Both companies said they had submitted license applications to the US Food and Drug Administration on Thursday.
The FDA may approve the shots for use by youth before November. That means you can take it to your pediatrician’s office, school or anywhere else as Halloween.
According to the American Academy of Pediatrics, there are more than 28 million children between the ages of 5 and 11 in the United States.
The FDA is already planning a panel of outside experts to review the data on October 26. Officials are not required to follow the panel’s recommendations, but they usually do.
If permitted, infants would be given two injections of Pfizer-BioEntech every three weeks, but with a lower dosage, as do teens and adults.
School districts and public health officials have begun preparing for vaccinations, but the work is still in its infancy. Health and vaccine experts expect the vaccine to be given in some schools, pediatricians’ offices, and many pharmacies.
According to experts, the refrigeration requirements for the Pfizer-BioNTech vaccine may pose some challenges, but schools and public health departments routinely administer it, so it is a pediatric vaccine not related to COVID-19. I have experience.
Pediatric clinics and other management sites do not allow children to be vaccinated with existing supplies because the dosage to children is lower and prepared differently than adults. Pfizer said that if approved, it will begin shipping the pediatric dose as soon as it is approved by US health officials.
According to both companies, applications will be filed after the vaccine can safely generate a strong immune response in young subjects in late-stage trials.
Both companies said the antibody levels in the vaccinated child volunteers were similar to those of young adults.
The FDA has already reviewed Pfizer-BioNtech research data after the companies began granting authorizations in September. However, companies are still required to submit other information, and the adjusted timeline could extend approval until November, The Wall Street Journal reports.
Toddlers are one of the last groups in the United States waiting for a vaccine against the FDA-approved coronavirus.
They have a lower risk of serious illness and hospitalization than adults, according to health experts, but since the early days of the pandemic, highly contagious delta variants have spread mainly to unvaccinated people. Many children go to the hospital.
Many parents want to protect their children as the school year begins and young children are vaccinated.
Some parents with young children are eager to get their young children vaccinated. He enrolled them in a clinical trial, in hopes that the baby would get a real shot, not a placebo.
Doctors and health officials say it is important to vaccinate children not only to protect them from the virus, but also to protect children and the families around them.
Pediatricians and public health professionals say a lot of work needs to be done to address the concerns of parents about vaccinating infants, including those who have received the COVID-19 vaccine themselves. Has received.
According to one study, nearly one-third of parents of children ages 5 to 11 “wait and see” how the shots work before vaccinating their children. Published in September by the Kaiser Family Foundation.
According to the survey, about 34% of parents of children aged 5 to 11 years will vaccinate their children immediately after the vaccine is approved for that age group.
After approval at the age of 5–11 years, the only group waiting for the vaccine is the younger 6-month-old.
Pfizer said the results of the survey of infants aged 6 months to less than 5 years could be out by the fourth quarter of this year.
For ages 5-11, businesses are looking for what’s called an emergency use authorization. It is provided by the FDA in a public health emergency based on the best evidence available at the time.
To accelerate the availability of the COVID-19 vaccine for pandemic emergencies, the FDA has approved shots for emergency use, including Pfizer-BioNtech.
Children up to the age of 12 are allowed to get Pfizer-BioNTech shots under an emergency use authorization. Currently, the vaccine is fully approved for people over the age of 16.
In one major study, Pfizer and BioNTech enrolled approximately 2,268 subjects over a period of 5-11 years. Two-thirds of subjects were vaccinated twice at three-week intervals, and the rest were vaccinated with placebo. Children received a lower dose of 10 micrograms, compared to a dose of 30 micrograms consumed by adults.
Pfizer hasn’t provided detailed results yet, but an analysis of data on children who received the vaccine looked at people aged 16 to 25 who received a separate dose of 30 micrograms. A study by Pfizer noted that neutralizing antibody levels were up a month after the second dose.
Neutralizing antibodies, which prevent the virus from invading cells and replicating, play an important role in the body’s immune response to COVID-19.
The companies still say how well the shots protected against COVID-19 because too few young subjects became ill to compare the proportion of vaccinated children to placebo-vaccinated children.
Nevertheless, the FDA generally approves vaccines based on data showing that vaccines that have already been shown to be prophylactic in the elderly produce similar antibody levels in infants to adults.
According to Pfizer, vaccinated babies have fewer side effects, such as fever and chills, than children aged 16 to 25.
According to Pfizer, there have been no reported cases of myocarditis, an inflammatory heart disease that has been reported to have a rare side effect, mainly in young men.
write to Jared S Hopkins ([email protected])
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