect Bites You, Flee to Your Doctor

In a way, SARS-CoV-2 resembled science fiction’s hypothetical dark matter: Its existence could be inferred but couldn’t be clearly defined—until it appeared. In other words, coronavirus disease 2019 (COVID-19) may have taken a lot of people by surprise, but its possibility wasn’t in doubt. As Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), and David Morens, MD, NIAID’s senior scientific adviser, write, this has been “but the latest example of an unexpected, novel, and devastating pandemic disease…[w]e have entered a 

But while coronaviruses aren’t new to us, COVID-19 shifted our recent experiences with SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome) into hyperspeed. “We weren’t prepared for it. It put us on our heels,” David Aronoff, MD, tells 

. He speaks to the way infectious disease experts live now—always on the 

 for the next pathogenic threat. “We’re 

 concerned that something will be around the corner. And we’re living on a street that’s all corners.”

Aronoff is director of the Division of Infectious Diseases, Department of Medicine, and professor and Addison B. Scoville Jr. Chair in Medicine at Vanderbilt University Medical Center. He has a lot to do in his regular jobs, but like his colleagues in infectious disease, he pretty much dropped everything else to concentrate on COVID-19—“to just lean into it,” he says. That includes, for instance, giving 2 lectures on COVID-19 one day, and 3 the next.

But that doesn’t mean that he, or others in the field, have abandoned preparations for other pathogenic threats. There’s always something else on the radar. In fact, “we haven’t gone a generation without emerging threats,” Aronoff says. “It characterizes the profession that we’re confronted by them on a regular basis.”

With the current pandemic running everyone in health care ragged, this may not be the best time to ask, “What’s next?” But…what’s next? What pathogen(s) not called COVID-19 should we be most concerned about? And where will it (they) be coming from?

On Aronoff’s list of concerns: Diseases that might not cause pandemics, but cause small epidemics. “I get particularly nervous about antibiotic-resistant infections that we thought we had control over, but then lost control of. Gonorrhea is a good example. It’s increasingly hard to treat with antibiotics, and increasingly easy to spread.”

Priya Nori, MD, also puts antibiotic-resistant infections at the top of her list. Nori is associate professor of medicine (infectious diseases) and of orthopedics at Albert Einstein College of Medicine and medical director of the Antimicrobial Stewardship Program at Montefiore Health System. She also co-developed the Infectious Diseases Society of America and the Centers for Disease Control and Prevention (CDC)’s 

resource page for stewardship during COVID-19. This includes up-to-date information from infectious diseases physicians, pharmacists, and infection preventionists (IPs) on personal protective equipment, vaccines, therapeutics, stewardship—“anything you can think of related to the pandemic,” she says.

As she speaks on a Zoom call, enormous COVID-19 molecules loom over her shoulders, a sad metaphor for these days (“I put the background up for a med student lecture weeks ago, and now I don’t know how to take it down,” she says).

“If we think of it in the immediate COVID aftermath, we’re greatly concerned that we’ll see emergence of lots of multidrug-resistant bacteria and fungi,” Nori says. “And these are not novel pathogens necessarily, these are things we had before but that were starting to get lots of attention the past few years before COVID because they had become so widespread. These are the most concerning things, I think, to the folks [who] practice infection prevention and ID [infectious disease]. As soon as COVID starts calming down because of control measures and vaccinations, I think we’re going to unmask all these other things that COVID left in its wake.”

One reason, she says, is that there was a lot of excess antibiotic use, especially in the early stages of the pandemic, which has probably abated now that people are more aware of how the disease works and its long-term effects. “But we’re worried because lots of patients, if they’re fortunate enough to survive COVID, unfortunately end up in a sort of chronically medicalized state. There’s a whole new population of long-term-care residents who are now bedbound, plugged in to lots of devices, meaning catheters, tracheostomy tubes, PEG [percutaneous endoscopic gastrostomy] tubes, urinary catheters. This is exactly the type of host who becomes colonized with multidrug-resistant pathogens, which can spread within health care facilities, like long-term care and acute care.”

One of the things that CDC infectious disease experts have found to be a problem, possibly re-emergent due to the COVID-19 pandemic, is carbapenem-resistant 

, Nori says. “Any kind of carbapenem-resistant Enterobacteriaceae, especially the extensively drug-resistant ones, like New Delhi metallo-beta-lactamase–producing Enterobacteriaceae, these are definitely the things to watch for.”

Moreover, people who have been hospitalized with COVID-19 are particularly vulnerable to all the “old” hospital-acquired infections. They may have survived COVID-19, but they survive with substantial damage, immunologically and to organs, and then pick up other infections along the way.

However, in some interesting ways, COVID-19 may actually have contributed to the benefits side of the ratio in hospitals. Nori says, “Because of the really heightened control measures for COVID-19 in hospitals, somehow 

has not played a role in this as we initially thought. Part of that is that we were not testing as much for 

, but even if you correct for that, it seems like 

 has maybe not been as much of an issue as some of these other pathogens.”

Does that good thing balance out some of the bad things? “Potentially,” Nori says. “But then you worry that you’re just sort of squeezing the balloon, and that one thing gets better but at the expense of another thing. So, it’s probably a little too early to celebrate. Maybe 3 years down the road, if it seems this really mitigated that issue, then I think it is definitely a win.”

In addition to home-grown pathogens, we have to worry about others that come from far-flung regions. Both Aronoff and Nori point to what some of our deadliest contagions have had in common: The viruses were transferred via air. “If you look back over the history of the world,” Nori says, “it’s really respiratory viral pandemics that have been the ones that have infected and killed people across borders and have gone on and on for many years and sometimes revisit.

“As far as long-term concerns,” she adds, “definitely what’s likely to lead to a pandemic state is another respiratory viral pathogen, without a doubt, because these are the things that spread most quickly, that are most transmissible between human beings, and have extensively high viral loads that make it very easy to spread between individuals.”

