Trial Shows Pfizer Vaccine Safe For Kids As FDA Panel Breaks With Biden On Booster Plan

COVID-19 vaccines for young children could some sooner than booster shots for the rest of us.
COVID-19 vaccines for young children could some sooner than booster shots for the rest of us. Screenshot
Millions of parents with young kids breathed a collective sigh of relief across the United States Monday morning, as Pfizer announced its trial of its two-dose COVID-19 vaccine found the shots were safe and effective for children ages five to 11.

While full authorization for Pfizer’s vaccine in kids five to 11 could still be weeks or months away depending on how swiftly the U.S. Food and Drug Administration approves Pfizer’s trial data, the news that a vaccine for kids is entering the official approval process couldn’t have come at a better time. Children now make up more than 20 percent of daily new coronavirus cases in the United States, according to the American Academy of Pediatrics.

Meanwhile, the FDA might soon be at odds with President Joe Biden’s administration on the topic of booster shots of COVID-19 vaccines for most Americans. On Friday, the FDA’s main vaccine advisory panel voted against a previously announced Biden administration plan to authorize third booster doses of Pfizer’s two-shot vaccine for all U.S. residents over the age of 16.

These new developments in vaccines for young kids and potential booster shots for the rest of us come as Texas football season is getting underway, leading some to wonder if large crowds of maskless football fans could possibly lead to upticks in coronavirus cases across the Lone Star State.

On Monday, Pfizer’s Chairman and CEO Albert Bourla touted the new and promising results of his company’s vaccine trial on children ages five to 11.

“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. 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,” Bourla said in a statement.

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S.,” he continued, “underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S." — Pfizer’s Chairman and CEO Albert Bourla

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There definitely isn’t a feeling of urgency coming out of the FDA’s vaccine advisory panel in terms of making COVID-19 booster shots widely available any time soon. Late last week, that panel voted 16 to 2 against recommending booster doses for those 16 and up, but voted unanimously to recommend Pfizer boosters for U.S. residents 65 and older or who are at high risk for severe illness if they catch the coronavirus.

Back in August, the Biden administration and U.S. Centers for Disease Control and Prevention director Dr. Rochelle Walensky announced their intention to make booster shots of both Pfizer and Moderna’s two-shot vaccines widely available by September 20 to any U.S. resident who received either vaccine.

Weeks later, internal concerns within the FDA and CDC reportedly began to brew about a lack of sufficient data from Moderna to approve booster doses of its vaccine, which made it seem likely that approval for at least Moderna boosters wouldn’t meet the September 20 date put forth by the Biden administration. But Friday’s FDA panel vote against broad eligibility for Pfizer boosters was an even bigger blow to the administration’s stated goal of getting booster shots into the arms of even healthy U.S. residents starting in late September.

The FDA isn’t obligated to follow the advice of its vaccine advisory panel and could hypothetically still recommend broad eligibility for Pfizer booster shots, but it's followed the panel’s guidance throughout the pandemic so far. The agency is expected to make an official recommendation on booster shots later this week, while the CDC’s main vaccine advisory committee is set to debate booster policy on Wednesday and Thursday.
click to enlarge The latest COVID data from the Department of State Health Services shows fewer hospitalizations, but ICU beds are still scarce. - SCREENSHOT
The latest COVID data from the Department of State Health Services shows fewer hospitalizations, but ICU beds are still scarce.
Across Texas, coronavirus hospitalizations have continued to fall in recent days. There were 11,838 COVID-19 patients in state hospitals as of Sunday, down from a summer surge peak of 13,928 on August 24. Harris County’s COVID-19 hospitalizations have followed a similar downward trend.

Despite the decline in coronavirus patients in state and local hospitals over the past few weeks, intensive care unit beds are still in scarce supply thanks to the Delta variant-induced surge. As of Sunday, there were only 304 staffed adult ICU beds across Texas, and only 59 adult ICU beds available in the entire nine-county trauma service region surrounding Houston.

While the start of the school year across Texas led to a predictable increase in COVID-19 cases among children (potentially due to inconsistent policies on masking across the state), it’s still unclear as to whether or not the start of football season has led to any shifts in local coronavirus metrics.
click to enlarge There weren't too many masks at NRG at the last Texans home game. - PHOTO BY JACK GORMAN
There weren't too many masks at NRG at the last Texans home game.
Photo by Jack Gorman
When tens of thousands of fans packed into NRG Stadium for the first Texans home game on September 12, Houston Press writer Jesse Sendejas Jr. who was in attendance noted that the overwhelming majority of them were maskless, despite the Texans’ official stance that masking at games is “strongly encouraged for all fans, regardless of whether or not you are vaccinated.”

Harris County Judge Lina Hidalgo and Houston Mayor Sylvester Turner have both recommended that all locals mask-up in public due to the increasing number of breakthrough infections among the vaccinated, and because of the potential for even inoculated people to spread COVID-19 if infected by the extremely contagious Delta variant.

Given those recommendations, the Press reached out to both the Houston Health Department and Harris County Public Health Monday to ask whether either health department was tracking the dates of Texans home games to see if they’re followed by any upticks in local coronavirus metrics, just as they keep a close watch around major holidays when folks are expected to gather in large groups. Neither the city nor the county health department immediately responded to our requests for comment on the matter.
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Schaefer Edwards is a staff writer at the Houston Press who covers local and regional news. A lifelong Texan and adopted Houstonian, he loves NBA basketball and devouring Tex-Mex while his cat watches in envy.
Contact: Schaefer Edwards