I actually had to pull out the lawnmower this week, to cut some weedy grass running amok in the yard. Nonetheless, I'm buoyed by the approach of the vernal equinox next Tuesday, the official start of spring. Winter will be done, and with it the winter respiratory viruses. They will reliably be replaced with spring respiratory viruses.
Here's a look at the pediatric infectious disease news the past week.
Details on the Failed GSK RSV Vaccine Trial
We've known for about a year that GlaxoSmithKline's RSV vaccine trial in pregnant people was stopped due to safety concerns: a higher rate of preterm births in the vaccine group compared to placebo. Now we have more details, similar to what was reported to FDA and shared in various meetings. Preterm birth rate was 6.8% (237 of 3494 infants) in the vaccine group and 4.9% (86/1739) in the placebo group; it was statistically significant. Neonatal mortality was higher in the vaccine group, 0.4% versus 0.2%, but did not reach statistical significance.
On the other hand, vaccine effectiveness was pretty good:
The currently approved maternal RSV vaccine from Pfizer also had a hint of a safety signal for preterm birth, less so than the GSK product, and these signals combined resulted in the Pfizer vaccine being approved for a later time in gestation, at 32 weeks at the earliest. Postmarketing surveillance is ongoing. Perhaps the most difficult part of assessing this safety signal is whether it is real or not. We are lacking a key factor in making this assessment: biologic plausibility, i.e. the mechanism by which these vaccines might cause preterm birth. Without that, it is still possible this represents just a chance observation. From my perspective, I would still encourage RSV vaccination for pregnant people as well as nirsevimab therapy for at risk infants born to unvaccinated mothers. We have time for more discussions of any new data prior to our next RSV season this fall.
Waterborne Disease Outbreaks Associated With Drinking Water
I'm a big fan of CDC's Surveillance summaries, and this one published last week is of interest. The report concerns 214 outbreaks from 2015-2020. I wasn't thrilled to see my home state represented prominently.
Outbreaks occurred year-round, and biofilm exposures predominated.
In case you aren't familiar with biofilm-associated outbreaks, here's the quick explanation from the text:
"...microbial communities that attach to moist surfaces (e.g., water pipes) and provide protection and nutrients for many different types of pathogens, including Legionella and NTM [non-tuberculous mycobacteria]... Biofilm can grow when water becomes stagnant or disinfectant residuals are depleted, resulting in pathogen growth... Furthermore, biofilm pathogens are difficult to control because of their resistance to water treatment processes (e.g., disinfection)... Exposure to biofilm pathogens can occur through contact with, ingestion of, or aerosol inhalation of contaminated water from different fixtures (e.g., showerheads) and devices (e.g., humidifiers)..."
Not to minimize the severity of these events, but I couldn't help thinking about a whole new version of Hitchcock's Psycho shower scene based on this.
Legionella was by far the most common pathogen. The report has detail on every outbreak by year and location, as well as a listing of contributing factors. It's a great roadmap for future prevention.
Measles (Again)
It seems like I could devote every week's post entirely to measles and not run out of things to say. Here's the current US situation.
As I've stated previously, it's the sheer number of unconnected sites that concerns me now. Let's put this into some perspective.
As of March 14, we have 58 cases reported from 17 jurisdictions. In all of 2023, we had the same number, 58, reported from 20 jurisdictions in the US. So, we're way ahead of the game for recent years, but we're also not breaking any records compared to pre-pandemic times.
Looking more closely at the 2 biggest years recently, the 2014 (and somewhat 2015) numbers had a large contribution from a single site, Disneyland. More impressively, the 1274 measles cases in 2019, the highest number in the US since 1992, largely involved orthodox Jewish communities in New York - relatively epidemiologically isolated communities with very low immunization rates. A CDC update in fall 2019 (I couldn't find a final tally) stated that 75% of cases for the entire country that year originated from these communities.
Fingers crossed that we don't eclipse the 2019 figures this year, but with reduced vaccination rates and already widespread measles transmission occurring, it doesn't look good. We're just now coming to the spring break and summer travel season - importation of measles from travelers has been a large contributor to US measles outbreaks in the past.