What’s more, it’s very likely, she predicts, that the next pandemic could be due to a respiratory viral pathogen that hasn’t been seen before, because of some kind of mixing of genetic elements from different species. The species-mixing element concerns Aronoff as well: As we’ve discovered, many viruses that live in animals can jump to humans.

However, the next big threat could also very well be an old one. In many ways, the world has been becoming more hospitable to pathogens we thought we’d seen the end of. And it’s hard to fight the 2 main things that drive the threat, Aronoff says: evolution and opportunism. Pathogens like cholera, diphtheria, tuberculosis (TB), and malaria take advantage of people gathering or living in crowded spaces, people with already poor health.

“Infectious disease is a kind of barometer for other causes, geopolitical, social disturbances or inequities, even political,” says Aronoff. “TB is a great example. It hits on all cylinders: crowding, lack of effective vaccines, malnutrition, poverty. It’s a disease that’s been around forever, but scares us in ID as a newly forming threat. It’s both a looming and perennial threat.”

On the other hand, Nori says, “That’s what makes this whole area of study so fascinating. It’s the convergence of the climate crisis, politics, conflicts…. Infectious diseases that we previously eradicated, or things that really should be under control in the year 2021, like cholera, diphtheria, those are reemerging because of regional conflicts.”

Another factor, climate change, is also driving changes in infectious disease. As animals and people migrate, searching for a more livable environment, we see vector-borne or insect-borne diseases shift with them. “There may not be emerging or entirely new diseases, but 

Now add in human mobility (as in global travel), and it’s a recipe for another worldwide catastrophe. The reality is that plagues have been a part of human life since hunter-gatherer days—it’s just that nowadays the diseases get around the world much faster. It took the Black Plague roughly 2 years to travel from Italy to Scandinavia. It took SARS-CoV-2 about 4 months to travel from China to Seattle, Washington, to New York, New York. Dengue, chikungunya, Zika—they’re all on the move. Zika, for one, started out in a relatively small area of the world, and is now found in 

It all sounds ominous, but Aronoff is reassuring, in a restrained sort of way. We might not have been prepared for COVID-19, he says, “but we’ve learned lessons about how to deal with other pathogens. It’s possible to be frozen in anxiety and fear about what’s next, but this is what we’re trained to do. We’re trained to look for emerging threats and figure out how to deal with them.”

What can be done to make the next pandemic—and there will be one—less traumatic? “We need more,” Nori says. “We need more advocacy, we need more resources diverted toward really bolstering very strong IP programs in hospitals and long-term care. The decisions we make, the policies we put into place, they’re impacting the entire system, and not just the one patient at a time. I hope that resources are allocated accordingly after all this, whereby it’s a more proactive approach, rather than trying to fix a problem after it’s too late. If you really invest in that workforce, the ones leading prevention and patient safety, then collateral damage to the system won’t be nearly as bad.

“Health leaders recognize it, definitely, now. They see where the holes are. Unfortunately, where hospitals find themselves now in terms of the bottom line, that type of resources investment is probably not going to be possible for a long time. What’s awesome, though, is that the new CDC director [Rochelle Walensky, MD, MPH,] is an infectious disease physician who practiced medicine. She gets it. She gets what we all do, and I think once the dust settles on all this, she’s going to be a tremendous advocate for IPs.”

As we scrounge for silver linings to the COVID-19 cloud, one might be the growing recognition of how crucial the IP job is. “It’s certainly been a really interesting year for our discipline,” Nori says. “Finally, I think people understand what we try to do on a day-to-day basis. Infection prevention has really come into the forefront.”

In fact, given all that’s been going on, and all that could be going on, Nori thinks it’s time for a loud shout-out to IPs. “I want to advocate for our people. They’re holding this whole thing together. And by extension, infectious disease physicians. We hold the fort. We’re the glue. We keep the hospital running, make sure elective surgeries can still happen. We continue to think about these things when everybody else goes to sleep at night.

“If this country, the world, successfully emerge from this whole crisis…thank your neighborhood IP, basically.” She chuckles. “Give ’em a hug and kiss. Well, maybe not a kiss.”

When the world gets back to some kind of normal, maybe it will include some positive change coming out of this health crisis. In the meantime, to avoid turning the world into one huge disaster movie, Aronoff warns, “It’s really important that we keep our head in the game.”

“We remain at risk for the foreseeable future,” say both Fauci and Morens. “COVID-19 is among the most vivid wake-up calls in over a century. It should force us to begin to think in earnest and collectively about living in more thoughtful and creative harmony with nature, even as we plan for nature’s inevitable, and always unexpected, surprises.”

This may not be the best time to ask, “What’s next?” But…what’s next? What pathogen(s) not called COVID-19 should we be most concerned about? And where will it (they) be coming from?

Ready for the Next Pandemic? (Spoiler Alert: It’s Coming)

The general trends for coronavirus disease 2019 (COVID-19) are looking great these days: infections, hospitalizations and deaths have been plummeting, as more vaccines are administered and—perhaps more important—vaccine hesitancy seems to be 

. But children’s hospitals are seeing something that has given medical experts pause: a 

 in multisystem inflammatory syndrome (MIS-C) and it happens to children who’ve gotten COVID-19. Linda Spaulding RN, BC, CIC, CHEC, CHOP, is a member of 

’s Editorial Advisory Board. Spaulding tells 

 that the effect that COVID-19 has on children hasn’t been given much attention, but it’s a serious matter. According to the Centers for Disease Control and Prevention (CDC), 

 “is a condition where different body parts can become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs.” The CDC admits that it does not “yet know what causes MIS-C. However, many children with MIS-C had the virus that causes COVID-19, or had been around someone with COVID-19.” Spaulding says that MIS-C can do irreparable damage to the heart. “It can be fatal in kids.” 

What’s your take on multisystem inflammatory syndrome?

