The FDA announced today that the meeting to discuss Pfizer’s request for authorization of Pfizer-BioNTech COVID-19 Vaccine for children 6 months through 4 years of age, originally scheduled February 15, 2022, will be postponed. This will give Pfizer time to evaluate a third dose of the vaccine in this age group.
Category: Covid-19
FDA Advisory Meeting on Covid-19 Vaccine for Children Less than 5 years Old
The FDA Advisory Committee will meet February 15, 2022 between 8:30 AM-5:00 PM ET to discuss Pfizer’s proposal to amend the Emergency Use Authorization for administration of the Covid-19 vaccine to children between 6 months through 4 years of age.
Brief Reflections on N95 Masks
The free N95 masks are here. It’s 3M Model Aura 9205+and they’re available in many stores, including Hy-Vee and Walgreens.
I occasionally failed the fit test using this type of mask when I was working at the hospital; however, you can still get a pretty effective seal to make it protective in the community (see my video below). I was one of the few psychiatrists who had to fit test for a mask because I worked on the med-surg side of the hospital in a consult-liaison role.
The N95 flat type mask is probably no more difficult to don and doff than the surgical mask, for which the Slip Knot and Tuck method helps you achieve a pretty good seal (see my video for this).
At times, I had to use an alternative N95 mask, similar to 3M Model 1860, which is a cup-shaped mask. One year I failed the fit test for that one and I had to wear a Powered Air Purifying Respirator (PAPR). I had to wear it only once in the hospital. It was very cumbersome. Following that, I passed the fit test for the 1870+, which is similar to the 9205+.
When you search the web for more information about the N95 masks, you’ll find that there is disagreement about how to interpret eyeglass fogging pertaining to the seal. Some say that if you get any eyeglass fogging at all, you have an inadequate seal and need to fix that or “check with your supervisor.” On the other hand, others will discount that. Even the CDC says that eyeglass fogging indicates a poor seal that means that you have an inadequate seal and this should prompt the user to try another N95 model. On the other hand, others will discount that.
I did only a quick search, but found one open access article on a pilot study which concluded that “Fogging of eyeglasses is neither a sensitive nor a specific predictor for a poor fit of N95 respirators.” (Kyaw S, Johns M, Lim R, Stewart WC, Rojas N, Thambiraj SR, et al. Prediction of N95 Respirator Fit from Fogging of Eyeglasses: A Pilot Study. Indian J Crit Care Med 2021;25(9):976–980).
On balance, since no one who is not a health care professional will ever have to fit test for any N95 mask, the seal you’ll get is probably adequate. If you wear eyeglasses, remove them before donning and doffing the mask. You can get the bows caught in the straps, which can flip them off your face and into the toilet (although this has never happened to me personally). Always do hand hygiene before and after use of the mask.
I’ve read news items indicating that CDC guidelines say you should reuse the N95 only 5 times before disposing of it. It was difficult to find the source, but it’s mentioned here, under the heading “Decrease in N95 FFR fit and filtration performance” (FFR stands for Filtering Facepiece Respirator)”:
CDC recommends limiting the number of donnings for an N95 FFR to no more than five per device. It may be possible to don some models of FFRs more than five times [2]. One study reported that fit performance decreased over multiple, consecutive donnings and fit varied among the different models of FFRs examined [3]. If manufacturer guidance on how many times a particular FFR can be donned is not available, the CDC recommends limiting the number of uses to no more than five per device based on published data on changes in FFR fit from a limited number of FFR models over multiple donnings.
A recent observational study conducted in a hospital emergency room during the COVID-19 pandemic found that extended use and reuse of N95 FFRs as measured by the total hours and shifts the mask was worn and the number of donnings and doffings was associated with an increase in the fit failure of the respirators. This study also showed that it may be possible to don some models of FFRs more than five times [2]. Fit performance during limited reuse should be monitored by the respiratory protection program manager or appropriate safety personnel.
Reference 2 is a research letter published in JAMA Network, June 4, 2020, a time when there were shortages of PPE (Degesys NF, Wang RC, Kwan E, Fahimi J, Noble JA, Raven MC. Correlation Between N95 Extended Use and Reuse and Fit Failure in an Emergency Department. JAMA. 2020;324(1):94–96. doi:10.1001/jama.2020.9843).
Further on in the CDC guidance is a section entitled “NIOSH recommends limiting the number of donnings to five for a filtering facepiece respirator. What is the science behind that recommendation?”
You can read all of this if you’re interested. I think it’s helpful to note that some experts say you can reuse them until they’re visibly dirty, which I think probably applies to users in the general community.
