On Tuesday, doses of the Pfizer-BioNTech vaccine were administered to members of the public, for the first time ever, anywhere, in Great Britain. The United States is expected to follow suit later this week. Food and Drug Administration (FDA) officials have reviewed the data from Pfizer’s clinical trials and confirmed that the vaccine meets both its safety and efficacy standards, suggesting that approval is imminent and the conclusion of the pandemic within sight.
Operation Warp Speed, the federal government’s partnership with pharmaceutical companies such as Pfizer, Moderna, Johnson & Johnson, and AstraZeneca, appears to have been an unqualified success. Its execution will likely come to be regarded as one of the great achievements in this country’s history, and perhaps even all of human history. It will also be remembered as one of the most important accomplishments of President Trump’s administration, whatever his other shortcomings in handling the pandemic.
And yet, just as an answer to our prayers appears, just as an end to the death and the social and economic devastation wrought by the virus is in sight, a new strain of vaccine skepticism is infecting more and more people.
I say vaccine skepticism — and withhold the use of the term “anti-vaxxer” — because for the most part, those expressing concerns over the coronavirus vaccines are not doing so for facially preposterous reasons. They don’t have an all-encompassing suspicion that inoculations cause autism, or worry that the coronavirus vaccine will implant a Bill Gates-made Microsoft microchip in your bloodstream. They certainly don’t believe, as Candace Owens does, that Dr. Anthony Fauci is profiting off the delivery of an unsafe vaccine because the government agency he works for, the National Institutes of Health, assisted in its development.
Skeptics’ apprehension toward a vaccine produced in record time as a result of an unprecedentedly enormous, concerted effort to make it, one representing a remarkable new advance in medical technology, is very natural. It is not inherent proof of stupidity or paranoia for the average citizen to be, if not suspicious, then at least nervous about being inoculated with such a vaccine. It’s proof of humanity.
However, these concerns — natural as they may be — are unfounded.
One of the more common and understandable misconceptions fueling worries about the vaccine is that corners are being cut on safety standards to quickly bring it to market. Regrettably, vice president-elect Kamala Harris and other prominent Democrats have played into this fear for political gain.
Here are the facts. Vaccines under consideration for approval “are being held to the same rigorous safety and efficacy standards as all other vaccines in the United States,” according to the Centers for Disease Control and Prevention (CDC). In fact, the latest from clinical trials for the Pfizer vaccine more than pass muster.
The FDA has stated that “the pre-licensure safety database for preventive vaccines for infectious diseases typically consists of at least 3,000 study participants vaccinated with the dosing regimen intended for licensure.” Pfizer’s FDA-reviewed trial had nearly 44,000 participants, half of whom received the vaccine. Two months of post-inoculation monitoring revealed “a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an [emergency authorization].” In other words, there is zero evidence to suggest that there are long-term adverse health consequences for those with the vaccine.
Now, some will point out that because of how quickly it was developed, there is no way to definitively prove that the vaccine will have no deleterious effects down the line. This is true; there’s no way to prove a negative. That said, there is also no reason to think that there will be complications from the vaccine.
Well, no convincing reason, at least. The coronavirus vaccine will be the first mRNA vaccine ever brought to market, and that has, again, naturally, caused some anxiety over what its side effects could be. What is a mRNA vaccine? Here’s how the CDC describes them:
To trigger an immune response, many vaccines put a weakened or inactivated germ into our bodies. Not mRNA vaccines . . .
COVID-19 mRNA vaccines give instructions for our cells to make a harmless piece of what is called the “spike protein.” The spike protein is found on the surface of the virus that causes COVID-19.
COVID-19 mRNA vaccines are given in the upper arm muscle. Once the instructions (mRNA) are inside the muscle cells, the cells use them to make the protein piece. After the protein piece is made, the cell breaks down the instructions and gets rid of them.
Next, the cell displays the protein piece on its surface. Our immune systems recognize that the protein doesn’t belong there and begin building an immune response and making antibodies, like what happens in natural infection against COVID-19.
At the end of the process, our bodies have learned how to protect against future infection. The benefit of mRNA vaccines, like all vaccines, is those vaccinated gain this protection without ever having to risk the serious consequences of getting sick with COVID-19.
While these will be the first widely distributed mRNA vaccines, they have been worked with and studied for decades, including for diseases such as the flu, Zika, rabies, and cytomegalovirus (CMV). Oncologists working on cancer research have also used mRNA.
Much of the concern over mRNA vaccines stems from a mistaken belief that they actually alter the DNA of the inoculated. They don’t. For the Associated Press, Dr. Dan Culver of the Cleveland Clinic explains that mRNA “cannot change your genetic makeup. The time that this RNA survives in the cells is relatively brief in the span of hours. What you are really doing is sticking a recipe card into the cell making protein for a few hours.”
One additional aspect of these vaccines that has raised suspicions over their safety is the proclaimed success rate of Pfizer and Moderna’s vaccines. After all, in some years the flu vaccine proves only around 40 percent effective. How can the vaccine for a novel virus be 95 percent effective? Well, for one thing, we only know the efficacy (performance in clinical trials) and not the effectiveness (performance in the real world) of the coronavirus vaccines. At the New York Times, Carl Zimmer points out that “if previous vaccines are any guide, effectiveness [for the coronavirus vaccines] may prove somewhat lower . . . because the people who join clinical trials are not a perfect reflection of the population at large.” Moreover, the coronavirus is less prone to mutations than influenza, rendering its vaccines more effective.
It should come as no surprise that some Americans harbor concerns over the coronavirus vaccines. The speed with which they were developed and the fact that they will be the first to use mRNA naturally beget some skittishness. That the incoming vice president of the United States stoked some of these fears herself couldn’t have helped. But the FDA has held these vaccines to the same standards as other ones, the sinister theories that have been floated about mRNA have been disproven, and the vaccines’ exceptional performance in clinical trials should not be held against them.
We can see the light at the end of the tunnel now, and that light appears to be about as bright as we could have hoped for. Not only are the vaccines effective, but the FDA has found Pfizer’s product to be equally so with vulnerable groups, such as those with preexisting conditions and the elderly. Let’s be careful not to sow distrust in our saving grace. That means resisting both mandatory-vaccination schemes that betray a lack of trust in the average American and the temptation to believe that it’s too good to be true.