Waiting for a vaccine for coronavirus? In the meantime we have chocolate stout pudding shots!
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It’s been awhile since I have done a Science Sundays post, but since I’ve been getting a lot of questions about the COVID-19 vaccine clinical trial I enrolled in this week I decided to compile it all together here!
Yes, I volunteered to test out a experimental vaccine to protect against COVID-19. When I have told friends and family this bit of information it has been received with either praise and thanks or shock and fear. However, let it be known I am not doing this for the praise (or the money, I decided to sign up before remembering that’s part of it), nor should anyone be afraid for me.
As a scientist by day, even though vaccines are not my specialty, I know a thing or two about them . But I am not here to go down that path, just accept it for now if you disagree (although I would love to chat), and let this post focus on how clinical trials work.
The vaccine trial for which I signed up is in Phase 3 of clinical trials, of which there are currently 9 other vaccines [1] to make it this far. It is record breaking to even think that we could have an approved vaccine in 2021 (fastest was 4 years for mumps [2]). But that’s not because they are skipping steps or lessening requirements, there have been a TON of people working on this as a result of increased funding opportunities and the virus being an easier target than others [3].
Fauci says speed on COVID-19 vaccine will not compromise safety
So what’s the process of a clinical trial? Once scientists have identified potential targets for vaccines and have proven their efficacy in pre-clinical studies, the next step is human trials.
In Phase 1 (currently 29), the vaccine is only given to a small group of people to determine if it is safe and to get some information on the immune response.
In Phase 2 (currently 18), the test group is in the hundreds, typically different groups of people to ensure it works in both, or different doses, and also collects more data on safety.
Then in Phase 3 (currently 9), the vaccine is given to thousands of people, in order to solidify its safety and identify any rare side effects, as well as examine its effectiveness. In this phase there is also a control group which is given a placebo, usually saline (salt water). [1,4]
In June, the FDA said that a vaccine for coronavirus would need to protest at least 50% of those vaccinated in order to be considered effective (for reference flu vaccines are usually 40-60%) [6]. At that time it could be approved for distribution. However, China and Russia have already approved trials without results from Phase 3 trials, which is obviously a risky thing to do [1,4].
I am enrolled in the BioNTech/Fosun Pharma/Pfizer Phase 3 clinical trial [4, 5]. Phases 1/2 tested two versions, both of which were shown to cause volunteers to produce antibodies and T cell responses that provided protection against the virus. One of the two had a lot fewer side effects, which is the one I may have received (after first going through an entire medical history, current medications, blood draw, urine test, nasal swab, reading all the things, being given opportunities to ask questions, etc).
I say may because this is a 50/50 trial where half the participants receive placebo, and neither me nor the people who administered it know which I received. That way there is no recording bias when they examine the results from my bloodwork every time I come in for a check up, and thus recording accurate results that are not skewed my what the reported expected to see if they has known I was given the vaccine versus the placebo. Yay experimental design!
How long am I in this study? Potentially for the next 26 months.
But how can I say we may have a vaccine in 2021 if the trial I am in is set for 26 months? By the end of the year/early 2021 one or more of the vaccines in Phase 3 trials right now will have 6 months or more of data from thousands of volunteers about it safety and effectiveness. At that point, decisions will be made to approve based on that data, assuming it offers at least 50% protection. But to ensure it protects long term and to check if there are any side effects that take longer to present the studies will continue for around 2 years.
UPDATE 12/29/20: Due to EUA approval (52% protection after the first dose 95% after the second [7]) I was unblinded and found out I was in fact in the vaccine group! But I will remain in the study to continue their data collection for long term protection.
Will we need to be vaccinated every year like for the flu? Will we need a booster? Basically, how long does this vaccine protect us and what are the long term side effects, if any? If we don’t take the leap of faith to administer early, how many more people will die because they were not given the chance to be vaccinated? These are questions to weigh when considering the current situation. There are those in the population that would benefit from the vaccine more than others, and what are the pros and cons in administering it to that population a little early, assuming all data at that point is positive?
Even then, once a vaccine has been approved we still have to think about distribution, which will likely come in waves due to the high demand with those at higher risk receiving it first [2]. Some companies have started preparing for manufacturing and distribution but it is a huge undertaking.
So long story short, finding a vaccine target that works as a vaccine and doesn’t have adverse side effects and can be distributed to the population takes A LOT of work and time.
In the meantime, I decided to come up with my own shot, chocolate stout pudding shots which are the antithesis of corona in my corona-virus sugar cookies. Light beer seasoned with lime? Meet dark stout beer mixed with chocolate.
No seriously, when I was trying to decide upon a recipe to pair with this post, I knew it had to be a shot so I’ve had these giant syringes ready for the occasion. After sales of Corona beer plummeted simply due to the stigma of having a similar name to coronavirus, I decided I needed to pick a beer that represented the opposite, and then made pudding with it.
And then I found the Black is Beautiful oatmeal stout that Rhinegeist made (in collaboration with Weathered Souls Brewing Co. in TX) and knew it was meant to be, bringing in yet another serious issue of 2020.
Two years ago: Chicken Enchilada Dip
Three years ago: Fall Leaves Butter Cookies
Six years ago: Swag Bars
Seven years ago: Crock Pot Balsamic Chicken
Eight years ago: Sausage Stuffed Zucchini Boats
Nine years ago: Beermosa
Source: The Spiffy original
Did you make this recipe? I want to see!
Tag @THESPIFFYCOOKIE on Instagram and hashtag it #THESPIFFYCOOKIE
REFERENCES:
- https://www.theguardian.com/world/ng-interactive/2020/sep/04/covid-vaccine-tracker-when-will-a-coronavirus-vaccine-be-ready
- https://discoveries.childrenshospital.org/covid-19-vaccine/
- https://www.statnews.com/2020/07/30/a-huge-experiment-how-the-world-made-so-much-progress-on-a-covid-19-vaccine-so-fast/
- https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
- https://www.aventivresearch.com/clinical_study/covid-19-vaccine/
- https://www.washingtonpost.com/health/2020/06/30/coronavirus-vaccine-approval-fda/
- https://www.bmj.com/content/371/bmj.m4826
2 comments
Erin, I appreciate this post a lot. As one who is high risk, due to age and asthma, the idea of participating in a trial, as you are, is really scary. At the same time, I very much appreciate your willingness to participate. I’m not sure I am interested in a vaccine that has a success rate of 50%. I don’t know what the success rate for most vaccines is, but 50% seems very low to me. I’ve spent the majority of my life fighting to get to where I could have a good life, and now that I have it, I don’t want to do anything to jeopardize what I have. If I were to get a 50% success vaccine, I probably wouldn’t change my current life style much. I would still limit how much I go out and would still wear a mask, just on principle. Hopefully 12 years of marriage where we’ve essentially been together all the time will be enough to keep us from killing each other if we end up spending a lot more of our life as it is now… ;-)
I definitely can understand that, and hopefully the vaccine will have a higher rate as obviously that would be preferred. While 50% is not the best it’s certainly better than 0% (flu vaccines are 40-60%)! That way we can at least contain the spread by 50%. Then maybe with more time another would be approved with a higher effectiveness.