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FDA Clears COVID Boosters for Ages 5-11 — But When Will Vaccines for Kids Under 5 Be Approved?

As we’ve moved through various stages of the pandemic — with cases inching back up to levels of previous spikes yet there being little meaningful attempts at encouraging masking, social distancing or remote solutions —  parents are understandably eager to ensure their children are as protected as possible as they move about their lives. On Tuesday, the US Food and Drug Administration announced that Pfizer-BioNTech’s COVID-19 Vaccine dosage for kids between the ages of 5 and 11 have been granted emergency use authorization for single boosters five months after their initial two-part series.

This means that if your child was previously vaccinated at least five months ago, they can soon (pending CDC approval, which is expected) be boosted too!

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” FDA Commissioner Robert M. Califf, M.D. said in a statement. “The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19. Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe. If your child is eligible for the Pfizer-BioNTech COVID-19 Vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death.”

Boosters had previously been granted emergency use authorization for kids 12 through 14 back in January, to help older children have more significant offs of preventing severe outcomes from COVID-19. The booster allows the vaccine to stay more effective for longer, as research suggests that the efficacy of the vaccine “wanes after the second dose of the vaccine in all authorized populations.”

“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research said in the statement.

Obviously this news will come as a relief to parents who were staring down a summer of unknowns for their kids in this approved age group, but naturally it also raises the questions from parents with younger children.

When will we see approval on vaccines for kids under 5?

On Monday, The American Medical Association (AMA) Chief Experience Officer Todd Unger spoke on the status of COVID-19 vaccines for younger children with Paul Offit, MD, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia in the AMA’s daily COVID-19 update podcast.

Discussing the two mRNA vaccines in the works, Offit noted that both Moderna and Pfizer are moving toward approval with the former submitting a two-dose vaccine (with 25 micrograms per dose given to kids 6 months to 6 years four weeks apart) to the FDA and the latter undergoing a three-dose trial (with three micrograms per dose, with the first two doses three weeks apart and a third dose a month later.)

“I haven’t seen preliminary data on that trial but I have seen just preliminary data, meaning top line, press release data from the Moderna trial,” Offit said. “My suspicion, if I had to make a guess, and it is a guess, is that probably sometime in mid-June, both of these vaccines will be considered but we’ll see…If we do meet in mid-June you would think by no later than beginning of July, this vaccine or these vaccines would be available for children less than six years of age.”

While the timing can still feel agonizingly slow for parents who are increasingly burnt out and concerned about the current pandemic response, Offit notes (and it really is worth repeating) that “this is the fastest vaccine ver made,” having been brought from isolation, sequencing and trials in under a year.  Add in variants and the need to troubleshoot dosages for different ages and the timing is still remarkably fast.

And, if the timeline works the way Offit guesses, then this could also mean these vaccines would be available in time for back-to-school season which, paired with getting older children boosted, could be beneficial for so many families heading into the fall and winter months where people are more worried about the healthcare infrastructure being able to handle an uptick in cases.

Before you go, check out our favorite natural cold and cough products we love for kids:

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