Yes, kids, the FDA released the Phase III vaccine trial data from Pfizer, and the overall picture is extremely positive.
We all know that I am no epidemiologist. My assistance with summation was provided by “Your local epidemiologist,” who is a, you guessed it, someone who writes about epidemiology. I have to say I love em, but it will be nice when they are back to “lurking in the shadows” watching for new virus trends. Something that should have been going on all along, but our president chose to cut 90% of our pandemic response because of many reasons, mainly his wall thingy. Anywho….
So after sifting through about 150 pages of data and recommendations, I would say that the vaccine is very safe. There are no significant reactions, and those are in the “annoying but mild category,” you know the kind that makes all the old men in a provider’s office bitch about the symptoms. Seriously, guys, it is embarrassing to watch grown people bitch about how all vaccines give them the disease or make them sick. You do get some reaction with the vaccination that is at most a 99th of the symptoms from an actual disease. Yet many will refuse a vaccine with this tired assed excuse. Others, of course, would rather douse themselves in essential oils and rub crystals. I watch in Utah in horror as companies like Young Living and doTerra have put out an anti-vax message instead of supporting a vaccine for anything. I have talked about alternative therapies many times and find them to be a lot like snake oil. There always is a possibility that something good will come out of using essential oils and crystals. If you are looking for something to cure things, this ain’t it.
Anyway, the vaccine. Here are some high points (once again from Your Local Epidemiologist and Pfizer:
Efficacy.
• Benefits are starting 14 days after the first dose. Typically it takes about two weeks for the immune system to come up to speed.
• After the first dose, efficacy was 52%.
• After your second dose (3 weeks later), efficacy is 95%. We are confident that effectiveness ranges from 90-98%.
• Efficacy doesn’t meaningfully differ by age, race/ethnicity, or comorbidity. This is good news because, quite often, there can be issues.
Adverse events.
• Very few.
• The most common solicited adverse reaction (i.e., what we were expecting) were mild to moderate: injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%)
• The chance of getting a serious adverse event was low (<0.5%). A severe event is more likely in the second dose than the first and was less frequent among older adults than younger participants.
• An unsolicited (i.e., not expected) adverse event that came up more in the vaccine group was swollen lymph nodes (lymphadenopathy). Sixty-four people in the vaccine group compared to 6 people in the placebo group. One might be able to relate this to the vaccine.
• 4 people in the vaccine group got Bell’s palsy (compared to 0 in the placebo group). These cases occurred at 3,9, 37, and 48 days after vaccination. This isn’t much of a concern because it reflects the same rate of Bell’s palsy in the general population. Something to keep an eye on.
• 6 people died during the trial (4 in placebo; 2 in vaccine group). The study did not relate deaths to the vaccine. Mostly associated with heart attacks.
While this is all promising, there are some unknowns in the study. We do not know the long-term efficacy of the vaccine. This means this is a two-dose one-time vaccine, and we are good forever, or is this an every year thing, or well, we just don’t know.
We don’t know the safety or efficacy of high-risk populations. This is something, like above, that is just not known because the vaccine is too new.
Your local epidemiologist says in the end: The FDA will likely approve the vaccine on Thursday.
Here are some links provided and since I gained info from these sources:
Non-facebook link: https://yourlocalepidemiologist.com/phase-iii-data/
Here is the FDA document: https://www.fda.gov/media/144245/download
Here is the Pfizer document: https://www.fda.gov/media/144246/download
Of note, I am not your Friendly Epidemiologist; I am just your favorite Nurse Practitioner. The only study I do is the reading of it. Get the vaccine. I would say that benefits outweigh potential risks. More soon on the vaccine on the podcast.
Anyhow, till then, be the kind of person that your dog and your mom hope you are.