The vaccine has arrived. UPS and FedEx reported their first deliveries anywhere between 6-730am last Monday. I got a picture of our 1950 vaccine doses around 930am that day and by noon, our Employee Health and pharmacy teams had done a dry run and vaccinated some front line ER and ICU nurses. Our initial mass vaccination program is underway. The CDC provided vaccination cards and the hospital will load a record of the vaccination into a state database.
The vaccine packaging is a little underwhelming. It’s a standard small box with typical medical wording on it. Each box contains 195 multidose vials. That means our pharmacy team will be responsible for warming them up (stored at -80 C), adding a diluent to the vial, and then drawing up 0.3 cc five times to use one vial. Vials are designed to give 5 doses. Each box, therefore, contains 975 doses but you may have heard that it’s believed you can do 6 doses per vial. As it turns out, our pharmacy and employee health team can get 6 most of the time, increasing the total amount of vaccines we can give. Once each vial is warmed up and diluted, it must be used within hours. The pharmacy will not let any doses go to waste.
Healthcare workers are very excited about the vaccine. I have tremendous respect for first responders, those in the military, and others who accept injury and death as a risk of their job, but most HCW never really signed up for that risk except in extreme situations. Although I think we’ve all figured out how to be as safe as we can be at work, it is a tremendous relief for many to have a significantly reduced risk of illness and death from COVID because we are getting the vaccine. But vaccinating HCWs is just the first step towards eradicating the virus. It will take months to get enough people vaccinated to allow us to get back to normal, both inside the hospital and within our own lives. In the interim, people are dying at alarming rates.
I’ve been asked by a lot of people if I’m getting the vaccine and the answer is YES. A couple of months ago my answer was that I wanted to see the data and hear what the experts had to say. Ultimately, as I consider the risk to benefit ratio, getting the vaccine was a no-brainer. The decision to get the vaccine in this first window or not is actually very interesting from a bioethics perspective. I suspect there are some hospitals mandating that staff get vaccinated and it’s possible that some jobs will require vaccination. I’m pretty impressed that my hospital at this point has not made it mandatory. I think this is in part due to the vaccine being new and being used under an emergency use authorization. With that said, I think that all of the docs in my group got it and other docs I’ve talked to around the hospital were making sure that they were on the list to get it as well. Another ethical component is who gets vaccinated first within the hospital. It’s important to vaccinate nurses, respiratory therapists, docs, housekeepers who clean the contaminated rooms, etc…and not every hospital has enough doses to vaccinate all of these people who are involved in the care of patients with COVID. We were lucky to be able to offer the vaccine to get all the key frontline employees.
I got my vaccine early Wednesday afternoon. More than 48 hours later, I’m feeling pretty good. My arm was a little sore starting about 8 hours after the shot like any vaccine. I took Advil in the morning and it was better. Because it fit my schedule best, I signed up for the first 2 hour window the hospital offered for vaccination. I guess I shouldn’t have been surprised at the long line of people who got there before me and before our time slot officially opened. I felt like I was waiting in line for general admission concert (remember those?). It really was amazing and efficient. They had 6 stations set up for vaccination. After our vaccination, we were “observed” in our auditorium (physically distanced) for 15 minutes while the movie Elf was playing. If not for the snowstorm on Wednesday, I would have been happy to hang out a bit longer and watch the movie, but it was a day off and I wasn’t scheduled to be in the hospital that day, so I left.
I talked to the PR video team both during and after my vaccination. I’ve never had the experience of getting filmed and interviewed while getting a “new” shot, wondering if I might be the one in a million that has an allergic reaction. I think I was a little speechless when asked how I felt at that moment and it’s taken me a little bit to collect my thoughts. I’m extraordinarily impressed with how much science was accomplished in 9 months. I’m excited for my colleagues who are excited to have the opportunity to feel safer at work. I’m relieved that in the near future, my chances of getting sick, infecting my family, or dying, are dramatically lower than last week. Ultimately, it’s about doing my part to protect myself, my family, my colleagues, my community, and my patients. I hope getting the vaccine and sharing my experiences with it will encourage others to do the same.
Let’s talk about the vaccine. This is not a live virus or weakened COVID virus. In fact, it’s not the virus at all. You cannot get COVID from the virus. Instead, it’s the mRNA component of one of the spike proteins on the virus. mRNA is used in the body to make proteins. Research goes back to the 1990s and seems to have passed a critical milestone in learning how to beat the body’s own defenses in the early 2000s (papers published in 2005), though this is the first successful and approved mRNA vaccine. Once injected, our cells start to produce the spike protein and then our body recognizes it as a foreign material and creates an immune response. Then when we are exposed to the actual COVID virus, our body has the antibodies and rest of the immune response to properly fight it off. Part of the secret of why this vaccine is effective, may be related to the nanotechnology in the lipid (fat) solution that carries it and helps get it into our cells. It turns out that mRNA is also much quicker to make since a computer can spit it out compared to growing weakened virus in a lab and that contributed to the speed that the vaccine could be developed. It reminds me of a conversation I had with a vaccine scientist back in early March. She told me she thought a vaccine could be developed in 12-18 months, and I was super impressed and couldn’t believe it. Then she reminded me that it’s taking advantage of 10-20 years of research and work the industry has been doing. Getting to this point, an approved vaccine, is pretty amazing.
