EMA Begins Review on Allowing Vaccination for Ages 12 and Above
[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. Once approval is granted and vaccination expands to younger age groups, concerns have arisen that the additional consumption of vaccine supplies may delay the schedule for the U.S. to supply surplus vaccines to other countries. Meanwhile, 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, "The FDA is expected to approve the Pfizer vaccine for ages 12 to 15 as early as the end of this week or early next week." This vaccine is currently authorized for use in both the United States and the European Union (EU) for individuals aged 16 and older.
Once the FDA approval is granted, the U.S. Centers for Disease Control and Prevention (CDC) will immediately convene an advisory committee to review clinical data and recommend approval of the Pfizer vaccine for ages 12 to 15.
The FDA did not comment on the NYT report. Previously, an FDA spokesperson stated, "We are conducting the review for (Pfizer vaccine approval for those aged 12 and older) as quickly and transparently as possible."
Earlier, Pfizer reported that its own clinical trial results from March showed significant immune response in the 12 to 15 age group with no serious adverse events.
If vaccination for those aged 12 and older begins, it is expected to contribute to achieving herd immunity as anticipated by authorities. Although younger age groups typically do not exhibit severe symptoms when infected with COVID-19, they can still transmit the virus to adults, so vaccinating them could help prevent further virus spread.
However, if U.S. authorities expand Pfizer vaccine administration to younger age groups following FDA approval, it will further consume the remaining Pfizer vaccine surplus in the U.S. This raises the possibility of disruptions to the U.S. government's plans to supply surplus vaccines to other countries as part of so-called vaccine diplomacy.
Jennifer Nuzzo, an infectious disease researcher at the Johns Hopkins Center for Health Security, said, "It is time to discuss the moral issue of whether to vaccinate our country's low-risk younger population or to help the international community where many adults are dying due to low vaccination rates."
Meanwhile, the EMA has also begun 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.
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