The current emergency use authorization (EUA) for Pfizer’s COVID-19 antiviral pill for high-risk adolescents will continue to remain in effect even if it receives full approval for use in some adults.
Tag Archive for: EUA
The treatment is not expected to neutralize the currently dominant XBB.1.5 subvariant of Omicron.
The U.S. Food and Drug Administration said on Tuesday it will now review only a small number of emergency use authorization requests for COVID tests that are likely to have a significant benefit to public health, including fulfilling an unmet need.
Moderna Inc. on Tuesday sought U.S. authorization for its COVID-19 booster shot tailored against the BA.4 and BA.5 subvariants of Omicron and said if cleared it would be ready to deliver the doses in September.
The agency revised its EUA to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid.