© Reuters. FILE PHOTO: A person walks past a Pfizer logo in the Manhattan neighborhood of New York City, New York, USA, April 1, 2021. REUTERS / Carlo Allegri
WASHINGTON (Reuters) -Pfizer Inc. has begun submitting data to federal regulators as part of the process to win the U.S. Emergency Use License (EUA) of their COVID-19 vaccine for children under 5, Bloomberg reported Tuesday.
“The rolling submission of data asks regulators to purge the shot as a two-dose vaccine, although it is expected that a three-shot regimen may eventually become standard,” the Bloomberg report quoted unnamed individuals as saying. is familiar with the data.
The vaccine from Pfizer (NYSE 🙂 and partner BioNTech are already approved for emergency use in children in the United States aged 5 and older. It has full approval for adults.
Representatives of Pfizer as well as of the U.S. Food and Drug Administration and the Department of Health and Human Services could not be immediately reached for comment on the report.
The Washington Post said Monday that companies could apply for an EUA for children ages 6 months to 4 years as early as Tuesday.
Pfizer said in a statement late Monday that it had not yet sought approval and “continues to collect and analyze data from both two and three doses in our younger age cohort.”
The FDA has also approved a third booster dose of the Pfizer / BioNTech syringe for adults and children 12 years of age and older. It gave the green light for a two-dose vaccine for children aged 5 to 11 years.
The companies previously said they had to change their study because under 5 years of age they did not have such a strong immune response as the larger dose that older children received.
Last month, Pfizer said it expected to have those results in April. The rolling submission, if approved, would allow the company and health authorities to start moving forward with shots for those under 5 years of age until the rest of the data becomes available.
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