Pediatric Covid ICU Admissions
A recent report of registry data from 55 hospitals during the first almost 2 years of the pandemic showed that about 8% children <21 years of age admitted to intensive care with covid had immunocompromising conditions (ICC). Secondary bacterial infection was more common (9.5% versus 7.3%) and mortality (11.4% versus 4.6%) was higher in the ICC group.
That Pesky Flu
The map is getting a little greener, apropos of springtime. Note in the link you can animate the map to show progression from the fall to the current week.
Better seen here, we did experience a little pause in our decrease of ILI, now headed down but at 3.7% still above the official "epidemic is over" mark of 2.9% for this year.
Any Chipmunk Sightings?
My 2024 Farmer's Almanac says that the real harbinger of spring in the eastern US is the appearance of the eastern chipmunk (Tamias striatus) above ground. As opposed to their squirrel brethren, chipmunks at my house don't bother my bird feeder, so I'm OK with them. I learned that although they stay below ground for the winter, they aren't true hibernators but rather experience torpor. They may sleep for several days in their bedrooms, followed by a trip to the underground pantry for snacks. Sounds like a good plan for retirement.
It was a busy week for infectious diseases, not in the sense of more outbreaks but rather more epidemiologic and vaccine data that point to better health for the future.
The big topic of the week was the Advisory Council on Immunization Practices regular February 2-day meeting. In retrospect, pediatric healthcare providers won't have any major new recommendations to work with; those are likely coming following the next meeting the end of June. I wasn't able to view as much of the meeting as I had hoped, patient care interfered a bit, but I did review all the presentations for those that I missed hearing live. Let's dive in.
ACIP
The Council discussed 9 different topics, but only 3 involved voting: COVID-19 vaccines (vote in favor of a spring vaccine for some high-risk people), Chikungunya vaccine (vote for use in some US adult travelers and in laboratory workers), Td vaccine availability for those with contraindications to receiving pertussis vaccine (discussion followed by a vote regarding the Vaccines for Children progam), influenza vaccines, polio vaccines, RSV vaccines for adults, meningococcal vaccines, pneumococcal vaccines, and the new Vaxelis combined product for diphtheria, tetanus, pertussis, polio, Hib, and hepatitis B. I'll expand on just a few of these topics. (Note all of the graphs/figures below are from the ACIP web site presentation slide link for the February meeting.)
RSV
We saw the most up-to-date representation of RSV epidemiology, showing that the epidemic curve for this year looks a lot like prepandemic years (see last presentation in RSV session).
A good part of the discussion centered on risk of Guillain-Barre syndrome following vaccine, compared to risks of GBS in the baseline population. Both are rare events, but I think at this point it is reasonable to conclude that GBS is a rare risk of RSV vaccination, though not enough to outweigh benefits for high risk populations.
A quick look at the benefits versus GBS risks for adults > 60 years of age (Melgar presentation from RSV session):
Note risks might vary with vaccine type - hard to know with rare events and large confidence intervals, plus both in the ballpark of background GBS numbers.
Influenza
This session was interesting for me to see a preliminary assessment of vaccine effectiveness for the 2023-2024 flu season. I'll just show you an overview of VE in the pediatric population; note that multiple methodologies are used to measure VE. (See slides from Frutos presentation in the influenza section.)
This is good VE for flu, certainly the CDC and WHO were on track for choosing the best combination of strains for this season. Look for the vote for next season's vaccine composition in June.
