A student is helped by transitional kindergarten teacher Annette Cuccarese to put on a mask during the first day of school at Tustin Ranch Elementary School in Tustin, CA on Wednesday, August 11, 2021.
Paul Bersebach | MediaNews Group | beautiful pictures
Pfizer and BioNTech On Tuesday asked the Food and Drug Administration to expand the use of its Covid-19 vaccine to most children under the age of 5.
The companies said the FDA has asked them to begin submitting data, which is being submitted on a rotating basis to fast-track the approval process, to authorize the first two doses that will eventually be a triple vaccine. dose for children six months. up to 4 years old. Pfizer and BioNTech say data on the third dose will be finalized and submitted to the FDA in the coming months.
Pfizer and BioNTech began applying for urgent approval to meet a “urgent public health need” of younger children because the omicron variant has caused a spike in hospitalizations in this age group.
“As the number of children under the age of 5 hospitalized with COVID-19 soars, our shared goal with the FDA is to prepare for future surges of variation and provide parents with an option to help protect their children from this virus,” said Pfizer CEO Albert Bourla. statement.
Bourla said children under 5 will eventually need a third dose for the best protection against omicrons and future Covid variants. By getting FDA approval for the first two doses, parents can start vaccinating their children while they wait for the third dose, Bourla said. Pfizer and BioNTech are expected to finalize their application for the first two doses of emergency approval in the coming days.
Toddlers and children under 5 are the last remaining age group not eligible for vaccination. The FDA is expected to fast-track the approval process for children ages 6 months to 4 years as it does for other age groups. Once approved, the pediatrician will be able to give the injections within a few days.
Parents are eagerly awaiting vaccines for younger children as the omicron variant sweeps across the country, triggering an unprecedented wave of infections over the past month.
Although children are at a much lower risk of developing severe illness from Covid than adults, their hospitalization with the virus increased in recent rally infections, raising concerns about the long-term impact on children’s health.
Dr Rochelle Walensky, director of the Centers for Disease Control and Prevention, told reporters in January: “Sadly, we are seeing increased hospitalization rates for children aged 0 to 4 years. , children who are not currently eligible for the Covid-19 vaccine. .
The White House’s chief medical adviser, Dr. Anthony Fauci, said last month that he hopes the FDA will allow it vaccines for children around February. At that point, younger children will likely need a three-dose vaccine, Fauci said.
Pfizer revised its clinical trial in December to study a third shot after two doses of its 3-microgram vaccine failed to produce an adequate immune response in children 2 to 4 years of age. Adults receive two doses of 30 micrograms in their primary series of injections.
Pfizer vaccine researcher Dr. Alejandra Gurtman said last month that the drugmaker planned to have data on children under the age of 5 ready by late March or early April. , a group of 250 doctors last month sent a letter asking the FDA to cut the red tape and allow a dose of 3 micrograms for children. Doctors say it is immoral not to give parents the option to vaccinate their young children as the pandemic rages across the country.
“As children return to day-care centers, preschools, and other unavoidable group facilities, we all know that the number of young children infected with omicrons will increase exponentially, creating a the greatest health opportunity that children face collectively during the entire pandemic,” the doctors wrote in their letter.
According to CDC data, at least 1,000 children have died from Covid since the pandemic began in 2020, and hospitals have seen more than 94,000 hospitalizations of children with Covid. The virus has infected more than 11.4 million children, accounting for 18.6% of all cases since the pandemic began, according to the American Academy of Pediatrics.
More than 6,000 children have developed a multisystem inflammatory syndrome known as MIS-C, according to the CDC. MIS-C is a rare, but serious, Covid-related condition characterized by multi-organ inflammation. According to CDC data, at least 55 children have died from MIS-C.
Dr. Grace Lee, professor of paediatrics at Stanford University, said the pandemic has burdened an entire generation of children, with long-term effects yet to be seen.
“I also really believe we still haven’t addressed the long-term impact of Covid infections in children.” told CDC’s independent vaccine advisory committeewhich she chaired, earlier this month just before the agency cleared the Pfizer boosters for kids ages 12 to 15.
“I think we haven’t even scratched the surface of what we’re going to see,” Lee said.
