FDA panel meets to discuss vaccines for kids, kicking off authorization process

Written by on October 26, 2021

(WASHINGTON) — An advisory panel at the Food and Drug Administration will vote Tuesday on whether to move forward with authorizing vaccines for children ages 5-11.

The vote will be the first step in a regulatory process for the two-shot Pfizer vaccine for kids. If the panel votes in favor of the vaccine after reviewing Pfizer’s data from clinical trials, the process will move to the Centers for Disease Control and Prevention.

If both agencies support the data, kids could be able to get their first shots in early November.

“If all goes well, and we get the regulatory approval, and the recommendations from the CDC, it’s entirely possible, if not, very likely, that vaccines will be available for children from 5 to 11 within the first week or two of November,” Dr. Anthony Fauci, chief medical adviser for the White House, said in an interview on Sunday on ABC’s This Week.

Many parents are desperate to protect their children after the delta surge over the summer led to increased cases and hospitalizations among kids. Though the variant is not more deadly, it is more transmissible — and because kids are unvaccinated, the variant rocketed through schools and camps.

The most recent data from Pfizer’s clinical trials found that the vaccine for 5-11 year olds was nearly 91% effective against symptomatic illness.

The vaccine also appeared safe. None of the children in the clinical trials experienced a rare heart inflammation side effect known as myocarditis, which has been associated with the mRNA vaccines in very rare cases, mostly among young men.

The Pfizer vaccine, if authorized for kids, will be given at a smaller, one-third dose.

The White House has purchased enough pediatric doses to vaccine all 28 million children ages 5 to 11. If authorized, it will be distributed to thousands of sites, including pediatricians, family doctors, hospitals, health clinics and pharmacies enrolled in a federal program that guarantees the shots are provided for free.

Some states are planning to provide the vaccine through schools as well.

The 5-11 age group would be the youngest and latest to receive eligibility. The Pfizer vaccine has already been authorized for adolescents 12 and up, and everyone 18 and older is eligible for all three vaccines, Pfizer, Moderna and J&J.

Whether parents will embrace the vaccines for their kids is still a question. In a September poll, the Kaiser Family Foundation found that about a third of parents with kids ages 5-11 were willing to vaccinate their kids right away, while another third wanted to “wait and see.” The figures represented a slight uptick in vaccine acceptance among parents of elementary-school-aged kids since July.

Although children are less likely to die of COVID-19 than older adults, pediatricians say there is still an urgent need for a safe vaccine for children. Children can still become very sick and spread the virus to others. So far, more than 6 million children have tested positive in the United States, according to the American Academy of Pediatrics.

Trials for children 2 years and up, the next age group that could become eligible, are ongoing. Data from the clinical trials is expected sometime this winter.

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