FDA Approves Pfizer Coronavirus Vaccines for Children Ages 5-11, Israel Expected to Do Same

WASHINGTON – On Friday, the Food and Drug Administration paved the way for children ages 5 to 11 to receive the COVID-19 vaccine from Pfizer.

The FDA approved children’s doses, just a third of the amount given to teens and adults, for emergency use, and up to 28 million more American children could be eligible for vaccines next week.

One more regulatory hurdle remains: On Tuesday, advisers to the Centers for Disease Control and Prevention will make more detailed recommendations on which youth should be vaccinated, with a final decision from the agency’s director expected shortly thereafter.

“With this vaccine, children can go back to something that is better than being locked up at home in a remote school, unable to see their friends,” said Dr. Kawsar Talaat of Johns Hopkins University. “The vaccine will protect them and it will also protect our communities.”

Some countries have started using other COVID-19 vaccines in children under the age of 12, including China, which has just started vaccinating 3-year-olds. But many of those using the vaccine made by Pfizer and its partner BioNTech are watching the US decision, and European regulators have only just begun to consider child-sized doses from companies.

Israel, which generally follows FDA clearances, is also expected to quickly launch vaccines for children ages 5 to 11. On Friday, the Health Ministry said the Israel Center for Disease Control would hold a panel discussion on COVID-19 vaccines for the very young. established on November 4, partially open to the public for the first time.

With the FDA’s action, Pfizer plans to begin shipping millions of vials of the pediatric vaccine, in orange caps to avoid confusion with the purple-capped doses for everyone else, to doctors’ offices, pharmacies and other vaccination sites. The children will receive two injections, three weeks apart.

Israel’s Channel 12 news reported that the Pfizer mini-doses are expected to arrive in Israel on November 15. Israel was one of the first countries to receive the regular doses of the injection when it was launched late last year.

Syringes loaded with the Pfizer COVID-19 vaccine lie ready for a nurse to use in Jackson, Miss., On Sept. 21, 2021. (AP / Rogelio V. Solis)

While children are at lower risk of serious illness or death from COVID-19 than older people, children ages 5 to 11 have still been severely affected, including more than 8,300 hospitalizations, about a third requiring intensive care, and nearly 100 deaths since then. the start of the coronavirus pandemic, according to the FDA.

And with the extra-contagious Delta variant in circulation, the government has counted more than 2,000 coronavirus-related school closures since the beginning of the school year, affecting more than a million children.

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

Nearly 70% of children ages 5 to 11 hospitalized for COVID-19 in the US have other serious medical conditions, such as asthma and obesity, according to federal tracking. Additionally, more than two-thirds of hospitalized youth are black or Hispanic, reflecting long-standing disparities in the impact of the disease.

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

A Pfizer study of 2,268 schoolchildren found that the vaccine was nearly 91% effective in preventing symptomatic COVID-19 infections, based on 16 COVID-19 cases among children who received sham injections compared to just three who were vaccinated.

Finley Martin, 14, receives an injection of the Pfizer COVID-19 vaccine at First Baptist Church of Pasadena on Friday, May 14, 2021 in Pasadena, California (AP / Marcio José Sánchez)

The children’s dose was also safe, with similar or fewer temporary reactions, such as arm pain, fever or pain, that teens experience.

But the study was not large enough to detect extremely rare side effects, such as the inflammation of the heart that occasionally occurs after the second full dose, mostly in young men and teenagers. It is not clear whether younger children who receive a lower dose will also face this rare risk.

Some parents are expected to vaccinate their children before vacation family gatherings and the cold winter season.

But a recent survey from the Kaiser Family Foundation suggests that most parents won’t rush to get vaccinated. About 25% of parents surveyed earlier this month said they would vaccinate their children “immediately.” But the remaining majority of parents were roughly split between those who said they would wait to see how the vaccine works and those who said they will “definitely” not vaccinate their children.

The similarly made Moderna vaccine is also being studied in young children, and both Pfizer and Moderna are also testing vaccines for infants and preschool children.

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