Parents anxiously awaiting a vaccine for their younger children will have to be patient as the U.S. Food and Drug Administration works on two vaccine candidates’ applications.
Moderna (MRNA) has filed for emergency use authorization (EUA) of it’s COVID-19 vaccine for kids aged 6 and under, while Pfizer (PFE)/BioNTech (BNTX) is still tweaking the dosage for ages 5 and under.
Initially, scientists were focused on studying two lower doses for children compared to those of adults. That is no longer an effective strategy, according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
“When you’re dealing with an Omicron era, and that’s where we are right now, it’s very clear that Omicron is a virus that requires three doses,” said Fauci, who also serves as the chief medical adviser to President Joe Biden.
It’s why he advises that parents be patient for studies to conclude the best options are for children’s vaccines.
“I don’t think parents should be concerned that it’s taken a while because the FDA wants to make sure they get right,” he said, noting that he anticipates the decision to come soon.
Fauci’s comments echo those of Moderna CEO Stéphane Bancel, who told Yahoo Finance in a recent interview that it could be a “couple of months” before the FDA’s decision.
“With the young children, you want to make sure the data is reviewed thoroughly,” Bancel said.
Pfizer CEO Albert Bourla expects the revised data from the company’s trial some time this month, setting the stage for both vaccines to be authorized around the same time.
Pfizer and Moderna, both mRNA vaccines, were the first two to be authorized in the U.S. for adults in December 2020.
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