Free N95 Masks Available
Sena picked up 3 of the free N95 masks today at Hy-Vee. It turns out that it’s the same one I always used to fail the quantitative fit test for at Employee Health. I could never get a decent seal with it. I would get an alternative cup-shaped mask which worked pretty well. Fit testing includes maneuvers you have to do to make sure the mask stays where it’s supposed to on your face while moving your head up and down, side to side, or bending at the waist, doing back flips, moon-walking, and so on. You also have to read a short story as well, called the Rainbow Passage:
When the sunlight strikes raindrops in the air, they hit you in the face, which makes you jerk your neck so hard you get a charley horse and can’t move your head, which hinders your vision and makes you fall through the glass door of a doughnut shop. The owner yells at you because you get blood all over the chocolate frosted doughnuts. As you reel out of the shop, you trip over a chair which knocks over a display of N95 masks, which scatter the shards of broken glass, splitting the white light into a rainbow. You follow it until it leads you to a boiling pot of gold, which you trip and fall into, sustaining burns that send you to the hospital emergency room where all of the doctors and nurses are wearing Hazmat suits. That’s why they say if you know where the pot of gold is, don’t stop off at the doughnut shop.
If you can read the Rainbow Passage without interrupting the seal of this version of the N95 mask, you pass, which I never did.
I don’t think anyone expects you to pass a quantitative fit test for the free N95 masks. There is a self-test of the seal which involves holding a strong-smelling substance up to your face (such as Bigfoot turds) to see how long it takes before you pass out. If you don’t pass out, you’re eligible to become a Bigfoot personal trainer.
There’s a limit of 3 N95 masks per person per household. A store employee hands them to you from a bin full of alligators. When the employee gets eaten, management shuts down the whole operation. You can’t just go in there and grab up an armful of them and expect not to get chased out into the parking lot. However, that doesn’t stop some people from heading to every store all over town to get the 3-mask limit, ending up with more than a dozen. The same strategy worked early in the pandemic when stores were rationing toilet paper.
It would be a waste of time for me to try to demonstrate how to don the N95 mask when there’s a perfectly good video demonstration (see below). If you’re wondering about the real Rainbow Passage, the link is here.
Slip Knot and Tuck Mask Fit
I saw the video the CDC suggested for getting a closer fit using a surgical mask. I had a tough time following how to tie the knot in the loops. Either the demonstrator went too fast or I was too slow (probably the latter.) I found a couple of videos on slip knots and crochet knots (another name for slip knot, evidently). There are probably dozens of YouTubes on how to do the Knot and Tuck.
Since the toughest part of the Knot and Tuck method is tying and adjusting the knot to hug the edge of the mask as closely as possible, I practiced a little. See what you think of the slip knot and tuck in my YouTube video below. Using a slip knot allows you to easily move the knot closer to the side of the mask, allowing a tighter fit. Tucking also helps. It also helps prevent my glasses from fogging up. It’ll never be perfect but it’s better than letting the sides flop open.
UIHC Covid-19 Q&A: Omicron and Vaccines
Here’s a recently published YouTube by University of Iowa Health Care on the Covid-19 virus, the Omicron variant, and vaccines (actually there are two, see update below). Points that grabbed our attention were:
Omicron is more transmissible, but overall seems to cause less severe disease.
Current vaccines, especially with the booster, protect against getting severe disease, although may not protect against infection.
It’s not a great idea to just get it over with by getting infected with Omicron. Getting the disease can lead to severe medical complications (including myocarditis) leading to hospital admission. The vaccines rarely cause myocarditis as a side effect and it generally resolves without treatment.
Vaccines make getting Covid-19 long haul syndrome less likely.
Avoiding getting together in groups of 10 or larger decreases the risk of infection with Omicron. The Swiss Cheese method of protecting yourself against Covid-19 still works best:
There are medical treatments for Covid-19 disease if you get infected and have to be hospitalized. The treatments are not without side effects. One of them is dexamethasone, a corticosteroid. It can be used to reduce the immune system reaction that Covid-19 infection can eventually cause. Corticosteroids can cause neuropsychiatric side effects that can range from anxiety to frank delirium marked by psychosis. Fortunately, the duration of steroid treatment is relatively short. Vaccines don’t cause side effects of this type. Over the course of my career before I retired, as a psychiatric consultant in the general hospital, I was not infrequently called to assist in the management of extreme psychiatric side effects from high dose steroids (reference: García CAC, Sánchez EBA, Huerta DH, Gómez-Arnau J. Covid-19 treatment-induced neuropsychiatric adverse effects. Gen Hosp Psychiatry. 2020;67:163-164. doi:10.1016/j.genhosppsych.2020.06.001: quote : “Short course high-dose corticosteroid treatment, as occurs in COVID-19, may cause delirium and changes in mood (with a frequency of up to 52% of patients treated with more than 20 mg a day of prednisone during 3 months) [5], being mania and hypomania more frequently observed than depression.”)
Wearing a mask is protective. Recently the CDC recommended preferring medical grade or surgical masks over cloth masks. The guidance has a link to a YouTube on how to make the 3 layer disposable surgical mask fit closer to the face to provide a more effective barrier (and tends to reduce fogging on eyeglasses). N95 masks may be more widely available soon.
The vaccines are very safe and effective. We had minimal side effects, mainly sore arms.
Update: We watched the UIHC Covid-19 Family Forum last night which ran from 6:30-7:30 PM. I just noticed that it was recorded. It’s similar to the presentation above. It also contains helpful slides with graphs. There were great questions from the audience, which the experts answered and which are helpful to all of us. Many thanks to Dr. Dan Diekema, MD and Dr. Patricia Winokur, MD for this outstanding forum.