The vaccine study was very large and thorough. There were about 18000 people in each of the vaccine and placebo groups that were followed for 2 months after vaccination to look for side effects and infection rates from the vaccine. This is a standard timeframe for vaccine studies since most side effects happen within 2 months. In order to show that the vaccine was effective, they needed enough of the patients to get COVID. For better or worse, the researchers got volunteers in hot spot cities and since COVID was pretty prevalent, they had no trouble reaching the right number of infections. The results were amazing. There were only 8 symptomatic COVID infections in the vaccine group and 162 in the placebo group. The vaccine worked. Had COVID not been as prevalent, it would have taken longer to reach the numbers of infections they needed. They did not track asymptomatic infections so we just don’t know yet how good the vaccine is in preventing all infections.
There are some side effects. The majority of people had mild to moderate pain at the injection site. Fatigue and headache were also commonly reported, particularly after the second dose. The frequency of any severe systemic event after 1 dose was <1% and the incidence of a serious adverse event was similar between the two groups (Vaccine 0.6% and Placebo 0.5%).Yes, this is a new vaccine. But we’ve had other new vaccines in our lifetime. There’s vaccines that prevent pneumonia, meningitis, chicken pox and shingles, and HPV (to prevent cervical cancer). My kids have gotten all of them based on their age.
Here’s the bottom line.
This was a big study that met the standard milestones for vaccine research.
The first dose conveys some immunity by day 12 and the second dose really improves immunity by one week afterwards (around day 28 after the first dose).
Overall, participants were 95% less likely to have symptomatic COVID if they received the vaccine versus the placebo.
There were mostly minor adverse events that are generally self-limited. One of our concerns is if we end up missing work due to a fever, particularly after the second dose.
We do not know if it prevents asymptomatic infection/spread which is why we’ll need to wear masks, distance, and practice good hand hygiene for a while longer.
We do not know the duration of immunity.We need more data to look at kids <16, pregnant women, and those who are immunocompromised. Check with your doctor to assess your risk/benefit ratio.
Healthcare workers are lining up to get their vaccination ASAP. When it’s available to the public, I hope everyone dose as well. Since I also get asked questions about getting your individual vaccine, unless you are a frontline worker or in a nursing home, please be patient. There is no reason to call your doctor’s office yet. They don’t have it and don’t know if/when they’ll get it. Even if you’re in a high-risk category, you don’t need to call your doctor yet. Information will be forthcoming after this initial wave of vaccinations, but that’s still probably weeks away. It looks like CVS and Walgreen’s will be doing a lot of the community vaccinations and both pharmacy chains have info up on their websites already.
More good news. The Moderno vaccine is just around the corner. The vaccine received external advisory board approval yesterday and should get FDA emergency use authorization approval within hours. Compared to the Pfizer vaccine, it has similar mRNA technology, similar efficacy, though perhaps not as effective in the 65+ age group. It doesn’t need to be kept in such extreme temperatures, so this may make it easier to handle in the non-hospital world, and requires a second dose at 28 days instead of 21 days like Pfizer. Hospitals are expecting this vaccine to arrive next week. Vaccine distribution is controlled at the state level throughout the country. The individual state decides how many dosages get shipped to each hospital or nursing home, using data such as size, patient population, freezer capability, employee number, etc…
I forgot to include some volume/data updates last week, so my apologies. I actually wrote it out but forgot to move it from an email draft into my word document that houses this series of posts (now at 46,044 words). Although we’re testing more people than the spring, we’ve made more COVID positive tests these last three weeks in the ER than in any three consecutive weeks since I started tracking data in April. Our positivity rate among our symptomatic patients is about 50% and the highest it’s been in any week since April. In the ED patient population, the positivity rates for our asymptomatic/screening patients and our overall rate are also the highest they’ve been since spring.
Although not at the absolute peak number of patients requiring COVID isolation in the ED, we are approaching numbers that are similar to our busiest 4-week crunch in April for total patients. Additionally, our admission numbers for this patient subgroup, approach our busiest numbers in that same time period. We are much busier with possible COVID patients now than we’ve been since spring.Finally, in other news this week, the FDA authorized an over the counter at home COVID test this week. Last week I wrote about the Pixel test that you swab yourself at home but mail in the sample. This new test, the Ellume COVID 19 Home Test, is done at home, analyzed at home, and results are sent to your phone. Like other tests, a small number of positive and negative results may not be correct, but overall, it looks pretty good, particularly in the symptomatic patient. This kind of testing access is another positive step in reducing the spread of COVID.
The vaccine will be a game changer but vaccinating the front-line workers is just the first step towards turning the tides against COVID. It gives us hope that science will win out and we can begin to see the true roadmap to recovery. But the data today remains concerning and we’ll see a lot more deaths and sickness before we see the benefits of widespread vaccination. Your continued diligence is still necessary.
I saw a great line that I’m completely sharing from a podcast.“The vaccine is here. But you don’t want to be the last soldier killed before the truce.”
Don’t let your guard down. Follow the rules that have kept you safe since the beginning.
Science matters. Wear a mask. Practice physical distancing.