There is a lot to talk about this week (code for grab a large glass of wine and sit down). I will get into the details of the increasing cases we’re seeing in the emergency department and will also touch on the impact of the Delta variant (you’ll recall last week I said I was worried about its potential), vaccine boosters, as well as a very rare complication seen in patients who receive the Johnson & Johnson vaccine. Almost every state in America has seen an increase in the number of positive cases each day. Johns Hopkins is reporting that the daily number of confirmed new infections has more than doubled over the past 3 weeks. Remember that as cases go up, 1 to 2 weeks later, we will see hospitalizations go up, and then a couple of weeks after that we will see deaths go up. We’ve repeated this cycle several times already.
Let’s start with what we’re seeing in the emergency department. Our day-to-day business is pretty normal. In fact, this past Monday, we had our busiest day since February 5, 2020 (during the peak of flu season and before the pandemic). Most of the ER’s in the area are quite busy now with non-COVID related cases. High ER volumes is probably not a good thing in general from a public health perspective. Many of you probably saw the news recently that Virginia has closed five psychiatric hospitals to new admissions. This will ultimately impact all ER’s as well. We will have a harder time placing psychiatric patients in hospitals, particularly those that are under court order to go to a psychiatric hospital. This will result in longer ER stays for these patients as we seek definitive care for them. Many of these patients will be in police custody which will impact the amount of police officers available to respond to other emergencies. Now, let’s look at the impact of COVID on the ER this past week. After only seeing scattered positive cases in the emergency department the last 6 weeks, we definitely made more Covid diagnoses this week than the last several weeks combined. Most of the patients presented with Covid symptoms, at least one patient was previously vaccinated, and we did see a couple of patients that were asymptomatic but tested positive on routine screening for admission. An important point to remember is that vaccinations do not guarantee you won’t get COVID (though they certainly help your odds of not getting it if exposed), but the vaccine greatly increase the odds that if you get COVID, you will have a mild case that doesn’t require hospitalization and the chances of dying are greatly reduced. Back to the ER. The total number of new diagnoses we made are certainly not as high as they were a few months ago, though it’s the highest number of new cases we’ve seen in a while. You would have to go back to the week of May 12 to find the same number of patients that tested positive among the symptomatic group as well as total cases (including all screening tests). We saw cases pretty consistently start to decrease around April 1 and then again around May 1. Since June, positive cases have been relatively infrequent among our symptomatic and asymptomatic patients. The number for this week is a real change and I suspect next week will be worse. We will definitely have to see how this trends out over the next 2 to 4 weeks. On the hospital side, whereas we briefly had 0 hospitalized Covid patients just a short time ago, that number is beginning to increase as well.
I remain very concerned about the potential impact of the Delta variant, which is much more transmissible than other variants. Around the country, many hospitals are seeing patient admission totals that exceed the winter surges. Mississippi reported have 10 critically ill pediatric patients, so it’s hitting all age groups. Hospitalization rates appear inversely proportional to the state’s vaccination rates. Although the DMV is ranked above average in the vaccination rate compared to other states, my understanding is that only about 55% of Arlington County residents are fully vaccinated (2 weeks status post 2nd shot) though about 70% have received one shot. There are other counties in the region with higher rates. The second dose of vaccine makes a huge difference protecting you against the Delta strain. Nationally, only 1/3 of 12-18 year olds are vaccinated and up to 25% of 18-25 year olds say they won’t get the vaccine. We have a lot of work to do to increase vaccination rates among these age groups.
Discussions continue between Pfizer and the FDA regarding the benefits of a booster shot. I have no issue with getting a booster shot and most of us expect that we will need one at some point. The big question is about the timing of it. Do you need a booster shot 6 months after your series is complete or 12 months, perhaps a year or 2 later? The short answer is we do not know yet. Most healthcare workers are coming up on 8 months since our 2nd shot, so we’re definitely curious. Immunity does seem to hold up well for at least 6 to 8 months, and likely longer. France has been doing booster shots for several months and Israel just started offering a booster shot for immunocompromised patients. The UK is planning to administer booster shots to certain populations starting this fall. Studies are looking at the benefit of the immune response in immunocompromised patients with a booster shot. About 3% of Americans have a “weakened” immune system, including patients with AIDS, cancer, transplant recipients, and others with autoimmune disorders like rheumatoid arthritis and inflammatory bowel disease. We’ve seen some research with booster shots in the transplant population. These are likely the population where a booster shot will have the biggest benefit and will likely be a reasonable population to start on. For the general healthy population, at this point, the science does not lead us to believe that a booster shot is necessary 6 months out from your original second dose. A better use of the supply would be to use them to vaccinate everyone in America 12 and up and others around the world. Reducing the total number of cases worldwide will reduce the number of variants being developed. Hospitalizations and deaths are overwhelmingly being seen in the unvaccinated population and at this point, in my opinion, this is the population we should be focusing on. The science is continuing to develop so perhaps we’ll have an answer that is clearer in the near future.
