Pfizer submits data for US approval of COVID shots for children under 5 years – Reuters report


© 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.

Disclaimer: Fusion Media would like to remind you that the data on this website is not necessarily real-time or accurate. All CFDs (stocks, indices, futures) and Forex prices are not provided by stock exchanges but rather by market makers and therefore the prices may not be accurate and may differ from the actual market price, which means that the prices are indicative and not suitable for commercial purposes. Therefore, Fusion Media does not bear any responsibility for any trading losses you may incur as a result of the use of this data.

Fusion Media or anyone involved in Fusion Media will not assume any liability for loss or damage resulting from reliance on the information, including data, quotes, charts and buy / sell signals contained on this website. Please be fully informed about the risks and costs associated with trading in the financial markets, this is one of the most risky forms of investment possible.

Give a Comment