Hi Everyone and Happy 'Hump' Day... as in it's Wednesday for us working folk and we're over the Omicron 'hump' as well.
I know it has been a month since I posted an update but honestly, it was obscenely busy in the ER and hospital, and I didn't think I needed to send an update during Omicron that everyone was getting covid because I'm sure you noticed.
The great thing about being over the omicron hump is that we are starting to de-escalate those contingency plans at the hospital- elective surgeries and procedures are resuming, ER wait times are improving and beds are opening up. Most visitor policies have not changed however and we are still not allowing visitors. However, there are some dark days behind us (literally and figuratively) and this last surge was a doozy.
Admittedly this update has some dense data to pull apart but it's important to be looking at quality data when making decisions, so bear with me.
Local updates:
Lake county, IL:
Testing positivity: 8% (down 70% in the past week!- during our peak this number was 18%)
Vaccination rates > 5 years old: 79% (vaccinated plus boosted > 18: 74%)
Hospital beds used for covid: 22% (down from 50% during our peak)
ICU beds used for covid: 29% (down from 60% during our peak)
Kenosha county, WI:
Testing positivity: 22% (during our peak this number was 38%)
Vaccination rates > 5 years old: 61% (vaccinated plus boosted > 18: 46%)
Hospital beds used for covid: 15% (down from 47% during our peak)
ICU beds used for covid: 21% (down from 60% during our peak)
Racine county, WI:
Testing positivity 20% (during our peak this number was 36%)
Vaccination rates > 5 years old: 63% (vaccinated plus boosted > 18: 50%)
Hospital beds used for covid: 12% (down from 28% during our peak)
ICU beds used for covid: 18% (down from 45% during our peak)
Locally what is going on is that cases and hospitalizations are plummeting, but deaths remain stable, as there is always a lag there. For example, the patients that got exposed to covid over the Christmas/New Years holidays took until mid January to be hospitalized and end of January to have severe disease and die- about a month lag. We will still see the aftermath of omicron for this subset of people for several more weeks but cases are stabilizing and the crushing volume has diminished. For kids: lots of kids getting covid (more on that below) but almost no hospitalizations for covid. Kids are being hospitalized for other reasons (ie RSV is a big one right now) and are found to also be covid positive due to high prevalence in the community but are not hospitalized because of covid.
Data and research updates:
Pediatric Vaccines:
Lots to unpack here, bear with me. Skip if you don't have kids or don't want to know about pediatric vaccines.
The Pfizer vaccine for kids aged 6 months to 5 years will be presented for EUA status later this month. It is a 3-microgram dose (compared with a 10-microgram dose in 5- to 11-year-olds and 30 micrograms for people aged 12 and older). They are testing a 3 dose series: the first two doses 3 weeks apart (like the ages 5 and above) and then a third dose 8 weeks after the second. This should be approved shortly.
Data from the Pfizer study for ages 5-11 did not show efficacy at preventing covid infection. It was approved despite failing to meet this end point. Reasons for this: it passed safety data with flying colors, i.e. no adverse event data that was significant; it still showed that vaccination was able to prevent pediatric hospitalizations and complications secondary to covid. Remember they tested their data during a time of 'OG' covid (Alpha/Beta/Delta) and not Omicron. You may notice if you have children that this is consistent with the data- kids are getting covid despite being fully vaccinated, but they are not getting hospitalized or significantly sick.
Data from the 6 mo to 2 year ago group on the other hand, did show efficacy and good safety data. Some people are wondering why Pfizer applied first for ages 5-11 with data that didn't show efficacy rather than for ages 6 mo to 5 years with data that did show efficacy and that is because all vaccines are approved by age de-escalation and they don't skip age groups. So think of it as the opposite of being on a sinking ship when they announce "women and children first". This is "adults, you go first.... kids, stand back and wait your turn, we'll get to you later". Well, now it's later and we are approving the vaccine for kids and working our way back in age.
To summarize: The mRNA vaccines (Pfizer, Moderna) showed excellent efficacy at preventing orignal covid and delta (up to 90%). They still showed excellent efficacy for omicron (up to 70%) but there was much more breakthrough due to the high rate of mutation. For kids ages 5-11, the data did not show the vaccine is useful for prevention, but it does not have significant adverse events and it does reduce hospitalizations, severe disease and complications. In younger kids age 2 mo to 5 years, it also showed efficacy and safety and prevention of hospitalization. In medicine, we have to take the Hippocratic Oath that says "First, do no harm". The pediatric vaccine is still "worth it" to prevent severe disease in kids as the harm of an adverse event from the vaccine in children is exceedingly low. Just don't expect to let your kid go to a party with a bunch of covid kids and not come home with covid.
