Pfizer said on Monday that its COVID-19 vaccine is in the works for children ages 5 to 11 and it will soon seek US authorization for this age group – an important step toward introducing vaccinations to youth.
The vaccine, made by Pfizer and its German partner BioNTech, is already available for people 12 years of age and older. But now that there has been a surge in pediatric infections due to children back in school and the extra-infectious delta variant, many parents are anxiously waiting to be vaccinated for their young children.
For elementary school-aged children, Pfizer tested a much lower dose — one-third the amount that is now in each shot given. Dr. Bill Gruber, senior vice president at Pfizer, told the Associated Press that even after their second dose, children ages 5 to 11 developed the same levels of coronavirus-fighting antibodies as teenagers and young adults.
The child supplements also proved safe with similar or less temporary side effects — such as sore throat, fever or pain — that teens experience, he said.
“I think we’ve really hit the sweet spot,” said Gruber, who is also a pediatrician.
Gruber said the companies aim to apply for emergency use in this age group to the Food and Drug Administration by the end of the month, with applications from European and British regulators shortly thereafter.
Earlier this month, FDA chief Dr. Peter Marks told the AP that once Pfizer changes the results of its study, its agency will evaluate the data “hopefully in a few weeks” to decide in order to decide whether the shots are safe and effective for young children.
Many Western countries have not yet vaccinated people under the age of 12, awaiting evidence that the correct dosage is and that it works safely in young children. But Cuba last week started vaccinating children under the age of 2 with its home vaccines, and Chinese regulators approved two of its brands up to the age of 3.
According to the American Academy of Pediatrics, while children have a lower risk of serious illness or death than older people, more than 5 million children in the US have tested positive for COVID-19 and at least 460 have died. Has been. Cases in children have increased dramatically as the delta variant has swept across the country.
“I feel very urgent” in making the vaccine available to children under the age of 12, Gruber said. “There is a demand for parents to be able to bring their children back to a normal life.”
In New Jersey, 10-year-old Maya Huber asked why she couldn’t get vaccinated like her parents and two teenage brothers. Her mother, Dr. Nisha Gandhi, a critical care physician at Englewood Hospital, enrolled Maya in the Pfizer study at Rutgers University. But the family hasn’t relaxed their masking and other virus precautions until they know whether Maya has received the real vaccine or the dummy shot.
Once she knows she’s safe, Maya’s first goal: “A big slumber with all my friends.”
Maya said it was exciting to be a part of the study, even though she was “super scared” about being jab. But “after you get it, at least you feel happy that you did it and relieved that it didn’t hurt,” she told the AP.
Pfizer said it conducted a low-dose study in 2,268 kindergarteners and elementary school-aged children. What the FDA called an immunity “bridging” study: evidence that young children developed antibody levels that have already been shown to be protective in teens and adults. That’s what Pfizer said Monday in a press release, not a scientific publication. The study is still ongoing, and there are not enough COVID-19 cases yet, which may offer additional evidence to compare rates between people vaccinated and those given placebo _.
The study is not large enough to detect any extremely rare side effects, such as heart swelling that sometimes occurs after the second dose, mostly in younger men. The FDA’s Marks said the pediatric study should be large enough that there is no high risk to young children. Pfizer’s Gruber said that once the vaccine is authorized for young children, they, like everyone else, will be carefully monitored for rare risks.
A second US vaccine maker, Moderna, is also studying its shots in elementary school-aged children. Pfizer and Moderna are also studying babies as young as 6 months old. Results are expected later in the year.