FDA panel of experts meets on Tuesday for key review stage – NBC New York – .

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FDA panel of experts meets on Tuesday for key review stage – NBC New York – .


New York City Mayor Bill de Blasio said COVID-19 vaccines could start being given to children ages 5 to 11 early next month if federal health officials grant permission to use the vaccine. emergency Pfizer injections for this subset in the coming days.

“We may be starting a weekend,” de Blasio said on Tuesday, indicating that Saturday November 6 or Sunday November 7 could be the time when vaccines could start being given to children in this age group.

A key step in the authorization process takes place on Tuesday. The FDA’s Vaccines and Related Biologics Advisory Committee reviews data from Pfizer and hears from regulators at a one-day meeting on the vaccine’s safety and efficacy and votes on whether its benefits l outweigh the potential serious side effects in children.

If the panel votes in favor and the FDA allows the injections, the Centers for Disease Control and Prevention will make additional recommendations on who should receive them the first week of November. Children could start immunizations early next month – with the first young people in the line fully protected by Christmas.

Pfizer full strength injections are already recommended for anyone 12 years of age or older, but pediatricians and many parents eagerly await the protection of young children to stem delta variant infections and help keep children healthy. school.

A week ago, New York Gov. Kathy Hochul urged parents to start trying to schedule immunization appointments for their young children “now,” adding: “You don’t want to hear that first appointment is in February ”when the FDA gives the go-ahead.

It is not known how many pediatric offices have agreed to appointments for vaccines for children not yet federally approved to receive the vaccines.

At this point, Dr Joseph Sellers, a pediatrician and president of the New York State Medical Society, which represents about 30,000 physicians statewide, said it could be difficult, if not impossible, until that the logistics are smoothed out.

“We don’t know how quickly the vaccine will be in our hands – it’s a different dose. A different colored bottle with a different cap so we don’t mess up, ”Sellers said. “The governor may be doing more work for us, but I’m glad she is. “

With 1.5 million children in this age group statewide, the stakes are high.

Hochul said she was open to reopening mass vaccination sites, such as the Javits Center in Manhattan, or placing more emphasis on school vaccination centers.

While the FDA is expected to approve the Pfizer vaccine for children aged 5 to 11 in about a week, and CDC approval could come in early November, Gov. Kathy Hochul tells parents to make an appointment for their children as soon as possible. as possible. . Andrew Siff of NBC New York reports.

When asked last week if she supports the COVID vaccine requirement for eligible children, Hochul said she “sees things a little more short-term,” and that would be something to be debated for. fall 2022.

For his part, de Blasio said he does not currently support mandatory COVID vaccines for eligible children in New York public schools.

Last week, the FDA review confirmed Pfizer’s results showing the two-dose injection was nearly 91% effective in preventing symptomatic infections in young children. The researchers calculated the figure based on 16 cases of COVID-19 in young people who received dummy injections compared to three cases in vaccinated children.

No serious illness was reported in young people, but those vaccinated had much milder symptoms than their unvaccinated counterparts.

Most of the study data was collected in the United States in August and September, when the delta variant became the dominant COVID-19 strain.

The FDA review did not reveal any new or unexpected side effects. Those that did occur were mainly arm pain, fever, or body aches.

However, FDA scientists noted that the study was not large enough to detect extremely rare side effects, including myocarditis, a type of heart inflammation that sometimes occurs after the second dose.


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