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Examining Data on COVID-19 Vaccines and Side Effects (Part 1 of 3)

By Russell Payne -

As of the writing of this article, the United States stands at about 70% of adults (58% of the total population) having received at least one shot of a COVID-19 vaccine. However, to reach herd immunity, a state where community transmission of COVID-19 will slow due to a lack of new people to infect, most experts estimate that between 70% and 90% of the total population, including those who are currently ineligible to be vaccinated, will need to be immune to COVID-19.

If we take a step back and examine the total US population, including children and other people who are unable to get the COVID-19 vaccine (as of 6 August, 2021) the data, according to the CDC, shows that 58% of the population has received at least one dose of a vaccine and 50% have been fully vaccinated.

Number of people in the United States fully vaccinated against COVID-19.

While many Americans have not yet been vaccinated because of scheduling, accessibility or other reasons pertaining to the logistics of the situation many Americans remain hesitant for reasons relating to the vaccine and the Coronavirus.

So, in this three part series, we’ll examine some of the claims that have been circulated about the vaccines, the actual risks associated with the vaccines, and the actual risks of remaining unvaccinated.

What you Might have heard about Vaccines

Although Americans’ interest and trust in vaccines has been generally trending downward, with the percentage of Americans who believe vaccines are important falling by 10% in the past twenty years, the vaccination situation around the COVID-19 pandemic is markedly different.

Claim: The COVID-19 vaccine was developed quickly using experimental technology and so no one really knows what the side effects will be.

Although these are the first vaccines approved for use using mRNA technology, this technology is far from new. In fact, mRNA research in the United States began over 30 years ago when Katalin Karikó, Ph.D., began research in the U.S. If COVID-19 did not exist we probably would have seen the first mRNA vaccines for the flu just a few years later. Moderna was actually founded in 2010 specifically to develop and produce vaccines using mRNA technology.

If we combine this with the fact that the American government agreed to guarantee the purchase of millions of doses of COVID-19 vaccines before the proof of efficacy that manufacturers normally wait for, we see that these vaccines could be produced so quickly because they began the production process before they were approved. This gamble by the U.S. government ended up paying off in a big way since now the country has more than enough vaccines to both vaccinate the domestic population and donate vaccines to nations in need.

Claim: The COVID-19 vaccine, because of its mRNA contents, will alter the DNA of the patient that receives it.

According to the CDC, mRNA vaccines work in three steps. First, the vaccine, like most vaccines, is administered through a shot normally given in the muscle of the upper arm. The vaccine containing mRNA will circulate into the muscle cells and the cells will use the mRNA to construct spike proteins associated with the Coronavirus. After these proteins are produced, our immune system will recognize these spike proteins and, in the same way that we build an immunity via contracting the virus, develop antibodies against the spike proteins. Then, once our immune system has developed these antibodies, it will deploy them if and when it comes into contact with that same spike protein.

A key part of this is that mRNA never enters the nucleus of the cell where DNA is housed. You should imagine mRNA as a copy of instructions, a copy that is normally made from copying DNA. The difference here is that these instructions are coming from outside the cell rather than being copied from your own DNA. And, as soon as our cells are finished making proteins, as instructed by the mRNA, the cells will break down the mRNA into its component parts and that’s that. At no point in this process does the mRNA come into the vicinity of a person’s DNA and, even if it did, it would not alter the DNA.

Claim: The COVID-19 vaccine could cause infertility in women.

To address this, it makes the most sense to quote an expert. Albert Hsu, MD, a reproductive endocrinologist at MU Health Care, says:

“While studies are ongoing, there is no data that the COVID-19 vaccines may cause infertility and no credible scientific theories for how the COVID-19 vaccine may cause female infertility,” Hsu said. “Statements linking COVID-19 vaccines to female infertility are currently speculative at best.”