Linda Spaulding RN, BC, CIC, CHEC, CHOP: 

Infection preventionists have been watching this since the beginning of COVID. It is called MIS-C, which is, as you mentioned, multisystem inflammatory syndrome in children. And it can happen when they first get infected with COVID or it can present after they’ve recovered from COVID; two, three, four weeks after they’ve had COVID. It’s very important that parents are watching for this and that they get the kids to the hospital for proper treatment. Essentially, the kids will show up usually with a red rash. They don’t have COVID anymore. Parents aren’t thinking COVID. But it’s being compared to a disease called Kawasaki disease, which is also the same inflammatory…. The difference is this is related to COVID, whereas Kawasaki is not. But we still in the health care facility, we’re still diagnosing it as Kawasaki, but we know it is MIS-C. And then that’s how we identify it in order to report it to the department of health who goes on to report it to Centers for Disease Control and Prevention (CDC). And essentially, the kids will have a rash. They’ll run a fever. They might get low blood pressure or hypertension. G.I. symptoms such as diarrhea. And it can lead on to myocarditis, which is an inflammation of the heart. And that’s when we start seeing more of the kids being 

admitted; when it gets a little bit more involved. And with COVID we know we’re looking for the majority of the time the beginnings of a respiratory tract infection or runny nose. Just slight congestion, some people have. Other people go on to develop worse respiratory issues. With Kawasaki or MIS-C, we aren’t always seeing the respiratory involvement. It’s more of the rash and the G.I. symptoms leading on to myocarditis, the inflammation of the heart, but it can be fatal in kids. And I don’t think it’s really been getting enough publicity. Everybody’s been focusing on the vaccine. “When are we going to have the vaccine out there?” The unfortunate thing is there is no vaccine for children. And we’ve seen this MIS-C in as many as, well thousands of children to at this point, and they can go all the way up to age 17 or 18. So it’s not just the small children. And the kids that we have to worry the most about are the kids that have cystic fibrosis or sickle cell anemia; other underlying health issues, because that’s going to make a difference related to the recovery.

You mentioned inflammation of the heart. And I know from talking to you and other experts that that’s one of the things people are worried about. Young people may get COVID-19 and appear to bounce back. But 10 or 20 years down the road they might get heart problems. Is this one of your concerns also?

People keep talking about, “Well the young kids. They’ll get it. They’ll get over it. It’s no big deal.” But that’s not the reality of it. There are many young kids that have gotten COVID and are now dealing with what they’re calling long-haulers disorder. And that’s when they do have heart damage, or they have lung damage. And it appears right from what we know is that will be lifelong. The young people that think, “Oh, I can go do what I want to do. And if I get COVID, that’s fine. I’ll get over it.” That’s not the case. And the information needs to be gotten out to younger people. And it’s very difficult to change young adults thought processes, but they could actually get COVID and that could change the rest of their life. If you end up with heart damage, there’s no going back from that. They end up with lung damage, and you’re having problems breathing when you’re just walking, how are you going to work? You’re 19 or 20 years old. It could affect your life forever. And that’s one of the things that I don’t think is really getting out to the young people. And if it is, you know, when I was that age: “Nothing’s going to affect me.” You think you’re invincible.

You just mentioned an age group of 19 to 20 years old. When you talk about the children who could get MIS-C, are we talking about infants on up to young adults?

As far as MIS-C, we’ve seen it from a year old to sometimes 14 or 15, maybe the 16-year-old population. Over that is just when they get COVID and they get the lung damage, heart damage.

An epidemiological question: Is this a disease that’s caused by SARS-CoV-2 that’s not COVID-19?

MIS-C is related to COVID-19. That’s why it’s called multisystem inflammatory syndrome. And then the C stands for COVID.

And it’s just how COVID-19 can affect different people in different ways, right? Officials at children’s hospitals are quite concerned about this. What are the protocols for helping children in this situation? Is it the same as how you would help an adult suffering from COVID-19?

Yes. You’re just going to support them with IV fluids, support them with whatever medications that are needed for however they’re presented. If they’re presenting for fever, we give them antibiotics to bring their fevers down. If they need a ventilator, because of breathing issues, we put them on a ventilator. The majority of them, if they don’t have underlying diseases like cystic fibrosis, or some of the other childhood issues, then they do pretty good. But there are children who have died from MIS-C. And I think that’s an important thing for parents to know. Prevent your kids from getting COVID. You don’t have to worry about whether or not they’re going to get MIS-C.

I’ve seen statistics. I’m sure you’ve seen statistics … and there are a lot out there. As you always say, go to the CDC or go to the World Health Organization to get updated information and even then, check twice. I’ve read that kids don’t get COVID-19 and they don’t spread it. Does MIS-C put that in doubt?

I’m glad you brought that up, because: one, kids do get COVID. And when I was getting ready to talk to you, I decided to look up just how many kids have had COVID since the beginning of this. And I think this is where, the public isn’t getting this information, because this will be a surprise to quite a few people. And when I looked it up, there have been 3,104,010 cases of COVID-19 among kids between the ages of zero and 20. So that’s 3 million kids. That means that 13.1% of all the cases of COVID-19 that we’ve seen in the US have been children. And the problem with that is the numbers could be much higher because of at any given time, we might have 10 states reporting, you might have 24 states reporting. Rarely do all the states report how many children they have. Rarely do states report how many children have died of COVID. Every single state has decided to publish their information differently. It’s very difficult to pull a number together and look at it. But right now, it looks like the case rate for children: there is about 4124 children per 100,000, they get COVID. We have a population of 100,000, 4124 of those will be kids.

And you’re getting those statistics from where?

It’s from the American Academy of Pediatrics.

I’ll go back to the question you asked, I wonder why this is not getting out?

Well, I think it gets out once in a while, but it’s not a hot topic. We’re focusing so much on should kids go back to school, but nobody’s talking about the issues around that; in the number of kids that have had COVID already. And I don’t know why the numbers aren't reported out more. It may be because they’re reported so differently in every state, that it’s difficult to get a good grasp on what we’re looking at. Or it’s just not newsworthy, so to speak, but it is talked about in hospitals every morning. “How many kids do we have? How many adults do we have?”

