Prescribing Information for ▼PAXLOVID (nirmatrelvir / ritonavir) can be found here: Great Britain and Northern Ireland. Adverse event reporting information can be found at the bottom of the page. Please note, there are differences between the SmPC for Northern Ireland and the SmPC for Great Britain. Please refer to the appropriate SmPC depending on where you are based.
Paxlovid has a Conditional Marketing Authorisation in Great Britain. A Conditional Marketing Authorisation means that further evidence on this medicinal product is awaited. New information on this medicinal product will be reviewed when any relevant information of significance becomes available and at least every year and the product information will be updated as necessary.
For information tailored to where you are based, please select the appropriate tab below:
Great Britain
Northern Ireland
PAXLOVID reduced the risk of progression to severe COVID-191,4*
Primary Endpoint results (final analysis in the mITT population):1
Paxlovid demonstrated ~89% relative risk reduction in hospitalisation or death
compared with placebo (absolute risk reduction -6.14%) (P<0.0001).
**RRR=(44/647)-(5/671)/(44/647)5
Secondary Endpoint results (final analysis in the mITT1 population):1
COVID-19 related hospitalisation or death from any cause through Day 28:
Results from subgroup analyses were generally consistent regardless of baseline serology, age, BMI, sex and number of co-existing conditions.¶
EPIC-HR Trial Design: The safety and efficacy of Paxlovid were evaluated in EPIC-HR (N=2113), a phase 2/3, randomised, double-blind, placebo-controlled study in nonhospitalised, symptomatic adult participants with a laboratory-confirmed diagnoses of SARS-CoV-2 infection at high risk for progression to severe disease. The primary endpoint assessed the proportion of participants with COVID-19–related hospitalisation or death from any cause through Day 28 when treated ≤3 days of symptom onset. The secondary endpoint similarly assessed patients treated ≤5 days of symptom onset.1,4
References:
1. Pfizer Data on File excerpts from Full Clinical Study Report for EPIC-HR and Core Data Sheet, February 2024
2. Goyal A, Reeves DB, Cardozo-Ojeda EF, Schiffer JT, Mayer BT. Viral load and contact heterogeneity predict SARS-CoV-2 transmission and super-spreading events. eLife. 2021;10:e63537.
3. Schiffer JT, Johnston C, Wald A, Corey L. 2020. An early Test-and-Treat strategy for severe acute respiratory syndrome coronavirus 2. Open Forum Infectious Diseases 7:ofaa232. DOI: https://doi.org/10.1093/ofid/ofaa232, PMID: 32661497
4. PAXLOVID GB Summary of Product Characteristics. Pfizer Inc.
5. BMJ Best Practice. Understanding Statistics: risk. Available at: https://bestpractice.bmj.com/info/us/toolkit/learn-ebm/how-to-calculate-risk/ (Accessed February 2024).†
Find out more about how PAXLOVID works.
Learn more about the safety profile & tolerability of PAXLOVID.
Learn about PAXLOVID dosing and potential drug interactions before you prescribe.
PAXLOVID reduced the risk of progression to severe COVID-191,4*
Primary Endpoint results (final analysis in the mITT population as per SmPC):1,4
Paxlovid demonstrated ~89% relative risk reduction in hospitalisation or death
compared with placebo (absolute risk reduction -6.14%) (P<0.0001).
**RRR=(44/647)-(5/671)/(44/647)5
Secondary Endpoint results (final analysis in the mITT1 population as per SmPC):1,4
COVID-19 related hospitalisation or death from any cause through Day 28:
Results from subgroup analyses were generally consistent regardless of baseline serology, age, BMI, sex and number of co-existing conditions.¶
EPIC-HR Trial Design: The safety and efficacy of Paxlovid were evaluated in EPIC-HR (N=2113), a phase 2/3, randomised, double-blind, placebo-controlled study in nonhospitalised, symptomatic adult participants with a laboratory-confirmed diagnoses of SARS-CoV-2 infection at high risk for progression to severe disease. The primary endpoint assessed the proportion of participants with COVID-19–related hospitalisation or death from any cause through Day 28 when treated ≤3 days of symptom onset. The secondary endpoint similarly assessed patients treated ≤5 days of symptom onset.1,4
References:
1. Pfizer Data on File excerpts from Full Clinical Study Report for EPIC-HR and Core Data Sheet, February 2024
2. Goyal A, Reeves DB, Cardozo-Ojeda EF, Schiffer JT, Mayer BT. Viral load and contact heterogeneity predict SARS-CoV-2 transmission and super-spreading events. eLife. 2021;10:e63537.
3. Schiffer JT, Johnston C, Wald A, Corey L. 2020. An early Test-and-Treat strategy for severe acute respiratory syndrome coronavirus 2. Open Forum Infectious Diseases 7:ofaa232. DOI: https://doi.org/10.1093/ofid/ofaa232, PMID: 32661497
4. PAXLOVID NI Summary of Product Characteristics. Pfizer Inc.
5. BMJ Best Practice. Understanding Statistics: risk. Available at: https://bestpractice.bmj.com/info/us/toolkit/learn-ebm/how-to-calculate-risk/ (Accessed February 2024).†
Find out more about how PAXLOVID works.
Learn more about the safety profile & tolerability of PAXLOVID.
Learn about PAXLOVID dosing and potential drug interactions before you prescribe.
Adverse Events
Adverse Events should be reported. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/ or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.
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PP-UNP-GBR-7812. January 2024