Pfizer became the first company in the United States to apply to request an emergency authorization from the United States Food and Drug Administration (FDA) to use its vaccine against COVID-19 in the country.
The dose of the pharmaceutical company and BioNTech, its German partner, is 95 percent effective, based on final analysis of data from clinical trials.
After applying on Friday, what’s next in the process? We tell you.
What will the FDA do after the request?
The agency will proceed to review the data. However, it should be clarified that they will not analyze the results presented by Pfizer, but the raw data of the company.
This process it will take three weeks.
What information does the agency request from Pfizer?
Data from two months of safety monitoring of half of the people enrolled in their studies.
What comes next?
The FDA and a board of outside advisers, who are specialists in infectious diseases and vaccines, will meet Dec. 8-10.
Note: on the 8th of that month, the agency is expected to publish the report made by its staff on the data from the clinical trials of the Pfizer and BioNTech vaccine.
Why is that post important?
Because it will give an idea of where the resolution that the FDA will expose will go, that is, if they are in favor of authorizing emergency use or not.
What happens after the end of the meeting between the FDA and the external advisory group?
They will take a non-binding vote on whether the public use of the injection should be allowed or not.
If the agency gives its approval, does that mean that the entire US population can be vaccinated?
No. Because this is a request for a use of emergency, the first people to receive it would be the groups most at risk from COVID-19, that is, health workers and the elderly.
To vaccinate the general population, any company must obtain full approval from the FDA.
How long can that take?
Full approval of a vaccine will likely require six months of safety follow-up, as well as extensive inspections of the company’s manufacturing sites.
However, the agency may change these regulations due to the emergency that the country is experiencing due to COVID-19.
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