The American pharmaceutical company Pfizer and BioNTech reported today that they are delaying their application for the Food and Drug Administration (FDA) to authorize their vaccine against Covid-19 for children under five years of age.
Pfizer earlier this month began applying for emergency use authorization for its vaccine in children aged six months to four years, but the company announced that they will need three doses, instead of two, as it initially suggested.
According to the company, the request has been postponed until next week because there is not enough data on the effectiveness of a third injection.
We need more time to evaluate additional data, but we believe a third dose will be needed to effectively protect infants against disease caused by the SARS-CoV-2 coronavirus, Pfizer said.
The companies said they don’t expect to have protection data on all three doses until early April.
According to the country’s health authorities, infection rates remain high in pediatric ages, especially due to the recent wave of the Omicron variant.
The drugmakers said on Friday that the data was coming in quickly, and that they believe they will be able to start distributing the vaccines as early as February 21.
This Friday, the Centers for Disease Control and Prevention (CDC) concluded that the booster dose of the Pfizer and Moderna vaccines lose effectiveness after four months of inoculation, but still protect from hospitalization .
After months of research, the CDC suggests the need for additional doses because the booster offers 91 percent protection against severe symptoms of the disease in the first 60 days, but drops to 78 percent at four months
