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FDA Panel Endorses Pfizer's Low-Dose COVID-19 Vaccine For Kids Aged 5-11

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Dr. Alfredo Carpineti

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Dr. Alfredo Carpineti

Senior Staff Writer & Space Correspondent

Alfredo (he/him) has a PhD in Astrophysics on galaxy evolution and a Master's in Quantum Fields and Fundamental Forces.

Senior Staff Writer & Space Correspondent

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Ira Lichi/Shutterstock.com

Image Credit: Ira Lichi/Shutterstock.com

A key advisory panel for the Food and Drug Administration (FDA) has recommended the Pfizer/BioNTech’s COVID-19 vaccine for children ages 5 to 11. This is a huge step in getting the 28 million kids in this age range across the US vaccinated. The dosage, however, will only be a third of that given to teens and adults.

The 18-members Vaccines and Related Biological Products Advisory Committee voted almost unanimously for the endorsement, and it is now up to the FDA itself to make a decision on it. An advisory group on vaccines for the Centers for Disease Control and Prevention (CDC) is expected to come to a decision on this early next week as well. If an endorsement is issued and is then signed off by the CDC, vaccination for kids across the US could begin in the first week or two of November, according to Dr Anthony Fauci.

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The Biden Administration has announced that it has the doses ready to be issued immediately. Currently, in the US, children aged 5 to 11 account for 16.5 percent of all COVID-19 cases according to the American Academy of Pediatrics. Children are less likely to experience symptoms but they get infected at similar rates as adults and can pass the virus on to others.

“We don’t want children to be dying from COVID, even if it is far fewer children than adults, and we don’t want them in the ICU,” panel member Dr Amanda Cohn said before the vote, reports CNBC.

Pfizer submitted a request for FDA approval earlier this month after promising results from the vaccine in children published in September. The Phase2/3 clinical trial included 2,268 participants between 5 and 11 years old and tested the same regimen that has now been recommended by the FDA committee. Even though the dose is lower (just one-sixth of a grain of salt in weight), the immune response was comparable to what has been previously seen in teens and young adults.

"While the brutal toll of the pandemic will reverberate for years to come, let’s make the choice to finally put children first," Dr Lee Beers, president of the American Academy of Pediatrics, told the New York Times.

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This summer and fall have been particularly bad for pediatric cases with hundreds of thousands of new COVID-19 cases every week. Of medical concern is how different or seasonal diseases combined with COVID could be truly dangerous for younger children. This has been a serious worry since the summer when Texas saw an increase in hospitalizations of children due to increasing COVID cases mixed with an unseasonably early outbreak of Respiratory syncytial virus (RSV). 


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