Pfizer vaccine could prevent tens of thousands of cases in 5-11 year olds, FDA panel says – .

Pfizer vaccine could prevent tens of thousands of cases in 5-11 year olds, FDA panel says – .

Vaccinating children aged five to 11 would prevent tens of thousands of Covid-19 cases over a six-month period, according to data presented to a panel of U.S. advisory experts debating whether to recommend to do so.

The data, which was presented by Pfizer to the committee and supported by a similar analysis from the Food and Drug Administration, suggests that the benefits of vaccinating young children far outweigh the risks.

The panel will vote later Tuesday on whether to recommend that the FDA authorize the BioNTech / Pfizer vaccine for these young children. If so, the FDA will likely give the green light in a few days, making the United States the first country to approve Pfizer for this age group.

William Gruber, senior vice president of vaccine research and development at Pfizer, told the committee: [adverse event] The study profile did not suggest any safety concerns for immunizing children five to less than 12 years of age.

Analyzes from Pfizer and the FDA suggested that vaccinating young children would prevent between 45,000 and 60,000 Covid-19 infections for every million children who received the vaccine over a six-month period, assuming the virus is as widespread as it is now. That would stop more than 200 hospitalizations and a handful of deaths during that time.

Models suggest that deploying the Pfizer vaccine to children aged five to 11 could cause around 200 cases of heart inflammation, although it is not expected to result in death.

Speaking at the start of the meeting, Fiona Havers, a doctor with the Centers for Disease Control and Prevention, said infection rates in young children had increased over the summer.

“In total, there have been over 1.9 million reported cases of Covid-19 in this age group, and as of July and August of this year, there has been a sharp increase in cases in this age group, ”she told the panel. Children between the ages of five and 11 currently account for 10.6% of cases in the United States, but only 8.7% of the population, she added.

Health experts say extending vaccines to the 28 million children of the age group is a crucial step towards increasing levels of immunity in the United States, where only 57% of the population is fully vaccinated. But reluctance to vaccinate among some parents could slow this effort, they warned.

“In the United States, many children have had their lives on hold because they could not be vaccinated and there is not enough vaccination in the population over 12 years of age. [of age] to prevent recognized cases in schools from disrupting in-person learning, ”said Amesh Adalja, senior researcher at the Johns Hopkins Center for Health Security in Baltimore.

“Vaccinating this group will be an important step towards increased immunity in the population. “

Pfizer said the United States was the first country to seek regulatory approval for its Covid-19 vaccine for children aged five to 11.

A study by the company found that the BioNTech / Pfizer vaccine is 90% effective in preventing symptomatic Covid-19 infection in children five to 11 years of age when given in doses “the size of” one child ”, equivalent to one-third the size of an adult. Pull. It also demonstrated “the safety and tolerability” of the vaccine for the age group, the company said last week.

In the United States, more than 6.3 million children have been diagnosed with Covid-19 since the start of the pandemic, with a weekly number of new cases peaking at 252,000 in early September, according to the American Academy of Pediatrics .

Children are less vulnerable to serious illnesses than adults. According to the Centers for Disease Control and Prevention, 637 deaths of people under the age of 18 have been reported in the United States during the pandemic.

“We like to say that low risk doesn’t mean no risk,” said Sara Goza, physician and former president of the AAP.

“We expect to see some vaccine hesitation around Covid-19 and pediatricians are ready, willing and able to talk to parents and children about this vaccine and why we think it is important. ”

About a third of parents told a Kaiser Family Foundation survey that they would vaccinate their children aged five to 11 “right away,” while a quarter said they definitely would not vaccinate their children. The rest said they would wait and see or vaccinate their children only if necessary.

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