Pfizer study suggests COVID-19 vaccine is safe and protective in young adolescents

Pfizer study suggests COVID-19 vaccine is safe and protective in young adolescents

Pfizer announced on Wednesday that its COVID-19 vaccine is safe and strongly protective in children as young as 12, a step towards starting vaccines in this age group before they return to school in autumn.
Most of the COVID-19 vaccines deployed around the world are intended for adults, who are more exposed to the new coronavirus. Pfizer’s vaccine is licensed for ages 16 and over.

In a study of 2,260 American volunteers aged 12 to 15, preliminary data showed that there were no cases of COVID-19 among fully vaccinated adolescents compared to 18 cases among those who received dummy injections , Pfizer reported in a press release Wednesday.

This is a small study, which has yet to be published, so another important piece of evidence is how well the injections boosted children’s immune systems. The researchers reported “robust antibody responses,” the statement said.

The children had side effects similar to those of young adults, the company said. The main side effects are pain, fever, chills and fatigue, especially after the second dose. The study will continue to follow participants for two years for more information on long-term protection and safety.

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Pediatric studies underway for other vaccines

Pfizer and its German partner BioNTech plan in the coming weeks to ask the US Food and Drug Administration (FDA) and European regulators to authorize the emergency use of injections from the age of 12.

“We share the urgency to expand the use of our vaccine,” Pfizer CEO Albert Bourla said in a statement. He expressed “the hope of starting to vaccinate this age group before the next school year” in the United States.

A spokesperson for Pfizer Canada said the company intends to file the pediatric data with Health Canada.

Health Canada authorizes the use of vaccines in different age populations in this country.

Pfizer is not the only company seeking to lower the age limit for its vaccine. The results are also expected from an American study on Moderna’s vaccine in young people aged 12 to 17.

But a sign that the results were promising, the FDA has already allowed the two companies to begin American studies on children aged 11 and under, up to the age of six months.

AstraZeneca started a study of its vaccine in children aged 6 to 17 in Britain last month. Johnson & Johnson are planning their own pediatric studies. And in China, Sinovac recently announced that it has submitted preliminary data to Chinese regulators showing that its vaccine is safe in children as young as three.

While most of the COVID-19 vaccines in use around the world were first tested on tens of thousands of adults, pediatric studies won’t need to be so large. Scientists have information about the safety of these studies and subsequent vaccinations in millions of additional adults.

A key question is dosage: Pfizer gave participants 12 years and older the same dose adults receive, while testing different doses in younger children.

U.S. FDA timeline unclear

It is not known how quickly the FDA would respond to Pfizer’s request to allow vaccination from the age of 12. Another question is when the country would have enough vaccines – and people to put them in the arms of teenagers – to keep children in line.

Supplies are expected to increase steadily in the spring and summer, as states open up vaccinations to younger, healthier adults who so far have not had a turn.

Children make up about 13% of documented COVID-19 cases in the U.S. Although children are much less likely than adults to become seriously ill, at least 268 have died from COVID-19 in the United States alone and more 13,500 were hospitalized, according to a tally from the American Academy of Pediatrics. That’s more than dying from the flu in an average year. In addition, a small number have developed severe inflammatory disease linked to the coronavirus.

Caleb Chung, seen in this December 2020 photo receiving his first dose of Pfizer vaccine or a placebo, says the study was “really a place where I could actually help.” (Richard Chung / The Associated Press)

Caleb Chung, who turns 13 later this week, agreed to volunteer after his father, a pediatrician at Duke University, presented the option. He does not know if he received the vaccine or a placebo.

“Usually I’m just home doing online classes and there’s not much I can do to combat the virus,” Caleb said in a recent interview. The study “was really a place where I could really help.”

His father, Dr Richard Chung, said he was proud of his son and all the other children who volunteered for needle sticks, blood tests and other tasks that a study involves. .

“We need the kids to do these trials so the kids can be protected. Adults can’t do this for them, ”Chung said.

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