Immunization – ĂŰĚŇÓ°ĘÓ America's Education News Source Fri, 17 Jun 2022 16:13:26 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 /wp-content/uploads/2022/05/cropped-74_favicon-32x32.png Immunization – ĂŰĚŇÓ°ĘÓ 32 32 FDA Authorizes Moderna and Pfizer Vaccines for Kids as Young as 6 Months /article/fda-advisory-panel-backs-moderna-and-pfizer-vaccines-for-kids-under-5/ Wed, 15 Jun 2022 22:06:27 +0000 /?post_type=article&p=691595 Updated, June 17

The Federal Food and Drug Administration on Friday authorized both Moderna’s and Pfizer-BioNTech’s vaccines for children as young as 6 months old — meaning COVID shots for the last age group of Americans without access may be just days away.

The vaccines now await sign-off from the Centers for Disease Control and Prevention, the final step before children under 5 can begin rolling up their sleeves. The White House expects providers to begin administering doses on Tuesday, immediately after the federal Juneteenth holiday.

On Wednesday, an FDA panel of experts — made up of pediatricians, infectious disease experts and vaccine researchers — voted 21-0 in favor of both vaccine options.

“There are so many parents who are absolutely desperate to get this vaccine, and I think we owe it to them to give them the choice,” said committee member Jay Portnoy, a professor of pediatrics at Children’s Mercy Hospital in Kansas City, Missouri.

Philip Chan, medical director for the Rhode Island Department of Health, called the panel’s unanimous vote a “major milestone in COVID prevention.” His state is ready to distribute the shots as soon as they receive the all clear, he said.

“We’ve pre-ordered thousands of [doses], and we expect them to ship within 24 or 48 hours after the FDA issues the EUA” (emergency use authorization), he told ĂŰĚŇÓ°ĘÓ Wednesday. With EUA now granted, the COVID shots should soon be on their way.

Parents who are eager to finally vaccinate their young children took advantage of the public comment period at the FDA’s Wednesday committee meeting to urge advisors to recommend authorization. Michael Baker, the father of a 1 and a 3 year old, described the tough choices he has had to make to protect his children from the virus. He shared a slide of all the events they have missed out on during the pandemic, including weddings, holidays and funerals.

“All I am asking is now that … I have the choice to vaccinate my children, [that] I have the choice to do it in the most timely fashion possible,” he said to the committee.

FDA/YouTube

Parents like Baker awaiting vaccines for their little ones have been on a months-long rollercoaster that has repeatedly raised their hopes only to later send them crashing down. In late February, Pfizer-BioNTech first submitted a request asking the FDA to grant emergency authorization for a two-dose regimen of their vaccine for children 6 months to 4 years old, only to then withdraw the application just five days later. Then in April, when Moderna was on the verge of submitting its EUA application for the age group, the FDA postponed the committee review process until Pfizer’s shots were also ready.

Just 29% of children 5 to 11 years old and 59% of youth 12 to 17 years old have so far received two vaccine doses, according to data from the American Academy of Pediatrics. 

However, Katelyn Jetelina, creator of Your Local Epidemiologist, wrote in her hyper-popular newsletter that parents of young kids should still take COVID seriously and vaccinate their children.

“The rate of severe disease is lower compared to adults, but this is an inherently flawed comparison because kids don’t die as often as adults. Since the beginning of the pandemic, 442 children aged 0-4 years old have died from COVID-19. If we compare to other vaccine preventable diseases among children, deaths due to COVID19 are highest. We cannot become numb to these deaths,” she explained.

FDA

COVID cases across the U.S. are finally leveling off after a springtime surge fueled by an Omicron subvariant spurred bumps in pediatric infections and hospitalizations through the final weeks of the school year.

You can view the FDA’s and watch the full recording of its June 15 vaccine advisory committee’s virtual meeting:

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Pfizer Shot 91% Effective at Preventing COVID in Children Ages 5-11 /pfizer-biontech-vaccine-over-90-effective-at-preventing-covid-in-children-ages-5-11/ Fri, 22 Oct 2021 17:38:47 +0000 /?p=579574 The Pfizer-BioNTech coronavirus vaccine is 91 percent effective at preventing COVID infection in youth ages 5 to 11, the pharmaceutical companies’ data released Friday reveal.

The protection provided by the shots, the companies say, supports authorization of the vaccine for the 28 million U.S. children in that age group. The Food and Drug Administration has a hearing scheduled Tuesday with expert advisors to review the case for authorization. 

Two weeks ago, Pfizer and BioNTech submitted their formal request to the FDA for the green light to deliver doses to 5- to 11-year olds. 

If the review timeline spans a similar length as that of vaccines for 12- to 15-year olds, the agency could grant authorization ahead of the Thanksgiving holiday — meaning that the vast majority of K-12 students may soon be eligible for immunizations.

The vaccine efficacy numbers come from a Pfizer and BioNTech provided to the FDA, released Friday morning by the federal agency. In their trial, the companies tested a 10 microgram dose of the vaccine, one-third the size of the shot for teenagers and adults, and found that it produced a “robust” antibody response. Immunity and side effects, they said, were comparable to those produced by the larger dose in 16- to 25-year-old patients. 

No new safety problems or cases of heart inflammation were observed in the trial, which tested 2,268 participants. Israeli studies have found myocarditis to occur in , so it’s possible the condition would have been too rare to have been detected in the main study. 

The news comes as children make up over , amounting to about a quarter of all reported infections per week nationwide, according to mid-October data published by the American Academy of Pediatrics. Over have closed so far this year due to outbreaks of the virus, according to Burbio, an organization that has tracked schools through the pandemic, though COVID-related school closures have slowed considerably in recent weeks as and schools hone their protocols to curb spread.

The White House has made it clear that immunizing children will be a priority once shots are authorized for 5- to 11-year olds. The Biden administration will match schools with COVID-19 vaccine providers, the White House Wednesday. The Department of Health and Human Services will also enlist community-based clinics, doctor’s offices, hospitals and faith-based organizations in rapidly distributing vaccines.

Two-thirds of parents of children aged 5 to 11 years say they will immunize their children against COVID-19 once shots are authorized for the age group, according to by the COVID-19 Vaccine Education and Equity Project.

“While we’re encouraged to see that a majority of parents intend to vaccinate their children against COVID-19 once they are eligible, there is clearly more work to be done to help address parents’ questions and ease concerns about the vaccines,” Beth Battaglino, CEO of the nonprofit HealthyWomen, one of the partner organizations behind the polling, said in a .

Pfizer-BioNTech vaccinations have been fully approved by the FDA for individuals ages 16 and above, and have emergency use authorization for teenagers ages 12 to 15. Shots for kids younger than five may arrive .

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