The United States has postponed Pfizer and BioNTech's COVID-19 vaccinations for children under the age of six months to four years.
As reported by Al Jazeera Saturday, February 12, 2022, this delay is at least two months after the United States Food and Drug Administration (FDA) said they needed more data.
The FDA said parents waiting for vaccines for some 18 million children in the toddler age group should be reassured that a COVID-19 vaccine is confirmed to meet standards.
"If we don't meet those standards, we can't continue," said Dr Peter Marks, director of the FDA's Center for Biological Evaluation and Research.
The FDA has planned to make decisions about vaccines for toddlers based on preliminary trial data. This is due to the great public health impact of the surge in infections caused by the Omicron variant.
Pfizer and BioNTech have submitted data on administering the first two doses of a three-dose regimen for this age group.
The submission came as a surprise because in December they said the results of an initial trial of the low-dose vaccine were not as expected in two to four-year-olds and changed their clinical trial to test a three-dose version.
The Pfizer/BioNTech main series of vaccines is two-dose in all older age groups. But in December, Pfizer changed the design of its clinical trial to test a third dose of the vaccine in children aged two to four years because the response was lower than for those aged 16 to 25.
This delay may be disappointing for parents of young children who are rushing to face quarantines and the closure of kindergartens and daycare centers.
However, Dr Amesh Adalja, an infectious disease expert at the Johns Hopkins University Center for Health Security, said there was considerable resistance to the FDA's decision to pursue authorization so quickly.
“Because this age group is at very low risk for severe illness from COVID-19 and vaccine uptake in the five-11 year old [age group] is very suboptimal.”