Meningococcal Vaccines
The focus of the discussion was how best to incorporate meningococcal B vaccine now that we have an approved combination vaccine containing this serogroup. Here are the main options discussed, from the 1st Schillie presentation:
The issues are complex, primarily due to 3 factors. First, meningococcal group B infections are extremely rare; traditional cost-effectiveness models show that meningococcal B vaccination in the US is by far the most expensive vaccine; very few cases are prevented due to the rarity of infection. Second, vaccination at age 11-12 risks significant waning of immunity by the age for peak meningococcal disease in adolescents; it might make sense to move the first dose to a later age. (The main argument against this is the confusion caused by eliminating the long-standing practice for vaccination at age 11-12, perhaps lowering overall vaccine acceptance.) Third, it is clear that not all meningococcal disease risk in adolescents is equal: college attendance is prime, but there are other behavioral risk factors (1st Schillie presentation):
The discussion was mainly to hear input from all stakeholders and then go back to the drawing board. Expect a vote on this at the June meeting - it will greatly impact your summer vaccine guidance for adolescents and young adults.
COVID Vacines
This section of the meetings seemed to garner the most publicity. Of course most of the results presented dealt with adults, given the relatively lower risk for bad outcomes in children plus low rates of vaccinations. Most helpful I thought were the discussions about covid VE in recent months looking at the fall monovalent vaccine.
These are great numbers. Also mentioned was the fact that waning of efficacy hasn't been seen yet, but that could just be a result of not having enough time to pass since the fall vaccine. Other good news is that in vitro studies suggest that the current monovalent vaccine is likely to protect against newer variants.
Special situation for people ages 65 years and older: People ages 65 years and older should receive 1 additional dose of any updated (2023–2024 Formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech) at least 4 months following the previous dose of updated (2023–2024 Formula) COVID-19 vaccine. For initial vaccination with Novavax COVID-19 Vaccine, the 2-dose series should be completed before administration of the additional dose.
That "should" wording was the subject of much debate, finally choosing this wording more for simplicity of recommendations. The gnashing of teeth came about for a good reason - people in the lower end of this age population who do not have underlying risk factors will have less benefit from a spring vaccine because rates of bad outcomes in the post-pandemic period are lower.
Recommendations for younger people with moderate or severe immunocompromise have slightly different wording:
People ages 12–64 years who are moderately or severely immunocompromised may receive 1 additional dose of any updated (2023–2024 Formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech) at least 2 months after the last dose of updated (2023–2024 Formula) COVID-19 vaccine indicated in Table 2. Further additional doses may be administered, informed by the clinical judgement of a healthcare provider and personal preference and circumstances. Any further additional doses should be administered at least 2 months after the last updated (2023–2024 Formula) COVID-19 vaccine dose.
People ages 65 years and older who are moderately or severely immunocompromised should receive 1 additional dose of any updated (2023–2024 Formula) COVID-19 vaccine (i.e., Moderna, Novavax, Pfizer-BioNTech) at least 2 months after the last dose of updated (2023–2024 Formula) vaccine indicated in Table 2. Further additional doses may be administered, informed by the clinical judgement of a healthcare provider and personal preference and circumstances. Any further additional doses should be administered at least 2 months after the last updated (2023–2024 Formula) COVID-19 vaccine dose.
For all age groups, the dosage for the additional doses is as follows: Moderna, 0.5 mL/50 ug; Novavax, 0.5 mL/5 ug rS protein and 50 ug Matrix-M adjuvant; Pfizer-BioNTech, 0.3 mL/30 ug.
As an aside and not receiving much media attention, a new report showed that vaccine mandates didn't help and probably hurt. States with vaccine mandates didn't have higher covid vaccination rates and actually had lower covid booster uptake and flu vaccination rates. Yikes!
Nipah Virus
Never heard of it, or hard-pressed to find facts at the tip of your tongue? Most providers in the US don't need to know much about this bat-borne virus, but if you have any patients planning a trip to Bangladesh you may want to advise them not to consume raw date palm sap (not on my list of delicacies so far) and to stay away from pigs.
NiV gets its name from the village of Sugai Nipah in Malaysia, site of a 1999 outbreak highlighted by cases of encephalitis in pig farmers. Outbreaks typically occur in Bangladesh and India. Now, the World Health Organization reports that 2 individuals, including a 3-year-old girl, have died from the infection after consuming raw date palm sap. The sap likely was contaminated with fruit bat droppings laced with NiV. In addition to signs and symptoms of encephalitis, typical findings are those of nonspecific febrile illness. Diagnosis is difficult until/unless encephalitis findings appear. It's a relatively uncommon infection even in Bangladesh, but mortality is high.
