Pfizer could apply for full FDA approval for its COVID vaccine as soon as the end of the month
The full approval means the pharmaceutical company is able to produce the vaccine reliably and consistently
JACKSONVILLE, N.C. (WITN) - The first coronavirus vaccine to get full FDA approval could come as soon as this time next month.
Pfizer began the process to get its COVID-19 vaccine the full stamp of approval from the federal agency. It has requested the Food & Drug Administration expedite the process to have a decision made within six months, ahead of the ten-month process the agency typically uses to make the decision.
“Just more reassurance for the public to know that these vaccines are safe, they’re effective,” said Onslow County Health Director Kristen Richmond-Hoover. “It follows sequentially, with when the emergency use is granted based on the studies that they did first, and then as more data builds, that’s when we see those further approvals.”
To receive full FDA approval, the pharmaceutical company must prove it can produce the vaccine reliably and consistently and provide data that shows it is safe and effective. Data gathered from the over 1.3 million doses administered in the United States so far has led Pfizer to believe it is at least 95% effective.
“Everything that’s new has to be new for some period of time,” said Richmond-Hoover. “So, there has to be a period of time for us to gather data and gather information before the FDA will even grant emergency use. There are stringent studies and transparent processes of data sharing and experts reviewing that data.”
A survey from the Kaiser Family Foundation found 15% of people were holding off on getting the vaccine to gather more information about it.
“Why would I not want to do my part? It’s going to protect me. It’s going to protect my loved ones,” said Ryland Matthews, who got his dose of the single-shot Johnson & Johnson vaccine Friday. “Once the FDA gives its stamp of approval, I see no reason why a lot of people wouldn’t want to go and get it.”
The full approval would only be authorized for people 16 and older. Still, the company could receive emergency use authorization to administer its vaccine to children between the ages of 12 and 15 as soon as Wednesday.
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