Myths vs. Facts: Making Sense of COVID-19 Vaccine Misinformation

MYTH: The COVID vaccines were not rigorously tested, which is why they have only emergency authorization approval and not full Food and Drug Administration approval. (Update: Pfizer’s vaccine received full FDA approval on August 19)

FACT: “Vaccine developers didn’t skip any testing steps, but conducted some of the steps on an overlapping schedule to gather data faster.”—Johns Hopkins Medicine
Assoumou: This is the most common question I get asked. I think there is a perception that things moved very fast, but we want to underscore that the technology being used now was being studied for a decade. The main difference between emergency use versus full FDA approval is that you need two months of monitoring rather than six months. When you look at the history of vaccines, if patients were to develop side effects, these occurred within two months. We are now over six months into our experience with these vaccines. We have not seen anything that would make us believe that the risks outweigh the benefits. And vaccines have saved so many lives.

Hamer: The development was more rapid than many other vaccines. But it used the same process of phase one and phase two trials following appropriate safety measures. Stage three trials were large-scale trials done rigorously with very clear outcome definitions. The safety measures and approaches taken are standard for clinical trials. They just did it more rapidly than usual. The full process review is ongoing and we are already hearing that Pfizer will have full FDA authorization by September and Moderna soon after.

MYTH: The technology used to create the COVID vaccines is too new to be safe.

FACT: The technology used, called messenger RNA, or mRNA, is not new. Research on it actually began in the early 1990s, and two diseases that are very close to COVID—SARS (severe acute respiratory syndrome) in 2003, and MERS (Middle East respiratory syndrome)—helped bring the mRNA vaccine development to present day use.—Centers for Disease Control and Prevention, Understanding mRNA COVID-19 Vaccines
Assoumou: The reason this is called SARS-COV-2 is that there was a SARS-1, the original one, and scientists were working on this vaccine. So when this pandemic arrived they had already developed a lot of the science. A decade of work was actually going on. That’s one issue I like to emphasize when people think it was rushed.

The other point I like to remind people is that these vaccines went through all the regulatory steps like any other vaccines. None of this was rushed. The FDA reviewed all the data. When you say “Emergency use,” people think it was rushed, but the way to think about it is that the benefits outweigh the risks.

MYTH: Breakthrough cases prove that even if I get the vaccine, I might still get COVID. So why bother?

FACT: As of August 9, the CDC said there had been 8,054 vaccinated people who were hospitalized or died who had also tested positive for coronavirus—out of more than 166 million fully vaccinated Americans. That’s roughly .005 percent. Additionally, CDC director Rochelle Walensky has said that 99.5 percent of all deaths from COVID-19 are in the unvaccinated.—Politifact, Fact Checking Joe Biden’s Figure on Unvaccinated COVID-19 Deaths
Hamer: COVID vaccines have been shown to be very powerful in preventing more severe disease and the need for hospitalization. Breakthroughs occur at a much, much lower rate than in people who are unvaccinated. The breakthroughs have been occurring more frequently with the Delta variant because of the high level of infectiousness (or transmissibility) of the Delta variant and lower protection of current vaccines against this variant. But people having breakthroughs have much more mild infection, more like an upper respiratory infection. The vaccines prevent severe disease and complications and allow people to return to a more normal state.