Pfizer Seeks Complete Approval For Paxlovid For High Risk COVID-19 Patients

  • Pfizer Inc PFE has submitted a new drug application to the FDA for the approval of Paxlovid for patients at high risk for progression to severe illness from COVID-19. 
  • Paxlovid is currently authorized for emergency use to treat mild-to-moderate COVID-19 in adults and pediatric patients at high risk for progression to severe COVID-19, including hospitalization or death. 
  • The submission provides the longer-term follow-up data necessary for acceptance and potential approval.
  • Related: Pfizer Halts Enrollment In Paxlovid COVID-19 Trial In Standard-Risk Population.
  • According to the U.S. Centers for Disease Control and Prevention, 50-60% of the U.S. population is estimated to have one or more risk factors for progressing to severe COVID-19 illness.
  • The submission is supported by non-clinical and clinical data, including results from the Phase 2/3 EPIC-HR study in which Paxlovid reduced the risk of hospitalization or death by 88% compared to placebo. 
  • An integrated analysis of data across the EPIC-HR and EPIC-SR studies showed an 84% reduction in hospitalizations or death compared to placebo and regardless of vaccination status.
  • Price Action: PFE shares are up 2.86% at $52.48 during the market session on the last check Thursday.

Posted In: BriefsCOVID-19 CoronavirusBiotechLarge CapNewsHealth CareFDAGeneral

Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.

All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.

Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.

Rate collection and criteria: Click here for more information on rate collection and criteria.