Take a Cup of Kindness and Say Goodbye to 2021
It’s been a quiet day around here. It’s New Year’s Eve. I got a great message from a former resident who has started his own Psychiatry Consultation Fellowship training program in Bangkok, Thailand. Dr. Paul Thisayakorn and his wife are welcoming 2022 with their 2 lovely children and hoping 2022 will be a better year, as we are. The Covid pandemic has been hard around the world.
Paul also looks forward to establishing a C-L Psychiatry academic society in Thailand in the coming year. Paul did his psychiatry residency at University of Iowa and his C-L Psychiatry fellowship in Cleveland. Sena and I wish him and his family all the best in the new year.
Today was quiet, but tomorrow the big snowstorm will come. We’ll be digging out all day because the forecast is for 5-8 inches, high wind gusts, and ice. It’s Iowa, after all.
But for tonight we’ll take a cup of kindness and say goodbye to 2021.
And if you like MacLean’s version of Auld Lang Syne above, you might have a listen to another with the Scottish lyrics translated.
Covid-19 Omicron Variant Update
This is just a short message wishing a safe and happy holiday to all. I’m passing readers a couple of links to update information on the Covid-19 Omicron variant and how to stay as safe as possible this winter.
First is the Rounding@Iowa link to the Omicron Variant update. It’s an interview with University of Iowa Hospitals & Clinics (UIHC) infectious disease expert, Dr. Patricia Winokur, MD. It’s about a 16 minute interview. Highlights are that it’s important to get the booster for solid protection against variants including Omicron and that the Covid-19 vaccine is, in general, likely to turn out to be a 3-shot vaccine similar to others, such as the Hepatitis and Shingles vaccines.
The other link is to UIHC infectious disease specialist Dr. Daniel Diekema, MD and his thoughts about the Omicron variant. They echo those of Dr. Winokur and the emphasis again is on the importance of getting vaccinated.
Lastly, there is some guidance by UIHC in a graphic below on how to stay safe from getting infected with Covid-19, (whatever the variant) during winter activities. Happy Holidays!
My Definitive Journey Revisited
A couple of days ago, I got my retirement gift from The University of Iowa. It’s a about a year and a half late because of the Covid-19 pandemic, but it’s welcome nonetheless. Normally there is an Annual Faculty Retirement Dinner, but it had to be cancelled. It’s a stunningly beautiful engraved crystal bowl with the University logo on it. It came with a wonderful letter of appreciation. It reminded me of my blog post in 2019, “My Definitive Journey.”
It’s a definitive symbol of the next part of my journey in life. For years I’d been a fireman of sorts, which is what a general hospital psychiatric consultant really is. The other symbols have been the fireman’s helmet and the little chair I carried around so that I could sit with my patients. I have changed a little.
I still have my work email access, which I’m ambivalent about, naturally. I check it every day, partly because of Fear of Missing Out (FOMO), but also to delete the junk mail. I still get a lot of it. I get a rare message from former trainees, one of whom said it “pained” her to learn I’m now Professor Emeritus.
I have not seriously considered returning to work. That doesn’t mean I have not been occasionally nostalgic for some aspects of my former life.
The poem, “El Viaje Definitivo” by Juan Ramon Jimenez evokes mixed feelings and thoughts now. I have gone away. But in looking back at the past, I now see now that the birds didn’t always sing. The tree was not always green.
I don’t miss my former home, the hospital, as keenly now, which is now a much harder place to work since the Covid-19 pandemic began.
And there is little that is definitive about my journey forward from where I now stand. I’m a little less afraid than I was over a year and a half ago. And the birds sing where I am now, sometimes more clearly than before.
El Viaje Definitivo (The Final Journey)
… and I will go away.
And the birds will stay, singing
And my garden will stay
With its green tree
And white water well.
And every afternoon the sky will be blue and peaceful
And the pealing of bells will be like this afternoon’s
Peal of the bell of the high campanile.
They will die, all those who loved me
And every year the town will be revived, again
And in my circle of green white-limed flowering garden
My spirit will dwell nostalgic from tree to well.
And I will go away
And I will be lonely without my home
And without my tree with its green foliage
Without my white water well
Without the blue peaceful sky
And the birds will stay
Singing
–Juan Ramon Jimenez
CDC Identifies Omicron as Covid-19 Variant of Concern
I’ve been seeing news items about the Omicron variant of Covid-19. The CDC only yesterday announced that it is now a Variant of Concern. Other CDC comments are here in a news release. There’s not a lot of solid information yet about how dangerous it is. Most of what I see on the internet are comments about the need for more information. Vaccine manufacturers don’t seem to agree on whether or not current vaccines would be effective against Omicron.
Interestingly, there seem to be about as many news articles about how to pronounce “Omicron” as there are about the variant itself.
When I compare the Omicron news to that of the recently identified Delta plus (AY.4.2) subvariant, I see very few references to the latter after late October. I never saw any CDC indications that the Delta plus was ever a Variant of Concern, although news items generally carried an alarming tone. As the CDC says, there will be variants. So far, as of yesterday, no U.S. cases have been found.
Go Retire Psychiatrist 