FDA gives full approval of Pfizer COVID-19 vaccine and what that means


Arkansas Otolaryngology Center wants to help our patients understand the recent news about COVID-19 vaccines.


Initially, the Pfizer vaccine, Moderna vaccine, and Johnson and Johnson vaccine were given emergency use authorization.


On Monday, August 23, 2021, the Food and Drug Administration (FDA) gave full approval to Pfizer's COVID-19 vaccine.

The U.S. gave full approval to Pfizer’s COVID-19 vaccine Monday, potentially boosting public confidence in the shots and instantly opening the way for more universities, companies and local governments to make vaccinations mandatory. (Neergaard US regulators give full approval to Pfizer COVID-19 vaccine) Read the full article here

Many people have already received a vaccine, so what does the full approval by the FDA mean?

It means Pfizer’s shot for people 16 and older has now undergone the same rigorous testing and regulatory review as dozens of other long-established vaccines.
For full approval, the FDA required six months of follow-up data. FDA inspectors also visited the plants where the vaccines are made and reviewed each step of the production process for extra assurance that the shots are made under safe, sterile conditions. (Perrone What does full approval of PFIZER'S COVID-19 vaccine mean?) Read the full article

Sources:

Neergaard, Lauran. “US Regulators Give Full Approval to Pfizer COVID-19 Vaccine.” AP NEWS, Associated Press, 23 Aug. 2021, apnews.com/article/coronavirus-vaccine-pfizer-approval-1361ff61d06b815652a08a7cc0683a72.


Perrone, Matthew. “What Does Full Approval of PFIZER'S COVID-19 Vaccine Mean?” AP NEWS, Associated Press, 24 Aug. 2021, apnews.com/article/business-health-coronavirus-pandemic-coronavirus-vaccine-061cccd14adcb85e5eab91ebc8b3a234.