The Delta variant has affected pockets of people that once seemed less at risk for COVID. The more transmissible strain of the virus has infected vaccinated individuals and young children at a higher rate than the previous iteration of the virus. With that in mind, pharmaceutical companies have sought to fill the gaps. Pfizer first proposed a booster shot for fully vaccinated adults, and now the company has announced that a trial found its vaccine has a “safe” and “robust” response in children five to 11 years old.
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On Sept. 20, Pfizer announced its highly anticipated results from a Phase 2/3 trial. The company said the trial showed a “favorable safety profile and robust neutralizing antibody responses in children five to 11 years of age using a two-dose regimen.” During the trial, 2,268 children received two doses 21 days apart. The dosage was 10 micrograms, which is smaller than the 30 micrograms used on people 12 years and older. According to the statement, the vaccine was well-tolerated by the children. The side effects reported were similar to those seen in people aged 16 to 25.
These are the first results published about children taking a U.S. COVID vaccine. Pfizer said it plans to submit data from the full Phase 3 trial to be peer-reviewed and published shortly. The company also said it plans to share the data with the U.S. Food and Drug Administration (FDA) and other pertinent regulators as soon as possible in hopes of gaining fast approval.
On Sept. 13, Scott Gottlieb, MD, a former FDA commissioner and current Pfizer board member, said he believed Pfizer would file very quickly for approval. The FDA has said its decision will come in a matter of weeks and not months after it receives the submission. Based on that timeline, Gottlieb told CBS’ Face the Nation that he predicts there could be a Pfizer vaccine available to children by Halloween.
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“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S.—underscoring the public health need for vaccination,” Pfizer CEO Albert Bourla said in the statement. “These trial results provide a strong foundation for seeking authorization of our vaccine for children five to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
As Bourla noted, COVID cases in children have been on the rise. The American Academy of Pediatrics (AAP) reported that since the beginning of the pandemic, children represented 15.5 percent of total accumulated cases. However, for the week ending Sept. 8, children accounted for 28.9 percent of reported weekly COVID cases, although they only make up 22.2 percent of the U.S. population. In the week between Sept. 2 and Sept. 9, more than 243,000 children tested positive for COVID.
Pfizer doesn’t plan to stop at vaccinating children aged five to 11. According to the statement, the company intends to have trials for children aged two to five, and six months to two years, during the fourth quarter of this year.
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