Good Attitudes
It's a sign of our times that I was pleasantly surprised to see a vaccine attitude survey with good news. Investigators from RAND corporation, University of Iowa, and CDC performed an online survey of 1351 parents to assess their willingness to have their children 5-18 years of age receive a vaccine to prevent Lyme disease. About two-thirds of parents definitely or probably would vaccinate their children. The boldface numbers below show statistically significant predictors of willingness to have their children receive Lyme vaccine, with willingness of the parent to receive the vaccine the strongest predictor.
In case you were wondering, for the purposes of this survey the high incidence states were Connecticut, Delaware, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, Washington D.C. (yes, I don't need to be reminded it's not a state), West Virginia, and Wisconsin. They also looked at states characterized as "emerging" Lyme disease states (Iowa, Ohio, Illinois, Indiana, Michigan, North Carolina), but this group had a slightly lower rate of willingness than in high incidence states. Lyme vaccine trials in the pediatric and adult populations are ongoing, so don't be surprised if parents and children have this option in the next year or so.
Speaking of attitudes, take a look at AAP's new guidance for improving vaccine communication and uptake. It has an excellent literature review and describes various strategies that pediatric healthcare providers can use to improve vaccine acceptance. It is still true that different studies sometimes have reported different conclusions on how best to discuss vaccine hesitancy with parents, likely because it is very difficult to design studies that deal with such subjective issues in a uniform manner.
WRIS
Winter respiratory infection season is still chugging along, mostly due to influenza which is stubbornly persisting in scattered areas in the US. What a crazy patchwork!
New Covid Isolation Guidelines
Maybe this has overshadowed everything in the news. I've discussed this recently in the blog and was expecting the new guidelines to come in April, but CDC bumped it up by a month. It incorporates new information about covid epidemiology, hospitalization rates, and outcomes with balancing for impacts on the economy and on school and work attendance into a comprehensive guideline for all respiratory infections. So, no longer do we have a specific number of days after covid diagnosis to remain out of school or work. The document has multiple links and is pretty complicated. The CDC's press release is a good summary, however. Note that vaccination is still stressed heavily, though I expect it will be ignored by the same hardcore group of antivaxxers. Here's the quick blurb:
"When people get sick with a respiratory virus, the updated guidance recommends that they stay home and away from others. For people with COVID-19 and influenza, treatment is available and can lessen symptoms and lower the risk of severe illness. The recommendations suggest returning to normal activities when, for at least 24 hours, symptoms are improving overall, and if a fever was present, it has been gone without use of a fever-reducing medication."
I am very much in favor of these new recommendations. Circumstances have changed, and we have learned a lot from management of the pandemic these past few years. I just hope our vaccination rate will improve and that people with any respiratory symptoms at all will be aware that they can pose a significant risk to others who may have circumstances putting them at high risk for hospitalization or death from respiratory viruses. Also, please note this only applies to community settings; there are no changes for healthcare settings.
Squirrel Redux
If I were superstitious, I wouldn't mention the fact that my neighborhood squirrels still have not attacked my newly-positioned bird feeder. I was bemused by an article in the Local Living section of the Washington Post last Thursday, clearly written by a squirrel lover. Squirrels do have value, and I have no desire to wipe them off the face of the earth. I just don't want them eating all my bird seed.
A friend of mine in South Carolina with an array of bird feeders and birds also has come to terms with squirrels, albeit somewhat differently than my crazy solution. He just monitors things, and when the squirrels reach a point that he feels they become a significant barrier to maintaining bird happiness and seed access, he uses a humane trap to collect squirrels and then release them far from his neighborhood. I won't disclose where he releases them, but it sounded like a good place for squirrels and unlikely to bother too many people. I wonder if any of them found their way back to him.
