In the past few weeks, Delta Variant has caused havoc in some US States – Alabama, Louisiana, Wyoming, Idaho, and Mississippi.
Despite the sounding alarms from officials, there are many Americans who are reluctant to receive COVID-19 vaccines.
So, in a highly anticipated move, FDA has granted full approval to the Pfizer-BioNTech COVID-19 vaccine.
Earlier in December 2020, FDA approved Pfizer-BioNTech & Moderna COVID-19 for emergency use.
According to the CDC data, since the emergency use authorization, 204 million doses of Pfizer-BioNTech have been administered to Americans.
In a poll run by Kaiser Family Foundation, 30% of unvaccinated Americans are willing to receive COVID-19 shots once FDA gives full approval to the vaccine.
Now, that this has been done, unvaccinated Americans will get the confidence to receive the COVID-19 vaccine. Biden Administration believes the full approval will spark a nationwide boost in vaccinations.
Many businesses & universities were waiting in line to enforce the COVID-19 vaccine requirement once FDA gives full approval to vaccines.
Yesterday, on CNN’s “State of Union”, U.S. Surgeon General Vivek Murthy said the full approval of vaccine could persuade a significant number of unvaccinated Americans.
Recommended Read: Lab Study Claims A Common Drug Can Decrease COVID-19 Infection By Up To 70%
Emergency Use Authorization vs Full FDA Authorization
After the green light given to Pfizer/BioNTech from the regulators, many of you might be wondering what does this means?
Emergency Use Authorization
Before giving a nod to the emergency use authorization, the FDA requires at least half of the participants of the original studies to be followed for at least two months after vaccination. This is because the vast majority of vaccine-related side effects occur right after vaccination.
Full FDA Approval
Full FDA approval requires participants in the original studies to be followed for at least six months. Before giving the approval, FDA reviews the data collected from the same study participants but over a longer period of time.
During this period, all adverse events are examined. When submitting the application for full approval, the manufacturer must also provide in-depth manufacturing plans and processes, as well as a higher level of oversight and inspections. Therefore adding more time to the review process.
Recommended Read: Pfizer Submits Phase 1 Aftereffects of Covid-19 Immunization Promoter Preliminary to Fda for Survey
That’s all for now.
Now that FDA has fully approved the Pfizer-BioNTech vaccine, will you get vaccinated?\
Let me know your answer in the comments section given below.
