Gov. Polis calls on FDA to review positive Pfizer vaccine data for kids 5 to 11

By: - September 20, 2021 4:18 pm
Polis and vaccine

Gov. Jared Polis, left, makes remarks to the media as he watches Gina Harper, clinical coordinator with pharmacy, reconstitute a dose of the COVID-19 vaccine before it is administered to the first patients in Colorado at UC Health Poudre Valley Hospital on Dec. 14, 2020 in Fort Collins. (Helen H. Richardson/The Denver Post, pool)

Following Monday’s announcement from drug companies Pfizer and BioNTech that their COVID-19 vaccine appears safe and effective for 5- to 11-year-olds, Gov. Jared Polis called on federal regulators to expedite the approval process.

“Given that the country is currently experiencing a pandemic, the (Food and Drug Administration) should cancel their weekend plans and postpone other agenda items to meet immediately to review the data,” Polis, a Democrat, said in a statement. “If the vaccine is found effective and safe for children aged 5-11, as it already is for everyone aged 12 and above, the FDA should move forward right away with approval.”


Pfizer and BioNTech announced the new findings in a Monday news release. Before kids ages 5 to 11 can receive the two-dose vaccine, the companies must submit their data to FDA regulators, who could then take weeks to scrutinize it before authorizing the vaccine for young children.

Recently, Polis has had harsh words for federal regulators, whom he accused of dragging their feet on approving COVID-19 booster shots and vaccines for young children. The lengthy review process is meant to ensure vaccines are safe and effective, and large studies that take more time can help regulators to identify rare side effects.

In August, the FDA officially approved what’s commonly known as the “Pfizer-BioNTech vaccine,” or just the “Pfizer vaccine,” for everyone 16 and older. Children ages 12 to 15 can currently receive the Pfizer vaccine under an emergency use authorization.

“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine,” Albert Bourla, Pfizer’s chairman and CEO, said in the news release. “We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children.”

Pfizer’s latest study included 2,268 children ages 5 to 11, according to the statement. The effectiveness of the vaccine at preventing COVID-19, and the reported side effects, were similar to those experienced by people ages 16 to 25 who received the Pfizer vaccine. Some of the most common side effects for that age group were fatigue, headache and pain at the injection site, according to FDA-reviewed data.

Based on data collected prior to its approval, the Pfizer vaccine is associated with an increased risk of heart inflammation. This reaction is rarely experienced but is most prevalent among boys ages 12 to 17, according to the FDA. The Centers for Disease Control and Prevention maintains a webpage with information about this condition.

Young people ages 12 to 19 currently represent 9.71% of the Coloradans who’ve received at least one dose of a COVID-19 vaccine, according to state data. That means approximately 363,000 12- to 19-year-olds have been vaccinated against COVID-19 in Colorado.

An FDA-issued emergency use authorization for children ages 5 to 11 would appear to make the vaccine available to more than 400,000 additional Coloradans, based on population data from the American Community Survey. State data show that nearly 3.74 million Coloradans had received at least one dose of a COVID-19 vaccine as of Sunday.

According to the Centers for Disease Control and Prevention, the delta variant — now the most common strain of COVID-19 in the U.S. — is more than two times as contagious as previous variants of the respiratory illness. Recent data show the delta variant’s higher transmissibility even applies to vaccinated people.

While hospitalizations and deaths from COVID-19 are far less common for children than for older people, approximately 1 in 30 people hospitalized with COVID-19 in Colorado is between the ages of 10 and 19, according to the state’s most recent data.


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Faith Miller
Faith Miller

Reporter Faith Miller covers the Colorado Legislature, immigration and other stories for Colorado Newsline.