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Thanksgiving Covid update

Hello! Just a quick covid check in to see how we’re all doing. Although... I feel like these check-ins are never quick. At least not for me, because it takes many hours to read through all the studies, the pre-prints, the rebuttals and the editor notes as well as evaluate the studies themselves. But…. Here we are, the latest and greatest in covid data. First, local cases: slowly increasing in all areas from my last update Lake County, IL: Testing positivity: 3% Fully vaccinated (over age 12): 80% Hospital beds in use for Covid patients: 6% ICU beds in use for Covid patients: 14% Kenosha County, WI: Testing positivity: 11% Fully vaccinated (over age 12): 62% Hospital beds in use for Covid patients: 9% ICU beds in use for Covid patients: 29% Racine County, WI Testing positivity: 11% Fully vaccinated (over age 12): 64% Hospital beds in use for Covid patients: 8% ICU beds in use for Covid patients: 17% On to the latest news and studies: Lots of information on pediatric vaccines (skip if not interested in this age group): Pfizer has received EUA for children ages 5-11 now. The dose is 10 ng or 1/3 of the adult dose of 30 ng. Moderna has submitted their data for this age group as well, but it will likely be 1-2 months before the FDA votes on EUA for that. If you are hoping to get your child vaccinated with Moderna, expect to wait another 1-2 months for approval. Moderna’s pediatric dose is higher than Pfizer’s pediatric dose, similar to their adult dose being higher than Pfizer's (100 ng moderna vs 30 ng Pfizer). While Pfizer does have EUA for ages 5-17 now and FDA approval for ages 18 & up, the voting committee was underwhelmed by the evidence to support children getting vaccinated, citing lower risk of severe disease as compared to adults. They did not have any safety concerns. In their vote to approve EUA for ages 5-11, they stated it was important to vote for EUA status so that all parents that wanted to vaccinate their children would have the opportunity to do so. They also felt that children were at enough risk from covid to approve the vaccine, citing both direct risks (1.9 million infections, 9,000 hospitalizations, over 90 deaths in ages 5-11 as well as long covid syndrome) and indirect risks (missing school and being a driver of community transmission). Lastly, CDC noted that we vaccinate for other diseases that do not have as high of disease risk or burden as Covid infection. They gave the example of hepatitis A vaccine which pre-vaccination was responsible for 3 deaths per year on average. In comparison, there were 66 pediatric covid deaths on average per year pre-vaccine. Other guidance they gave: -Vaccinate children regardless of underlying health conditions- no restrictions on vaccination - Severe disease appears to be random in children- no predictors known yet like we know for adults - Children should still get vaccinated even if they have recovered from covid natural infection at some point for the same reasons they recommend this for adults: 38% of children had detectable antibodies in one study after natural infection and we can’t accurately or easily predict who will fall into that category (although Harvard is studying it) - One study cited found the risk of reinfection is significantly higher after natural infection than after vaccination which was a well done study - Children should get vaccinated even if they have a positive antibody test presently- they don't need to wait - Dosing is based on the age of the child, not on their BMI or weight. A bigger kid (physically) doesn’t need a bigger dose. The lower dose is used because children respond more robustly to vaccines than young adults and older adults, so children do not need a very large dose to produce an immune response Vaccine adverse effects: Vaccine-induced myocarditis was addressed in a recent safety review. The CDC presented on suspected vaccine induced myocarditis deaths. Of 86 million doses given at the time of the study, there had been 9 reports of suspected vaccine-induced myocarditis deaths. Three cases of the 9 are still under investigation but the other 6 cases have concluded their investigation and 3 of the 6 deaths were confirmed to be from myocarditis itself and not vaccine induced. Meaning 3 of the 6 cases investigated confirmed a viral or bacterial cause for myocarditis, not a vaccine cause. The safety review didn’t comment on whether the other 3 deaths were confirmed to be vaccine induced, but it is reasonable to assume that there were 3 vaccine induced myocarditis deaths of the 86 million doses. Booster dose: Details are still being worked out on the best dosing schedule for long term efficacy. Many studies have now cited waning vaccine efficacy after about 6-8 months. What we don’t know yet is if a booster dose will be the last required