Yes, I know; you have been beaten nearly to death with data and statistics on the Corona-19 pandemic. This observation by a doc in the trenches (in NV) is somber and at least concerning if not downright frightening. You might not want to read it before you turn in for the night but you definitely should before stepping out your front door.
by Dr. Merritt Dunlap
CURRENT COMMUNITY STATUS
STATE OF NEVADA-getting about 2,000 cases daily.
QUAD COUNTIES-getting 150-200 cases daily. Hospital almost full. Medical system getting very stressed.
WASHOE COUNTY-getting about 500 cases daily. Hospitals very stressed and opening new units.
NATION-over 200,000 new cases daily. Daily death rates at record levels.
Not good all the way across the board. My office used to diagnose about 1 or 2 cases a week. We’re now diagnosing up to 5 a day. The state and county trends look like they may be starting to crest this wave but we’ll have to wait a week to see how this really plays out. Bottom line is that there’s a lot of virus out there, it’s transmitting all over the place and if you don’t want to join these statistics you simply can’t be in an enclosed space with someone without having a mask on.
The good news is that monoclonal antibody treatment is now available (although in limited supplies). For the high risk patients, I can order this treatment (for the time being). The limited number of patients I’ve treated with it reported feeling much better within 48 hours with no side effects. It’s not a failsafe but it’s definitely a step in the right direction.
Before I start about the vaccines I need to make something very clear: There are no risk free choices for you. If you choose not to get a vaccine, you are simply choosing the risk of getting COVID-19, continuing with the status quo and everything that goes with both. If you choose to get a vaccine you are choosing the known (and theoretical) risks that go with the vaccine. I’ll talk more about how to make a choice that’s right for you in future communications.
QUICK COVID-19 REFRESHER
I want to remind you about the actual disease of COVID-19. Overall infection mortality rate appears to be about 0.3-0.5% (roughly 3-5 times higher than the flu). However, this doesn’t mean YOUR mortality rate is 0.3-0.5%. That’s the OVERALL rate (it includes all the young folks and low risk folks). If you’re over 65 or have other medical conditions, your mortality rate is definitely higher. What scares me, personally, about this infection is the chance for long-term medical issues that comes with the infection. This is being called “Long COVID” or “Long-Haulers”. This is NOT trivial. 15-20% of people who get COVID-19 end up with this, even if they only had a mild infection. Remember, this virus causes a high tendency to form blood clots and get vasculitis (inflammation of the blood vessels). These patients have persisting problems with shortness of breath, debilitating fatigue, heart problems (myocarditis or cardiomyopathy), neurologic problems and a variety of other issues. Further, we don’t know (and can’t predict) who might end up with this and I can tell you from dealing with patients and friends who have this that it’s no joke. So when you think about making a decision for yourself, make sure you’re not just considering the overall mortality rate. Make sure you’re factoring in ALL the information. The whole enchilada as they say. You need to think very carefully and take all these things into consideration. Also remember, we’ve known from the beginning that a vaccine was our way out of this but it only works if people take it. One other little fun factoid I recently learned: Humans have never, in the history of mankind, eradicated a virus through natural herd immunity. Doesn’t happen. The only way we humans have been able to eradicate an infectious disease is through a vaccine.
PFIZER & MODERNA mRNA VACCINES (I’ll talk about other vaccines as we get more information on them)
Ok. As I’m sure you’re all aware, the first 2 vaccines on the block are the mRNA vaccines from Pfizer and Moderna. We anticipate that these will be going into arms by the 3rd week of December. These vaccines were developed with a technology in which a small piece of messenger RNA (essentially the blueprint for a protein) is delivered via a tiny lipid particle (nanoparticle) into your shoulder muscle. This technology has been nearly 20 years in the making but this is it’s first real test. Once inside the cytoplasm (outside the nucleus) of the muscle cells, your body uses its own machinery to manufacture spike proteins and your immune system goes after those spike proteins and creates immunizing antibodies. This is a different way to present spike proteins to your immune system. Historically, we would have inactivated a virus and given it to you or we would give you actual parts of a virus (like the spike proteins). This is how most vaccines have historically been made.