“A good analogy I’ve heard is that for your immune system to get mixed up and attack the placental protein would be like you mistaking an elephant for an alley cat because they’re both gray,” Morris said. “There is one small similarity, but the overall construction of the protein is so completely different, your immune system is way too smart to be confused by that.”

The long and short of this myth is that there is no real reason to believe that these vaccines will affect the reproductive system and there is no data behind the claim. With all of this being said, there is good reason to believe that pregnant women are at a higher risk of serious illness or death from COVID-19, which would suggest that women trying to conceive or become pregnant would be better served to become vaccinated sooner, before becoming pregnant, rather than later.

Claim: You don’t need to get vaccinated if you’ve already had COVID-19

It is true that most people who recover from COVID-19 do indeed develop some amount of immunity to the virus afterwards. According to the NIH, “the immune systems of more than 95% of people who recovered from COVID-19 had durable memories of the virus for up to eight months after infection.”

There is evidence that immunity may last longer than this and if you have already been infected with COVID-19 this is probably good news. With that being said, this does not guarantee that reinfection will not happen, and there are other alternatives available. Namely, there are vaccines available that do not have nearly the same risk associated with them as COVID-19 itself. This is all to say, while it is true that contracting COVID-10 will probably grant you immunity similar to the vaccine, there are easier ways to get that immunity.

Claim: Most COVID-19 cases are mild and so I do not need to get vaccinated.

While it is true that most COVID-19 cases are mild, and some transmission may occur before or without symptoms, the truth is that the mortality rate of COVID-19 tends to correspond with the availability of medical attention and several risk factors that may lead to developing a more serious case of COVID-19. With all of this being said, one of the best reasons to get vaccinated is to protect not only yourself, but others as well. Certain people may not be able to receive a vaccine for. Thus, your vaccination helps protect them as well as yourself by reducing the chance of transmission.

What is Emergency Use Authorization

For people worried about COVID-19 vaccination there are a few different facts about vaccination that you might be considering. Looking first at vaccines generally, and then at each individually there are a couple different items to keep in mind.

First, it is worth looking at Emergency Use Authorization (EUA) and how this differs from traditional FDA Approval. Emergency Use Authorization is, in many ways, just what it sounds like. This is a way for the FDA to “facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies”. For EUA to be issued for a vaccine, the vaccine must pass through three phases of trials and testing. In phase one vaccines are given to a small number of “generally healthy people” and in relatively low doses so that the FDA can assess whether or not it is safe to advance to the next phase of trials. In the absence of safety concerns, they advance to phase two studies “where various dosages are tested on hundreds of people with typically varying health statuses and from different demographic groups, in randomized-controlled studies”. Assuming these trials go well the vaccine then proceeds to phase three trials in which the vaccines are administered to a representative group of thousands of people in the way that they plan to administer it to the general public. This phase helps the FDA to determine what it would be like to administer the vaccine to the general public as well as to compare vaccine results against a larger control group. In short, Emergency Use Authorization is a process reserved for important treatments to time sensitive situations, hence the name.

This differs from regular FDA Approval in a number of ways, but the biggest difference is the timeline. New drugs can take upwards ten years and often phase one alone takes over a year. Phases two and three are apt to take upwards of two and three years themselves. Thus, in the case of COVID-19 the disease, and certainly the vaccines, have not been around long enough for this process to complete or even enter phase two.

This is all to say that the main difference is not the rigor of the testing but simply the timeline that the testing occurs on. The rigorous testing that these vaccines undergo as part of Emergency Use Authorization is also why only three of ninety-nine vaccines under development have been approved for use in the United States.

For reference, Emergency Use Authorization was a policy implemented by the Project Bioshield Act of 2004, which was aimed at purchasing a stockpile of vaccines as preparation for the possibility of a bioweapon attack. Since then it has been used to authorize certain medical equipment and influenza drugs during the H1N1 swine flu pandemic in 2009 as well as as a few countermeasures for potential MERS, Ebola and Zika epidemics.