Pfizer-BioNTech announced Feb. 1 that it is seeking to amend its Emergency Use Authorization to include a vaccine for children from 6 months to 4-years old. It expects to complete the request to the U.S. Food and Drug Administration within a few days.
The application requests authorization for an initial series off two injections of three micrograms. Data from the initial series will determine if the company seeks approval of a third dose eights weeks after the two-shot regiment is completed.
Albert Bourla, chairman and CEO said, “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.”
“If authorized, we are very excited about the prospect of offering parents the opportunity to help protect their children 6 months through 4 years of age from COVID-19 and the potentially severe consequences of infection,” said Dr. Ugur Sahin, CEO and Co-founder of BioNTech.
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This request by Pfizer/BioNTech is what is known as a “rolling submission.”
“In a traditional submission to the FDA a pharmaceutical company would submit all the trial information at one time for evaluation. However, when submitting for an expansion of the current EUA or a new EUA the FDA has allowed pharmaceutical companies to submit data on a rolling basis or as they collect the data from the clinical trial,” said Dr. Joshua Wyche, Assistant Vice President of Strategic Planning and Pharmacy Services. “This allows the FDA to evaluate the effectiveness and safety as the clinical trial is progressing instead of at the conclusion.”
Wyche said, if the EUA is approved, it will mean children ages 6-months through 4-years of age can be vaccinated and be protected from hospitalization, severe disease or death from COVID-19.
Dr. Brannon Traxler, the South Carolina Department of Health and Environmental Control’s public health director, said she sees this almost as the last piece of the puzzle.
“That is the population that still has not been eligible. We talk a lot about how everyone can get vaccinated if they want to, but the reality is there are those youngest children who have not had that ability so far,” she said. “This will get down to six months, assuming the FDA gives an emergency authorization. So then, hopefully, we will see all vaccination numbers going up, and we’ll see also corresponding decreases in cases.”
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The American Academy of Pediatrics said pediatric COVID-19 cases are above 100,000 for the 25th consecutive week. More than 11.4 million children have tested positive for the virus since the pandemic began.
COVID-19 related staff absences are prompting a Richmond County school to transition to the Learn@Home model.
Students at Blythe Elementary School made the transition beginning on Feb. 4. Students will return to in-person instruction on Monday, Feb. 7.
More than 30 Richmond County schools have been on remote learning since schools reopened on Jan. 4 after the winter break.
Dana Lynn McIntyre is a general assignment reporter for The Augusta Press. Reach her at dana@theaugustapress.com