Let me circle back to something you mentioned earlier about how children aren’t eligible for vaccinations.

They are not. Kids from the age of—I think it is—16 and up can get the Pfizer and Moderna. I don’t know what the age limit is going to be on the Johnson and Johnson, but I think it’s probably going to be pretty much the same area. They are doing studies now. I know Pfizer’s doing studies on younger children. And so hopefully in two or three months—probably more likely three months—we’ll have some data on that, on the efficacy and the safety. I’m sure right now they’re trying to figure out what is that dose that’s safe for kids.

You and I have talked about this offline; how we’re all dying to get our old lives back. To do what we used to do before we were hit with COVID 19. Now, that has to be weighed against the risk. Taking that into account: school openings. I’m asking you to step into a public policy debate here: but school openings and just opening society in general. Do we still know too little about COVID-19 to do that? Or is the harm of closing or at least social distancing starting to exceed the harm caused by COVID-19?

I think it depends on where you are in the country. So much of COVID is: It depends, unfortunately, because we still don’t know that much about it. But what we do know is that children that get COVID don’t spread it as easily and as fast as adults do. OK? Probably part of that reason, the kids are so short, and adults are up here. So, if they’re coughing, they’re coughing down here, and then it hits the floor. But when you get into the teenagers, then that’s different. But teenagers you can work with to have them wear masks to have them wash their hands a little bit easier than you can with 3-, 4- or 5-year-olds, or even kindergarteners. I think there is a smart way to do it. And I think if you’re in an area where you have only a few cases of COVID—and there are those areas, because the United States is so vast—then kids could go back to school safely, teachers could wear masks. And most likely there wouldn’t be any transmission. If you go to a place like New York, or even Florida here where the numbers are still in the thousands every day, then that increases the risk more. But there are schools out there that have opened up and have had absolutely no transmission within the school at all. You have to look at your geographical area and is it safe or is it not safe? My niece is a teacher in Cleveland, Ohio. And we’ve been talking back and forth, she finally got her second vaccine today. And so, she feels more comfortable going back to school now. She was concerned about it before. Because there was so much COVID in Ohio. Now, all the numbers are starting to come down. And the great news is that it’s starting to come down in the kids as well. I think over the next few months, it’ll be easier to open the schools. I think more teachers will be comfortable with it if they get vaccines, which I don’t blame them. If you have a high COVID population still in your area, then you do want to get vaccinated. But we have to look at each community: What is the circulating COVID in those communities? And open up all those communities that have low cases right now. Rural areas: Some of them have virtually no COVID right now, and other rural areas have high numbers. There is a way to open schools safely now. Just not all schools.

Is there anything I neglected to ask that you think is pertinent and that people should know about?

Be patient. We keep saying that. This will eventually come to an end at some point. Children will go back to school. And you do have to, when you’re making those decisions, you do have to think about the mental health of the children. Some of the hospitals that I’ve worked with, they have had an increase in children coming into their psych units, because of suicidal thoughts, because they’ve had enough of this. And they can’t tolerate it. But to know that the cases among children are coming down just like they are in adults. If you look at January 7, there were 171,079 cases among children reported. On February 18, there was only 70,640. It is starting to come down, things will get better. Health care workers have to get the information out to parents. Watch your child. If they come down with a red rash, post-COVID or when they have COVID or even if they don’t think they have COVID, that they don’t know, get the kids to a physician to take a look at them. Because that’s the important thing.

On what part of the body does the rash usually appear?

It’s on the entire body. It can be just on the trunk or it can be on the face, but the majority of the time, it’s everywhere. It’s a very noticeable rash.

This interview has been edited for clarity and length

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Linda Spaulding RN, BC, CIC, CHEC, CHOP:  “There have been 3,104,010 cases of COVID-19 among kids between the ages of zero and 20…. That means that 13.1% of all the cases of COVID-19 that we’ve seen in the US have been children.”

Q&A: MIS-C Means Kids Not Out of the COVID-19 Woods

As a panel of experts for the US Food and Drug Administration today 

 the data from clinical trials of Janssen’s single-dose vaccine for coronavirus disease 2019 (COVID-19), they may want to also consider how approval of a single-dose vaccine might play with the public. According to a report by the 

, a single-dose vaccine would nudge some Americans who are now hesitant about getting vaccinated toward getting the shot.

The report also finds that there’s more acceptance to getting the COVID-19 vaccine in general: 55% of Americans have either gotten their first shot of a vaccine or say that they want to get vaccinated as soon as possible. That’s an increase from the 47% who said the same thing in mid-January and the 34% who said the same thing in December.

However, 22% of respondents say that they will definitely not get vaccinated unless they have to in order to keep their jobs, or stay in school, or participate in other activities that they want to participate in but that require vaccination.

But even here, there may be an opportunity for overcoming vaccine hesitancy. The report says that 26% of those in the wait-and-see group say that they would be more likely to get the vaccine if it’s just one dose.

The survey of 1874 persons, conducted from February 15 to 23, includes oversamples of about 500 Blacks and 500 Hispanics. Thirty-four percent of Blacks and 26% of Hispanics who are 18 to 29 years old say that they will wait and see how the vaccine works for everybody else before they get it. Eighteen percent of White adults in the that age group say that they will wait and see.

Fear of side effects continues to be the main reason for vaccine hesitancy with 56% of those who “have not yet been vaccinated, including 80% of those in the ‘wait and see’ group, say they are ‘very concerned’ or ‘somewhat concerned’ that they might experience serious side effects from the vaccine,” the survey states.

Any American who wants the vaccine can get the vaccine at no cost, but apparently not everyone has gotten the news. About half of those in the wait-and-see group worry that they may have to pay for it. Also a factor in that group: fear that the side effects might make them miss work and concern that the vaccine might actually give them COVID-19.

