Pfizer announced on Tuesday that they have begun the Food and Drug Administration (FDA) application process for their COVID vaccines created for babies and children six months through four years old.
These very young children are the last age group that has not been approved for any of the vaccines.
The application that the pharmaceutical company submitted is for a two-dose program, but they said that a third dose may be added once they have more data.
“As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” Pfizer CEO Albert Bourla said in a statement. “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.”
Pfizer said that the third dose would likely be eight weeks after the second.
The application process could take several months.
In December, Timcast reported that the two-shot set of doses for younger children had failed to meet the standard for immune response set by the amounts for other children, hence testing a third.
“The abrupt alteration in the trial is a sign of the unexpected power of the coronavirus against vaccine immunity, making it look more like three-shot regimens will become the standard fare of the future. Pfizer and BioNTech will also evaluate the third dose among other age groups as the omicron variant weakens the potency of their vaccine,” Bloomberg reported.
The company said that the third dose for the age group is 3-micrograms. They are also testing a ten microgram third dose for children 5-12 years old and a study of 10 or 30 micrograms doses for 12 to 17.
“Control of omicron may only be possible with three or more doses,” said Kathrin Jansen, Pfizer’s head of vaccine research and development, in an investor conference call on Friday, according to their report.
The pharmaceutical company previously tried to get a vaccine for younger children approved by the end of 2021.
