The U.S. Food and Drug Administration (FDA) has decided to quickly review a vaccine and treatment for a new mutant omicron for COVID-19, if necessary.
The Wall Street Journal, citing a source on the 3rd local time, reported that the FDA recently met with pharmaceutical companies to establish guidelines on the research and data needed for the rapid evaluation of new vaccine products targeting the omicron mutation.
Accordingly, in accordance with the new regulations being established by the FDA, pharmaceutical companies that make Omicron mutated vaccines are expected to meet similar standards as when approved for COVID-19 booster shots.
Pharmaceutical companies may be able to apply for emergency use of a vaccine by studying the immune responses of hundreds of people instead of large-scale long-term clinical trials.
Sources said it will only take three months for pharmaceutical companies to develop a new vaccine and complete clinical trials.
Previously, Pfizer CEO Albert Bulla said that Pfizer and BioNtech would take about 100 days to develop a vaccine for omicron mutation, and Moderna predicted that it would take 60 to 90 days to start clinical trials of the new vaccine. .
YTN Kang Tae-wook ([email protected])
[저작권자(c) YTN & YTN plus 무단전재 및 재배포 금지]