As has been much noted and commented on, wanting the vaccine and getting the vaccine are two different things. “Most U.S. adults who have not yet gotten vaccinated (94% of all adults) say they do not have enough information about when and where to get a COVID-19 vaccine once they are eligible,” the report states. “This includes six in ten Black and Hispanic adults who say they don’t have enough information about where to get the vaccine.”

Twenty-six percent of people who are taking a wait-and-see approach about whether to get the COVID-19 vaccine say that they’d be more likely to get vaccinated if it involved just a single dose.

Chart Package: Erosion of COVID-19 Vaccine Hesitancy Seen

This week in particular it seems like there’s been increasing talk of things opening. From restaurants to schools and so many things in between, it seems as if we’re moving full steam ahead. Vaccines are being deployed and cases are down—all things we’ve been working toward and should celebrate. Two things though come to mind—are we being cautiously optimistic or blindly optimistic? How do we handle this challenging time where things are trending in the right direction but there are still many unknowns and work to be done?

First—vaccine distribution is increasing—several states are marking 

 receiving at least one dose. Now is the time that we work to deploy more doses and address perhaps one of the bigger issues we knew would occur—vaccine hesitancy. This is not a new issue and with a pandemic and vaccine development process that was so politicized, it’s not surprising this would be a biproduct.

Data on vaccine distribution though, specifically demographics, has been lagging and shed light on significant disparities. As a recent article in 

 continues to show that people in hard-hit minority communities are getting vaccinated at a much slower pace than people in wealthier white ones.” Coupled with hesitancy—we have a long road to go. Vaccine equity though, is a global issue and the variants are a prime reason why we should be emphasizing this. As the United States and many industrialized countries distribute their vaccines, there is a still a huge disparity as many countries are 

 Viral mutants that result in variants occur when the virus has room to movie (e.g. people to spread between), so when we reduce transmission globally, we reduce the risk of another B.1.1.7. These larger issues are important as we look to the future and what the next few months or even years will look like.

One of the trends I’ve noticed that as things re-open, is that we have often failed to do it in an incremental manner. We learned this in Arizona and ultimately, the U.S. has a bad habit of rushing things when the case counts start to decrease the burden on public health and healthcare. As more people become vaccinated, we will be navigating the aspects of a partially vaccinated public. This will be especially challenging as we learn more about prevention of infection and not just severe disease. As virologist Angela Rasmussen, PhD, 

: “Many scientists are reluctant to say with certainty that the vaccines prevent transmission of the virus from one person to another. This can be misinterpreted as an admission that the vaccines do not work. That’s not the case. The limited data available suggests the vaccines will at least partly reduce transmission, and the studies to determine this with more clarity are underway. There should be more data within the next couple of months. Until then, precautionary measures like masking and distancing in the presence of unvaccinated people will remain important.” While we wade through this optimistic but unknown period in COVID-19 response, it’s important to continue vigilance and patience in these reopening efforts—both within the hospital and in the public.

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As more people become vaccinated, we will be navigating the aspects of a partially vaccinated public. This will be especially challenging as we learn more about prevention of infection and not just severe disease.

Beware Pitfalls of Reopening Too Quickly

The entire health care system has been subjected to incredible change over the last 14 months as it tries to turn back the coronavirus disease 2019 (COVID-19) pandemic. Vascular access is no exception, Kelly Cawcutt, MD, MS, FACP, FIDSA, tells 

. Cawcutt, the associate medical director of infection control and epidemiology at the University of Nebraska Medical Center, says that she’s “seen a much longer length of stay in the ICU than we historically have had. [And] the longer that line is in, the more potential there is for an adverse event, including something like a central-line associated bloodstream infection.” A crisis often invites innovation and Cawcutt says that “at our organization, we have tried to bring our vascular access team and infection prevention team together into a CLABSI steering committee.”

Infections involving vascular access procedures have been a problem for a long time. Has it gotten worse because of COVID-19? Now, this beat reporter assumes that there’s not enough data yet to make that determination. Is that a correct assumption?

 Partially correct. What we’re actually seeing is that with the increasing number of patients from the COVID-19 pandemic, we’re seeing increased numbers of subsequent vascular access. Venous access, ranging from a peripheral IV, all the way to a central venous catheter, is the most common invasive procedure done in the hospital. When it comes down to the data related to reportable infections, such as central-line associated bloodstream infections, we are starting to see a tip up and some early publications showing some associations with increasing HAIs; specifically thinking about CLABSI that are likely due to the COVID-19 pandemic and are more prominent in COVID-19 patients.

 about CLEAN3. Can you tell us what that study was about and what your interpretations of the results might be?

Sure. So, this is a study that was recently published, as you noted, and it’s really looking at two major changes in what is considered a standard of care for peripheral IVs. Peripheral IVs are again, as I mentioned, incredibly common in the hospital. And you can absolutely get complications from those peripheral IVs, including early failure, meaning the IV doesn’t last as long as we’d like, or other complications like infections to the skin locally, or even a bloodstream infection. This can have huge impacts on our patients. But we don’t have a lot of data on how to best optimize peripheral IVs in our patients to minimize those risks. The CLEAN3 study is a single center randomized control trial comparing two different aspects of peripheral IVs. The first part is how we clean the skin. Taking kind of the standard of care from central lines 

with 2% CHG with alcohol combination, compared with our iodine alcohol combinations for skin antiseptics. And then, in addition, in that CHG we are using more recent technology for peripheral IVs to minimize the risk of IV contamination and number of access points to the IV compared to some more standard IV mechanical parts that we’ve had historically. And in this study, they randomized patients that are coming in through the emergency room really only looking at adults and assess the differences in patient satisfaction, in local infections, in complications, in rates of failure. Now, what they saw was with the improved structure of the IVs and the change to CHG alcohol, they did see a lower number of local skin infections and a lower number of complications, including a longer time in which that IV would stay in place. This again, compared to that more standard arm of therapy. What they didn’t have a lot of data for is bloodstream infections, specifically associated to that peripheral IV. And that’s because when you look at the overall number of peripheral IVs, you would need thousands and thousands of patients to really be able to tell a statistically significant difference, or clinically significant difference. Even though they enrolled about a thousand patients, they didn’t have enough patients to show a difference in that particular outcome. But with the outcomes they have, they did show decreased colonization. And like I said, some of these other adverse events. So really giving us some evidence that we can do better. And we can look toward potential other skin antiseptics and technology to improve our peripheral IV complication rates. Now, we really need to expand that study to more sites and more patients, to really look at how we evolved that to a standard of care and really understand the impact on things like bloodstream infections.

