FDA Commissioner Scott Gottlieb Speaks At Newseum On Patient Access To Innovation
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WASHINGTON, DC - MARCH 06: FDA Commissioner Scott Gottlieb speaks about teen vaping during a discussion about overcoming obstacles, at the Newseum on March 6, 2019 in Washington, DC.

The former head of the Food and Drug Administration and current member of Pfizer's board of directors, Dr. Scott Gottlieb, said that the pharmaceutical company's coronavirus vaccine could be approved for young kids below the age of 12 by early winter.

The official was interviewed in the "Face the Nation" where he expressed his prediction as being a crucial development in the United States' vaccination efforts. This comes as authorities continue to work on getting children back to in-person learning.

Pfizer's Vaccine for Children Under 12 Years

Gottlieb said that Pfizer would be in a position to file its observation data with the FDA sometime next month. The company would then expand its emergency use authorization to include children five years old and older as early as October later this year.

"The agency will be in a position to make an authorization, I believe, at some point, late fall, probably early winter. And probably, they're going to base their decision on what the circumstances around the country, what the urgency is to get to a vaccine for kids," Gottlieb said during the interview with CBS News.

In May, the pharmaceutical company's vaccine was authorized by the FDA to be allowed for use to vaccinate children aged 12 years to 15 years. The pharmaceutical company has been testing its two-dose COVID-19 vaccine in children aged two and older for some time.

Gottlieb said that the agency has "historically" taken about four to six weeks to review a company before giving its authorization. However, the official cautioned the process could take much longer if the FDA requests additional information.

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Across the United States, schools are struggling to fight off the spread of the coronavirus infection. Tens of thousands of students have already been forced to stay at home to quarantine or isolate themselves after being exposed to the virus.

During his speech, Gottlieb also shared his recommendations of how establishments can curb the spread of infections in schools. He said that school officials had two things they could do to decrease the chances of having students exposed to the virus. The first is to have testing twice a week, and the second is to keep students in "geographic pods" and "social pods" to keep them from interacting with the entire student body, The Hill reported.

Coronavirus Surge in the US

Gottlieb said that those two practices are the two most effective steps that school officials can take to protect their students. He also urged the use of face masks and emphasized their effectiveness in slowing down the spread of the infection.

In an earlier statement, the former FDA head also said that the Delta variant was responsible for the coronavirus surge experienced in the American South. He said he witnessed a clear indication that the pandemic in the South was peaking.

The official's comments come amid the United States recording a seven-day average of about 147,300 for new coronavirus cases. Based on data from Johns Hopkins University data, the numbers are an increase of 13% from the previous week. Many regions in the southern parts of the country, including Louisiana and Arkansas, have observed a spike in COVID-19 cases, primarily due to lower vaccination rates, CNBC reported.


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