COVID-19 has been the worst epidemic in recent history, and scientific advances to combat the virus have accelerated at an unprecedented pace. Among these advances are the more than 150 vaccines in development worldwide. But while you might think the severe impact of the Coronavirus would have people lining up to get vaccinated, the rapid pace of development has caused people to hesitate: currently, only 50% of Americans say that they would be willing to take a novel vaccine.
Count me in that 50%.
While it’s understandable that the rapid pace of COVID-19 vaccine development as compared to traditional vaccine development may cause initial hesitation, the facts and data suggest that this is a low-risk vaccine. And for those of us who are healthy and non-immunocompromised, it could be one of the most valuable contributions we make to our vulnerable communities.
One of the most common objections to the idea of taking a COVID-19 vaccine is the perception that development has been rushed. It inarguably has. Vaccines typically take 5+ years to go through clinical development, often with multi-year clinical trials. In comparison, multiple companies have already reached Phase III clinical trials in under a year.
But the question is not whether the development has been rushed, the question is whether standards are being lower? The answer is no. Any approved vaccine still has to go through Phase I, II, and III clinical trials. The Phase I trials focus predominantly on safety: if the vaccine has any severe adverse effects, these should arise in the early data. The Phase II and Phase III trials will examine efficacy of the vaccine, while continuing to monitor safety. The FDA has said that those who receive the vaccine must be at least 50% less likely to contract the disease to be approved, a threshold for efficacy comparable to an influenza vaccine. By the time vaccines get to Phase III trials, they are being tested on thousands of people. That is a significant base on which to evaluate the safety and efficacy of a vaccine.
Any vaccine that is approved by the FDA -- it is important to clarify where the vaccine is being approved, as Russia just approved a vaccine after only Phase II trials, much to the condemnation of the global scientific community -- will have successfully cleared all three Phases of trials. While it is true that vaccine trials typically take longer, that fails to take into account that no previous vaccine development initiative has been so tremendously funded in the way that COVID-19 vaccines have been through initiatives such as CEPI and Operation Warp Speed.
The truth is that vaccines are rarely well funded because they are so unprofitable, and there has never been a similar global pressure on development. It doesn’t mean that any vaccine developed has taken shortcuts--but it may mean traditional systems have inefficiencies.
The one safety data point that will not be collected at the time of a vaccine’s release is long-term safety data, such as how the vaccine affects our bodies years later. But this fear brings me to my next point, which is that the COVID-19 vaccine itself appears likely to be low risk.
A lot of the fear around vaccines comes from stories around live-attenuated vaccines. Live-attenuated vaccines were the first form of vaccine to be discovered and are weakened versions of an existing virus. These vaccines are great at eliciting strong immune responses because your system is getting the actual virus. The risk with these vaccines, however, is that an individual is receiving a living dose, and occasionally those weakened forms can mutate into something more similar to the fully-fledged virus the vaccine was trying to protect from. This phenomenon was well-known in regards to Vaccine-Derived Poliovirus, in which individuals contracted polio from vaccines that mutated.
It’s important to emphasize that this phenomenon is rare. But it does demonstrate the risk with live vaccines. So it may be no surprise that very few of the total vaccine candidates in clinical trials are live-attenuated: only four of the forty-two vaccines currently in clinical trials listed by BioCentury are noted as live-attenuated, and none of them are considered front-runners.
Of the front-runners, Moderna, BioNTech (Pfizer), CureVac, Inovio, and Sanofi (TranslateBio) are all investigating RNA or DNA vaccines; and AstraZeneca (Oxford) and Johnson & Johnson are investigating adenoviral vectors. What do these vaccine types have in common? None of them deliver live viruses to an individual. Instead, they deliver bits and pieces of COVID-19’s DNA in such a way that the individual’s own immune system produces COVID-19 proteins and then forms an immune response. In delivering only partial bits of the virus, the vaccine is already lower risk than a live vaccine would be.
It is important to note, however, that these vaccine modalities are novel. There were previous, to COVID-19, no approved RNA or DNA vaccines available on the market; and only one vaccine, approved for preventing rabies in animals, that relied on adenoviral vectors. Any novel modality has risk. In countering that risk, we have to rely on the initial safety data.
Multiple vaccines have already entered Phase III clinical trials, and so far all of these vaccines have demonstrated acceptable safety profiles. Moderna dropped its highest-dose vaccine candidate from its Phase III trials after one patient in Phase II spiked a fever of 103 degrees--but this patient was ultimately fine. Those receiving the medium and lower doses suffered from minor side effects, such as headache and muscle pain, symptoms quite similar to those after the flu vaccine. AstraZeneca’s adenoviral vector vaccine had a similar profile to those in Moderna’s lower-dose cohort, with some patients experiencing headaches and chills that were quickly resolved with Paracetamol. Thus far, no leading candidate has released safety profiles that warrant significant concern. Given that the vaccines in development are of similar type, it suggests that no vaccine likely to be approved in the near future will present a serious threat to the majority of consumers.
We have to acknowledge that there is risk involved in any medical procedure. While vaccines are extremely low risk, they are not totally without risk. In choosing to receive a vaccine for COVID-19, I would be inviting a health risk into my body that it wouldn’t otherwise be necessarily exposed to.
But COVID-19 is also a risk. And while I am in a relatively low-risk group if I were to be infected, do I feel more comfortable with my odds of having a bad reaction to a vaccine that has been designed to protect me, compared to a virus that has evolved to hurt me.
There is a risk if I stay unvaccinated; and there is a risk if I get vaccinated. But these risks consider only my personal safety, and any discussion of vaccines is not just about the risk to the individual receiving it, but rather the risk they create or mitigate for the community around them.
There are always some people who cannot get vaccines. Infants below six months don’t qualify for all vaccines, and any approved vaccine will require additional testing before it is approved for pediatric populations. Pregnant women similarly present a higher-risk group that will require additional long-term safety testing. Individuals with compromised immune systems are often discouraged from vaccinations generally, as are some elderly.
I am in my 20s and am extremely fortunate to not have any existing conditions that would put me at increased risk for receiving a vaccine. Of any potential vaccine recipient, individuals with my profile are the least likely to have a poor reaction, and the most likely to exhibit a robust response that elicits strong protection. For individuals who cannot receive a vaccine, the next best thing is for them to be surrounded by those who are vaccinated - this is the premise of Herd Immunity.
I am also of the age group most likely to spread COVID-19 by continuing to be mobile and social. Young adults are the most likely to continue working, traveling, and interacting with individuals outside their pods. We can protect our communities by getting vaccinated and thereby no longer being vectors through the disease can spread in our communities. Getting vaccinated also means we won’t accidentally bring the virus home to our parents, grandparents, or other higher-risk family members. Young people can quickly become the frontiers-people of vaccine-induced immunity, stopping the spread of COVID-19 in its tracks.
A vaccine isn’t just about my own safety, it’s about the safety of everyone around me, particularly those who are most vulnerable. If you are well enough, now is the time to step up.
They say we are at war with COVID-19; to all able-bodied people, consider this your draft notice.
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July 24, 2020