One of our Editorial Advisory Board members is a vascular access nurse. During the course of interviewing her once, she said that the longer you can keep an IV in the better. The fewer times you have to change it, the better. Do you agree with that assumption? This study seems to show positive results in this area.

This study is a little unique they have a standard where they change their peripheral IVs every four days. They don’t necessarily take that dogma of “if you can keep it in longer, it’s better.” But they did show longer longevity interval times of those peripheral IVs. In general, there are definite benefits to keeping an IV in place under the assumption that the IV is working. And it is secured appropriately with a good dressing in place. And that the health care team is accessing that IV in a clean way that really meets the standard of care to minimize risk of infection. If the IV is moving in the arm, kind of pistoning in and out of the skin, or starts to develop more redness and inflammation around it, then keeping it in with those kinds of changes is not ideal. If everything is done right, yes, keeping it in as long as we can versus putting in more lines or new lines is a good choice. But if once we start to have any problems with the integrity of the line or the skin surrounding it, then we need to be much more cautious about getting that line out before we have more complications, such as an infection.

As I mentioned, some of our readers are members of vascular access teams. Another core readership comprises infection preventionists. Do they work closely together enough?

I think that each organization is a little different with how well these teams are collaborating. In a perfect world, vascular access teams and infection prevention teams really should be working very tightly together to optimize the practice of putting our vascular access in place, but also the technology and procedures around that. What are we choosing to use? Are we moving our organization collaboratively up to the standard of care, or even evolving new standards with new technology, like we’re talking about with CLEAN3. I also think it’s really important that the vascular access team gets feedback on CLABSI rates and complication rates so they know if they’re seeing an increase of CLABSI or failure rates or any other complications related to lines they put in. But again, every organization is a little different. I think they do need to be tightly married. And personally, I always think there’s more room for improving our communication and our collaboration and things like this.

Do you know of a hospital system or a hospital itself that does this really well? That can be held up as an example?

I don’t know that it’s easy for me to say that there is one particular exemplar. I think different organizations do different aspects of this really well. I think at our organization, we have tried to bring our vascular access team and infection prevention team together into a CLABSI steering committee, and have collaboratively made decisions related to how we access our new data, our CLABSI rates and technology innovations that need to be brought in. But I think every organization that I’ve been at or that I’ve talked to…. I don’t know that I can say with full certainty, especially not having been intricately involved with all those organizations, that there’s one that does all of these things really well. And certainly, this year, when we are all stretched really, really thin, I am not sure how we’ve all done in 2020.

What organization are you affiliated with now?

I work at University of Nebraska in the medical center there. I’m the associate director for our infection control and hospital epidemiology program for Nebraska Medicine, and that is affiliated with our academic center, the University of Nebraska Medical Center.

What’s the main thing that you see changing in your area of interest, which is vascular access, because of COVID-19?

Oh, that’s a great question. And I should have put a caveat in here. I’m an infectious disease physician, but I’m also a critical care medicine physician. I work as a primary ICU doctor in our COVID units. And we’ve actually seen some huge changes in what happens in the ICU, especially to our patients with vascular access, as it pertains to COVID-19. So, a few things. One, we have seen a much longer length of stay in the ICU than we historically have had. So again, the longer that line is in, the more potential there is for an adverse event, including something like a central-line associated bloodstream infection. We’ve also seen changes in the way ICU patients are positioned. And most significantly, the idea of proning our patients. Flipping a patient who may have a vascular access device on the front of their body, but having them laying on their stomach for 16 hours a day, impacts the number of times we can assess the dressing or change the dressing. It may impact just gravitationally what happens with the pull of the dressing. And I think that can really impact things. And a lot of our treatments for COVID-19 have some immunosuppressive impact. And although the data is evolving, and very early there, we are seeing some early data signaling that certain medications may have an association with increased collapses. But that’s not borne out yet to say that that’s the cause.

Kelly Cawcutt, MD, MS, FACP, FIDSA:  “In a perfect world, vascular access teams and infection prevention teams really should be working very tightly together to optimize the practice of putting our vascular access in place.”

Q&A: How COVID-19 Changed Vascular Access Methods

 in December, when it comes to humanity’s battle against bacterial infection, the bacteria have a head start: “If you’re constantly focused on trying to escalate the war of destruction, I think that the bacteria will always win that war,” said Starls, an adjunct professor at Carnegie Mellon University. “They just have too many countermeasures available to them and our rate of developing new antibiotics is far slower than their rate of developing countermeasures.”

Which brings to us to the problems that multi-drug resistant organisms (MDRO) pose to infection preventionists (IPs) and, for that matter, to the entire health care system.

It’s a problem that investigators at Harvard Medical School and Shanghai Jiao Tong University School of Medicine hope will one day be solved, and that their work will have helped to solve it. Investigators say that surface bacteria can be illuminated using a blue light along with carvacrol, which is a phenolic monoterpenoid that can be found in oils made from oregano, thyme, pepperwort, wild bergamot, and other plants. It’s common, but also uncommon in that it contains hydrophilic molecules and the phenol moiety. That combined with the blue light can effectively treat skin and soft tissue infections (SSTIs), according to their 

Investigators wanted to see how their method would fare against such MDROs as 

. The two-step process for SSTIs can also conceivably be used to treat diabetic patients who suffer from wounds; the sort of wounds that are not always easily treated with antibiotics.