The single dose Johnson & Johnson vaccine has had a rough go of it. For starters, the initial studies did not show it to be as effective as the mRNA vaccines (though the projected 66% effectiveness rate was still better than the FDA required threshold). Then there was the contamination issue in the Baltimore plant that resulted in throwing out millions of doses. And there were the very rare blood clot cases that appear linked to the vaccine. This week, the FDA has said that the J&J vaccine may lead to an increased risk of Guillain-Barré Syndrome (GBS). Guillain-Barré is a neurological condition in which our body’s own immune system damages nerve cells causing muscle weakness and sometimes paralysis. The initial symptoms are usually weakness and tingling in your extremities (typically lower extremities first). Although weakness and tingling are fairly common conditions that we evaluate patients for in the emergency department, I cannot remember the last time I admitted a patient who ultimately had Guillain-Barré Syndrome. There have been a couple of publications in the neurology literature that reported clusters of GBS after patients received the J&J vaccine. At baseline, GBS occurs less than 6,000 times a year in the US, so it’s an extraordinarily rare condition, that has also been associated with the flu vaccine. The FDA is reporting approximately 100 cases they believe are associated with a J&J vaccine. This puts a rate of 1 per 120,000 recipients of the vaccine. The projected risk of GBS related to the flu vaccine is estimated in the range of 1-2 additional cases per million flu vaccines administered. If you’re more than 6 weeks out from your J&J dose, the odds of getting GBS are even lower.
I have never been particularly political. Politics is something I have tried to – and generally have the luxury of avoiding in these posts – but they certainly came into play in Tennessee this week for a doctor and I wanted to talk about how real a situation it is.
It is certainly very worrisome to me to see science and vaccinations be divided among political lines. The top vaccine official for the Tennessee Department of Health, Dr Michelle Fiscus, was fired recently. She believes it was in response to “Republican State law makers who are angry” about her efforts to vaccinate teenagers. As background, she worked with the Department of Health’s attorneys to create a letter to send to primary care providers about the COVID vaccine. The attorneys provided her with wording based on a decades old Tennessee Supreme Court ruling that allowed minors ages 14-17 to receive medical care without parental consent. Subsequently, the state decided to cease promoting all vaccines to teens. This means not sending reminder post cards or other notices about second doses, cancelling COVID vaccine clinics in schools, and cancelling other vaccine outreach for flu, measles, and other routine vaccinations.
Dr Fiscus released an open statement on her Twitter feed pointing out that nearly 40% of “immunization program directors left their position” during the pandemic. She writes “it is the mission of the Tennessee Department of Health to ‘protect promote and improve the health and prosperity of the people of Tennessee,’ and protecting them against the deadliest infectious disease event in more than 100 years IS our job….1 out of every 554 Tennessean has died from COVID-19… Less than 38% of Tennesseans have been vaccinated.” Finally, she says, “our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.
“We have to acknowledging that the forces of politics, a few businesses trying to make money, your cousin who read something on the internet seem real….but they are not the results of scientific research. Watching the United States slowly get back to some sort of normal with declined death and infection rates while parts of the world that are mostly unvaccinated keep dying from this disease should be very clear. But it would really help if the importance of vaccinations could be made loud and clear from all of our country’s leaders.
I do not understand the process enough to explain why the FDA has NOT approved the Pfizer and Moderna vaccines yet. I’ve read that the application is in process (I actually believe they’re still collecting safety data) but I’d like to see it approved. Certainly, some vaccine hesitancy would be removed if these vaccines were given full approval and not under emergency use authorization. It would also take away much of the argument that people make that prevent businesses and schools from mandating vaccination.
It does not look like the FDA will approve the Pfizer vaccine for those <12 years old this fall as anticipated. The FDA has requested additional safety data (4-6 months of safety data instead of the 2 months which was used for adults) which moves the time-table for approval to mid-winter. Before you ask questions, I’m hoping to really dive into kids, vaccinations, school openings, and risk in the next week or two.
As case numbers had declined over the last few months, I haven’t talked much about treatments. There is increasing support (recommended by the World Health Organization) based on a large study recently published in JAMA for using arthritis medications Actemra and Kevzara in our sickest COVID patients. These medications are interleukin-6 (IL-6) antagonists that block inflammation. The JAMA study of 11,000 patients showed that when using IL-6 antagonists with steroids, there is a reduced need for mechanical ventilation (33% to 26%) and a reduced risk of death (25% to 21%). Although that may not seem like a lot, for every 100 patients treated, 4 more will survive.
Science matters. Get vaccinated. Wear a mask when you’re supposed to. We’re almost there.