NYT "FDA Likely to Soon Approve Pfizer Vaccine for Ages 12-15" (Update)

EMA Begins Review on Allowing Vaccination for Ages 12 and Above

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Kim Suhwan] The U.S. Food and Drug Administration (FDA) is expected to soon approve the Pfizer vaccine for ages 12 to 15. The European Medicines Agency (EMA) has also begun reviewing whether to authorize the Pfizer vaccine for those aged 12 and older.

On the 3rd (local time), the New York Times (NYT), citing sources, reported that "the FDA is expected to approve the Pfizer vaccine for ages 12 to 15 as early as next week." Currently, this vaccine is authorized for use in individuals aged 16 and older in both the United States and the European Union (EU).

Once the FDA approval is granted, the U.S. Centers for Disease Control and Prevention (CDC) will promptly convene an advisory committee to review clinical data and recommend approval of the Pfizer vaccine for ages 12 to 15.

Earlier, Pfizer reported that its own clinical trial results from March showed the vaccine elicited a significant immune response in the 12 to 15 age group, with side effects similar to the mild symptoms experienced by those aged 16 to 25.

In fact, once vaccination for those aged 12 and older begins, it is expected to contribute to achieving herd immunity, which authorities are aiming for. Although younger age groups typically do not develop severe symptoms when infected with COVID-19, they can still transmit the virus to adults. Vaccinating this group would help block such virus spread.

Meanwhile, the EMA has also started reviewing whether to authorize Pfizer’s vaccine for those aged 12 and older.

On the 3rd, the EMA stated, "We will conduct a rapid review of the data submitted by Pfizer and announce the results next month." However, the EMA added that if additional data are required, the announcement could be delayed.

Previously, on the 30th of last month, Pfizer and BioNTech jointly submitted a request to the EMA to expand the authorized use of their jointly developed COVID-19 vaccine to include ages 12 to 15.