Pfizer has started the process of seeking emergency approval for the use of its vaccine against Kovid-19 for children aged six months to four years, the pharmaceutical company announced on Tuesday.
If approved by the US Food and Drug Administration (FDA), the vaccine will become the first in the United States for this age group.
In the first phase, the request refers to a series of two doses, but over time, a third will have to be considered as well, explained in a press release from the companies Pfizer and Biontek, reports Hina.
"We think that children aged six months to four years will need two doses to achieve a high level of protection against current and future variants of the virus," Pfizer CEO Albert Burla added in a statement.
If two doses are approved now, parents will have the opportunity to start vaccinating their child against covid pending the possible approval of the third dose, he added.
Pfizer states that they submitted the request "after a call" from the US drug agency, which apparently does not want to waste time and wants to speed up the process.
The request will be fully finalized in a few days, the company added, and the vaccine for that age may be available in a few weeks.
The FDA has announced that their expert panel in charge of examining the data will meet on February 15.
For children of that age, the drug company opted for a dose of just three micrograms per injection (compared to 30 for adults and 10 for five to 11-year-olds), to limit side effects. However, it turned out that such a reduced dose does not cause the desired immune response in children aged two to four, Pfizer announced in December.
The company therefore wanted to examine the application of the third dose of the vaccine for that age, so it supplemented the protocols of its clinical trials.
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