Washington, DC, had a record high temperature 1 day during our heat wave this past week, and I suppose if you glanced at the sun you might see some spots for a few seconds. But of course I'm referring to different spots in this post.
Measles
I'm probably the only person who has read all of my blog posts over time, so you're forgiven if you don't realize I'm in broken record mode here. I can't count the number of times I've warned providers to be on the lookout for measles cases, and now we are facing a global decline in immunization rates that probably puts us at greatest risk since the modern-day measles vaccine was available in 1968 (the original Enders vaccine appeared in 1963). We've enjoyed some low numbers in the US recently, but that appears to be changing with 9 cases (from Georgia, Missouri, New Jersey, and Pennsylvania) reportedto CDC so far this month.
CDC released an alert last week mentioning 23 US cases between December 1 and January 23.
I won't review everything about diagnosis of measles, the CDC website alert is a good resource with links to other sites, but I do want to highlight a few helpful nuances that aren't often mentioned. First, measles is fairly unique among exanthematous infections in that the prodrome interval, the time between onset of first symptoms and appearance of the rash, is long, usually a few days. Most infectious diseases accompanied by rash have very little or no time between onset of symptoms and appearance of the rash, with erythema infectiosum being a notable exception but not easily confused with measles clinically.
The measles prodrome consists of a febrile illness with cough, coryza, conjunctivitis, and Koplik's spots. You can find pictures of Koplik's spots everywhere on the web, but in my experience as an old geezer who has seen many cases of measles in children, they aren't that easy to see or photograph. Therefore, the photos available in textbooks and on line are skewed towards the most obvious. One needs to do a careful oral exam looking for gray or bluish-gray or white fine spots (almost sandpapery) anywhere on the buccal mucosa; the inside of the lower lip is particularly helpful. If you're not sure, find an old geezer clinician to confirm.
In the absence of Koplik spots, or if you don't see the child until the rash appears and the Koplik spots have resolved, pay close attention to the history. Specifically ask for a day-to-day accounting of symptoms; if you feel the parent or patient can recall reliably, noting at least a 2-3 day lag between the onset of high fever, cough, rhinorrhea, and conjunctivitis before the rash appears can be strongly suggestive of measles; the absence of this lag is against the diagnosis. Other alarms to increase your suspicion would be lack of 2 measles immunizations, international travel, and/or exposure to a suspected measles case.
"It ain't what they call you.....
..... it's what you answer to." - attributed to W.C. Fields, though I can't verify the origin.
I thought of Mr. Fields when I heard about administration errors involving the adult RSV vaccine (brand names Abrysvo and Arexvy) given to children and pregnant people. From my viewpoint, it was an accident waiting to happen, due to a name.
In order to speed payment allowance by the Vaccines for Children and other programs, the long-acting monoclonal antibody nirsevimab was officially designated a vaccine. Strictly speaking I guess this is correct: antibody administration is a form of passive immunization. However, the true RSV vaccines are intended only for adults with high risk conditions or for pregnant people to help protect newborns after birth. It was inevitable that confusion would ensue. The notice provides almost no details but does state that most administrations to young infants were "nonserious." Infants who wrongly received an adult RSV vaccine should be considered unprotected and still receive nirsevimab.
WHO Fans the Covid Mask/Distancing Controversy
WHO riled a lot of public health experts with its recent guidance for infection control in healthcare facilities. The main controversial elements involve recommendations to use physical barriers such as plastic windows for areas where patients first present (rated as conditional recommendation, very low certainty of evidence); maintaining a physical distance of at least 1 meter between people ("good practice statement"); and not sufficiently highlighting superiority of respirators (e.g. N95 masks) for general care - this particularly angered those who favor the aerosol, rather than droplet, mode of transmission for SARS-CoV-2. In general it seemed that the WHO panel carried over some details for infection control that do not have strong evidence for use and in some cases (plastic barriers) may be contradicted by other studies.