Adult vaccines:
Israel was kind enough to evaluate a FOURTH dose of mRNA vaccine and present the world with their data. It was given to adults over 60 and "at-risk" populations. Participants were eligible if they had their 3rd dose at least 4 months earlier. This specifically tested omicron as that is the world wide dominant strain now. Their conclusion was that rates of confirmed Covid-19 and severe illness were lower following a fourth dose compared to only three doses. Some countries (ex- Finland, Israel) have already approved this, but only for the immunocompromised. Whether we should or will do this here in the US is up for debate. There is good data that says to wait to give booster doses. Too many, too close together may be less effective than if they are spaced out by months (or even years). More to come on this for the US.
Some European countries had stopped recommending the moderna vaccine to anyone under 30 due to the higher rate of myocarditis with the higher moderna dose (as compared to pfizer). Myocarditis risk from the vaccine is highest in males ages 16-30, though nearly all cases self resolve without intervention. It is something to be aware of if you have a choice in mRNA vaccine and are under 30. Much of Europe has also moved away from Astra Zeneca's vaccine due to the potential for adverse events (clotting concerns). These "pauses" were re-evaluated in December 2021 and were ultimately resumed. I'm mentioning it here in case you are down to flipping a coin for which one to get and are a young male.
Moderna got full FDA approval for its covid vaccine, similar to Pfizer. It is also starting it's trial on a pediatric vaccine.
Moderna, BioNTech and Pfizer are all testing a booster aimed specifically at the Omicron variant. Who knows if this will be useful by the time they test it, evaluate it, report it and approve it. It seems we might have decent herd immunity to omicron by then or we might be on to another variant. Omicron was so infectious and spread so quickly that the combination of people recovered from infection and people fully vaccinated and boostered gives decent population protection.
U.S. vaccine maker Novavax is finally being evaluated for EUA. Many people have waited for this vaccine specifically because it is a traditional protein-based vaccine that is similar in effectiveness to the mRNA vaccines. In other words, to some people, it is the best of both worlds: a vaccine from traditional, safe technology that's been in use for decades plus excellent protection rates.
Treatments:
FDA revoked EUA for most monoclonal antibodies as they are ineffective against Omicron which is the dominant strain in the US (99% dominance). Sotrovimab is still approved and works. It is only indicated in outpatients with non-severe symptoms as a way to prevent progression to severe symptoms and hospitalization. There is a scoring system and you have to qualify for it based on your age, BMI and co-morbities. It has been very hard to come by due to the sheer numbers of Omicron cases. During the peak, we were getting 6 doses a week and could have easily been giving 6 doses a day for people who qualified. Some monoclonal antibody treatments are also approved now for children 12 and older.
Paxlovid- pfizer's oral drug: Pros - It is effective against all strains of our favorite virus including the big O. It is taken orally, so no pesky ER visit with an 8 hour wait or needles. You can take this one in the comfort of your own home. Cons- well, it's not readily available unless you are in a government program, but that is changing rapidly and it is becoming less elusive to find. There is a sourcing website for it and other covid treatments ( https://covid-19-therapeutics-locator-dhhs.hub.arcgis.com/?fbclid=IwAR39ck4EFQD3gFNv1wKW90LjczHlLjJhVIEQf4bdnebBshutuHmBTmz6ihQ) -it's only for prescribers but anyone can take a peek to see if it's available near them. Another weakness is the many medication interactions and don't forget it also tastes terrible. Basically more reasons to aim for prevention instead of having to deal with treatment.
Molnupiravir (by Merck): Pros: it's oral, it works well to treat covid symptoms and help people recover. Cons: it has some hefty safety concerns including birth defects, inserting DNA mutations or possible oncogenesis (cancer causing). It requires the correct use of birth control for 3 months after the last dose (for both men AND women- because it can alter sperm as well) which cuts out a large portion of the popultion... basically people of child bearing age who have sex... who knows how many people that is in this country, but I think it's a lot.
New variant:
Basically Omicron's spawn, or more scientifically BA.2 (Omicron is BA.1). Other pet names this one has received in the media is 'stealth omicron' because it doesn't have an SGTF that we use to test for variants easily. It needs to be sequenced and ain't nobody got time for that. However, it might get it's very own greek letter because its mutations are plentiful compared to 'plain vanilla' Omicron (85 vs 60... overachiever!). Before we all panic- we know little, so let's wait for good data. We have no data on severity compared to BA.1 and no idea if it's in the US and if so, how much Omicron is 1 vs 2. The UK, South Africa, Denmark, Norway and Sweden have done a good job of tracking it. Norway has reported cases of reinfection with BA.2 after BA.1. Data is pointing to this basically prolonging the omicron surge or that we have a second peak (um, no thank you) and if you had BA.1, you should have protection against BA.2. Prelimarly BA.2 is 1.5x more infectious than BA.1, which itself is already quite infectious. Early data also shows that vaccine effectiveness is holding at 70% for both Omicrons (plural Omicroi?).
Happy Hump Day and Ground Hog day and all the days. I feel like Spring is coming even if there is inevitably another variant. Until then, do good things in public like wash your hands and don't get in each other's faces.
- Dr. Green
Medlogic Primary Care