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TravelGuides – US FDA approves Covid-19 vaccine for emergency use in children ages 5-11 | Coronavirus

TravelGuides – US FDA approves Covid-19 vaccine for emergency use in children ages 5-11 | Coronavirus

The US Food and Drug Administration (FDA) on Friday paved the way for children ages five to 11 to get Pfizer’s Covid-19 vaccine.

After the FDA cleared kid-size doses – a third of the amount given to teens and adults – for emergency use, up to 28 million more American children could be eligible for vaccinations as early as next week.

One more regulatory hurdle remains: on Tuesday, advisers to the Centers for Disease Control and Prevention (CDC) will make more detailed recommendations on which children should get vaccinated, with a final decision by the CDC director expected shortly afterwards.

“With this vaccine, kids can go back to something that’s better than being locked at home on remote schooling, not being able to see their friends,” said Dr Kawsar Talaat of Johns Hopkins University. “The vaccine will protect them and also protect our communities.”

A few countries have begun using other Covid-19 vaccines on children under 12, including China, which just began vaccinations for three-year-olds. But many that use the vaccine made by Pfizer and its partner BioNTech are watching the US decision. European regulators just began considering the companies’ kid-size doses.

With FDA’s action, Pfizer plans to begin shipping millions of vials of the pediatric vaccine – in orange caps to avoid mix-ups with the purple-capped doses for everyone else – to doctors’ offices, pharmacies and other vaccination sites. Kids will get two shots, three weeks apart.

Pfizer/BioNTech’s new pediatric Covid-19 vaccine vials.
Pfizer/BioNTech’s new pediatric Covid-19 vaccine vials. Photograph: PFIZER/Reuters

While children are at lower risk of severe illness or death from Covid-19 than older people, five- to 11-year-olds still have been seriously affected, including more than 8,300 hospitalizations, about a third requiring intensive care, and nearly 100 deaths since the start of the coronavirus pandemic, according to the FDA.

And with the extra-contagious Delta variant circulating, the government has counted more than 2,000 coronavirus-related school closings just since the start of the school year, affecting more than a million children.

Earlier this week, FDA independent scientific advisers voted that the pediatric vaccine’s promised benefits outweigh any risks. But several panelists said not all youngsters will need to be vaccinated, and that they preferred the shots be targeted to those at higher risk from the virus.

Nearly 70% of five- to 11-year-olds hospitalized for Covid-19 in the US have other serious medical conditions, including asthma and obesity, according to federal tracking. Additionally, more than two-thirds of youngsters hospitalized are Black or Hispanic, mirroring longstanding disparities in the disease’s impact.

The question of how broadly Pfizer’s vaccine should be used will be a key consideration for the CDC and its advisers, who set formal recommendations for pediatricians and other medical professionals.

A Pfizer study of 2,268 children found the vaccine was nearly 91% effective at preventing symptomatic Covid-19 infections, based on 16 cases among kids given placebo shots compared with just three who got vaccinated.

The dosage also proved safe, with similar or fewer temporary reactions – such as sore arms, fever or achiness – that teens experience.

But the study was not large enough to detect any extremely rare side-effects, such as the heart inflammation that occasionally occurs after the second full-strength dose, mostly in young men and teen boys. It is unclear if younger children getting a smaller dose also will face that rare risk.

Some parents are expected to vaccinate their children ahead of family holiday gatherings and the winter cold season.

But a recent Kaiser Family Foundation survey suggests most parents won’t rush to get the shots. About 25% of parents polled earlier this month said they would get their children vaccinated “right away”. But the remaining majority were roughly split between those who said they will to wait to see how the vaccine performs and those who said they “definitely” won’t have their children vaccinated.

The similarly made Moderna vaccine also is being studied in young children, and both Pfizer and Moderna also are testing shots for babies and preschoolers.

TravelGuides – US FDA approves Covid-19 vaccine for emergency use in children ages 5-11 | Coronavirus

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