Frequently Asked Questions Part 1: COVID-19 Vaccine Products
By Shannon Rotolo, PharmD, BCPS
Recently, I shared with my friends and family that as a healthcare worker, when I have the opportunity to receive a COVID-19 vaccine with EUA (emergency use authorization) from the FDA this year, I planned to do it. (As of the time this is posted, I will have received BOTH of my doses of this vaccine!) I asked if anyone who was ambivalent or opposed to getting the vaccine would share what it was that made them hesitant, and / or which questions they wanted to see answered first. This is the list of questions from my friends and family. The IMPACT team encourages you to submit your own questions in the comment box below to be considered for future blog posts or chats!
Q: The vaccine trials were so fast! How do we know there aren’t long-term side effects?
A: This is such an excellent question. As a pharmacist, I take post-marketing side effects, or side effects that get reported only after a drug is FDA-approved, very seriously. This is something I think about with all medications, not just vaccines.
Many people are surprised to learn that many state-of-the-art, cutting-edge medications often go through Phase 3 trials that are as short as 12 or 24 weeks. The FDA usually reserves longer study designs for disease processes that have a relapsing-remitting or waxing-and-waning nature, and even then trials rarely last a full year, 52 weeks. Studies typically also include an extension phase or arm, where patients have the option of remaining on the study drug for another year or two, depending on the plan, and the study team continues to collect safety data. Researchers continue to study COVID-19 vaccines that have been improved and will do so for a full 52 weeks.
Looking at the three current front-running vaccine candidates, the length of their studies is fairly consistent with other recent drug trials. The table below contains these specifics.
V = scheduled visit, T = telephone safety assessment, * = not all participants
Sources: Pfizer, Moderna, AstraZeneca
Again, as a pharmacist, it’s important to me that post-marketing side effects are appropriately reported and tracked for all drugs, vaccines included, due to the possibility that we can learn about new or unexpected side effects after a drug is already FDA-approved. However, based on the nature of these products and the study design, we don’t have a reason to believe that is any more likely with these COVID-19 vaccines than it is with any other new medication. With other vaccines, most side effects tend to occur in the first few days to weeks after a dose.
Q: What, if any, side effects do we already know to expect?
A: We know there can be short-term side effects with any vaccine, and based on the data we have seen so far with the three front-runners mentioned earlier, the side effects to expect are going to be similar to the most common side effects we see with other vaccines.
Here is what I wanted to be prepared for after receiving a vaccine, and the advice I would give on how to manage each side effect.
Keep in mind the side effects are transient, so whether or not you choose to do any specific management, they should still go away on their own, usually in about 24-48 hours. If your side effects last longer than a few days, it’s a good idea to check in with your primary care physician or other healthcare professional to rule out other causes, and/or to submit a post-marketing adverse event (side effect) report.
Q: Has vaccine production been politicized? Operation Warp Speed has me concerned about potential for unsafe production.
A: Many of us have felt a bit disillusioned or untrusting after seeing inaccurate communication from various elected officials regarding mask-wearing, and I anticipate we will also see some misinformation and messages founded in fear instead of fact from those same individuals. I am concerned about vaccines being politicized in that sense. But in terms of vaccine production itself, it is reassuring to me that the research studies have taken place in multiple different countries, and that other countries – specifically the U.K. – have subjected that data to a rigorous review process similar to our own FDAs review and also found it to be safe and effective and recommended it for their citizens. I hope that is reassuring to others as well. The other piece of the puzzle that has the potential to be politicized to some extent is distribution and availability, which is the theme of the next question I was asked…
Q: For at-risk, marginalized populations, what is being done to ensure that vaccine is received?
A: There is so much to consider here, and some is beyond my area of expertise, but I will highlight a few things I’m concerned about with regards to vaccine uptake.
First is trust. We have seen Black, Indigenous, and people of color (BIPOC) communities hit hardest by this virus due to inequity in the healthcare system and many other sources of systemic racism in this country. We also know the medical community has historically – and even very recently! – eroded the trust of BIPOC, and we should be prepared to encounter some vaccine hesitancy. As a pharmacist, I want to make sure I am taking the time to listen to my patient’s concerns, and share only accurate information, and say “I don’t know (yet)” when I don’t have an answer. More broadly, I think partnering with community, grassroots, or faith-based organizations to make sure people are receiving timely and accurate information from people that they know and trust will be critical.
Next is access. I worry about medically underserved areas. I worry about pharmacy deserts, which are becoming increasing common in both urban and rural low-income areas, and which disproportionately impact BIPOC. Both of the mRNA vaccines require freezing, make it easier to ship vaccines in pizza-like boxes to more population-dense areas. How will vaccine be most effectively shipped and distributed in rural areas where they would not be able to use such a large supply before it expires, based on the complex storage conditions? I don’t know the answer yet. Right now, hospitals and health systems that are immunizing their employees are not charging them for their doses. But how will our broken health insurance system and cost impact uptake of the vaccine when this more widely distributed? I don’t know the answer to this question yet, either, but if we want to make sure we are all protected from this virus, we need to be able to provide vaccine to every person who wants it, and not allow health insurance status, employment status, or immigration status be barriers to achieving that goal.
Don’t forget to submit your questions for Part 2 in the comment box below!