Pfizer announced that its COVID-19 vaccine is safe for children ages 5 to 11

(Reuters)

Pfizer announced this Monday that your COVID-19 vaccine is safe for children ages 5 to 11 So what will soon apply for authorization in the United States for this age group, a key step to start vaccinating the little ones.

The vaccine made by Pfizer and its German partner BioNTech is now available for those over 12 years old. But now that children have returned to school in the US and the most contagious delta variant is causing a large increase in pediatric infections, many parents are eagerly awaiting vaccinations for their youngest children.

For school-age children, Pfizer tested a much lower dose, one-third the amount now given in each vaccine. However, after your second dose, children ages 5 to 11 developed levels of antibodies to coronavirus as strong as adolescents and young adultsDr. Bill Gruber, Pfizer’s senior vice president, told The Associated Press.

The dose for children too It was shown to be safe, with similar or minor temporary side effects – such as arm pain, fever or malaise – to those experienced by teens, he said.

A 13-year-old boy receives a dose of Pfizer in New York (Reuters)
A 13-year-old boy receives a dose of Pfizer in New York (Reuters)

I think we’ve hit the nail on the head”Said Gruber, who is also a pediatrician. The specialist said the companies intend to apply to the Food and Drug Administration (FDA) by the end of the month for emergency use in this age group, followed shortly after by requests to European and British regulators.

Earlier this month, Peter Marks, the head of the FDA, told the AP that Once Pfizer releases its study results, your agency will evaluate the data “hopefully in a matter of weeks” to decide if the vaccines are safe and effective enough for younger children..

So far, many Western countries have not vaccinated children under the age of 12, waiting to be shown what the appropriate dose is and if it works safely in the youngest. However, last week Cuba began vaccinating children up to 2 years of age with its own vaccines, and the Chinese authorities have authorized two of its brands up to 3 years.

Although children are at less risk of becoming seriously ill or dying than older children, More than 5 million children in the United States have tested positive for COVID-19 since the pandemic began and at least 460 have died, according to the American Academy of Pediatrics. Cases in children have increased dramatically as the delta variant spread across the country.

“I have a great sense of urgency” for the vaccine to be available to children under the age of 12, Gruber said. “There is a pent-up demand for parents to be able to return their children to a normal life.”

In New Jersey, 10-year-old Maya Huber asked why she couldn’t get vaccinated the way her parents and two teenage brothers have done. Her mother, Dr. Nisha Gandhi, an intensive care physician at Englewood Hospital, enrolled Maya in the Pfizer study at Rutgers University. But the family has not stopped taking precautions against the virus until they know if Maya has received the real vaccine or a fake one.

Once she knows she’s protected, Maya’s first goal: “a big sleepover with all my friends.” Maya said it was exciting to be part of the study even though she was “super scared” about getting the injection. But “after receiving it, at least you’re happy you did and relieved that it didn’t hurt,” she told the AP.

Pfizer said it had studied the lowest dose in 2,268 preschool and elementary school children. The FDA required what is called an immune “bridge” study – evidence that younger children developed levels of antibodies that have already been shown to be protective in adolescents and adults. That’s what Pfizer reported Monday in a press release, not a scientific publication. The study is still ongoing, and there have not yet been enough COVID-19 cases to compare the rates between those vaccinated and those who received a placebo, something that could offer additional evidence.

Enzo Russo, 14, receives a dose of Pfizer in Rio de Janeiro (Reuters)
Enzo Russo, 14, receives a dose of Pfizer in Rio de Janeiro (Reuters)

The study is not large enough to detect any extremely rare side effects, such as the inflammation of the heart that sometimes occurs after the second dose, especially in young men. Marks of the FDA said pediatric studies should be large enough to rule out any increased risk to young children. Pfizer’s Gruber said that once the vaccine is licensed for younger children, they will be carefully watched for rare risks, just like everyone else.

A second US vaccine maker, Moderna, is also studying its vaccines in school-age children. Pfizer and Moderna are also studying younger children, up to 6 months. Results are expected by the end of the year.

(With AP information)

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