Typical vaccine development often takes between 10 and 15 years to complete.
Less than two years after the COVID-19 outbreak in Wuhan, China, the Pfizer-BioNTech vaccine was the first approved by the United States’ Food and Drug Administration.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he recognizes some people feel this quick turnaround is cause for concern.
“There are some people who are saying, well, they [the FDA] did it too quickly. It usually takes years, sometimes, before you get a full approval,” Fauci said in an interview with pbs.org.
However, Fauci said that safety measures were not sacrificed to obtain such a swift result.
“They [the FDA] did it now because they had a voluminous amount of data… They just did not cut any corners. They examined every bit of it. And they did it well,” Fauci said. “That’s the reason why, when the FDA approves a product and intervention you can feel comfortable that it’s safe and effective.”
According to Fauci, this approval will likely impact the amount of people vaccinated in two ways, the first impact being on the people that have been hesitant and waiting for the FDA to give the green light.
“We have about a little bit less than 90 million people who are eligible to be vaccinated who have not yet gotten vaccinated,” Fauci said. “I hope that this [approval] is going to get those 20 to 30% or so of people to wind up deciding that now they feel comfortable with getting vaccinated.”
The second area to be impacted is mandates.
“In addition, it’s going to allow people who feel they want to mandate… who are reluctant to make vaccination a requirement for attendance or employment or what have you, who will feel much more comfortable doing so now that you have an official stamp of approval from the FDA,” Fauci said.
In addition to ‘comfortability,’ the approval allows for mandates to be much more legally viable. So much so that author on vaccine law, Brian Dean Abramson, is quoted as calling the change ‘seismic’ in an article on reuters.com, written by Tom Hals.
“He [Abramson] said it will become extremely difficult to challenge the FDA’s decision and the mandates that flow from it,” Hals wrote.
As shown below, those still concerned about the vaccine can research its efficacy, side effects, FDA warnings, and more through Kathy Katella’s article on yalemedicine.org, which covers these topics for Pfizer, Moderna, Johnson & Johnson, and two other vaccines not presently available in the United States.
“In April the company announced the [Pfizer] vaccine had 91.3% efficacy against COVID-19… It also found it to be 100% effective in preventing severe disease as defined by the CDC, and 95.3% as defined by the FDA,” Katella wrote.
Moderna is reportedly, “94.1% effective at preventing symptomatic infection in people with no evidence of previous COVID-19 infection (although the efficacy rate drops to 86.4% for people ages 65 and older),” Katella wrote.
The Johnson & Johnson vaccine comes in with the lowest reported efficacy rate at “72% overall efficacy.”
Although the efficacy of the Johnson & Johnson vaccine may be lower, efficacy nor any other statistic has anything to do with the reason that only Pfizer has been approved thus far.
“Pfizer presented their data in a very timely way to the FDA… They have already accepted some of the data from Moderna and from J&J. They don’t have the full package yet,” Fauci said. “So, people need to understand it’s a timing issue, not an efficacy or a safety issue.”