FDA endorses emergency use of Pfizer 1:44 booster vaccine
(CNN) -
Pfizer / BioNTech plans to request authorization for a COVID-19 vaccine for some children under the age of 12, which will put the United States one step closer to offering protection to a population that has become particularly vulnerable to as the fall season progresses.
"It's a matter of days, not weeks," Pfizer president and CEO Albert Bourla told ABC News on Sunday about when the company will submit data on children ages 5 to 11 to the FDA for consideration.
Currently, covid-19 vaccines are only approved for children over the age of 12, which has raised concern among health experts as cases in children rise, the school years begin, and the most transmissible delta variant spreads.
Nearly 26% of all COVID-19 cases nationwide are reported in children, according to recent data published by the American Academy of Pediatrics.
And an average of 266 children were hospitalized with COVID-19 every day last week, according to data from the US Centers for Disease Control and Prevention (CDC) on Sunday.
Once the Pfizer / BioNTech data is in, they will have to go through two committees, one for the U.S. Food and Drug Administration (FDA) and one for the CDC, the CNN medical analyst said Sunday, Dr. Johnathan Reiner.
If the data arrives this week, it will likely be in commission by the end of October, he added.
And there is a lot of data for you to see, he said.
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"This is a vaccine for children, so getting the correct dose, in terms of efficacy and side effects, is crucial," Reiner said.
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But even when a vaccine is available, a difficult task lies ahead of vaccinating children.
Less than half of American teens are fully vaccinated against COVID-19, according to a CNN analysis of CDC data.
In response, officials must do a better job of educating people about the importance of vaccination to the health of their children and their families in general, Reiner said.
"If you want children in school, the best way to keep them in school is to prevent them from contracting COVID," he said.
Until vaccines are approved for younger children, the CDC has recommended the use of face masks for students, teachers, and visitors in schools from kindergarten through 12th grade, along with better ventilation, physical distancing, and testing. detection.
"We know how to keep them safe," CDC Director Dr. Rochelle Walensky told CBS on Sunday.
"When we don't use proper mitigation, outbreaks are more likely."
Former FDA Commissioner Dr. Scott Gottlieb said he encourages parents to vaccinate their children when they can.
"This is a dangerous pathogen," Gottlieb told CNN.
"I would not be so arrogant about this virus, we know that this virus has long-term consequences for many people who contract it, including children."
The current increase is likely to subside by Thanksgiving, says Gottlieb
Gottlieb predicted on Sunday that the current increase in the spread of the coronavirus is likely to worsen in some parts of the country and then disappear by Thanksgiving.
"I think you will see a wave of infection across the Northeast when kids go back to school, the weather turns cold and people go indoors," Gottlieb told CNN's Pamela Brown.
The virus will not go away, Gottlieb said, but is expected to reach more manageable levels, which he estimates at about 20,000 cases per day.
According to the CDC, the current seven-day average for new cases in the US is more than 114,000 new cases per day.
The decline in cases is likely due to most people gaining immunity to the virus, Gottlieb said.
"Some people will get a vaccine; others will challenge their immunity with no choice but to get the infection," Gottlieb explained.
"People who choose not to get vaccinated will be vulnerable to infection through this delta wave."
As the United States enters flu season, Gottlieb said demand for tests will increase as people and their doctors try to determine whether their flu-like symptoms are due to COVID-19 or influenza.
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"That is why it is so important that diagnostic tests get into the hands of consumers and doctors' offices, things like where people can test at home will make the difference between distinguishing between covid and other respiratory infections, especially when the flu spreads, "Gottlieb said.
But even if COVID-19 cases drop by Thanksgiving, health experts are bracing for a tough northern winter ahead.
It is not yet clear what this year's flu season holds, but it could add additional stress to an already stressed health care system.
"The flu is still deadly, not as deadly as covid-19, but between 12,000 and 50,000 Americans lose their lives each year from the flu," said Dr. Peter Hotez, vaccinologist and dean of the National School of Tropical Medicine. from Baylor College of Medicine.
Last year's flu numbers were low, which health experts say could mean the coming seasons may be worse, as there has been little build-up of immunity.
"We have a huge flu season ahead of us at some point," Gottlieb said Sunday.
"It's written on the wall. Why can't they read it?"
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Recommending the booster dose for front-line workers is a 'difficult scientific decision,' says CDC director
On Friday, Walensky recommended a booster dose for adults at occupational risk for infection, as well as those with underlying conditions and those over 65, a decision she said was a "difficult scientific decision."
"And because of that difficult decision, and because of all the evidence that we reviewed at the FDA and the CDC, I thought it was appropriate that those people were eligible for boosters," Walensky told CBS's "Face the Nation" show on Sunday.
"So who are those people? People who live and work in high-risk settings. That includes people in homeless shelters, people in group homes, people in prisons. But, also, most importantly, they are people. who work with vulnerable communities, as well as our healthcare workers, our teachers, our grocery workers, our public transportation employees, "Walensky said.
CVS begins offering booster doses of Pfizer vaccine at nearly 6,000 US locations.
Although CDC vaccine advisers voted against recommending booster doses for people at high risk of infection due to their working or living conditions, Walensky accepted clearance from the FDA, including those individuals.
The recommendation is not currently intended for the general population, but there is little fear of causing dangerous side effects from adding that third dose, Walensky said.
"We have an extraordinary amount of security data," he said.
CNN's Jacqueline Howard, Maggie Fox and Aya Elamroussi contributed to this report.
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