“A growing number of patients with compromised immunity such as cancer and diabetic patients, invasive medical procedures, and the associated surgical site infections all have contributed to the increasing incidence of SSTI over the past decade,” the study states. “It has been suggested that the ability to control the surface of the wound contamination below 10 CFU/g of tissue is crucial to prevent sepsis, which might be achievable by blue light combined with carvacrol.”

Centers for Disease Control and Prevention

 (CDC), MDROs infect about 2.8 million people in the United States each year, killing about 35,000 of them. The CDC: “Dedicated prevention and infection control efforts in the U.S. are working to reduce the number of infections and deaths caused by antibiotic-resistant germs, but the number of people facing antibiotic resistance is still too high. More action is needed to fully protect people.”

Disinfecting bacteria on a wound would probably lessen instances of nosocomial infections, according to the authors of the study in 

. MDROs “are commonly colonized on the wound surface and openly exposed to the atmosphere, becoming one of the major sources for contaminating the health care environment and posing high risk to vulnerable patients to contract the bacteria in hospitals,” the study states. “Therefore, quick and efficacious eradication of surface wound bacteria could effectively minimize nosocomial infections.”

The blue light and carvacrol not only killed the bacteria, but also produced no adverse events to the animals used in the study. “We ascribe this safety profile to initiation of the phototoxic cascade reaction by blue light excitation of endogenous porphyrin-like molecules. These porphyrin-like molecules are primarily tetrapyrrole macrocycles—such as protoporphyrin, uroporphyrinogen III, coproporphyrinogen III, and coproporphyrin III—based on their absorbance and excitation spectra and ability to respond to blue light similarly as PPIX [protoporphyrin IX],” the study states.

Investigators wanted to see how their method would fare against Acinetobacter baumannii and methicillin-resistant Staphylococcus aureus, and results were promising.

Blue Light, Food Oils Combo Kills Superbugs, says Study

The expert’s advising the US Food and Drug Administration (FDA) will have a lot to chew over this Friday when they meet to discuss the phase 3 trial data for Janssen Ad26.COV2.S, the drug company’s candidate for a 

. The FDA’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC) will review Janssen’s evidence that the one-shot adenovirus prophylaxis provided 66.1% efficacy (95% CI, 55.0 – 74.8) in preventing COVID-19 versus placebo ≥28 days after administration. The 

 are the most extensively reported outcomes of an adenovirus vaccine candidate for the pandemic, and the first to highlight efficacy with a single-dose product.

Janssen Ad26.COV2.S is an intramuscular injection vaccine consisting of a replication-incompetent recombinant adenovirus type 26 (Ad26) vector which expresses the SARS-CoV-2 spike (S) protein.

Per the FDA, the product additionally includes inactive ingredients citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropylβ-cyclodextrin (HBCD), polysorbate 80, sodium chloride, sodium hydroxide, and hydrochloric acid.

Stored at 2-8 degrees Celsius, the vaccine is provided in a five-dose vial and administered at 0.5 mL per person.

The Ad26 platform is prominent in use with Ebola vaccines, and is being used for investigative prevention of Zika virus, filovirus, HIV, HPV, malaria, and respiratory syncytial virus (RSV) in other vaccine forms.

Since December 2020, the Ad26 platform has been used in vaccines administered to nearly 200,000 real-world and clinical trial participants, and has been associated with an overall “acceptable clinical safety profile,” the FDA wrote.

Ad26.COV2.S is currently being investigated in 5 randomized, double-blind, placebo-controlled clinical trials. The data supporting Janssen’s EUA application comes from Study 30001, a phase 3 efficacy and safety study comparing the vaccine candidate to placebo in preventing COVID-19 among 40,000 adult participants.

Included in the EUA review will be blinded safety data from Study 3009, a phase 3 efficacy and safety trial observed a two-dose regimen of Ad26.COV2.S that began in November 2020 but is yet to provide usable outcomes.

In Study 3001, 40,000 adults were randomized 1:1 to either intramuscular vaccine injection or placebo. Investigators sought co-primary endpoints of single-dose vaccine efficacy in preventing centrally confirmed, moderate to severe COVID-19 occurring at 2 time periods:

≥28 days after vaccination, among participants without evidence of prior SARS-CoV-2 infection at baseline

The trial population was required to have at least 30% of all participants aged ≥60 years old at baseline, and a maximum of 20% participants aged 18-40 years old, to assure observations could be made on older, greater-risk populations.

Median follow-up duration for participants in both efficacy and safety assessments was 8 weeks post-vaccination, the FDA’s equivalent to the mandated two-month minimum for COVID-19 vaccine EUA consideration. Janssen’s full analysis set included 29,111 (63%) participants who reached the eight-week mark.

The international study population was comprised of 46.7% (n = 18,356) Americans, 40.6% (15,981) residents of Latin America, and 12.7% (4984) residents of South Africa.

Mean participant age was 51.1 years old, with participants aged ≥60 representing 34.6% of the population. A majority of patients were male (55.5%) and White (62.1%). Black or African American (17.2%) and American Indian or Alaska Native (8.3%) comprised the next most represented races. At least 1 comorbidity indicative of increased COVID-19 severity risk was present in 40.8% of all participants.

In the first primary endpoint of Ad.26.COV2.S prevention of COVID-19 ≥14 days after vaccination, investigators observed 116 cases among vaccinated participants versus 348 in the placebo arm, indicating a 66.9% vaccine efficacy across all participant age groups (95% CI, 59.0 – 73.4). Among participants ≥60 years old, the efficacy was 76.3% (95% CI, 61.6 – 86.0).