Note that much of the controversy involves how much weight to give transmission simulation studies - e.g. distances that SARS-CoV-2 travels under experimental conditions rather than real-world evidence which is much more difficult to come by. It's hard for an individual medical practice to make these decisions on their own, best to abide by state or local health department guidance.
Spring Covid Vaccination?
Canada released guidance for covid vaccination this spring, advocating for an additional dose of the XBB.1.5 vaccine recommended last fall. I'd look for the US to make similar recommendations soon. ACIP has a regular meeting scheduled February 28-29, but no agenda is yet available. FDA doesn't have anything scheduled, and they may not need a separate advisory committee meeting for this.
WRIS
In general we seem to be trending downward with our winter respiratory infections, but still lots of runny noses, coughs, and more around.
For RSV I still look primarily at hospitalization rates in young children, the purple line in the graph below, because I think it's the most accurate gauge of RSV. I suspect almost all of these hospitalized children are tested for RSV and flu. The rate clearly is trending down, it's looking like we won't replicate the horrible RSV season of last year.
Influenza-like illness seems to be cooling off as well, as seen in FLUView. Note this measurement includes respiratory illnesses mimicking flu so could be any respiratory virus; there are many more ways to look at flu activity in general, all with their own inaccuracies. In the past I have found this map to be representative of what I've seen clinically in my practice areas.
Covid wastewater (I've said before why I prefer this qualitative measurement) continues to trend downward, and levels are below that seen last year.
All told this is good news for those of you trying to manage your packed patient waiting rooms. Let's just hope you don't have a case of measles sitting in there somewhere!
Do You Even Know What a Broken Record Sounds Like?
I used this term when I said I was sounding like a broken record for repeating over and over my warnings about measles. I harp (pun intended) on this because measles is the most contagious infectious disease known and most younger clinicians in the US have never seen a case, meaning it can be missed easily. However, those same clinicians might never have heard a broken record either. Vinyl records made a bit of a comeback recently but even I no longer have a turntable to play vinyl records; I do have a few moldy vinyl albums from the 1960s and 70s. I'm occasionally tempted to purchase a good turntable, but I have no place for it and it's yet another diversionary rabbit hole I don't need. I ain't gonna call out the name vinyl around here.
Last week's post dove into the dog days of summer, and another article this week kept my canine focus centered; I learned about a new breed to me, the Pyrenean Mountain Dog.
New Hope for Group B Strep Vaccine?
I don't usually hype phase I or phase II trials, but this past week's article in the New England Journal offers a glimmer of hope for maternal GBS vaccination to prevent neonatal disease. Maybe it's just wishful thinking, but we might have a breakthrough after decades of failures. We'll need to wait for a definitive phase III trial before we know. I refer you to the accompanying editorial by Carol Baker, the investigator most responsible for "discovering" the emergence of neonatal GBS disease in the 1970s. As in aside, I was a subject in her phase I trial of a GBS vaccine in the early 1980s. The fact that she was my fellowship director at the time wouldn't pass ethical muster today, but I had no side effects and I recall that I did have a good antibody response. Still, that vaccine didn't make it past further testing.
Bacterial Vaginosis
Other than neonatologists, most pediatric providers don't think about BV that often. However, it is very likely a factor contributing to preterm delivery. It's a confusing infection, or perhaps better termed a dysbiosis, consisting of vaginal colonization with various anaerobic bacteria and absence of lactobacilli. A few diagnostic criteria have been in use, but lately molecular screening tools have improved. A new study suggests that molecular screening of pregnant people could be cost effective in preventing pre-term births by identifying individuals with BV and treating them early. Investigators randomized 6671 pregnant people before 20 weeks gestation to have self-administered screening swabs versus regular care. Molecular testing was with a research (not commercially available) tool looking for high levels of Atopobium vaginae and/or Gardnerella vaginalis, and those testing positive were treated with azithromycin or amoxicillin. The differences in the rates of pre-term births in the treatment (3.8%) versus control (4.6%) groups were not statistically significant. However, results in the 3000+ nulliparous (could have had previous miscarriage or abortion) subjects did reach significant difference: 3.6% versus 5.9%. In my current telemedicine practice I see many pregnant individuals who have undergone some type of BV screening. I'm hoping more studies like this will shed light on this somewhat confusing dysbiosis.