This time, we’re not giving you any part of the virus at all—just the instructions for your own body to make a piece of the virus. Because you’re not getting any virus at all, the vaccine cannot give you COVID-19. Additionally, it’s important to understand that mRNA doesn’t interact with your own DNA (your genes) in any way (the mRNA never even gets into the nucleus of the cell where your DNA resides). mRNA is very fragile and has a short lifespan (hence the very cold storage requirements of mRNA vaccines). After your body uses the mRNA for a little while, the mRNA degrades and is digested by your cells. Incidentally, reading mRNA and disposing of it is a natural process and is happening constantly in our bodies.THAT WAS FAST!
Yes it was (kind of). This technology has been in the works for nearly 20 years, starting with SARS-CoV (the original) in 2002 and then with MERS in 2012. Those vaccines never made it to fruition, primarily because the virus died out, interest died out and then the money died out. However, we had the platform and the knowledge about the virus so that when SARS-CoV-2 showed up we were ready to roll with this technology. Then, along came the US Government which completely took the financial risk out of development allowing the science & trials to proceed unfettered. Put it all together and we’re witnessing one of the greatest scientific achievements in human history. This is not an exaggeration. Vaccines typically take 15-20 years and $1Billion+ to get to market (much of that money and time is spent trying to get to a Phase 3 trial). This one made it from concept to market in 11 months! Amazing.
Doing a Phase 3 trial is the critical piece in developing a working vaccine. The years and money to get to a phase 3 trial is what usually slows the process. With these vaccines, no corners have been cut. In fact, FDA Commissioner Stephen Hahn, despite tremendous political pressure to release data before the November 3 elections, stood firm that nothing would be done or announced until the trials had proceeded as designed and the data had been properly reviewed. In other words, no one has be permitted to interfere with the proper processes & procedures.
Does it work? So far, when you put both Phase 3 trials together, over 35,000 people have received the actual vaccines starting in late July of this year. The efficacy results have been nothing short of remarkable. Fewer than 6% of all those in the trials who got infected were vaccinated. And those who did get COVID-19 despite vaccination only had mild illness. Thus far in human history, of the myriad of vaccines that have been developed over the past century, there have only been 3 that reached a 90% efficacy level—the new shingles vaccine, the small pox vaccine and the measles vaccine. If this efficacy holds up, this would put these vaccines among the most elite ever developed. There are certainly still questions to be answered, but the preliminary data are very encouraging. There are lots of questions I, personally, have about efficacy in various populations of people but the data will not be out for public consumption until December 8th. I’ll certainly keep you posted.
SAFETY (DOES THE BENEFIT OUTWEIGH THE RISK?)
Biggest question on people’s minds. Is it safe? Have we studied it long enough? I think the answer to both is yes and here’s why I say that: In the history of vaccine development there has never been a serious side effect that has not been recognized within 6 weeks of using the vaccine. We have not seen any serious side effect from these vaccines and we’ve been watching 35,000 people for almost 5 months now. With that said, 35,000 is not 35 million. There may be a rare serious adverse event post approval and I think we need to stay humble about the initial amazing data on these vaccines. There are systems in place (as with any vaccine) that will pick these up and will continue to monitor patients for years to come. In addition, by the time most folks are getting a vaccine there will probably be an additional 20 million people (likely their doctors) vaccinated so they can see what happened to them as well. There is certainly no “Absolute Safety” and there never can be. Again, the question you face is which risk are you more willing to accept given the situation & information you have? I have no doubt that at some point in the next year there will be a situation where a person develops some type of horrible medical condition at some point after they’ve been vaccinated and you can bet your bottom dollar that the media will be all over it. However, the vaccine will only prevent what happens from SARS-CoV-2, not everything else in life. There are lots of little nuance questions I have regarding safety but, again, I’ll let you know after I see the raw data on 12/8.
HOW LONG WILL IMMUNITY LAST?