dose in what would then become a 3 shot series or if we will need repeated booster doses. Not enough time has passed yet to accurately answer that question. It could be that the vaccine ends up being a 3 shot series or it could end up being like the flu vaccine that needs to be given annually. Oral medications: Merck and Pfizer have developed an oral antiviral medication for covid. It is a protease inhibitor that is designed to be similar to a lock and key model for its target. There has been some confusion because ivermectin also works as a protease inhibitor which would seem to support ivermectin being useful in covid. To say that ivermectin is a protease inhibitor and this new drug is a protease inhibitor so they are equal would be like saying all locks are opened with one key. There are many different kinds of keys. If you want to unlock a door (covid), it’s better to call a locksmith who has the specific type of key you need that fits your lock (the Pfizer and Merck drugs) rather than call someone who has a bunch of keys, in hopes one might fit (ivermectin). Another analogy would be to say that a grape and a watermelon are both fruits- which is of course true, but they are not the same thing. Protease inhibitors in general are not new, many of the HIV drugs are protease inhibitors to stop replication of HIV. I mention this because Pfizer's drug specifically uses ritonavir which was one of the earliest HIV drugs but the ritonavir in this case is being used as a booster to increase the half life of the actual active drug PF-07321332, which is actually fairly brillant. I love recycling and I'm glad to hear that ritonavir has a found a useful home. It was not able to be easily used in HIV as a standalone drug because it interacts with so many other medications, increasing their concentrations. In this Pfizer medication, a very small dose of ritonavir is used to boost up the half life of the active PF-07321332 drug so it doesn't need to be dosed 4 times per day which would be difficult for compliance. Some "news" reports have stated that pfizer is presenting an HIV drug which is a twi of the truth. It does use an HIV drug but not anywhere near the HIV dosing and not for that antiviral purpose. The active drug molecule is the PF-07321332. These new oral drugs are expensive as they are very specific and required a lot of testing in vitro, in vivo in animals and in vivo in humans before they could submit their data for EUA. The best treatment for covid still remains not to get it at all (ie prevention). Statistics on the Lancet study on Israeli booster dose program I thought this data was interesting and useful to briefly discuss statistics and how they can be used to tell a story. It has been widely publicized that the Israeli booster program was very successful. Data post-booster shows that severe disease was reduced in all age groups. However, the subset data analysis of the 16–39-year-old age group had a very small ARR (Absolute Risk Reduction). This is where statistics and data need to be sorted through carefully because numbers can be twisted. The study found that in Israeli citizens under age 40, the risk reduction went from 7 per 100,000 to 2 per 100,000 which is an incredibly small actual risk reduction (i.e., 5 per 100,000) but produces a large relative risk reduction (i.e. 71% risk reduction). It is true to say the booster dose reduced risk by 71% of severe disease. It is also true that this number works out to be 5 cases of severe disease prevented per 100,000 infections. I mention this because we see this a lot in covid as each side is trying to sell "their" story. Both statements are true so it is really important to remember to evaluate good, high quality, peer-reviewed evidence and then apply that information to your own personal level of risk tolerance. Each person will interpret those two statements of risk reduction differently and tell themselves the story they want to hear about the booster dose. They do so with their own world lens and individual risk tolerance. In short, decide what is best for you individually in the broad context of data. Of course, no one wants to be on the wrong side of a statistic, even if it is small. As mentioned above, no one wants to be the 1 in 29 million that dies of vaccine induced myocarditis. But most people are willing to accept that level of very low risk. The paper authors do acknowledge that under age 40, the numbers are too small to make solid conclusions, and like everything else with covid, we need more time longitudinally to study this. Hope everyone has a nice Thanksgiving this week. Our office is closed on Thursday. I will send an update on our December holiday closing and Michele’s upcoming maternity leave this week as well. Best, Jill Green MD Medlogic Primary Care Kenosha, WI & Bannockburn, IL

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