- Pfizer and BioNTech are set to request FDA approval to provide its COVID-19 vaccination to children under the age of five.
- Children under the age of five are the only age group in the United States that do not have access to the COVID-19 vaccination.
- The vaccination might be accessible to young children by the end of February, according to sources.
As early as the end of February, a two-dose pediatric COVID-19 vaccination might be available for children aged 6 months to 5 years. Pfizer and BioNTech, a pharmaceutical business, stated on Feb. 1 that they have begun submitting data to the Food and Drug Administration (FDA) in order to update the existing emergency use authorization (EUA) for their vaccine to cover this younger age range.
The proposal is expected to be completed in the coming days by Pfizer and BioNTech. Children under the age of five are now the only age group in the United States without access to the COVID-19 vaccination.
The American Academy of Pediatrics (AAP) stated in a statement that the news was encouraging but that they wanted to analyze the facts. In a statement, AAP President Moira A. Szilagyi, MD, Ph.D., FAAP stated, “Pediatricians have experienced first-hand the worry, stress, and suffering that so many families of young children have faced while they await a vaccine.” “We support a transparent and data-driven procedure for evaluating this vaccine for this age range, and we look forward to providing it to our most vulnerable children.”
To discuss the submission, the FDA’s vaccine advisory group will meet on February 15Trusted Source. In a joint statement, Pfizer and BioNTech stated the action is “in response to the critical public health need in this community.” They also said the FDA has requested them to submit an application for a two-dose pediatric vaccination, while they continue to study how well three doses function in this age range. The firm stated data on a third dosage will be presented to the FDA in the coming months, with the expectation that if the data is good, the FDA would approve a three-dose regimen for this age range.
Coronavirus continues to spread among youngsters
According to the AAP, over 11.4 million children and teenagers have caught the coronavirus that causes COVID-19 in the previous two years. In the last two weeks, about 2 million of these incidents had happened. While many children with coronavirus infections have very moderate illnesses, others might get ill and need hospitalization. According to statistics from the Centers for Disease Control and Prevention, overall hospitalizations among children and teenagers in the United States have decreased in recent weeks, but they remain higher than at any previous time throughout the epidemic (CDC).
Furthermore, pediatric hospitalizations are still on the rise in various regions of the nation. A dangerous inflammatory disorder called a multisystem inflammatory syndrome in children (MIS-C) may occur in certain children who have had a coronavirus infection. Dr. John Bradley, an infectious disease expert at Rady Children’s Hospital in San Diego, stated, “We’re now witnessing an increase in the number of MIS-C patients.” “These are happening approximately a month or so after the predicted increase in pediatric COVID-19 infections following the holidays,” he added.
The COVID-19 vaccine, developed by Pfizer and BioNTech, has been shown to minimize the incidence of MIS-C in adolescents by 91 percent. Although statistics for that age range are not yet available, Bradley believes we will see a similar trend for younger children. “We know that if you immunize youngsters, you can avoid MIS-C,” he added, citing research from older children. “And half of the MIS-C is in school-aged and preschool children, including the younger children who are now being targeted by this vaccination.”
Begin with the first two doses of a three-dose series
Pfizer and BioNTech stated in mid-December that two doses of their vaccine — administered at 1/10 the power of adult dosage — failed to induce a strong adequate immune response in youngsters aged 2 to 4.
The immunological response found in children aged 6 to 24 months, on the other hand, was comparable to that seen in older teenagers and young adults. According to the firm’s press release, there were no safety issues in any of these younger age groups. Following the poor two-dose findings, Pfizer and BioNTech decided to expand their clinical study to investigate whether a third dosage, administered at least 8 weeks after the second, boosting the immune response in children aged 6 months to under 5 years.
According to The Washington Post, data on the third dosage will not be available until late March at the earliest. A pediatric vaccination for younger children would not have been ready until April if the FDA had waited until then. While the FDA waits for evidence on the three-dose regimen, moving ahead with a review of the two-dose plan will enable parents to start having their children vaccinated with two doses.
Bradley has no reservations about advising that parents put their younger kid on the vaccination as soon as it obtains FDA and CDC approval since there were no safety issues with the two-dose series. “We’re giving kids the kid’s immunization, not simply the adult vaccine,” Bradley said. “The vaccination dosage is meant to be lower in order to reduce negative effects.” We also have safety data from millions of 5- to 11-year-olds who got the pediatric COVID-19 vaccination in the United States, he added.
“At this moment, we have more knowledge on the safety of this vaccination for children than we’ve ever had on any other vaccine,” he added. Furthermore, “there is no reason to assume that the vaccine’s safety profile in a 2- to 4-year-old would be any different than in a 5- to 12-year-old.” The FDA and CDC may take longer to approve the vaccination for children aged 6 to 24 months, according to Bradley, “to convince us that the vaccine is just as safe for newborns as it is for older kids.”
Only a limited number of parents may opt to start their younger kid on the two-dose regimen if the authorities approve the vaccine later this month, with some waiting for the FDA to assess the evidence on three doses and others waiting even longer. According to the AAP, just around 20% of 5- to 11-year-olds are completely vaccinated, whereas approximately 55% of 12- to 17-year-olds are.
The approval of a pediatric COVID-19 vaccination for younger children, according to Dr. Andrea Anderson, associate head of the division of family medicine at GW Medical Faculty Associates, will benefit more than just the kid who receives the vaccine. “Even if the number of children hospitalized in this age range is lower, if a young kid contracts COVID, it is difficult for all family members,” she added. “Parents and caregivers must cope with the stress of caring for a sick kid, as well as the financial consequences of lost employment.”