More Tick Reminders
Folks at the CDC remind us about tickborne relapsing fever, aka soft tick relapsing fever (STRF). As the name implies it is a relapsing/remitting type of fever and can be pretty tough to diagnose, especially since it isn't seen equally in all parts of the US and is reportable only in 12 states (Arizona, California, Colorado, Idaho, Montana, Nevada, New Mexico, Oregon, Texas, Utah, Washington, and Wyoming) as of 2021. Think of it in campers or others who are active in the outdoors who have had recurrent fevers. CDC investigators reported on 251 cases over a 10-year period, 61 < 18 years of age. Here are some key geographic and clinical points to keep in mind for diagnosis:
'Demic Doldrums
Things remain calm, with a few things to report. Pediatrics published a supplement on covid and school management a couple weeks ago, took me a little while to go through everything. Hindsight usually is 20/20, but I'd say with the pandemic it's more like 20/60, largely due to incomplete data and a moving target with viral variants. However, I would draw your attention to one of the article about lessons learned. The authors include 8 lessons learned; I would put most of this still in the realm of opinion but it is well-reasoned:
School closures were necessary initially but should have been shorter
Masking works in schools (covered in 2 of the lessons)
In-person teaching with masking is better than school closure or hybrid education
Covid exposure is not a good reason to exclude school attendance
Efficacy of school ventilation improvement is not well-substantiated
Asymptomatic screening is ineffective
Vaccine trials should be carried out in adults and children in parallel, rather than delaying pediatric trials until adult data are available
Also in both covid and canine realms, the Pyrenean mountain dogs pictured below are actually sniffing out covid.
A new article reviewed evidence to date of dogs trained to sniff out the infection through various methods. A variety of dogs were trained, including mutts. However, the numbers are very low; it's hard for me to imagine a practical use of covid-sniffing dogs, but maybe this will lead to an effective breath test.
You also may have heard nirsevimab, the long-acting monoclonal antibody to prevent RSV in young children, was officially approved by the FDA. Next up is a CDC/ACIP meeting on August 3 to discuss nirsevimab and maternal RSV vaccination, with votes scheduled on recommendations for use.
Playing Games
No, I didn't forget that challenge in last week's post. Blame one of my sons for this. He told me that the New York Times games and puzzles are major revenue sources for the publisher. I receive bupkis for this blog, but I'm not above trying something that might keep readers interested. I couldn't find a credible study for his claim, but there is some evidence.
So, the answer to last week's challenge of the correct number of weather- and temperature-related references and puns in the Dog Days post is 16, including 1 in the Title (summer), 1 in the intro (steaming), 4 in the Bugs section (heating up, hot off the presses, febrile illness, tip of the iceberg), 2 in hep C (cool, clouded), 4 in 'Demic (hot air, cooled, boiling point, hot spots), and 4 in the Astrology section (summer, heat, cool, thunderbolt). Decision of the judges (me) is final.
And by the way, my house is back in the cool as of Friday, unfortunately following purchase and installation of a new air conditioner.
The covid state of emergency has ended, both globally and in the US (the latter officially on May 11). On May 4, the director general of the World Health Organization, Dr. Tedros Adhanom Ghebreyesus, declared that covid is now an established and ongoing health issue that no longer requires resources needed for a public health emergency of international concern (known in the business as PHEIC). Future planning from the WHO is now detailed in a new document, the 2023-2025 COVID-19 Strategic Preparedness and Response Plan. It weighs in at only 20 pages, so needless to say it is short on details. For that, you'll need to dig into the document links.
Meanwhile in the US, our official emergency will end on May 11 as previously planned. So far we don't have any true future response plan.
