Pfizer Expects FDA Approval to Vaccinate Children Under 12 by Halloween

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NEW YORK, NEW YORK - AUG.21: A view of Pfizer signage during the We Love NYC: The Homecoming Concert Produced by NYC, Clive Davis, and Live Nation on Aug. 21, 2021 in New York City. (Image: Jamie McCarthy/Getty Images for Live Nation)

Pharma giant Pfizer/BioNTech announced on Thursday that the company is seeking FDA approval for its COVID-19 mRNA vaccine to be administered to children between the ages of five and eleven.

The submission comes after new studies show that Pfizer’s vaccine effectiveness against infection and severe disease sharply wanes over time, the Epoch Times reported.

Three scientists from the company were recently recorded acknowledging that natural immunity, or the protection provided from getting COVID-19 and recovering, is similar to or better than the protection from the company’s vaccine.

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination,” Albert Bourla, chairman and chief executive officer of Pfizer said in the statement on September 20.

“These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old,” he said, adding that, “and we plan to submit them to the FDA and other regulators with urgency.” 

According to the announcement in “participants 5 to 11 years of age, the vaccine was safe, well tolerated and showed robust neutralizing antibody responses.”

“Children generally do not get severely ill with COVID-19 as much as older people do,” it said, “but there were still almost 175,000 cases among children in the week ending Sept. 30, according to the American Academy of Pediatrics (AAP).”

The company said it only administered one-third of the regular dose for children under 12 on two instances at 21 days apart during the test run, which Pfizer claims did not reveal any out-of-the-ordinary side effects.

Dr. Bill Gruber, a Pfizer senior vice president said, “The kid dosage also proved safe, with similar or fewer temporary side effects — such as sore arms, fever, or achiness — that teens experience.”

In its press statement, Pfizer expressed hope it would “submit these data to the FDA, EMA and other regulatory agencies around the world as soon as possible” and that, “results in children under five years of age are expected as soon as later this year.”

The Pfizer application is expected to be met with little objection. Chief Medical Advisor to the President, Anthony Fauci, previously during an appearance on MSNBC said about his expectations of vaccines becoming available for children,  “I think there’s a really good chance it will be before Halloween,” about the chances that there will be a COVID-19 vaccine available for children from five up, with Fauci adding that, “I believe there’s a reasonably good chance that it will be.”

When asked whether he was in favor of mandatory vaccination for children, Fauci said, “When you hear, ‘would I be in favor of mandating?’ in fact, I would be. But that gets taken out of context like I’m trying to impose some novel, new restriction on somebody, of taking away their rights,” he said.

“Look at what’s been going on for decades in schools — the requirement for vaccination,” he added, saying it would be “nothing new.”