In the secondary endpoint of COVID-19 prevention ≥28 days after vaccination among those with no SARS-CoV-2 history, investigators observed just 66 cases among vaccinated participants versus 193 in the placebo arm, indicating a vaccine efficacy of 66.1%. There were no statistically significant differences among younger and older participants in this outcome.

“The majority of COVID-19 cases were among participants in the United States, South Africa, and Brazil,” investigators wrote. “Study participants with comorbidities were not over-represented among COVID-19 cases as compared to the overall study population.”

In subgroup analyses assessing the vaccine’s efficacy in differing regions, investigators observed an efficacy of 74.4% (95% CI, 65.0 – 81.6) at ≥14 days and 72.0% (95% CI, 58.2 – 81.7) at ≥28 days in American participants.

Results among South African residents were 52.0% (95% CI, 30.3 – 67.4) and 64% (95% CI, 41.2 – 78.7) at the respective endpoints. Among Latin America residents, results were 64.7% (95% CI, 54.1 – 73.0) and 61.0% (95% CI, 46.9 – 71.8), respectively.

In preventing severe or critical COVID-19, Ad.26.COV2.S was associated with 76.7% efficacy at ≥14 days, and 85.4% at ≥28 days.

“In a post hoc analysis of all COVID-19 related hospitalizations starting 14 days after vaccination, including non-centrally confirmed cases, there were 2 cases in the vaccine group (with no cases after 28 days) compared with 29 cases in the placebo group (with 16 cases after 28 days),” investigators wrote. “As of February 5, 2021, there were 7 COVID-19 related deaths in the study in the placebo group and no COVID-19 related deaths in the vaccine group.”

Among 43,783 participants eligible for safety analysis, investigators observed no specific safety concerns that would warrant assessment prior to an EUA.

Common solicited adverse reactions associated with the vaccine included injection site pain (48.6%), headache (38.9%), fatigue (38.2%), and myalgia (33.2%)—a majority of which were mild and moderate in severity.

Investigators observed a “numerical imbalance” in non-serious urticaria events among vaccinated participants (n = 5) versus placebo (n = 1) within 7 days post-vaccination, as well as imbalances in thromboembolic events (15 vs 10) and tinnitus (6 vs 0). However, data was not considered sufficient enough to determine a causal relationship between the vaccine and these outcomes.

“There was more frequent, generally mild to moderate reactogenicity in participants 18 to 59 years of age compared to older participants,” investigators wrote. “There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection.”

On Friday morning, the FDA will convene for its third public expert panel hearing on the validity and benefit of a COVID-19 vaccine candidate up for EUA consideration.

The VRBPAC will provide recommendations, based on the above evidence and other submitted details on Ad.26.COV2.S, whether its benefits outweigh its risk in active immunization to prevent COVID-19 in persons aged ≥18 years old.

In December 2020, the VRBPAC gave supporting votes to Pfizer-BioNTech’s BNT162b2 and Moderna’s mRNA-1273 in separate meetings. The pair of two-dose mRNA-platform vaccines are currently the only authorized products in the US, having received emergency authorization shortly after their respective VRBPAC signoffs.

If VRBPAC support and emergency authorization comes at the end of this week, Janssen Pharmaceuticals anticipates to have approximately 4 million doses of Ad.26.COV2.S ready to ship in the US next week.

Janssen’s Single-Dose COVID-19 Vaccine Under FDA Review

New cases of coronavirus disease 2019 (COVID-19) infection, hospitalization, and death continue to plummet across the United States. Yesterday, there were 56,044 new cases of COVID-19, while 1415 people died from the disease, according to Johns Hopkins University. At the height of the recent surge, some days saw over 4000 deaths.

Some news on the COVID variants front as well. Health care experts have been telling 

 against the variants, but that they could be re-engineered as booster shots that would hopefully be very effective against the variants.

And those booster shots would arrive in a hurry, thanks to a 

 by the Food and Drug Administration (FDA). The FDA on Monday said that the makers of vaccines, treatments, and tests do not have to conduct large, time-consuming clinical trials to move those products to the frontlines.

Acting FDA Commissioner Janet Woodcock, MD, said in a statement that “we know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the performance of these products. By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts. We need to arm health care providers with the best available diagnostics, therapeutics and vaccines to fight this virus. We remain committed to getting these life-saving products to the frontlines.”

There is a precedent for this. The annual flu vaccines only need to show efficacy in small clinical trials. Two manufacturers of COVID-19 vaccines—Moderna and Pfizer-BioNTech—are busy 

 so that they will be more effective against the variants.

As more and more people get fully vaccinated—that is, get the two doses—what does that mean for them, exactly? Will they still have to social distance? How about wearing a mask? If a fully vaccinated person comes into contact with someone who has COVID-19, does the fully vaccinated person then have to quarantine? The questions boil down to this: How should we live our lives now? The Centers for Disease Control and Prevention (CDC) might be providing answers to those questions soon.

There are some dark clouds to watch besides the COVID variants. Children’s hospitals in America say that they are seeing a surge in cases of an illness that follows infection from COVID-19. It’s called multisystem inflammatory syndrome and symptoms include stomach pain, vomiting, diarrhea and fever. It affects youngsters between 1 and 14 years old, and disproportionately affects children of color. As reported by 

, hospital officials say that the illness seems to be more common than it was earlier in the pandemic. Between October 1, 2020 and January 7, 2021, COVID hospitalizations for adults exploded by almost 300%, according to 

 at the University of Minnesota. During that same period, pediatric COVID-19 hospitalizations rose 50%. Since January 7, adult hospitalizations fell by 54%. Hospitalizations for children fell by 25%.

Meanwhile, since the pandemic began, there have been over 28 million confirmed cases on COVID-19, in the US, while over 500,000 people have died from the disease. In the world, there have been about 112 million confirmed cases of COVID-19, while about 2.5 million people have died from the disease.

An FDA ruling this week quickens the process by which COVID-19 vaccine manufacturers can get to the market—and into arms—booster shots that are targeted at variants.