I don’t know. No one know. Only time will tell. However, we can make some educated guesses. Typically, the shorter the incubation period of a virus, the shorter the immunity from a vaccine for it lasts. SARS-CoV-2 is a medium incubation time virus (about 6 days on average). Flu is about 1-2 days and measles is about 10-14 days. We need a flu shot annually and we often get lifelong immunity from a measles vaccine. Therefore, it would be reasonable to guess that the immunity from a SARS-CoV-2 vaccine would last in the range of years rather than the range of decades. Again, only time will tell. By the way, it’s common (normal really) to require booster doses of most vaccines so even if we found it only lasted a few years, that would be considered normal.
WHEN WILL IT BE HERE AND WHEN/HOW CAN I GET IT?
The FDA is meeting on December 10. The states are gearing up to start administering the vaccines to Tier 1 recipients in the 3rd week of December. The CDC’s Advisory Committee on Immunization Practices (ACIP) put out guidance for states on who should be in Tier 1 on December 1st. It will be front line health care workers and the staff and residents of Long Term Care Facilities. Nevada has adopted this recommendation. It’s anticipated that Nevada will get about 165,000 doses of Pfizer vaccine this month but there are about 175,000 Nevadans in Tier 1. You can do the math. As production is ramped up further and distribution is optimized, we will continue moving through the various tiers getting people immunized in that order.
If you want to see how the State put together the 4 tiers, go to this link: https://nvhealthresponse.nv.gov/wp-content/uploads/2020/12/NEVADA-COVID-19-VACCINE-PLAYBOOK-VERSION-2.0.pdf and look at pages 21-24. We anticipate that between Pfizer and Moderna, millions of doses will be rolling out as soon as they get the go ahead from the FDA and will continue for as long as it takes. The nice thing about mRNA vaccines is that they don’t have to be grown in cells or culture media which takes a lot of time. They can be mass manufactured by machines so I’m optimistic that supplies will stay strong. There were some recent media headlines (take any corporate media information with a big grain of salt – they have agendas) about Pfizer having problems getting raw materials but that wasn’t for the mRNA, it was for the lipid delivery particle and I’ve been told that the delay has been resolved. Moderna has not had this issue to date.
Both mRNA vaccines are two shot series. The Pfizer vaccine is given 21 days apart. The Moderna vaccine is given 28 days apart. Excellent antibody responses are typically observed about 7 days after the 2nd dose. Additionally, you can’t mix them. If you start with Pfizer your 2nd dose must be Pfizer and vice versa. The Pfizer vaccine presents some unique challenges with regard to storage and transport. It needs to be kept at -70 Celcius (-94F). Therefore, anyone who gets a Pfizer vaccine will be required to go to a specific site (a hub) that has super-cold freezing capacity. There’s only one in Carson City and a couple in Reno. This will limit how much and how quickly we can administer that vaccine. It creates a bottle neck. The Moderna vaccine can be stored in a normal freezer so I anticipate this will be the one being given more commonly once it’s released. No word yet on when that will be or when those doses will be coming to my office but I’ll keep you informed. It’s anticipated that on a national level we’ll be vaccinating about 5 million people weekly once this gets rolling (barring any major hiccups in the process, obviously).
I know this doesn’t answer nearly all your questions (nor did I expect it would) but I’m getting tired of writing and I’m sure you’re getting tired of reading (if you’ve made it this far 😊). I will address the other vaccines as we get more information. I’ll also be notifying you of upcoming Zoom meetings I’ll be having to answer questions and I’ll do follow up emails on this topic. I’ll try my best to keep you informed so you can make the decisions that are best for you and your families.
As I mentioned, the FDA is meeting on December 10 regarding the Pfizer vaccine and again on December 17 regarding the Moderna vaccine. I anticipate both of these vaccines will receive an EUA. Despite all of the nonsense perpetrated by our states and the federal government through this pandemic I have absolute faith in the integrity of the people & process for testing and evaluating these vaccines. Not only do I know that the people reviewing this are among the very best vaccine experts in the world but I know that if they get this wrong the entire future of vaccines and the credibility of the FDA with be irreparably damaged. They know it to.
Finally, I have been asked several times if I’m going to take the vaccine. Barring any major surprises after I review the raw data on December 8th, the answer is an emphatic YES. Without hesitation.