FDA approval of COVID-19 vaccine could lead to more people getting vaccinated

Posted at 3:01 PM, Aug 09, 2021

(WXYZ) — The nation’s leading infectious disease expert, Dr. Anthony Fauci, is hopeful the FDA will fully approve Pfizer’s COVID-19 vaccine by the end of this month. Full FDA approval could spur more Americans to get vaccinated - some for unexpected reasons.

I’m very hopeful that full FDA approval for any COVID-19 vaccine will lead to more people getting vaccinated. Some of my patients have told me that they’re hesitant to get the vaccine because they don’t want to be guinea pigs. I get that. And that’s why we have clinical trials with volunteers. In order to apply for Emergency Use Authorization, Pfizer had to provide roughly 3 months of clinical data which includes safety data. That’s because most side effects show up in 2 to 3 months. And when applying for full FDA approval, Pfizer had to provide data that came directly from the real world. And there is plenty of that because so far, there have been over 198 million doses of Pfizer’s vaccine administered to Americans.

On top of that, millions of doses have been administered in 111 other countries that have approved Pfizer’s vaccine. So we are well beyond the experimental stage. There is plenty of data that shows overall, the vaccines are not dangerous, that they’re safe and effective. They protect against severe illness, hospitalization, and death. And hopefully, that’ll be enough for the reluctant or concerned folks to roll up their sleeves and get the shots started.

For some people, they might have to get the vaccine because of their financial situation. According to the US Equal Employment Opportunity Commission, workplaces have the legal authority to mandate fully approved COVID-19 vaccines. So if a person’s workplace says, “yup, everyone is safer if we’re all vaccinated”, then some folks might have to get the shots to keep their job. Or to apply for a new job.

One thing I really want to stress is that the FDA is working hard on the approval of Pfizer’s COVID-19 vaccine. But that does not mean they are rushing the process. Or cutting corners. The FDA’s approval is the gold standard. It’s a highly respected regulatory agency in the world. All eyes are on them, and they are not going to mess this up.