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Pfizer, FDA Postpone Approval for Younger Kid & Toddler COVID-19 Vaccine to Wait for Third Dose Data

A COVID-19 vaccine that is effective in kids under five remains the number one thing parents are craving at this late-pandemic moment, the wait may be a little bit longer, according to Pfizer and BioNTech’s latest news.

Pfizer announced on Friday that they would extend their rolling submission for Emergency Use Authorization and the FDA said they would hold off on their advisory meeting on the shot for kids and toddlers, both citing that they would wait for additional data on immune responses from a third dose before the vaccines would be authorized.

“The trial in children six months through four years of age is ongoing and data on the first two three µg doses in this age group are being shared with the FDA on an ongoing basis,” per their statement. “Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge.”

As SheKnows previously reported, the company had initially hoped to get approval for the vaccine in two-dose form by early March, but the new data emerging along with the recent surge in cases in kids has changed up the timeline as they anticipate needing a third dose in order to trigger the immune response necessary to protect kids and toddlers in this younger age group.

“Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” Pfizer said. “This is also supported by recent observations of three dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real world vaccine protection for omicron compared to the two-dose regimen. The companies expect to have three-dose protection data available in early April.”

Following Pfizer’s announcement, the FDA stated that their meeting to discuss authorization of the vaccine would also be put on hold until the new data arrived “to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.”

Before you go, check out our favorite all-natural cough and cold remedies for kids:


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