A few weeks ago, Pfizer/BioNTech and Moderna applied for full FDA approval for their COVID-19 vaccines. The two pharmaceutical companies, along with Janssen of Johnson & Johnson, have been able to provide COVID vaccines to the American public due to Emergency Use Authorization (EUA) from the FDA.
With many questioning the safety of the vaccines and the EUA process, it felt pertinent to compile some information on the subject.
What is an Emergency Use Authorization for the COVID vaccine?
According to the FDA, EUA “may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.”
It is important to note that one of said criteria are clinical trials and studies. This means they are still required for emergency use authorization and are only valid if conducted according to FDA standards.
Dr. William Moss, the executive director of the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health, spoke about some of the differences between EUA and full approval in an interview with ABC News.
Moss told ABC that while “both authorization and approval are rigorous processes that look at the safety and efficacy of a vaccine,” time is a key factor. Authorization requires “at least two months of follow-up data from phase 3 clinical trials” whereas approval needs at least six months of follow-up.
“We have more data on vaccine safety than with any other vaccine, even before the review of the full approval,” Moss said.
This phase 3 Moss mentions is where a vaccine is administered to thousands of participants from broad demographic groups in randomized, controlled clinical trials. Because of emergency declarations, some testing steps were done on overlapping schedules rather than consecutively.
Vaccine Truths & Myths
There are plenty of myths surrounding the COVID-19 vaccines, ranging from valid concerns to claims that sound like articles from The Onion: looking at you, magnet theory. The claim that the COVID-19 vaccine will magnetize the recipient is reminiscent of the late James Randi, magician and psychic skeptic, debunking claims of a magnetic man. For those unfamiliar, after applying some talcum powder, the so-called magnetic man could no longer stick metal objects to himself.
In terms of other, more reasonable claims, Johns Hopkins released a collection of myths being busted by two doctors. The whole piece is educational, but a common myth seen online is that the vaccine infects the recipient with COVID-19. The Johns Hopkins doctors refute this, writing:
“The two authorized mRNA vaccines instruct your cells to reproduce a protein that is part of the SARS-CoV-2 coronavirus, which helps your body recognize and fight the virus, if it comes along.”
Even Snohomish Health District (SnoHD) got in on this one, tweeting: “COVID-19 vaccines don’t give you COVID. The vaccines don’t contain the virus itself, so you cannot catch the virus from the vaccine.”
COVID-19 vaccines don't give you COVID. The vaccines don't contain the virus itself, so you cannot catch the virus from the vaccine. #vaxupsnoco
— SnoHD (@SnoHD) June 14, 2021
As of June 22, the CDC estimates that 150.5 million people—or roughly 53% of those 12 and older—are fully vaccinated throughout the US. SnoHD reports over 833,000 doses of COVID-19 vaccines administered and over 396,000 people being fully vaccinated. SnoHD estimated that 56% of those 12 or older are now fully vaccinated, putting Snohomish County slightly ahead of the national average.
Earlier this month, Governor Inslee announced a vaccine lottery in an effort to increase vaccination rates, as any vaccinated Washington State resident is eligible to win. However, the measure hasn’t appeared to have increased vaccination numbers, according to SnoHD Health Officer Dr. Chris Spitters during a Snohomish County Health Briefing.
“We are still seeing substantial numbers of people getting vaccinated, but it’s not the surge we had early on,” Snohomish County Executive said during the briefing.
“Early on, we got all the low hanging fruit and now we’re trying to reach the harder to reach people. People who are hesitant, less available to go to mass clinics… so naturally those numbers come down,” Dr. Spitters said. “But we still vaccinated 25,000 people last week. We want to see that continue.”