Pfizer has applied to the FDA for approval of its vaccine for children under five

2022-04-18 0 By

Pfizer and its partner BioNTech SE have asked U.S. health regulators to approve their COVID-19 vaccine for children under the age of five, the last age group not to be vaccinated.The application, filed with the US Food and Drug Administration (FDA) on Tuesday, could make the vaccine available to children aged six months to under six years in March.The companies said the FDA asked them to begin submitting data, which is submitted on a rolling basis, to fast-track the approval process to authorize the first two doses of the vaccine for children between six months and four years of age.Pfizer and BioNTech said data for a third dose should be completed and submitted to the FDA in the next few months.Some parents have been looking forward to getting their children vaccinated because of the large number of children hospitalized as the Omicron coronavirus variant swept through the United States.Despite disappointing results for some children during testing, the company applied for FDA approval of the two-dose regimen.Pfizer’s chief executive, Albert Bourla said in a statement: “because of the children under 5 years of age due to the increase in the number of new crown in the hospital infection is our common goal with the FDA to prepare for the future infection surge, and provide a choice for parents, to help protect their children from the effects of the virus.”Bourla said children under age 5 will eventually need a third dose of the vaccine to get the best protection against omicron and other variants.Children under five are the last age group not eligible for vaccination.The FDA is expected to speed up the vaccine approval process, and once approved, pediatricians will be able to administer the vaccine to children in a matter of days.While children are at much lower risk of serious illness from COVID-19 than adults, their hospital admissions for Omicron have increased during the recent surge in infections, raising concerns about the long-term effects on children’s health.”Unfortunately, we are seeing an increase in hospitalizations in children ages 0 to 4 who are not yet eligible for COVID-19 vaccine,” Dr. Rochelle Walensky, director of the CENTERS for Disease Control and Prevention (CDC), previously told reporters.Dr. Fauci, the White House’s chief medical adviser, also said he hopes the FDA will approve the coronavirus vaccine for children in February.Dr. Alejandra Gurtman, a vaccine researcher at Pfizer, said last month that the drugmaker plans to have data ready for children under 5 by the end of March or early April.However, a group of 250 doctors sent a letter to the FDA last month asking for fast-track approval of the 3-microgram dose for children.Doctors say it would be unethical not to let parents vaccinate their young children as the pandemic ravages the country.”As children re-enter day care centers, preschools and other inevitable group Settings, we all know that the number of young children infected with Omicron will skyrocket exponentially, creating the greatest health risk collectively faced by children throughout the pandemic,” the doctors wrote in the letter.At least 1,000 children have died of COVID-19 since the pandemic began in 2020, according to the CDC, and more than 94,000 infected children have been admitted to US hospitals, according to the latest data.Omicron has infected more than 11.4 million children, accounting for 18.6 percent of all cases in the United States since the pandemic began, according to the American Academy of Pediatrics.Grace Lee, a professor of pediatrics at Stanford University, says the pandemic has already burdened an entire generation of children, and its long-term effects remain to be seen.