Funding for Vaccines, Medications, and Tests
The official end of the emergency eventually means that the general public won't have access to free covid vaccines, medications and diagnostic tests. Naturally this varies with insurance type and also timing; any products still in circulation that were provided by the feds will remain free, but I haven't seen any estimates yet on how long these supplies will last. Nothing will really change for patients on Medicaid until September 2024, although access to Medicaid itself could change. The Infectious Diseases Society of America (IDSA) produced a nice table briefly outlining the situation. Unfortunately it's too big to copy well below, but a pdf version is available for download. Note that this all is completely separate from FDA's Emergency Use Authorization for vaccines, medications, and devices, which won't change until industry applications for full approval are submitted and evaluated.
Covid Vaccine Updates
First, I very much apologize for not mentioning in last week's post that the FDA on April 28 did make some allowances for additional vaccine doses for immunocompromised children. CDC has now posted this update in their Interim Clinical Considerations website for covid vaccination. Basically, any significantly immunocompromised person 6 months of age and older can receive additional bivalent vaccine, number of doses depending on prior vaccination status but also giving much leeway to the healthcare provider. Sadly, the site is still very messy, not user friendly for providers or individuals. CDC and IDSA did have a webinar on May 4 with some nicer graphics in some slides, but so far I've been unable to find the same graphics on the CDC website. Here's the quick look at vaccination for immunocompetent children ages 6 months to 4 years, and also for that "awkward" age of 5 years when the cutoffs for Pfizer and Moderna vaccines are different. You can download or watch the presentation yourself at the IDSA site.
The next major step for covid vaccines will be a meeting of the FDA's Vaccines and Related Biological Products Advisory Council (VRBPAC) on June 15. At that time the composition for the next vaccine will be determined, in time for a potential release in fall of 2023. The FDA's plan for subsequent covid vaccine adjustments was presented by Dr. Peter Marks, director of FDA's Center for Biologics Evaluation and Research, at the same May 4 IDSA meeting mentioned above. It is very similar to the process for annual influenza vaccine composition.
Covid Tracking Changes
We've been in more of a bind the past several months trying to track covid cases in an era of public exhaustion with the pandemic as well as non-reporting of home testing results. Additionally, CDC and local/state health departments have lessened their efforts, and most non-governmental groups have discontinued intense tracking as well. We are mostly left with tracking easily measurable data that probably are a good surrogate, at least for severe infections. Hospitalization rates for covid have been quite low for all age groups recently.
On May 5 CDC released 2 MMWR articles to clarify and justify tracking changes. Primary surveillance now will consist of the weekly hospitalization rates above as well as percentage of deaths attributed to covid. Secondary indicators are emergency department visits and percentage of positive covid testing in laboratories. Genomic and wastewater surveillance will be used to track variants. In the past, many of these outcomes have reflected in a timely manner the covid community levels when tracking of infection was more reliable, so perhaps it's not a bad trade off. Time will tell.
Other Changes and Events
The news has been saturated with Dr. Rochelle Walensky's announcement that she will step down as CDC director effective June 30. The announcement was short on rationale for the change. Previously Dr. Walensky had announced new strategic planning to revise CDC's structure and management, a badly needed overhaul. I hope this plan won't fall apart with her departure.
As I mentioned in a February posting, work on RSV vaccines is advancing, most recently with FDA approval of one vaccine for individuals 60 years of age and over. CDC and ACIP are expected to make recommendations at their June 21-23 meeting. Flu vaccine composition also will be discussed. In the meantime, FDA VRBPAC will discuss RSV vaccination of pregnant women to prevent or modify illness in newborns at their May 18 meeting.
Lastly, you may have seen press reports of a meeting of scientific advisors with the White House that attempted to put a number on the likelihood that we'll experience another big wave of covid in the next 2 years. Like all covid forecasts, many assumptions are made to produce such numbers and really should be accompanied by a sensitivity analysis that varies the assumptions so that we have a better range of what to expect. I haven't seen an actual publication for this latest estimate so can't really comment further.
My Book Report
I've been working on a book review that I hope to have completed in time for next week's blog. I'm also trying to remember when the last time was that I wrote a book report, probably elementary school. Stay tuned.
